Peer-reviewed articles

Year Title Authors Topic Reference Journal
2023 Adjuvant Endocrine Therapy and Ovarian Suppression for Premenopausal Patients With Hormone ReceptorPositive Breast Cancer: 12-Year Results of the SOFT Trial Stenger, M. BIG 2-02 SOFT ASCO post, January 2022; https://ascopost.com/news/january-2023/adjuvant-endocrine-therapy-and-ovarian-suppression-for-premenopausal-patients-with-hr-positive-breast-cancer/ The ASCO post
2023 Incidence and severity of anaphylaxis and hypersensitivity in trials of intravenous pertuzumab plus trastuzumab or the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection for HER2-positive breast cancer Swain S.M.,Tan A.R., Gianni L., et al. BIG 4-11 APHINITY European Journal of Cancer, 2023, 178, p.70-81 https://doi.org/10.1016/j.ejca.2022.09.024 European Journal of Cancer
2023 Ten-year survival of neoadjuvant dual HER2 blockade in patients with HER2-positive breast cancer Nuciforo,P., Townend, J., Piccart, M.J., et al. BIG 1-06 NeoALTTO European Journal of Cancer, March 01, 2023,Vol. 181,P92-101, https://doi.org/10.1016/j.ejca.2022.12.020 European Journal of Cancer
2022 Adjuvant Palbociclib for Early Breast Cancer: The PALLAS Trial Results (ABCSG-42/AFT-05/BIG-14-03) Gnant M, Dueck AC, Frantal S et al. BIG 14-03 PALLAS Journal of Clinical Oncology 40, no. 3, January 20, 2022; 282-293. DOI: 10.1200/JCO.21.02554 Journal of Clinical Oncology
2022 Serum thymidine kinase activity in patients with hormone receptor-positive and HER2-negative metastatic breast cancer treated with palbociclib and fulvestrant Malorni L, Tyekucheva S, Hilbers FS et al. BIG 14-04 PYTHIA Eur J Cancer.March 2022;164: 39-51. doi: 10.1016/j.ejca.2021.12.030. European Journal of Cancer
2022 Outcome of Patients With an Ultralow-Risk 70-Gene Signature in the MINDACT Trial Lopes Cardozo JMN, Drukker CA, Rutgers EJT et al. BIG 3-04 MINDACT Journal of Clinical Oncology. Published online January 21, 2022. DOI: 10.1200/JCO.21.02019 Journal of Clinical Oncology
2022 Aromatase inhibitors versus tamoxifen in premenopausal women with oestrogen receptor-positive early-stage breast cancer treated with ovarian suppression: Patient level meta-analysis of 7,030 women in four randomised trials. Bradley R, Braybrooke J, Gray R et al. BIG 2-02 SOFT; BIG 3-02 TEXT Lancet Oncol 2022. doi: 10.org/10.1016/S1470-2045(21)00758-0. Epub 2022 Feb 3 Lancet Oncology
2022 Six-year absolute invasive disease-free survival benefit of adding adjuvant pertuzumab to trastuzumab and chemotherapy for patients with early HER2-positive breast cancer: A Subpopulation Treatment Effect Pattern Plot (STEPP) analysis of the APHINITY (BIG 4-11) trial Gelber RD, Wang WV, Cole BF et al. BIG 4-11 APHINITY Eu J Can 166:219-228, 2022 European Journal of Cancer
2022 A phase III trial of alpelisib + trastuzumab fulvestrant versus trastuzumab + chemotherapy in HER2+ PIK3CA-mutated breast cancer Prez-Fidalgo JA, Criscitiello C, Carrasco E et al. BIG 18-04 ALPHABET Future Oncol.Vol. 18, nr. 19, 2022 Apr 25. doi: 10.2217/fon-2022-0045. Future Oncology
2022 Code of practice needed for samples donated by trial participants Coleman R, Chan A, Barrios C et al. General Lancet Oncol. 2022 Mar;23(3):e89-e90. doi: 10.1016/S1470-2045(22)00059-6. Lancet Oncology
2022 Effect of Metformin vs Placebo on Invasive DiseaseFree Survival in Patients With Breast Cancer - The MA.32 Randomized Clinical Trial Goodwin PJ, Chen BE, Gelmon KA et al BIG 5-11 MA.32 JAMA. 2022;327(20):1963-1973. doi:10.1001/jama.2022.6147 JAMA
2022 Radiation doses and fractionation schedules in non-low-risk ductal carcinoma in situ in the breast (BIG 307/TROG 07.01): a randomised, factorial, multicentre, open-label, phase 3 study Chua BH, Link EK, Kunkler IH et al BIG 3-07 DCIS Lancet Aug 2022; 400: 43140. doi:10.1016/S0140-6736(22)01246-6 The Lancet
2022 PREDICT underestimates survival of patients with HER2-positive early-stage breast cancer Agostinetto E, Ameye L, Martel S et al BIG 2-06 ALTTO npj Breast Cancer (2022) 8:87 ; https://doi.org/10.1038/s41523-022-00452-8 Nature
2022 Disparities in Access to Systemic Treatment for Breast Cancer in Thailand and Major Asian Territories Ithimakin S, Parinyanitikul N, Kim S-B et al BIG Asia collaboration J Breast Cancer, 25(3):207-217, June 2022. https://doi.org/10.4048/jbc.2022.25.e21 Journal of Breast Cancer
2022 Predictive role of CD36 expression in HER2-positive breast cancer patients receiving neoadjuvant trastuzumab Ligorio F, Di Cosimo S, Verderio P, et al. BIG 1-06 NeoALTTO J Natl Cancer Inst. Dec 8;114(12):1720-1727, 2022. doi: 10.1093/jnci/djac126. PMID: 35789270. J Natl Cancer Inst.
2022 Outcomes of patients with small and node-negative HER2-positive early breast cancer treated with adjuvant chemotherapy and anti-HER2 therapya sub-analysis of the ALTTO study Nader-Marta G, Debien V, Eiger D, Tsourti Z, et al. BIG 2 -06 ALTTO British journal of Cancer, Nov;127(10):1799-1807, November 2022. doi: 10.1038/s41416-022-01963-8. Epub 2022 Sep 1. PMID: 36050448; PMCID: PMC9643324. British Journal of Cancer
2022 Adjuvant Endocrine Therapy in Premenopausal Breast Cancer: 12-Year Results From SOFT Prudence A. Francis,Gini F. Fleming et al. BIG 2-02 SOFT Journal of Clinical Oncology, 09 December 2022; DOI: 10.1200/JCO.22.01065 Journal of clinical Oncology
2022 Adjuvant Exemestane With Ovarian Suppression in Premenopausal Breast Cancer: Long-Term Follow-Up of the Combined TEXT and SOFT Trials Pagani O.,Walley B.A.,Fleming G.F.,et al. Journal of Clinical Oncology,15 December 2022; DOI: 10.1200/JCO.22.01064 Journal of clinical Oncology
2022 Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high risk, early breast cancer C.E. Geyer, J.E. Garber, R.D. Gelber, et al. BIG 6-13: Olympia Annals of Oncology,2022, Volume 33, Issue 12, p.1250-1268. https://doi.org/10.1016/j.annonc.2022.09.159. Annals of Oncology
2022 Timelines to initiate a phase III trial across the globe: a sub-analysis of the APHINITY trial Franzoi M.A., Procter M., Twelves C., et al. BIG 4-11 APHINITY Ecancer, 2022, 16:1379. https://doi.org/10.3332/ecancer.2022.1379 Ecancer
2022 Cardiac safety of dual anti-HER2 blockade with pertuzumab plus trastuzumab in early HER2-positive breast cancer in the APHINITY Trial Elisa Agostinetto/Evandro de Azambuja BIG 4-11 APHINITY
2022 Impact of Age on Clinical Outcomes and Efficacy of Adjuvant Dual Anti-HER2 Targeted Therapy Lambertini, M., Fielding,S.,Loibl, S., et al. BIG 4-11 APHINITY Journal of the National Cancer Institute, August 2022, Volume 114, Issue 8, Pages 11171126,https://doi.org/10.1093/jnci/djac096 Journal of the National Cancer Institute
2021 Body Mass Index and weight change in patients with HER2-positive early breast cancer: exploratory analysis of the ALTTO BIG 2-06 trial. Martel S, Lambertini M, Agbor-Tarh D et al. BIG 2-06 ALTTO Published online on 5 January 2021. https://doi.org/10.6004/jnccn.2020.7606 JNCCN
2021 Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer in the APHINITY Trial: 6 Years' Follow-Up. Piccart M, Procter M, Fumagalli D et al. BIG 4-11 APHINITY DOI: 10.1200/JCO.20.01204 Journal of Clinical Oncology. Published online on 04 February 2021. Journal of Clinical Oncology
2021 Updated results from the international phase III ALTTO trial (BIG 2-06/Alliance N063D) Moreno-Aspitia A, Holmes EM, Jackisch C et al. BIG 2-06 ALTTO Eur J Cancer. 2021 Mar 22;148:287-296. doi: 10.1016/j.ejca.2021.01.053. Online ahead of print. European Journal of Cancer
2021 STAT3 activation in HER2-positive breast cancers: Analysis of data from a large prospective trial (ALTTO BIG 2-06). Sonnenblick A, Agbor-Tarh D, de Azambuja E et al. BIG 2-06 ALTTO Int J Cancer 2021 Mar 15;148(6):1529-1535. doi: 10.1002/ijc.33385 International Journal of Cancer
2021 70-gene signature as an aid for treatment decisions in early breast cancer: updated results of the phase 3 randomised MINDACT trial (BIG 3-04) with an exploratory analysis by age. Piccart M, van t Veer LJ, Poncet C et al. BIG 3-04 MINDACT Lancet Oncol. 2021 March 12. doi: https://doi.org/10.1016/S1470-2045(21)00007-3 Lancet Oncology
2021 Tumor cellularity and infiltrating lymphocytes (CelTIL) as a survival surrogate in HER2-positive breast cancer Chic N, Luen SJ, Nuciforo P et al. BIG 1-06 NeoALTTO Journal of the National Cancer Institute, March 31 https://doi.org/10.1093/jnci/djab057 Journal of the National Cancer Institute
2021 Palbociclib with adjuvant endocrine therapy in early breast cancer (PALLAS): interim analysis of a multicentre, open-label, randomised, phase 3 study Mayer EL, Dueck AC, Martin M et al. BIG 14-03 PALLAS Lancet Oncol. Published online on 15 January 2021. doi :https://doi.org/10.1016/S1470-2045(20)30642-2 Lancet Oncology
2021 Palbociclib for residual high-risk invasive HR-positive and HER2-negative early breast cancer-The Penelope-B trial Loibl S, Marm F, Martin M et al. BIG 1-13 PENELOPE-B J Clin Oncol. 2021 Apr 1;JCO2003639. doi: 10.1200/JCO.20.03639. Online ahead of print. Journal of Clinical Oncology
2021 Overcoming barriers to clinical trials cooperation: the Breast International Group example Piccart-Gebhart MJ, Goulioti T, Straehle C and Cameron D. BIG General DOI: 10.1200/EDBK_321475American Society of Clinical Oncology Educational Book41 (April 1, 2021) 1-9. ASCO Educational Book
2021 Patient-reported function, health-related quality of life, and symptoms in APHINITY: pertuzumab plus trastuzumab and chemotherapy in HER2-positive early breast cancer Bines J, Clark E, Barton C et al. BIG 4-11 APHINITY Br J Cancer. 2021 Apr 7. doi: 10.1038/s41416-021-01323-y. Online ahead of print. British Journal of Cancer
2021 Pertuzumab and trastuzumab as adjuvant treatment for HER2-positive early breast cancer: outcomes in Chinese patients in the APHINITY study Shao Z, Tseng LM, Huang CS et al. BIG 4-11 APHINITY Jpn J Clin Oncol. 2021 Mar 3;51(3):345-353. doi: 10.1093/jjco/hyaa216 Japanese Journal of Clinical Oncology
2021 Clinical behavior of recurrent hormone receptor-positive breast cancer by adjuvant endocrine therapy within the Breast International Group 1-98 Clinical Trial Leone JP, Cole BF, Regan MM et al. BIG 1-98 Cancer 2021;127(5):700-708. doi: 10.1002/cncr.33318. Epub 2020 Dec 8 Cancer
2021 Genomic aberrations and late recurrence in postmenopausal women with hormone receptor-positive early breast cancer: Results from the SOLE trial Guerini-Rocco E, Gray KP, Fumagalli C et al. BIG 1-07 SOLE Clin Cancer Res 2021;27(2):504-412. doi: 10.1158/1078-0432.CCR-20-0126. Epub 2020 Oct 20 Clinical Cancer Research
2021 Cumulative incidence of cardiovascular events under tamoxifen and letrozole alone and in sequence: A report from the BIG 1-98 trial Rabaglio M, Sun Z, Maibach R et al. BIG 1-98 Breast Cancer Res Treat 2021;185(3):697-707. doi: 10.1007/s10549-020-05981-z. Epub 2020 Nov 7 Breast Cancer Research and Treatment
2021 Adjuvant olaparib for patients with BRCA1- or BRCA2-mutated breast cancer Tutt ANJ, Garber JE, Kaufman B et al. BIG 6-13 OLYMPIA N Engl J Med 2021; 384:2394-2405 DOI: 10.1056/NEJMoa2105215 New England Journal of Medicine
2021 Genomic and transcriptomic analyses of breast cancer primaries and matched metastases in AURORA, the Breast International Group (BIG) molecular screening initiative Aftimos P, Oliveira M, Irrthum A et al. BIG 14-01 AURORA Cancer Discov. 2021 Nov;11(11):2796-2811. doi: 10.1158/2159-8290.CD-20-1647. Epub 2021 Jun 28. Cancer Discovery
2021 Effect of Celecoxib vs Placebo as Adjuvant Therapy on Disease-Free Survival Among Patients With Breast Cancer The REACT Randomized Clinical Trial Coombes RC, Tovey H, Kilburn L et al. BIG 1-03 REACT JAMA Oncol. Published online July 15, 2021. doi:10.1001/jamaoncol.2021.2193 JAMA Oncology
2021 The Effect of Metformin vs Placebo on Sex Hormones in Canadian Cancer Trials Group MA.32 Pimentel I, Chen BE, Lohmann AE et al. BIG 5-11 MA.32 JNCI J Natl Cancer Inst (2021) 113(2): djaa082. doi: 10.1093/jnci/djaa082 Journal of the National Cancer Institute
2021 Effect of metformin versus placebo on metabolic factors in the MA.32 randomized breast cancer trial Goodwin PJ, Dowling RJO, Ennis M et al. BIG 5-11 MA.32 npj Breast Cancer. 2021; 7:74 ; https://doi.org/10.1038/s41523-021-00275-z npj Breast Cancer
2021 Copy number aberration analysis to predict response to neoadjuvant anti-HER2 therapy: results from the NeoALTTO phase III clinical trial Venet D, Rediti M, Maetens M et al. BIG 1-06 NeoALTTO Clin Cancer Res. October 15 2021;27(20):5607-5618. doi: 10.1158/1078-0432.CCR-21-1317 Clinical Cancer Research
2021 Continuous vs intermittent extended adjuvant letrozole for breast cancer: Final results of randomized phase 3 SOLE (Study of Letrozole Extension) and SOLE Estrogen Substudy Jerusalem G, Farah S, Courtois A et al. BIG 1-07 SOLE Annals of Oncology. October 2021 ; vol.32, p.1256-1266. DOI:https://doi.org/10.1016/j.annonc.2021.07.017 Annals of Oncology
2021 Who are the women who enrolled in the POSITIVE trial: A global study to support young hormone receptor positive breast cancer survivors desiring pregnancy Partridge AH, Niman SM, Ruggeri M et al. BIG 8-13 POSITIVE Breast. 2021 Aug 3; 59:327-338. doi: 10.1016/j.breast.2021.07.021. The Breast
2020 Use of anastrozole for breast cancer prevention (IBIS-II): long-term results of a randomised controlled trial Cuzick J, Sestak I, Forbes JF et al. BIG 5-02 IBIS-II Lancet. 2020 Jan 11; doi: 10.1016/S0140-6736(19)32955-1. The Lancet
2020 Standard Anthracycline Based Versus Docetaxel-Capecitabine in Early High Clinical and/or Genomic Risk Breast Cancer in the EORTC 10041/BIG 3-04 MINDACT Phase III Trial Delaloge S, Piccart M, Rutgers E et al. BIG 3-04 MINDACT J Clin Oncol. 2020 Feb 21; doi: 10.1200/JCO.19.01371. Journal of Clinical Oncology
2020 Long-term cardiac outcomes of patients with HER2-positive breast cancer treated in the adjuvant lapatinib and/or trastuzumab Treatment Optimization Trial. Eiger D, Pond NF, Agbor-Tarh D et al. BIG 2-06 ALTTO Br J Cancer. 2020 Mar 16. doi: 10.1038/s41416-020-0786-x. [Epub ahead of print] British Journal of Cancer
2020 Adding pertuzumab to adjuvant therapy for high-risk HER2-positive early breast cancer in APHINITY: a GRADE analysis Zambelli A, Pappagallo G, Marchetti P. BIG 4-11 APHINITY J Comp Eff Res. 2020 Feb 14. doi: 10.2217/cer-2019-0168. Journal of comparative effectiveness research
2020 Quality of life after breast-conserving therapy and adjuvant radiotherapy for non-low-risk ductal carcinoma in situ (BIG 3-07/TROG 07.01): 2-year results of a randomised, controlled, phase 3 trial King MT, Link EK, Whelan TJ et al. BIG 3-07 DCIS Lancet Oncol. 2020 Mar 20. pii: S1470-2045(20)30085-1. doi: 10.1016/S1470-2045(20)30085-1. Lancet Oncology
2020 High hepatocyte growth factor expression in primary tumor predicts better overall survival in male breast cancer Qiu SQ, van Rooijen J, Nienhuis HH et al. BIG 2-07 Male BC Breast Cancer Res. 2020 Mar 18;22(1):30. doi: 10.1186/s13058-020-01266-x. Breast Cancer Research
2020 The legacy of Professor Aron Goldhirsch. A Gelber RD, Coates AS, Gelber S et al. General Ann Oncol 2020;31(6):671-673. doi: 10.1016/j.annonc.2929.03.288. Epub 2020 Mar 23 Annals of Oncology
2020 Early Modulation of Circulating MicroRNAs Levels in HER2-Positive Breast Cancer Patients Treated with Trastuzumab-Based Neoadjuvant Therapy Di Cosimo S, Appierto V, Pizzamiglio S et al. BIG 1-06 NeoALTTO Int J Mol Sci. 2020 Feb 18;21(4). pii: E1386. doi: 10.3390/ijms21041386. International Journal of Molecular Sciences
2020 Road map to safe and well-designed de-escalation trials of systemic adjuvant therapy for solid tumors Piccart MJ, Hilbers FS, Bliss JM et al. BIG-NABCG collaboration DOI: 10.1200/JCO.20.01382 Journal of Clinical Oncology. Published online October 14, 2020. Journal of Clinical Oncology
2020 STAT3 activation in HER2-positive breast cancers: Analysis of data from a large prospective trial Sonnenblick A, Agbor-Tarh D, de Azambuja E et al. BIG 2-06 ALTTO Int J Cancer. 2020 Nov 5. doi: 10.1002/ijc.33385. Online ahead of print.PMID: 33152119 International Journal of Cancer
2020 Prognostic role of distant disease-free interval from completion of adjuvant trastuzumab in HER2-positive early breast cancer: analysis from the ALTTO (BIG 2-06) trial Lambertini M, Agbor-Tarh D, Metzger-Filho O et al. BIG 2-06 ALTTO ESMO Open. 2020; 5(6): e000979. Published online on 4 November 2020. doi: 10.1136/esmoopen-2020-000979 ESMO Open
2020 Identifying oncogenic drivers associated with increased risk of late distant recurrence in post-menopausal, estrogen receptor-positive, HER2-negative early breast cancer: results from the BIG 1-98 study Luen SJ, Asher R, Lee CK et al. BIG 1-98 Ann Oncol 2020;31(10):1359-1365. doi: 10.1016/j.annonc.2020.06.024 Epub 2020 July 8 Annals of Oncology
2020 Estimation of historical control rate for a single arm de-escalation study Application to the POSITIVE trial Sun Z, Niman SM, Pagani O et al. BIG 8-13 POSITIVE Breast 2020;53:1-7. doi: 10.1016/j.breast.2020.05.012. Epub 2020 Apr 9 Breast
2020 Absolute improvements in freedom from distant recurrence to tailor adjuvant endocrine therapies for premenopausal women: Results from TEXT and SOFT Pagani O, Francis PA, Fleming GF et al. BIG 2-02 SOFT; BIG 3-02 TEXT J Clin Oncol 2020;38(12):1293-1303. doi: 10.1200/JCO.18.01967. Epub 2019 Oct 16. Journal of Clinical Oncology
2019 Plasma miRNA levels for predicting therapeutic response to neoadjuvant treatment in HER2-positive breast cancer: Results from the NeoALTTO trial Di Cosimo S, Appierto V, Pizzamiglio S, Tiberio P, Iorio MV, Hilbers F, de Azambuja E, de la Pena L, Izquierdo M, Huober J, Baselga J, Piccart M, De Braud FG, Apolone G, Verderio P, Daidone MG. BIG 1-06 NeoALTTO 2019 Jul 1;25(13):3887-3895 doi: 10.1158/1078-0432.CCR-18-2507 Clinical Cancer Research
2019 Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial Ribi K, Luo W, Colleoni M, Karlsson P, Chirgwin J, Aebi S, Jerusalem G, Neven P, Di Lauro V, Gomez HL, Ruhstaller T, Abdi E, Biganzoli L, Mller B, Barbeaux A, Graas MP, Rabaglio M, Francis PA, Foukakis T, Pagani O, Graiff C, Vorobiof D, Maibach R, Di Leo A, Gelber RD, Goldhirsch A, Coates AS, Regan MM, Bernhard J, SOLE Investigators. BIG 1-07 SOLE Br J Cancer. 2019 Apr 10. doi: 10.1038/s41416-019-0435-4 British Journal of Cancer
2019 Pharmacokinetic and exploratory exposure-response analysis of pertuzumab in patients with operable HER2-positive early breast cancer in the APHINITY study Kirschbrown WP, Kgedal M1, Wang B1, Lindbom L2, Knott A3, Mack R3, Monemi S1, Nijem I1, Girish S1, Freeman C4, Fumagalli D5, McConnell R6, Jerusalem G7, Twelves C8, Baselga J9, von Minckwitz G10, Bines J11, Garg A12. BIG 4-11 APHINITY Cancer Chemother Pharmacol. 2019 Apr 11. doi: 10.1007/s00280-019-03826-1 Cancer Chemotherapy and Pharmacology
2019 Pharmacokinetics of pertuzumab administered concurrently with trastuzumab in Chinese patients with HER2-positive early breast cancer Luo Y, Li W, Jiang Z, Zhang Q, Wang L, Mao Y, Tjan-Heijnen VCG, Im SA, McConnell R, Bejarano S, Fumagalli D, Bines J, Wang B, Garg A, Kirschbrown WP, Xu B BIG 4-11 APHINITY Anticancer Drugs. 2019 Sep;30(8):866-872. doi: 10.1097/CAD.0000000000000808 Anticancer Drugs
2019 Analytical validation of a standardized scoring protocol for Ki67 immunohistochemistry on breast cancer excision whole sections: an international multicenter collaboration Leung SCY, Nielsen TO, Zabaglo LA, Arun I, Badve SS, Bane AL, Bartlett JMS, Borgquist S, Chang MC, Dodson A, Ehinger A, Fineberg S, Focke CM, Gao D, Gown AM, Gutierrez C, Hugh JC, Kos Z, Laenkholm AV, Mastropasqua MG, Moriya T, Nofech-Mozes S, Osborne CK, Penault-Llorca FM, Piper T, Sakatani T, Salgado R, Starczynski J, Sugie T, van der Vegt B, Viale G, Hayes DF, McShane LM, Dowsett M; International Ki67 in Breast Cancer Working Group of the Breast International Group North American Breast Cancer Group (BIG-NABCG). BIG-NABCG collaboration Histopathology. 2019 Apr 24. doi: 10.1111/his.13880. Histopathology
2019 Circulating Tumor DNA in HER2-Amplified Breast Cancer: A Translational Research Substudy of the NeoALTTO Phase III Trial Roth F, Silva MJ, Venet D, Campbell C, Bradburry I, Rouas G, de Azambuja E, Maetens M, Fumagalli D, Rodrik-Outmezguine V, Di Cosimo S, Rosa D, Chia S, Wardley A, Ueno T, Janni W, Huober J, Baselga J, Piccart M, Loi S, Sotiriou C, Dawson SJ, Ignatiadis M. BIG 1-06 NeoALTTO Clin Cancer Res. 2019 Mar 12. doi: 10.1158/1078-0432.CCR-18-2521. Clinical Cancer Research
2019 Pregnancies during and after trastuzumab and/or lapatinib in patients with human epidermal growth factor receptor 2-positive early breast cancer: Analysis from the NeoALTTO (BIG 1-06) and ALTTO (BIG 2-06) trials Lambertini M, Martel S, Campbell C, Guillaume S, Hilbers FS, Schuehly U, Korde L, Azim HA Jr, Di Cosimo S, Tenglin RC, Huober J, Baselga J, Moreno-Aspitia A, Piccart-Gebhart M, Gelber RD, de Azambuja E, Ignatiadis M BIG 1-06 NeoALTTO & BIG 2-06 ALTTO Cancer. 2019 Jan 15 doi: 10.1002/cncr.31784. Cancer
2019 Dissecting the effect of hormone receptor status in patients with HER2-positive early breast cancer: exploratory analysis from the ALTTO (BIG 2-06) randomized clinical trial Lambertini M, Campbell C, Gelber RD, Viale G, McCullough A, Hilbers F, Korde LA, Werner O, Chumsri S, Jackisch C, Wolff AC, Vaz-Luis I, Ferreira AR, Prat A, Moreno-Aspitia A, Piccart M, Loi S, de Azambuja E BIG 2-06 ALTTO Breast Cancer Res Treat. 2019 May 27 doi: 10.1007/s10549-019-05284-y Breast Cancer Research and Treatment
2019 Pathway level alterations rather than mutations in single genes predict response to HER2-targeted therapies in the neo-ALTTO trial Shi W, Jiang T, Nuciforo P, Hatzis C, Holmes E, Harbeck N, Sotiriou C, Pea L, Loi S, Rosa DD, Chia S, Wardley A, Ueno T, Rossari J, Eidtmann H, Armour A, Piccart-Gebhart M, Rimm DL, Baselga J, Pusztai L. BIG 1-06 NeoALTTO Ann Oncol. 2019 Jan 9. doi: 10.1093/annonc/mdy530. Annals of Oncology
2019 Prognostic and predictive value of androgen receptor expression in postmenopausal women with estrogen receptor-positive breast cancer: results from the Breast International Group Trial 1-98 Kensler KH, Regan MM, Heng YJ, Baker GM, Pyle ME, Schnitt SJ, Hazra A, Kammler R, Thrlimann B, Colleoni M, Viale G, Brown M, Tamimi RM. BIG 1-98 Breast Cancer Res. 2019 Feb 22 doi: 10.1186/s13058-019-1118-z. Breast Cancer Research
2019 Pembrolizumab plus trastuzumab in trastuzumab-resistant, advanced, HER2-positive breast cancer (PANACEA): a single-arm, multicentre, phase 1b-2 trial Loi S, Giobbie-Hurder A, Gombos A, Bachelot T, Hui R, Curigliano G, Campone M, Biganzoli L, Bonnefoi H, Jerusalem G, Bartsch R, Rabaglio-Poretti M, Kammler R, Maibach R, Smyth MJ, Di Leo A, Colleoni M, Viale G, Regan MM, Andr F BIG 4-13 PANACEA Lancet Oncol 2019 March; doi: 10.1016/S1470-2045(18)30812-X. The Lancet Oncology
2019 Prognostic value of progresterone receptor by subtype in patients with estrogen receptor-positive, HER-2 negative breast cancer Van Asten K, Slembrouck L, Olbrecht S, Jongen L, Bouckaert O, Wildiers H, Floris G, van Limbergen E, Weltens C, Smeets A, Paridaens R, Giobbie-Hurder A, Regan MM, Viale G, Thrlimann B, Vergote I, Christodoulou E, van Calster B, Neven P. BIG 1-98 Oncologist 2019 Feb 24; doi: 10.1634/theoncologist.2018-0176. Oncologist
2019 Are we assuming too much with our statistical assumptions? Lessons learned from the ALTTO Trial Holmes EM, Bradbury I, Williams LS, Korde L, de Azambuja E, Fumagalli D, Moreno-Aspitia A, Baselga J, Piccart-Gebhart M, Dueck AC, Gelber RD BIG 2-06 ALTTO Ann Oncol. 2019 Jun 26.; doi: 10.1093/annonc/mdz195. Annals of Oncology
2019 Survival outcomes of the NeoALTTO study (BIG 106): updated results of a randomised multicenter phase III neoadjuvant clinical trial in patients with HER2-positive primary breast cancer Huober J., Holmes E., Baselga J., de Azambuja E., Untch M., Fumagalli F., Sarp S., Lang I., Smith I., Boyle F., Xu B., Lecocq C., Wildiers H., Jouannaud C., Hackman J., Dasappa L., Ciruelos E., Carlos Toral Pena J., Adamchuk H., Hickish T., de la Pena L., Jackisch C., Gelber R. D., Piccart-Gebhart M., Di Cosimo S. BIG 1-06 NeoALTTO Eur J Cancer. 2019 Sept. DOI: 10.1016/j.ejca.2019.04.038 European Journal of Cancer
2019 Neoadjuvant letrozole plus taselisib versus letrozole plus placebo in postmenopausal women with oestrogen receptor-positive, HER2-negative, early-stage breast cancer (LORELEI): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial Saura C, Hlauschek D, Oliveira M, Zardavas D, Jallitsch-Halper A, de la Pea L, Nuciforo P, Ballestrero A, Dubsky P, Lombard JM, Vuylsteke P, Castaneda CA, Colleoni M, Santos Borges G, Ciruelos E, Fornier M, Boer K, Bardia A, Wilson TR, Stout TJ, Hsu JY, Shi Y, Piccart M, Gnant M, Baselga J, de Azambuja E BIG 3-13 LORELEI Lancet Oncol. 2019 Sep;20(9):1226-1238. doi: 10.1016/S1470-2045(19)30334-1. Epub 2019 Aug 8. The Lancet Oncology
2019 The 41-gene classifier TRAR predicts response of HER2 positive breast cancer patients in the NeoALTTO study Di Cosimo S, Triulzi T, Pizzamiglio S, De Cecco L, de Azambuja E, Fumagalli D, Putzai L, Harbeck N, Izquierdo M, Pea L, Daidone MG, Huober J, Gori S, Cinieri S, Torri V, Baselga J, Piccart M, de Braud FG, Apolone G, Verderio P, Tagliabue E. BIG 1-06 NeoALTTO Eur J Cancer. 2019 Sep;118:1-9. doi: 10.1016/j.ejca.2019.06.001 European Journal of Cancer
2019 Missed opportunities and challenges for surgical breast cancer research in the era of personalized cancer treatment Rubio IT, Kontos M, Vrancken-Peeters M, Rouzier R, Skandarajah AR, Galimberti V, Kroman N, Caballero C, Ohno S; BIG Task Force Surgical Trials BIG Task Force Surgical Trials Eur J Surg Oncol. 2019 Nov 20. pii: S0748-7983(19)31447-7. doi: 10.1016/j.ejso.2019.11.503 European Journal of Surgical Oncology
2019 Lucitanib for the Treatment of HR+/HER2? Metastatic Breast Cancer: Results from the Multicohort Phase II FINESSE Study Hui R, Pearson A, Cortes J, Campbell C, Poirot C, Azim HA Jr, Fumagalli D, Lambertini M, Daly F, Arahmani A, Perez-Garcia J, Aftimos P, Bedard PL, Xuereb L, Scheepers ED, Vicente M, Goulioti T, Loibl S, Loi S, Pierrat MJ, Turner NC, Andre F, Curigliano G. BIG 2-13 FINESSE Clin Cancer Res 2019 Oct 16 DOI: 10.1158/1078-0432.CCR-19-1164 Clin Cancer Res. 2020 Jan 15;26(2):354-363. doi: 10.1158/1078-0432.CCR-19-1164. Epub 2019 Oct 16. Clinical Cancer Research
2019 Absolute improvements in freedom from distant recurrence to tailor adjuvant endocrine therapies for premenopausal women: Results from TEXT and SOFT Pagani O, Francis PA, Fleming GF, Walley BA, Viale G, Colleoni M, Lang I, Gomez HL, Tondini C, Pinotti G, Di Leo A, Coates AS, Goldhirsch A, Gelber RD, Regan MM BIG 2-02 SOFT; BIG 3-02 TEXT J Clin Oncol. doi: 10.1200/JCO.18.01967. 2019 Oct 16. Journal of Clinical Oncology
2019 Independent validation of EarlyR gene signature in BIG 1-98: A randomized, double-blind, phase III trial comparing letrozole and tamoxifen as adjuvant endocrine therapy for postmenopausal women with hormone receptor-positive, early breast cancer Buechler S, Gray KP, Gkmen-Polar Y, Willis S, Thrlimann B, Kammler R, Viale G, Leyland-Jones B, Badve* SS, Regan* MM. *Co-last authors. BIG 1-98 JNCI Cancer Spectr. doi: 10.1093/jncics/pkz051. Epub 2019 Aug 16. JNCI Cancer Spectrum
2019 Incidence and Management of Diarrhea With Adjuvant Pertuzumab and Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer Bines J, Procter M, Restuccia E, Viale G, Zardavas D, Suter T, Arahmani A, Van Dooren V, Baselga J, Clark E, Eng-Wong J, Gelber R, Piccart M, Mobus V, de Azambuja E, on behalf of the APHINITY Steering Committee and Investigators BIG 4-11 APHINITY Clin Breast Cancer. 2019 Sep 5 doi: 10.1016/j.clbc.2019.06.016. Clinical Breast Cancer
2019 Comparison of risedronate versus placebo in preventing anastrozole-induced bone loss in women at high risk of developing breast cancer with osteopenia Sestak I, Blake G M, Patel R, Coleman R E, Cuzick J, Eastell R BIG 5-02 IBIS-II Bone. 2019 Jul;124:83-88. doi: 10.1016/j.bone.2019.04.016 Bone
2019 An RB-1 loss of function gene signature as a tool to predict response to neoadjuvant chemotherapy plus anti-HER2 agents: a substudy of the NeoALTTO trial (BIG 1-06) Emanuela Risi, Chiara Biagioni, Matteo Benelli, Ilenia Migliaccio, Amelia McCartney, Martina Bonechi, Cristina Guarducci, Florentine Hilbers, Serena Di Cosimo, Jens Huober, Dario Romagnoli, Giulia Boccalini, Stefania Vitale, Christos Sotiriou, Laura Biganzoli, Angelo Di Leo, and Luca Malorni BIG 1-06 NeoALTTO Ther Adv Med Oncol. 2019; 11: 1758835919891608. Therapeutic Advances in Medical Oncology
2019 Adjuvant systemic treatment of premenopausal women with hormone receptorpositive early breast cancer: Lights and shadows Regan MM, Fleming GF, Walley B, Francis PA, Pagani O. BIG 2-02 SOFT; BIG 3-02 TEXT J Clin Oncol 2019 April 10;37(11)862-866. doi: 10.1200/JCO.18.02433. Epub 2019 Feb 27 Journal of Clinical Oncology
2019 Clinical and analytical validation of Ki-67 in 9069 patients from IBCSG VIII + IX, BIG1-98 and GeparTrio trial: systematic modulation of interobserver variance in a comprehensive in silico ring trial Denkert C, Budczies J, Regan MM, Loibl S, Dell'Orto P, von Minckwitz G, Mastropasqua MG, Solbach C, Thrlimann B, Mehta K, Blohmer JU, Colleoni M, Mller V, Klauschen F, Ataseven B, Engels K, Kammler R, Pfitzner BM, Dietel M, Fasching PA, Viale G. BIG 1-98 Breast Cancer Res Treat 2019 Aug;176(3:557-568. doi:10.1007/s10549-018-05112-9. Epub 2019 May 7 Breast Cancer Research and Treatment
2019 International comparison of cosmetic outcomes of breast conserving surgery and radiation therapy for women with ductal carcinoma in situ of the breast Olivotto IA, Link E, Phillips C, Whelan TJ, et al. BIG 3-07 DCIS Radiotherapy and Oncology. Volume 142, P180-185, January 01, 2020. Published online on August 17, 2019. doi:https://doi.org/10.1016/j.radonc.2019.07.024. Radiotherapy and Oncology
2019 A pooled analysis of the cardiac events in the trastuzumab adjuvant trials de Azambuja E, Ponde N, Procter M et al. BIG 1-01 HERA Breast Cancer Res Treat. 2020 Jan;179(1):161-171. doi: 10.1007/s10549-019-05453-z. Epub 2019 Oct 11 Breast Cancer Research and Treatment
2019 Post-mastectomy radiation therapy in human epidermal growth factor receptor 2 positive breast cancer patients: Analysis of the HERA trial Abi Jaoude J, de Azambuja E, Makki M et al. BIG 1-01 HERA Int J Radiat Oncol Biol Phys. 2020 Mar 1;106(3):503-510. doi: 10.1016/j.ijrobp.2019.10.022. Epub 2019 Oct 22. International Journal of Radiation Oncology. Biology. Physics.
2019 Autoimmunity and benefit from trastuzumab treatment in breast cancer: Results from the HERA trial. Sonnenblick A, Bailey A, Uziely B et al. BIG 1-01 HERA Anticancer Res. 2019 Feb;39(2):797-802. doi: 10.21873/anticanres.13177 Anticancer Research
2018 Characterization of male breast cancer: results of the EORTC 10085/TBCRC/BIG/NABCG International Male Breast Cancer Program Cardoso F, Bartlett JMS, Slaets L, van Deurzen CHM, van Leeuwen-Stok E, Porter P, Linderholm B, Hedenfalk I, Schrder C, Martens J, Bayani J, van Asperen C, Murray M, Hudis C, Middleton L, Vermeij J, Punie K, Fraser J, Nowaczyk M, Rubio IT, Aebi S, Kelly C, Ruddy KJ, Winer E, Nilsson C, Dal Lago L, Korde L, Benstead K, Bogler O, Goulioti T, Peric A, Litire S, Aalders KC, Poncet C, Tryfonidis K, Giordano SH. BIG 2-07 Male BC Ann Oncol. 2018 Feb 1;29(2):405-417. doi: 10.1093/annonc/mdx651. Annals of Oncology
2018 Association of p27 and Cyclin D1 Expression and Benefit from Adjuvant Trastuzumab Treatment in HER2-Positive Early Breast Cancer: A TransHERA Study Filipits M, Dafni U, Gnant M, Polydoropoulou V, Hills M, Kiermaier A, de Azambuja E, Larsimont D, Rojo F, Viale G, Toi M, Harbeck N, Prichard KI, Gelber RD, Dinh P, Zardavas D, Leyland-Jones B, Piccart-Gebhart MJ, Dowsett M; TransHERA investigators BIG 1-01 HERA Clin Cancer Res. 2018 Jul 1;24(13):3079-3086. doi: 10.1158/1078-0432.CCR-17-3473. Epub 2018 Mar 12. Clinical Cancer Research
2018 The Final Verdict: Chemotherapy Benefits Estrogen Receptor-Negative Isolated Local Recurrence. Chan N, Toppmeyer DL. BIG 1-02 CALOR J Clin Oncol. 2018 Apr 10, doi: 10.1200/JCO.2017.77.4877. Journal of Clinical Oncology
2018 Efficacy of Chemotherapy for ER-Negative and ER-Positive Isolated Locoregional Recurrence of Breast Cancer: Final Analysis of the CALOR Trial Wapnir IL, Price KN, Anderson SJ, Robidoux A, Martn M, Nortier JWR, Paterson AHG, Rimawi MF, Lng I, Baena-Caada JM, Thrlimann B, Mamounas EP, Geyer CE Jr, Gelber S, Coates AS, Gelber RD, Rastogi P, Regan MM, Wolmark N, Aebi S; International Breast Cancer Study Group; NRG Oncology, GEICAM Spanish Breast Cancer Group, BOOG Dutch Breast Cancer Trialists' Group; Breast International Group. BIG 1-02 CALOR J Clin Oncol. 2018 Feb 14 doi: 10.1200/JCO.2017.76.5719. Journal of Clinical Oncology
2018 Association of T-Cell Receptor Repertoire Use With Response to Combined Trastuzumab-Lapatinib Treatment of HER2-Positive Breast Cancer: Secondary Analysis of the NeoALTTO Randomized Clinical Trial Powles RL, Redmond D, Sotiriou C, Loi S, Fumagalli D, Nuciforo P, Harbeck N, de Azambuja E, Sarp S, Di Cosimo S, Huober J, Baselga J, Piccart-Gebhart M, Elemento O, Pusztai L, Hatzis C. BIG 1-06 NeoALTTO JAMA Oncol. 2018 Jun 14:e181564. doi: 10.1001/jamaoncol.2018.1564. JAMA Oncology
2018 Cardiac biomarkers for early detection and prediction of trastuzumab and/or lapatinib-induced cardiotoxicity in patients with HER2-positive early-stage breast cancer: a NeoALTTO sub-study (BIG 1-06) Ponde N, Bradbury I, Lambertini M, Ewer M, Campbell C, Ameels H, Zardavas D, Di Cosimo S, Baselga J, Huober J, Izquierdo M, Fumagalli D, Bozovic-Spasojevic I, Maetens M, Harbeck N, Pusztai L, Berghorn M, Im YH, Borrego MR, Chen DR, Rodeheffer R, Piccart M, Suter T, de Azambuja E. BIG 1-06 NeoALTTO Breast Cancer Res Treat. 2018 Apr;168(3):631-638. doi: 10.1007/s10549-017-4628-3. Breast Cancer Research and Treatment
2018 Circulating tumor DNA in HER2 amplified breast cancer: A translational research substudy of the NeoALTTO phase 3 trial Ignatiadis M, Silva MJ, Campbell C, Bradbury I, de Azambuja E, Maetens M, Fumagalli D, Rodrik-Outmezguine V, Di Cosimo S, Rosa D, Chia S, Wardley A, Ueno T, Janni W, Huober J, Baselga J, Piccart M, Sotiriou C, Loi S, Roth F, Dawson S BIG 1-06 NeoALTTO DOI: 10.1158/1538-7445.SABCS17-PD3-03 Published February 2018 Cancer Research
2018 Deregulation of A-to-I RNA editing is associated with poor prognosis in HER2+ breast cancers in the neoALTTO trial D Venet, F Roth, F Dupont, M Maetens, D Fumagalli, R Salgado, I Bradbury, L Pusztai, N Harbeck, M Izquierdo, L de la Pena, M Ignatiadis, E de Azambuja, J Huober, P Nuciforo, J Baselga, M Piccart, S Loi and C Sotiriou BIG 1-06 NeoALTTO DOI: 10.1158/1538-7445.SABCS17-P2-05-04 Published February 2018 Cancer Research
2018 Identifying clinically relevant subgroups of women with HER2-positive breast cancer: An analysis of Neo-ALTTO using the 41-gene TRAR score Di Cosimo S, Triulzi T, De Cecco L, Pizzamiglio S, de Azambuja E, Fumagalli D, Pusztai L, Harbeck N, Izquierdo M, de la Pena L, Huober J, Baselga J, Piccart M, Verderio P, Tagliabue E BIG 1-06 NeoALTTO DOI: 10.1158/1538-7445.SABCS17-P2-09-03 Published February 2018 Cancer Research
2018 Low levels of HER2 extracellular domain (ECD) compared to intracelluar domain (ICD) in NeoALTTO may segregate benefit from lapatinib and trastuzumab in breast cancer DL Rimm, D Carvajal-Hausdorf, N Harbeck, D Fumagalli, V Rodrik-Outmezguine, L delaPena, E deAzambuja, J Huober, J Baselga, M Piccart, E Holmes and L Pusztai BIG 1-06 NeoALTTO DOI: 10.1158/1538-7445.SABCS17-P2-09-07 Published February 2018 Cancer Research
2018 T-cell receptor beta chain variable region (TRBV) expression patterns predict response to combined trastuzumab/lapatinib treatment in the NeoALTTO/BIG-1-06 trial R Powles, D Redmond, C Sotiriou, S Loi, D Fumagalli, P Nuciforo, N Harbeck, E de Azambuja, S Sarp, S Di Cosimo, J Huober, J Baselga, M Piccart-Gebhart, O Elemento, C Hatzis and L Pusztai BIG 1-06 NeoALTTO DOI: 10.1158/1538-7445.SABCS17-P2-09-01 Cancer Research
2018 The use of breast imaging for predicting response to neoadjuvant lapatinib, trastuzumab and their combination in HER2-positive breast cancer: Results from Neo-ALTTO Di Cosimo S, Campbell C, Azim HA Jr, Galli G, Bregni G, Curigliano G, Criscitiello C, Izquierdo M, de la Pena L, Fumagalli D, Fein L, Vinholes J, Ng WMJ, Colleoni M, Ferro A, Naume BJ, Patel A, Huober J, Piccart-Gebhart M, Baselga J, de Azambuja E BIG 1-06 NeoALTTO Eur J Cancer. 2018 Jan; doi: 10.1016/j.ejca.2017.10.036. Epub 2017 Dec 8. European Journal of Cancer
2018 A RB-1 loss of function gene-signature (RBsig) as a tool to predict response to neoadjuvant chemotherapy (CT) plus anti-HER2 agents (H): A substudy of the NeoALTTO trial (BIG 1-06). Risi E, Biagioni C, Benelli M, Migliaccio I, McCartney A, Bonechi M, Guarducci C, Hilbers F, Di Cosimo S, Baselga J, Romagnoli D, Boccalini G, Vitale S, Grilli A, Bicciato S, Sotiriou C, Biganzoli L, Di Leo A, Malorni L BIG 1-06 NeoALTTO DOI: 10.1200/JCO.2018.36.15_suppl.570 Journal of Clinical Oncology
2018 Association between adaptive immune signature and outcome in HER2-positive breast cancer treated with trastuzumab and lapatinib in the NCCTG-N9831 (Alliance) and NeoALTTO trials. Saranya Chumsri, Daniel Serie, Afshin Mashadi-Hossein, Jennifer M. Kachergus, Sarah Warren, Gerardo Colon-Otero, Ann H. Partridge, Lisa A. Carey, Florentine Hilbers, Veerle Van Dooren, Eileen Holmes, Serena Di Cosimo, Olena Werner, Jens Bodo Huober, Jose Baselga, Christos Sotiriou, Edith A. Perez, Amylou C. Dueck, Alvaro Moreno-Aspitia, E Aubrey Thompson BIG 1-06 NeoALTTO DOI: 10.1200/JCO.2018.36.15_suppl.577 Journal of Clinical Oncology
2018 Pregnancies during and following trastuzumab (T) and/or lapatinib (L) in patients (pts) with HER2-positive (HER2+) early breast cancer (EBC): Analysis from the NeoALTTO (BIG 1-06) and ALTTO (BIG 2-06) trials Lambertini M, Martel S, Campbell C, Guillaume S, Hilbers F, Schuehly U, Korde L, Azim H. A., Di Cosimo S, Tenglin R. C., Bodo Huober J, Baselga J, Moreno-Aspitia A, Piccart-Gebhart M. J., Gelber R. D., De Azambuja E., Ignatiadis M BIG 1-06 NeoALTTO & BIG 2-06 ALTTO DOI: 10.1200/JCO.2018.36.15_suppl.10065 Journal of Clinical Oncology 36, no. 15_suppl (May 20 2018) 10065-10065. Journal of Clinical Oncology
2018 Rethinking Extended Adjuvant Antiestrogen Therapy to Increase Survivorship in Breast Cancer Abderrahman B, Jordan VC BIG 1-07 SOLE JAMA Oncol. 2018 Jan doi: 10.1001/jamaoncol.2017.3510. JAMA Oncology
2018 Extended adjuvant intermittent letrozole versus continuous letrozole in postmenopausal women with breast cancer (SOLE): a multicentre, open-label, randomised, phase 3 trial Colleoni M, Luo W, Karlsson P, Chirgwin J, Aebi S, Jerusalem G, Neven P, Hitre E, Graas MP, Simoncini E, Kamby C, Thompson A, Loibl S, Gavil J, Kuroi K, Marth C, Mller B, O'Reilly S, Di Lauro V, Gombos A, Ruhstaller T, Burstein H, Ribi K, Bernhard J, Viale G, Maibach R, Rabaglio-Poretti M, Gelber RD, Coates AS, Di Leo A, Regan MM, Goldhirsch A; SOLE Investigators. BIG 1-07 SOLE 2018 Jan;19(1):127-138. doi: 10.1016/S1470-2045(17)30715-5. Epub 2017 Nov 17 The Lancet Oncology
2018 Effect of Adjuvant Trastuzumab for a Duration of 9 Weeks vs 1 Year With Concomitant Chemotherapy for Early Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: The SOLD Randomized Clinical Trial Joensuu H, Fraser J, Wildiers H, Huovinen R, Auvinen P, Utriainen M, Nyandoto P, Villman KK, Halonen P, Granstam-Bjrneklett H, Lundgren L, Sailas L, Turpeenniemi-Hujanen T, Tanner M, Yachnin J, Ritchie D, Johansson O, Huttunen T, Neven P, Canney P, Harvey VJ, Kellokumpu-Lehtinen PL, Lindman H. BIG 1-10 SOLD JAMA Oncol. 2018 May 31. doi: 10.1001/jamaoncol.2018.1380 JAMA Oncology
2018 Integration of Clinical Variables for the Prediction of Late Distant Recurrence in Patients With Estrogen Receptor-Positive Breast Cancer Treated With 5 Years of Endocrine Therapy: CTS5 Dowsett M, Sestak I, Regan MM, Dodson A, Viale G, Thrlimann B, Colleoni M, Cuzick J. BIG 1-98 J Clin Oncol. 2018 Apr 20 doi: 10.1200/JCO.2017.76.4258. Journal of Clinical Oncology
2018 Aurora kinase A as a possible marker for endocrine resistance in early estrogen receptor positive breast cancer. Lykkesfeldt AE, Iversen BR, Jensen MB, Ejlertsen B, Giobbie-Hurder A, Reiter BE, Kirkegaard T, Rasmussen BB BIG 1-98 Acta Oncol. 2018 Jan doi: 10.1080/0284186X.2017.1404126. Acta Oncologica
2018 Adjuvant Letrozole and Tamoxifen Alone or Sequentially for Postmenopausal Women With Hormone ReceptorPositive Breast Cancer: Long-Term Follow-Up of the BIG 1-98 Trial Ruhstaller T, Giobbie-Hurder A, Colleoni M, Jensen MB, Ejlertsen B, de Azambuja E, Neven P, Lang I, Jakobsen EH, Gladieff L, Bonnefoi H, Harvey VJ, Spazzapan S, Tondini C, Del Mastro L, Veyret C, Simoncini E, Gianni L, Rochlitz C, Kralidis E, Zaman K, Jassem J, Piccart-Gebhart M, Di Leo A, Gelber RD, Coates AS, Goldhirsch A, Thurlimann B, Regan MM; members of the BIG 1-98 Collaborative Group and the International Breast Cancer Study Group. BIG 1-98 J Clin Oncol. doi: 10.1200/JCO.18.0044. 2018 Nov 26. Journal of Clinical Oncology
2018 Tailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer Francis PA, Pagani O, Fleming GF, Walley BA, Colleoni M, Lng I, Gmez HL, Tondini C, Ciruelos E, Burstein HJ, Bonnefoi HR, Bellet M, Martino S, Geyer CE Jr, Goetz MP, Stearns V, Pinotti G, Puglisi F, Spazzapan S, Climent MA, Pavesi L, Ruhstaller T, Davidson NE, Coleman R, Debled M, Buchholz S, Ingle JN, Winer EP, Maibach R, Rabaglio-Poretti M, Ruepp B, Di Leo A, Coates AS, Gelber RD, Goldhirsch A, Regan MM; SOFT and TEXT Investigators and the International Breast Cancer Study Group. BIG 2-02 SOFT; BIG 3-02 TEXT N Engl J Med. 2018 Jun 4. doi: 10.1056/NEJMoa1803164. New England Journal of Medicine
2018 Adjuvant Anti-HER2 Therapy, Treatment-Related Amenorrhea, and Survival in Premenopausal HER2-Positive Early Breast Cancer Patients Lambertini M, Campbell C, Bines J, Korde LA, Izquierdo M, Fumagalli D, Del Mastro L, Ignatiadis M, Pritchard K, Wolff AC, Jackisch C, Lang I, Untch M, Smith I, Boyle F, Xu B, Barrios CH, Baselga J, Moreno-Aspitia A, Piccart M, Gelber RD, de Azambuja E BIG 2-06 ALTTO J Natl Cancer Inst. 2018 Jun 5. doi: 10.1093/jnci/djy094. Journal of the National Cancer Institute
2018 Characterisation of the HLA-DRB1*07:01 biomarker for lapatinib-induced liver toxicity during treatment of early-stage breast cancer patients with lapatinib in combination with trastuzumab and/or taxanes C F. Spraggs, LR Parham, L P Briley, L Warren, L S Williams, D Fraser, Z Jiang, Z Aziz, S Ahmed, G Demetrious, Z Tong, A O. Mehta, N Jackson, J Byrne, M Andersson, M Toi, L Harris, J Gralow, JA Zujewski, R Crescenzo, A Armour, E Perez, M Piccart BIG 2-06 ALTTO Pharmacogenomics J. 2018 May 22;18(3):480-486. doi: 10.1038/tpj.2017.39. Pharmacogenomics Journal
2018 Impact of body mass index (BMI) and weight change after treatment in patients (pts) with HER2-positive (HER2+) early breast cancer (EBC): Secondary analysis of the ALTTO BIG 2-06 trial Martel S, Lambertini M, Agbor-Tarh D, Ponde N, Gombos A, Paterson V, Hilbers F, Korde L, Manukyants A, Dueck A. C., Maurer C, Piccart-Gebhart M. J., Moreno-Aspitia A, Desmedt C, Di Cosimo S, De Azambuja E BIG 2-06 ALTTO DOI: 10.1200/JCO.2018.36.15_suppl.10067 Journal of Clinical Oncology 36, no. 15_suppl (May 20 2018) 10067-10067. Journal of Clinical Oncology
2018 Clinical significance of CD73 in triple-negative breast cancer: multiplex analysis of a phase III clinical trial Buisseret L, Pommey S, Allard B, Garaud S, Bergeron M, Cousineau I, Ameye L, Bareche Y, Paesmans M, Crown JPA, Di Leo A, Loi S, Piccart-Gebhart M, Willard-Gallo K, Sotiriou C, Stagg J. BIG 2-98 TAX 315 Ann Oncol. 2018 Apr 1;29(4):1056-1062. doi: 10.1093/annonc/mdx730. Annals of Oncology
2018 Immune Infiltration in Invasive Lobular Breast Cancer Desmedt C, Salgado R, Fornili M, Pruneri G, Van den Eynden G, Zoppoli G, Roth F, Buisseret L, Garaud S, Willard-Gallo K, Brown D, Bareche Y, Rouas G, Galant C, Bertucci F, Loi S, Viale G, Di Leo A, Green AR, Ellis IO, Rakha EA, Larsimont D, Biganzoli E, Sotiriou C. BIG 2-98 TAX 315 J Natl Cancer Inst. 2018 Jul 1;110(7):768-776. doi: 10.1093/jnci/djx268 Journal of the National Cancer Institute
2018 Postmastectomy Radiation Therapy in Women with T1-T2 Tumors and 1 to 3 Positive Lymph Nodes: Analysis of the Breast International Group 02-98 Trial Zeidan YH,Habib JG,Ameye L,Paesmans M,de Azambuja E,Gelber RD,Campbell I,Nordenskjld B,Gutirez J,Anderson M,Lluch A,Gnant M,Goldhirsch A,Di Leo A,Joseph DJ,Crown J,Piccart-Gebhart M,Francis PA. BIG 2-98 TAX 315 Int J Radiat Oncol Biol Phys. 2018 Jun 1;101(2):316-324. doi: 10.1016/j.ijrobp.2018.01.105. International Journal of Radiation Oncology
2018 p-STAT3 in luminal breast cancer: Integrated RNA-protein pooled analysis and results from the BIG 2-98 phase III trial. Sonnenblick A, Salgado R, Brohe S, Zahavi T, Peretz T, Van den Eynden G, Rouas G, Salmon A, Francis PA, Di Leo A, Crown JPA, Viale G, Daly L, Javdan B, Fujisawa S, de Azambuja E, Lieveke A, Piccart MJ, Bromberg JF, Sotiriou C BIG 2-98 TAX 315 Int J Oncol. 2018 Feb; doi: 10.3892/ijo.2017.4212. Epub 2017 Nov 27. International Journal of Oncology
2018 Adjuvant Letrozole and Tamoxifen Alone or Sequentially for Postmenopausal Women With Hormone Receptor-Positive Breast Cancer: Long-Term Follow-Up of the BIG 1-98 Trial Ruhstaller T, Giobbie-Hurder A, Colleoni M, Jensen MB, Ejlertsen B, de Azambuja E, Neven P, Lng I, Jakobsen EH, Gladieff L, Bonnefoi H, Harvey VJ, Spazzapan S, Tondini C, Del Mastro L, Veyret C, Simoncini E, Gianni L, Rochlitz C, Kralidis E, Zaman K, Jassem J, Piccart-Gebhart M, Di Leo A, Gelber RD, Coates AS, Goldhirsch A, Thrlimann B, Regan MM; members of the BIG 1-98 Collaborative Group and the International Breast Cancer Study Group. BIG 1-98 J Clin Onco 2019 Jan 10; doi: 10.1200/JCO.18.00440. Journal of Clinical Oncology
2018 Association of somatic driver alterations with prognosis in postmenopausal, hormone receptor-positive, HER2-negative early breast cancer: A secondary analysis of the BIG 1-98 randomized clinical trial Luen SJ, Asher R, Lee CK, Savas P, Kammler R, Dell'Orto P, Biasi OM, Demanse D, JeBailey L, Dolan S, Hackl W, Thrlimann B, Viale G, Colleoni M, Regan MM, Loi S. BIG 1-98 JAMA Oncol 2018 Oct 1; doi: 10.1001/jamaoncol.2018.1778. Jama Oncology
2018 Integration of clinical variables for the prediction of late distant recurrence in patients with oestrogen receptor positive breast cancer treated with 5 years of endocrine therapy Dowsett M, Sestak I, Regan MM, Dodson A, Viale G, Thrlmann B, Colleoni M, Cuzick J. BIG 1-98 CTS5. J Clin Oncol 2018 Jul 1; doi: 10.1200/JCO.2017.76.4258 Journal of Clinical Oncology
2018 Tailoring adjuvant endocrine therapy for premenopausal breast cancer Francis PA, Pagani O, Fleming GF, Walley BA, Colleoni M, Lng I, Gmez HL, Tondini C, Ciruelos E, Burstein HJ, Bonnefoi HR, Bellet M, Martino S, Geyer Jr. CE, Goetz MP, Stearns V, Pinotti G, Puglisi F, Spazzapan S, Climent MA, Pavesi L, Ruhstaller T, Davidson NE, Coleman R, Debled M, Buchholz S, Ingle JN, Winer EP, Maibach R, Rabaglio?Poretti M, Ruepp B, Di Leo A, Coates AS, Gelber RD, Goldhirsch A**, Regan MM**, the SOFT and TEXT Investigators and the International Breast Cancer Study Group. BIG 2-02 SOFT; BIG 3-02 TEXT N Engl J Med 2018 Jul 12; doi: 10.1056/NEJMoa1803164 New England Journal of Medicine
2018 A randomized phase II study evaluating different maintenance schedules of nab-paclitaxel in the first-line treatment of metastatic breast cancer: final results of the IBCSG 42-12/BIG 2-12 SNAP trial Gennari A, Sun Z, Hasler-Strub U, Colleoni M, Kennedy M, Von Moos R, Corts J, Vidal MJ, Hennessy B, Walshe J, Parraga KA, Ribi K, Bernhard J, Murillo SM, Pagani O, Barbeaux A, Borstnar S, Rabaglio-Poretti M, Maibach R, Regan MM, Jerusalem G; International Breast Cancer Study Group, Cancer Trials Ireland and SOLTI Group BIG 2-12 SNAP Ann Oncol. 2018 Mar 1;29(3):661-668. doi: 10.1093/annonc/mdx772 Annals of Oncology
2018 Exploratory analysis of single-gene predictive biomarkers in HERA DASL cohort reveals that C8A mRNA expression is prognostic of outcome and predictive of benefit of trastuzumab Willis S, Polydoropoulou V, Sun Y et al. BIG 1-01 HERA JCO Precis Oncol. 2018; 2: PO.18.00016. Published online 2018 Nov 1. doi: 10.1200/PO.18.00016 JCO Precision Oncology
2017 Pathological characterisation of male breast cancer: Results of the EORTC 10085/TBCRC/BIG/NABCG International Male Breast Cancer Program Vermeulen MA, Slaets L, Cardoso F, Giordano SH, Tryfonidis K, van Diest PJ, Dijkstra NH, Schrder CP, van Asperen CJ, Linderholm B, Benstead K, Foekens R, Martens JWM, Bartlett JMS, van Deurzen CHM. BIG 2-07 Male BC Eur J Cancer. 2017 Sep;82:219-227 European Journal of Cancer
2017 Male breast cancer: finding the way in this uncommon path. Maurer C, Martel S, de Azambuja E BIG 2-07 Male BC ESMO Open. 2017 Mar 16; doi: 10.1136/esmoopen-2017-000169. eCollection 2017. ESMO Open
2017 Male breast cancer precursor lesions: analysis of the EORTC 10085/TBCRC/BIG/NABCG International Male Breast Cancer Program Doebar SC, Slaets L, Cardoso F, Giordano SH, Bartlett JM, Tryfonidis K, Dijkstra NH, Schrder CP, van Asperen CJ, Linderholm B, Benstead K, Dinjens WN, van Marion R, van Diest PJ, Martens JW, van Deurzen CH, BIG 2-07 Male BC Mod Pathol. 2017 Apr;30(4):509-518 Modern Pathology
2017 Abstract GS3-03: A phase III multicentre double blind randomised trial of celecoxib versus placebo in primary breast cancer patients (REACT Randomised EuropeAn celecoxib trial) RC Coombes, H Tovey, L Kilburn, J Mansi, C Palmieri, J Bartlett, J Hicks, A Makris, A Evans, S Loibl, C Denkert, E Murray, R Grieve, R Coleman, M Schmidt, P Klare, M Rezai, B Rautenberg, N Klutinus, U Rhein, K Mousa, S Ricardo-Vitorino, G von Minckwitz and J Bliss BIG 1-03 REACT DOI: 10.1158/1538-7445.SABCS17-GS3-03 Published February 2018 Cancer Research
2017 11 years' follow-up of trastuzumab after adjuvant chemothera-py in HER2-positive early breast cancer: final analysis of the HERceptin Adjuvant (HERA) trial Cameron D, Piccart-Gebhart MJ, Gelber RD, Procter M, Goldhirsch A, de Azambuja E, Castro G Jr, Untch M, Smith I, Gianni L, Baselga J, Al-Sakaff N, Lauer S, McFadden E, Leyland-Jones B, Bell R, Dowsett M, Jackisch C; Herceptin Adjuvant (HERA) Trial Study Team BIG 1-01 HERA Lancet 2017 Mar 25 doi: 10.1016/S0140-6736. The Lancet Oncology
2017 Impact of baseline BMI and weight change in CCTG adjuvant breast cancer trials. Yerushalmi R, Dong B, Chapman JW, Goss PE, Pollak MN, Burnell MJ, Levine MN, Bramwell VH, Pritchard KI, Whelan TJ, Ingle JN, Shepherd LE, Parulekar WR, Han L, Ding K, Gelmon KA. BIG 1-01 HERA Ann Oncol. 2017 Mar 31. doi: 10.1093/annonc/mdx152. [Epub ahead of print] Annals of Oncology
2017 Role of Troponins I and T and N-Terminal Prohormone of Brain Natriuretic Peptide in Monitoring Cardiac Safety of Patients With Early-Stage Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer Receiving Trastuzumab: A Herceptin Adjuvant Study Cardiac Marker Substudy. Zardavas D, Suter TM, Van Veldhuisen DJ, Steinseifer J, Noe J, Lauer S, Al-Sakaff N, Piccart-Gebhart MJ, de Azambuja E. BIG 1-01 HERA J Clin Oncol. 2017 Mar 10;35(8):878-884. doi: 10.1200/JCO.2015.65.7916. Epub 2016 Oct 23. Journal of Clinical Oncology
2017 Effect of MAF amplification on treatment outcomes with adjuvant zoledronic acid in early breast cancer: a secondary analysis of the international, open-label, randomised, controlled, phase 3 AZURE (BIG 01/04) trial Coleman R, Hall A, Albanell J, Hanby A, Bell R, Cameron D, Dodwell D, Marshall H, Jean-Mairet J, Tercero JC, Rojo F, Gregory W, Gomis RR. BIG 1-04 AZURE Lancet Oncol. 2017 Nov;18 doi: 10.1016/S1470-2045(17)30603-4. Epub 2017 Oct 13. The Lancet Oncology
2017 HER2-overexpressing breast cancers amplify FGFR signaling upon acquisition of resistance to dual therapeutic blockade of HER2. Hanker AB, Garrett JG, Estrada MV, Moore PD, Ericsson PG, Koch JP, Langley E, Singh S, Kim PS, Frampton GM, Sanford EM, Owns P, Becker J, Groseclose MR, Castellino S, Joensuu H, Huober J, Brase JC, Samira M, Brohe S, Venet D, Brown D, Baselga J, Piccart M, Sotiriou C, Arteaga CL. BIG 1-06 NeoALTTO Clin Cancer Res. 2017 Apr 5. doi: 10.1158/1078-0432.CCR-16-2287 Clinical Cancer Research
2017 The AURORA pilot study for molecular screening of patients with advanced breast cancer-a study of the breast international group. Maetens M, Brown D, Irrthum A, Aftimos P, Viale G, Loibl S, Laes JF, Campbell PJ, Thompson A, Cortes J, Seiler S, Vinnicombe S, Oliveira M, Roth F, Bareche Y, Fumagalli D, Zardavas D, Desmedt C, Piccart M, Loi S, Sotiriou C. BIG 14-01 AURORA NPJ Breast Cancer. 2017 Jun 29;3:23. doi: 10.1038/s41523-017-0026-6. eCollection 2017 npj Breast Cancer
2017 PALLAS: PALbociclib CoLlaborative Adjuvant Study: A randomized phase Ill trial of palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for HR+/HER2- early breast cancer E.L. Mayer, A.M. Demichele, G. Pfeiler, W. Barry, O. Metzger, P. Rastogi, F. Symmans, H.J. Burstein, K. Miller, S. Loibl, S. Schmatloch, T. Goulioti, D. Zardavas, C. Fesl, M. Koehler, C. Huang Bartlett, X. Huang, M. Piccart, E.P. Winer, M. Gnant BIG 14-03 PALLAS Annals of Oncology (2017) 28 (suppl_5): v43-v67. 10.1093/annonc/mdx362 Annals of Oncology
2017 Prognostic and predictive importance of the estrogen receptor coactivator AIB1 in a randomized trial comparing adjuvant letrozole and tamoxifen therapy in postmenopausal breast cancer: the Danish cohort of BIG 1-98 Alkner S, Jensen MB, Rasmussen BB, Bendahl PO, Fern M, Rydn L, Mouridsen H; Danish Breast Cancer Cooperative Group. BIG 1-98 Breast Cancer Res Treat. 2017 Nov;166(2):481-490. Breast Cancer Research and Treatment
2017 High expression of FGD3, a putative regulator of cell morphology and motility, is prognostic of favorable outcome in multiple cancers Willis S, Sun Y, Abramovitz M, Fei T, Young B, Lin X, Ni M, Achua J, Regan MM, Gray KG, Gray R, Wang V, Long B, Kammler R, Sparano JA, Williams C, Goldstein LJ, Salgado R, Loi S, Pruneri G, Viale G, Brown M, Leyland-Jones B. BIG 1-98 J Clin Oncol Precis Oncol. doi: 10.1200/PO.17.00009. 2017 October 13. Journal of Clinical Oncology Precision Oncology
2017 HER2 status predicts for upfront AI benefit: A TRANS-AIOG meta-analysis of 12,129 patients from ATAC, BIG 1-98 and TEAM with centrally determined HER2 Bartlett JMS, Ahmed I, Regan MM, Sestak I, Mallon EA, Dell'Orto P, Thrlimann B, Seynaeve C, Putter H, Van de Velde CJH, Brookes CL, Forbes JF, Viale G, Cuzick J, Dowsett M, Rea DW; Translational Aromatase Inhibitor Overview Group (Trans-AIOG). BIG 1-98 Eur J Cancer. 2017 Jul;79:129-138. doi: 10.1016/j.ejca.2017.03.033. Epub 2017 May 8. European Journal of Cancer
2017 Cholesterol, Cholesterol-Lowering Medication Use, and Breast Cancer Outcome in the BIG 1-98 Study. Borgquist S, Giobbie-Hurder A, Ahern TP, Garber JE, Colleoni M, Lang I, Debled M, Ejlertsen B, von Moos R, Smith I, Coates AS, Goldhirsch A, Rabaglio M, Price KN, Gelber RD, Regan MM, Thurlimann B. BIG 1-98 J Clin Oncol. 35:1179-1188, 2017 (IBCSG 18-98) Journal of Clinical Oncology
2017 A high level of estrogen-stimulated proteins selects breast cancer patients treated with adjuvant endocrine therapy with good prognosis L H Weischenfeldt K, Kirkegaard T, Rasmussen BB, Giobbie-Hurder A, Jensen MB, Ejlertsen B, Lykkesfeldt AE BIG 1-98 Acta Oncol. 2017 May 10:1-7. doi: 10.1080/0284186X.2017.1324211. Acta Oncologica
2017 Treatment Efficacy, Adherence, and Quality of Life Among Women Younger Than 35 Years in the International Breast Cancer Study Group TEXT and SOFT Adjuvant Endocrine Therapy Trials Saha P1, Regan MM1, Pagani O1, Francis PA1, Walley BA1, Ribi K1, Bernhard J1, Luo W1, Gmez HL1, Burstein HJ1, Parmar V1, Torres R1, Stewart J1, Bellet M1, Perell A1, Dane F1, Moreira A1, Vorobiof D1, Nottage M1, Price KN1, Coates AS1, Goldhirsch A1, Gelber RD1, Colleoni M1, Fleming GF1; SOFT; TEXT Investigators; International Breast Cancer Study Group. BIG 2-02 SOFT; BIG 3-02 TEXT J Clin Oncol. 2017 Jun 27:JCO2016720946. doi: 10.1200/JCO.2016.72.0946. Journal of Clinical Oncology
2017 Concurrent and sequential initiation of ovarian function suppression with chemotherapy in premenopausal women with endocrine-responsive early breast cancer: an exploratory analysis of TEXT and SOFT Regan MM, Walley BA, Francis PA, Fleming GF, Lng I, Gmez HL, Colleoni M, Tondini C, Pinotti G, Salim M, Spazzapan S, Parmar V, Ruhstaller T, Abdi EA, Gelber RD, Coates AS, Goldhirsch A, Pagani O BIG 2-02 SOFT; BIG 3-02 TEXT Ann Oncol 0: 1-8, 2017. First published online July 29, 2017 Annals of Oncology
2017 Adjuvant endocrine therapy for premenopausal women: Type and duration Francis PA. BIG 2-02 SOFT; BIG 3-02 TEXT E-published Breast 2017 June 29 Breast
2017 The BIG 2.04 MRC/EORTC SUPREMO Trial: pathology quality assurance of a large phase 3 randomised international clinical trial of postmastectomy radiotherapy in intermediate-risk breast cancer J. S. Thomas, A. M. Hanby, N. Russell, G. van Tienhoven, K. Riddle, N. Anderson, D. A. Cameron, J. M. S. Bartlett, T. Piper, C. Cunningham, P. Canney, I. H. Kunkler, and On behalf of the SUPREMO Trial Management Group BIG 2-04 SUPREMO Breast Cancer Res Treat. 2017; doi: 10.1007/s10549-017-4145-4 Breast Cancer Research and Treatment
2017 Adjuvant anti-HER2 therapy, treatment-induced amenorrhea (TIA) and survival in premenopausal patients (pts) with HER2-positive (HER2+) early breast cancer (EBC): Analysis from the ALTTO trial (BIG 2-06) M. Lambertini C. Campbell J. Bines L. Korde M.A. Izquierdo Delso D. Fumagalli K. Pritchard A. Wolff C. Jackisch I. Lang M. Untch I. Smith F.M. Boyle B. Xu C.H. Barrios J. Baselga A. Moreno-Aspitia M. Piccart R. Gelber E. De Azambuja BIG 2-06 ALTTO Ann Oncol. 2017 Sept 1 doi: 10.1093/annonc/mdx362.009 Annals of Oncology
2017 Impact of Diabetes, Insulin, and Metformin Use on the Outcome of Patients With Human Epidermal Growth Factor Receptor 2Positive Primary Breast Cancer: Analysis From the ALTTO Phase III Randomized Trial Sonnenblick A., Agbor-Tarh D., Bradbury I., Di Cosimo S., Azim H. A., Fumagalli D., Sarp S., Wolff A. C., Andersson M., Kroep J., Cufer T., Simon S. D., Salman P., Toi M., Harris L., Gralow J., Keane M., Moreno-Aspitia A., Piccart-Gebhart M., de Azambuja E. BIG 2-06 ALTTO J Clin Oncol. 2017 May 1;35(13):1421-1429. doi: 10.1200/JCO.2016.69.7722. Epub 2017 Mar 13. Journal of Clinical Oncology
2017 Updated results from the phase III ALTTO trial (BIG 2-06; NCCTG (Alliance) N063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone (T), their sequence (T?L) or their combination (L+T) in the adjuvant treatment of HER2-positive early breast cancer. A Moreno-Aspitia, E McCormick Holmes, C Jackisch, E De Azambuja, F. M. Boyle, D W. Hillman, BIG 2-06 ALTTO J Clin Oncol. doi: 10.1200/JCO.2017.35.15_suppl.502 Journal of Clinical Oncology 35, no. 15_suppl (May 2017) 502-502. Journal of Clinical Oncology
2017 Characterization of male breast cancer: results of the EORTC 10085/TBCRC/BIG/NABCG International Male Breast Cancer Program F Cardoso, J M S Bartlett, L Slaets, C H M van Deurzen, E van Leeuwen-Stok, P Porter, B Linderholm, I Hedenfalk, C Schrder, J Martens, J Bayani, C van Asperen, M Murray, C Hudis, L Middleton, J Vermeij, K Punie, J Fraser, M Nowaczyk, I T Rubio, S Aebi, C Kelly, K J Ruddy, E Winer, C Nilsson, L Dal Lago, L Korde, K Benstead, O Bogler, T Goulioti, A Peric, S Litire, K C Aalders, C Poncet, K Tryfonidis, S H Giordano BIG 2-07 Male BC Ann Oncol. 2017 Oct 28. doi: 10.1093/annonc/mdx651. Annals of Oncology
2017 A randomized phase II study evaluating different maintenance schedules of nab-Paclitaxel in the first-line treatment of metastatic breast cancer: final results of the IBCSG 42-12/BIG 2-12 SNAP trial Gennari A, Sun Z, Hasler-Strub U, Colleoni M, Kennedy MJ, Von Moos R, Corts J, Vidal MJ, Hennessy B, Walshe J, Amillano Parraga K, Ribi K, Bernhard J, Morales SM, Pagani O, Barbeaux A, Borstnar S, Rabaglio-Poretti M, Maibach R, Regan MM, Jerusalem G. BIG 2-12 SNAP Ann Oncol. 2017 Dec 8. doi: 10.1093/annonc/mdx772. Annals of Oncology
2017 Long-term follow-up of the intergroup exemestane study Morden JP, Alvarez I, Bertelli G, Coates AS, Coleman R, Fallowfield L, Jassem J, Jones S, Kilburn L, Lnning PE, Ortmann O, Snowdon C, Van de Velde CJH, Andersen J, Del Mastro L, Dodwell D, Holmberg S, Nicholas H, Paridaens R, Bliss JM, Coombes RC BIG 2-97 IES J Clin Oncol 2017; doi: 10.1200/JCO.2016.70.5640. Journal of Clinical Oncology
2017 Immunohistochemical versus molecular (BluePrint and MammaPrint) subtyping of breast carcinoma. Outcome results from the EORTC 10041/BIG 3-04 MINDACT trial. Viale G, de Snoo FA, Slaets L, Bogaerts J, van t Veer L, Rutgers EJ, Piccart-Gebhart M, Stork-Sloots L, Glas A, Russo L, DellOrto P, Tryfonidis K, Litire S, Cardoso F BIG 3-04 MINDACT Breast Cancer Res Treat. 2018 Jan; doi: 10.1007/s10549-017-4509-9. Epub 2017 Sep 19. Breast Cancer Research and Treatment
2017 Characterisation of multifocal breast cancer using the 70-gene signature in clinical low-risk patients enrolled in the EORTC 10041/BIG 03-04 MINDACT trial. Aalders KC, Kuijer A, Straver ME, Slaets L, Litiere S, Viale G, Vant Veer LJ, Glas AM, Delorenzi M, van Dalen T, Tryfonidis K, Piccart-Gebhart M, Cardoso F, Rutgers EJ BIG 3-04 MINDACT Eur J Cancer. 2017 Jul doi: 10.1016/j.ejca.2017.03.034. Epub 2017 May 3. European Journal of Cancer
2017 Adjuvant pertuzumab and trastuzumab in early HER2-positive breast cancer von Minckwitz G, Procter M, de Azambuja E, Zardavas D, Benyunes M, Viale G, Suter T, Arahmani A, Rouchet N, Clark E, Knott A, Lang I, Levy C, Yardley DA, Bines J, Gelber RD, Piccart M, Baselga J; APHINITY Steering Committee and Investigators. BIG 4-11 APHINITY N Engl J Med. 2017 Jul 13 doi: 10.1056/NEJMoa1703643. New England Journal of Medicine
2017 Neoadjuvant buparlisib plus trastuzumab and paclitaxel for women with HER2+ primary breast cancer: A randomised, double-blind, placebo-controlled phase II trial (NeoPHOEBE). Loibl S, de la Pena L, Nekljudova V, Zardavas D, Michiels S, Denkert C, Rezai M, Bermejo B, Untch M, Lee SC, Turri S, Urban P, Kmmel S, Steger G, Gombos A, Lux M, Piccart-Gebhart M, Von Minckwitz G, Baselga J, Loi S BIG 6-11 Neo-PHOEBE Eur J Cancer. 2017 Nov; doi: 10.1016/j.ejca.2017.08.020. Epub 2017 Sep 17. European Journal of Cancer
2017 De-escalating and escalating treatments for early-stage breast cancer: the St. Gallen International Expert Consensus Conference on the primary therapy of early breast cancer 2017 Curigliano G, Burstein HJ, P Winer E, Gnant M, Dubsky P, Loibl S, Colleoni M, Regan MM, Piccart-Gebhart M, Senn HJ, Thrlimann B; St. Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2017, Andr F, Baselga J, Bergh J, Bonnefoi H, Y Brucker S, Cardoso F, Carey L, Ciruelos E, Cuzick J, Denkert C, Di Leo A, Ejlertsen B, Francis P, Galimberti V, Garber J, Gulluoglu B, Goodwin P, Harbeck N, Hayes DF, Huang CS, Huober J, Hussein K, Jassem J, Jiang Z, Karlsson P, Morrow M, Orecchia R, Osborne KC, Pagani O, Partridge AH, Pritchard K, Ro J, Rutgers EJT, Sedlmayer F, Semiglazov V, Shao Z, Smith I, Toi M, Tutt A, Viale G, Watanabe T, Whelan TJ, Xu B. St Gallen Consensus Ann Oncol 2017 doi: 10.1093/annonc/mdx308 Annals of Oncology
2017 Oncology Physicians' Perspectives on Practices and Barriers to Fertility Preservation and the Feasibility of a Prospective Study of Pregnancy After Breast Cancer Rosenberg SM, Gelber S, Gelber RD, Krop E, Korde LA, Pagani O, Partridge AH. BIG 8-13 POSITIVE J Adolesc Young Adult Oncol. 2017 Sep;6 doi: 10.1089/jayao.2017.0031. Journal of Adolescent and Young Adult Oncology
2017 Regional Nodal Irradiation After Breast Conserving Surgery for Early HER2-Positive Breast Cancer: Results of a Subanalysis From the ALTTO Trial Gingras I, Holmes E, De Azambuja E, Nguyen DH, Izquierdo M, Anne Zujewski J, Inbar M, Naume B, Tomasello G, Gralow JR, Wolff AC, Harris L, Gnant M, Moreno-Aspitia A, Piccart MJ, Azim HA Jr BIG 2-06 ALTTO J Natl Cancer Inst. 2017 Aug 1;109(8). doi: 10.1093/jnci/djw331. Journal of the National Cancer Institute
2017 Impact of Diabetes, Insulin, and Metformin Use on the Outcome of Patients With Human Epidermal Growth Factor Receptor 2-Positive Primary Breast Cancer: Analysis From the ALTTO Phase III Randomized Trial Sonnenblick A, Agbor-Tarh D, Bradbury I, Di Cosimo S, Azim HA Jr, Fumagalli D, Sarp S, Wolff AC, Andersson M, Kroep J, Cufer T, Simon SD, Salman P, Toi M, Harris L, Gralow J, Keane M, Moreno-Aspitia A, Piccart-Gebhart M, de Azambuja E. BIG 2-06 ALTTO J Clin Oncol. 2017 May 1; doi: 10.1200/JCO.2016.69.7722 Journal of Clinical Oncology
2016 Correlation between severe infection and breast cancer metastases in the EORTC 10994/BIG 1-00 trial: investigating innate immunity as a tumor suppressor in breast cancer. Touati N, Tryfonidis K, Caramia F, Bonnefoi H, Cameron D, Slaets L, Parker B, Loi S. BIG 1-00 p53 Eur J Cancer 2016; 72 (72):95-102. 10.10161/j.ejca.2016.11.015 European Journal of Cancer
2016 Effects of Estrogen Receptor and Human Epidermal Growth Factor Receptor-2 Levels on the Efficacy of Trastuzumab: A Secondary Analysis of the HERA Trial. Loi S, Dafni U, Karlis D, Polydoropoulou V, Young BM, Willis S, Long B, de Azambuja E, Sotiriou C, Viale G, Rschoff J0, Piccart MJ, Dowsett M, Michiels S, Leyland-Jones B. BIG 1-01 HERA JAMA Oncol. 2016 Apr 21. doi: 10.1001/jamaoncol.2016.0339. [Epub ahead of print] JAMA Oncology
2016 Trastuzumab re-treatment following adjuvant trastuzumab and the importance of distant disease-free interval: the HERA trial experience. Metzger-Filho O, de Azambuja E, Procter M, Krieguer M, Smith I, Baselga J, Cameron D, Untch M, Jackisch C, Bell R, Gianni L, Goldhirsch A, Piccart M, Gelber RD for the HERA Study Team. BIG 1-01 HERA Breast Cancer Res Treat 155:127-132, 2016. (IBCSG 28-02) Breast Cancer Research and Treatment
2016 Poor prognosis after second locoregional recurrences in the CALOR trial. Wapnir IL, Gelber S, Anderson SJ, Mamounas EP, Robidoux A, Martn M, Nortier JW, Geyer CE Jr, Paterson AH, Lng I, Price KN, Coates AS, Gelber RD, Rastogi P, Regan MM, Wolmark N, Aebi S; CALOR trial investigators. BIG 1-02 CALOR Ann Surg Oncol. 2016 Sep 23. [Epub ahead of print] Annals of Surgical Oncology
2016 Pathway level alterations rather than mutations in single genes predict response to HER2-targeted therapies in the neo-ALTTO trial W. Shi, T. Jiang, P. Nuciforo, C. Hatzis, E. Holmes, N. Harbeck, C. Sotiriou, L. Pea, S. Loi, D. D. Rosa, S. Chia, A. Wardley, T. Ueno, J. Rossari, H. Eidtmann, A. Armour, M. Piccart-Gebhart, D. L. Rimm, J. Baselga, L. Pusztai. BIG 1-06 NeoALTTO ANNALS OF ONCOLOGY 2016 Sept 29, pii: mdw434 Annals of Oncology
2016 PIK3CA mutations are associated with reduced pathological complete response rates in primary HER2-positive breast cancer: pooled analysis of 967 patients from five prospective trials investigating lapatinib and trastuzumab. Loibl S, Majewski I, Guarneri V, Nekljudova V, Holmes E, Bria E, Denkert C, Schem C, Sotiriou C, Loi S, Untch M, Conte P, Bernards R, Piccart M, von Minckwitz G, Baselga J. BIG 1-06 NeoALTTO Ann Oncol. 2016 Aug;27(8):1519-25. doi: 10.1093/annonc/mdw197. Epub 2016 May 13. Annals of Oncology
2016 Plasma microRNA levels for predicting therapeutic response to neoadjuvant treatment in HER2-positive breast cancer: Results from Neo-ALTTO Di Cosimo S, Appierto V, Tiberio P, Verderio P, Pizzamiglio S, Bottelli S, Iorio M, Baselga J, Piccart M, Huober J, Brase J, de la Pena L, Fumagalli D, de Azambuja E, de Braud F, Daidone MG. BIG 1-06 NeoALTTO SABCS2016, 2016; P3-02 SABC2016
2016 RNA Sequencing to Predict Response to Neoadjuvant Anti-HER2 Therapy: A Secondary Analysis of the NeoALTTO Randomized Clinical Trial Fumagalli D, Venet D, Ignatiadis M1, Azim HA Jr, Maetens M, Roth F, Salgado R, Bradbury I, Pusztai L, Harbeck N, Gomez H, Chang TW, Coccia-Portugal MA, Di Cosimo S, de Azambuja E, de la Pea L, Nuciforo P, Brase JC, Huober J, Baselga J, Piccart M, Loi S, Sotiriou C BIG 1-06 NeoALTTO JAMA Oncol. 2016 Sep 29. doi: 10.1001/jamaoncol.2016.3824. JAMA Oncology
2016 Liquid biopsy-based clinical research in early breast cancer: The EORTC 90091-10093 Treat CTC trial M. Ignatiadis, B. Rack, F. Rothe, S. Riethdorf, C. Decraene, H. Bonnefoi, C. Dittrich, C. Messina, M. Beauvois, E. Trapp, T. Goulioti, K. Tryfonidis, K. Pantel, M. Repollet, W. Janni, M. Piccart, C. Sotiriou, S. Litiere, J.-Y. Pierga BIG 1-12 Treat CTC European Journal of Cancer 63 (2016) 97e104 European Journal of Cancer
2016 Prognostic and predictive effects of diabetes, hypertension, and coronary artery disease among women on extended adjuvant letrozole: NCIC CTG MA.17. Goodwin RA, Jamal R, Booth CM, Goss PE, Eisenhauer EA, Tu D, Shepherd LE. BIG 1-97 MA.17 Eur J Cancer. 2016 May;58:97-103. doi: 10.1016/j.ejca.2016.01.014. Epub 2016 Mar 14. European Journal of Cancer
2016 New onset vasomotor symptoms but not musculoskeletal symptoms associate with clinical outcomes on extended adjuvant letrozole - Analyses from NCIC CTG MA.17. Liedke PE, Tu D, Shepherd L, Chavarri-Guerra Y, Pritchard KI, Stearns V, Goss PE. BIG 1-97 MA.17 Breast. 2016 Jun;27:99-104. doi: 10.1016/j.breast.2016.02.010. Epub 2016 Apr 5. Breast
2016 Treatment adherence in the BIG 1-98 trial of tamoxifen, letrozole alone and in sequence. Chirgwin J,Giobbie-Hurder A, Coates AS, Price KN, Ejlertsen B, Debled M, Gelber RD, Goldhirsch A, Smith I, Rabaglio M, Forbes JF, Neven P, Lng I, Colleoni M, Thrlimann B for the BIG 1-98 Collaborative and International Breast Cancer Study Groups. BIG 1-98 J Clin Oncol 34:2452-2459, 2016. Journal of Clinical Oncology
2016 Treatment Adherence and Its Impact on Disease-Free Survival in the Breast International Group 1-98 Trial of Tamoxifen and Letrozole, Alone and in Sequence. Chirgwin JH, Giobbie-Hurder A, Coates AS, Price KN, Ejlertsen B, Debled M, Gelber RD, Goldhirsch A, Smith I, Rabaglio M, Forbes JF, Neven P, Lng I, Colleoni M, Thrlimann B. BIG 1-98 J Clin Oncol. 2016 May 23. pii: JCO638619. [Epub ahead of print] Journal of Clinical Oncology
2016 The genomic grade assay compared with Ki67 to determine risk of distant breast cancer recurrence. Ignatiadis M, Azim HA Jr, Desmedt C, Veys I, Larsimont D, Salgado R, Lyng MB, Viale G, Leyland-Jones B, Giobbie-Hurder A, Kammler R, Dell'Orto P, Roth F, Laos I, Ditzel HJ, Regan MM, Piccart M, Michiels S, Sotiriou C. BIG 1-98 JAMA Oncol 2:217-224, 2016. JAMA Oncology
2016 Evaluating markers for guiding treatment. Baker SG, Bonetti M. BIG 1-98 J Natl Cancer Inst (2016) 108 (9): djw101 doi:10.1093/jnci/djw101 First published online May 18, 2016 (6 pages). Journal of the National Cancer Institute
2016 Clinical implications of somatic mutations in post-menopausal early-stage estrogen receptor (ER)-positive HER2-negative breast cancer (BC): Results from the BIG 1-98 study. Loi S, Asher R, Lee CK, Luen S, Savas P, Kammler R, Dell'Orto P, Blasi OM, Demanse D, JeBailley L, Dolan S, Hackl W, Thuerlimann B, Viale G, Regan M, Colleoni MA BIG 1-98 SABCS2016, 2016; S1-10 SABC2016
2016 Twelve-month estrogen levels in premenopausal women with hormone-receptor positive breast cancer receiving adjuvant triptorelin plus exemestane or tamoxifen in the SOFT trial: the SOFT-EST substudy Bellet M, Gray KP, Francis PA, Lang I, Ciruelos E, Lluch A, Climent MA, Cataln G, Avella Mestre A, Bohn U, Gonzlez-Martin A, Costa RF, Cataln R, Azaro A, Rajasekaran A, Morales J, Vzquez J, Fleming GF, Price KN, Regan MM, SOFT-EST Investigators, SOLTI, and International Breast Cancer Study Group. BIG 2-02 SOFT; BIG 3-02 TEXT J Clin Oncol 34:1584-1593, 2016. (IBCSG 24-02) Journal of Clinical Oncology
2016 Impact of CYP19A1 and ESR1 variants on early-onset side effects during combined endocrine therapy in the TEXT trial. Johansson H, Gray KP,Pagani O, Regan MM, Viale G, Aristarco V, Macis D, Puccio A, Roux S, Maibach R, Colleoni M, Rabaglio M, Price KN, Coates AS, Gelber RD, Goldhirsch A, Kammler R, Bonanni B, Walley BA; the TEXT principal investigators. BIG 2-02 SOFT; BIG 3-02 TEXT Breast Cancer Res 18:110, 2016. (IBCSG 25-02) (Journal impact factor 5.211). Breast Cancer Research
2016 Are SOFT and TEXT results practice changing and how? Pagani O, Regan MM, Francis PA. BIG 2-02 SOFT; BIG 3-02 TEXT Breast 27:122-125, 2016. (IBCSG 24-02 and 25-02 commentary) Breast
2016 Adjuvant tamoxifen plus ovarian function suppression versus tamoxifen alone in premenopausal women with early breast cancer: patient-reported outcomes in the Suppression of Ovarian Function Trial. Ribi K, Luo W, Bernhard J, Francis PA, Burstein HJ, Ciruelos E, Bellet M, Pavesi L, Lluch A, Visini M, Parmar V, Tondini C, Kerbrat P, Perell A, Neven P, Torres R, Lombardi D, Puglisi F, Karlsson P, Ruhstaller T, Colleoni M, Coates AS, Goldhirsch A, Price KN, Gelber RD, Regan MM, Fleming GF. BIG 2-02 SOFT; BIG 3-02 TEXT J Clin Oncol 34:1601-1610, 2016. (IBCSG 24-02) Journal of Clinical Oncology
2016 Adjuvant ovarian function suppression and cognitive function in women with breast cancer. Phillips KA, Regan MM, Ribi K, Francis PA, Puglisi F, Bellet M, Spazzapan S, Karlsson P, Budman DR, Zaman K, Abdi EA, Domchek SM, Feng Y, Price KN, Coates AS, Gelber RD, Maruff P, Boyle F, Forbes JF, Ahles T, Fleming GF, Bernhard J. BIG 2-02 SOFT; BIG 3-02 TEXT Br J Cancer 114:956-964, 2016. (IBCSG 24-02) British Journal of Cancer
2016 Absolute Benefit of Adjuvant Endocrine Therapies for Premenopausal Women With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer: TEXT and SOFT Trials. Regan MM, Francis PA, Pagani O, Fleming GF, Walley BA, Viale G, Colleoni M, Lng I, Gmez HL, Tondini C, Pinotti G, Price KN, Coates AS, Goldhirsch A, Gelber RD. BIG 2-02 SOFT; BIG 3-02 TEXT J Clin Oncol. 2016 Apr 4. pii: JCO643171. Journal of Clinical Oncology
2016 Lapatinib-Related Rash and Breast Cancer Outcome in theALTTOPhase III Randomized Trial. Sonnenblick A, de Azambuja E, Agbor-Tarh D, Bradbury I, Campbell C, Huang Y, Dueck AC, Pritchard KI, Wolff AC, Jackisch C, Lang I, Untch M, Smith I, Boyle F, Xu B, Gomez H, Perez EA, Piccart M, Azim HA Jr. BIG 2-06 ALTTO J Natl Cancer Inst. 2016 Apr 20;108(8). pii: djw037. doi: 10.1093/jnci/djw037. Print 2016 Aug. J Natl Cancer Inst.
2016 Regional nodal irradiation after breast conserving surgery for HER2-positive breast cancer: Results of a sub analysis from the ALTTO trial. Gringas I, Holmes EM, De Azambuja E, Nguyen DHA, Izquierdo MA, Zujewski JA, Inbar MJ, Naume B, Tomasello G, Gnant M, Moreno-Aspitia A, Piccart-Gebhart MJ, Azim HA. BIG 2-06 ALTTO Journal of Clinical Oncology. 2016; 34 , (supp; abstr 604) Journal of Clinical Oncology
2016 Discordant assessment of tumor biomarkers by histopathological and molecular assays in the EORTC randomized controlled 10041/BIG 03-04MINDACTtrial breast cancer : Intratumoral heterogeneity and DCIS or normal tissue components are unlikely to be the cause of discordance. Viale G, Slaets L, de Snoo FA, Bogaerts J, Russo L, Van't Veer L, Rutgers EJ, Piccart-Gebhart MJ, Stork-Sloots L, Dell'Orto P, Glas AM, Cardoso F. BIG 3-04 MINDACT Breast Cancer Res Treat. 2016 Feb;155(3):463-9. doi: 10.1007/s10549-016-3690-6. Epub 2016 Jan 28. Breast Cancer Research and Treatment
2016 70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer Cardoso F, van't Veer LJ, Bogaerts J, Slaets L, Viale G, Delaloge S, Pierga JY, Brain E, Causeret S, DeLorenzi M, Glas AM, Golfinopoulos V, Goulioti T, Knox S, Matos E, Meulemans B, Neijenhuis PA, Nitz U, Passalacqua R, Ravdin P, Rubio IT, Saghatchian M, Smilde TJ, Sotiriou C, Stork L, Straehle C, Thomas G, Thompson AM, van der Hoeven JM, Vuylsteke P, Bernards R, Tryfonidis K, Rutgers E, Piccart M; MINDACT Investigators BIG 3-04 MINDACT N Engl J Med. 2016 Aug 25;375(8):717-29. doi: 10.1056/NEJMoa1602253. New England Journal of Medicine
2016 LORELEI: A Phase II randomized, double-blind study of neoadjuvant letrozole plus taselisib (GDC-0032) versus letrozole plus placebo in postmenopausal women with ER-positive/HER2-negative, early-stage breast cancer. Saura C, De Azambuja E, Oliveira M, Dubsky PC, Zardavas D, Fesl C, Bardia A, Soberino J, Fornier MN, Boer K, Ng V, Fredrickson JO, Stout T, Singel S, Hsu JY, PIccart-Gebhart MJ, Baselga J, Gnant M. BIG 3-13 LORELEI Journal of Clinical Oncology. 2016; 34 , (suppl; abstr TPS613) Journal of Clinical Oncology
2016 Anastrozole versus tamoxifen for the prevention of locoregional and contralateral breast cancer in postmenopausal women with locally excised ductal carcinoma in situ (IBIS-II DCIS): a double-blind, randomised controlled trial. Forbes JF, Sestak I, Howell A, Bonanni B, Bundred N, Levy C, von Minckwitz G, Eiermann W, Neven P, Stierer M, Holcombe C, Coleman RE, Jones L, Ellis I, Cuzick J; IBIS-II investigators. BIG 5-02 IBIS-II Lancet. 2016 Feb 27;387(10021):866-73. doi: 10.1016/S0140-6736(15)01129-0. Epub 2015 Dec 11. Lancet
2016 Evaluation of targeted therapies in advanced breast cancer: the need for large-scale molecular screening and transformative clinical trial designs. Fadoukhair Z, Zardavas D, Chad MA, Goulioti T, Aftimos P, Piccart M. General Oncogene. 2016 Apr 7;35(14):1743-9. doi: 10.1038/onc.2015.249. Epub 2015 Jun 29. Oncogene
2016 Lapatinib-Related Rash and Breast Cancer Outcome in the ALTTO Phase III Randomized Trial Sonnenblick A, de Azambuja E, Agbor-Tarh D, Bradbury I, Campbell C, Huang Y, Dueck AC, Pritchard KI, Wolff AC, Jackisch C, Lang I, Untch M, Smith I, Boyle F, Xu B, Gomez H, Perez EA, Piccart M, Azim HA Jr BIG 2-06 ALTTO J Natl Cancer Inst. 2016 Apr 20; doi: 10.1093/jnci/djw037 Journal of the National Cancer Institute
2015 Pregnancy after breast cancer: Are young patients willing to participate in clinical studies? Pagani O, Ruggeri M, Manunta S, Saunders C, Peccatori F, Cardoso F, Kaufman B, Paluch-Shimon S, Gewefel H, Gallerani E, Abulkhair OM, Pistilli B, Warner E, Saloustros E, Perey L, Zaman K, Rabaglio M, Gelber S, Gelber RD, Goldhirsch A, Korde L, Azim HA Jr, Partridge AH. BIG 8-13 POSITIVE Breast. 2015 Jun;24(3):201-7. doi: 10.1016/j.breast.2015.01.005. Epub 2015 Feb 4. Breast
2015 Standardization of pathologic evaluation and reporting of post-neoadjuvant specimens in clinical trials of breast cancer: Recommendations from an international working group Provenzano E, Bossuyt V, Viale G, Cameron D, Badve S, Denkert C, MacGrogan G, Penault-Llorca F, Boughey JC, Curigliano G, Dixon JM, Esserman LJ, Fastner G, Kuehn T, Peintinger F, von Minckwitz G, White J, Yang W, Symmans WF BIG-NABCG collaboration Mod Pathol. 2015 Jul 24. [Epub ahead of print] Modern Pathology
2015 Recommendations for standardized pathological characterization of residual disease for neoadjuvant clinical trials of breast cancer by the BIG-NABCG collaboration Bossuyt V, Provenzano E, Symmans WF, Boughey JC , Coles C, Curigliano G, Dixon JM, Esserman LJ, Fastner G, Kuehn T, Peintinger F, von Minckwitz G, White J, Yang W, Badve S, Denkert C, MacGrogan G, Penault-Llorca F, Viale G, Cameron D BIG-NABCG collaboration Ann Oncol. 2015 Jul;26(7):1280-91. Epub 2015 May 27 Annals of Oncology
2015 Pregnancy after breast cancer: Are young patients willing to participate in clinical studies? Pagani O, Ruggeri M, Manunta S, Saunders C, Peccatori F, Cardoso F, Kaufman B, Paluch-Shimon S, Gewefel H, Gallerani E, Abulkhair OM, Pistilli B, Warner E, Saloustros E, Perey L, Zaman K, Rabaglio M, Gelber S, Gelber RD, Goldhirsch A, Korde L, Azim HA Jr, Partridge AH. BIG-NABCG collaboration Breast. 2015 Jun;24(3):201-7. doi: 10.1016/j.breast.2015.01.005. Epub 2015 Feb 4. Breast
2015 Defining breast cancer intrinsic subtypes by quantitative receptor expression Cheang MC, Martin M, Nielsen TO, Prat A, Voduc D, Rodriguez-Lescure A, Ruiz A, Chia S, Shepherd L, Ruiz-Borrego M, Calvo L, Alba E, Carrasco E, Caballero R, Tu D, Pritchard KI, Levine MN, Bramwell VH, Parker J, Bernard PS, Ellis MJ, Perou CM, Di Leo A, Carey LA BIG-NABCG collaboration Oncologist. 2015 May;20(5):474-82. Epub 2015 Apr 23 The Oncologist
2015 An international study to increase concordance in Ki67 scoring Polley MY, Leung SC, Gao D, Mastropasqua MG, Zabaglo LA, Bartlett JM, McShane LM, Enos RA, Badve SS, Bane AL, Borgquist S, Fineberg S, Lin MG, Gown AM, Grabau D, Gutierrez C, Hugh JC, Moriya T, Ohi Y, Osborne CK, Penault-Llorca FM, Piper T, Porter PL, Sakatani T, Salgado R, Starczynski J, Lnkholm AV, Viale G, Dowsett M, Hayes DF, Nielsen TO BIG-NABCG collaboration Mod Pathol. 2015 Jun;28(6):778-86. Epub 2015 Feb 20 Modern Pathology
2015 Tumour size is the only predictive factor of distant recurrence after pathological complete response to neoadjuvant chemotherapy in patients with large operable or locally advanced breast cancers: A sub-study of the (EORTC 10994/BIG 1-00) phase III trial. Fei F, et al. BIG 1-00 p53 Eur J Cancer 2015; 51 (3):301-309. European Journal of Cancer
2015 Efficacy of Adjuvant Trastuzumab for Patients With Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer and Tumors ? 2 cm: A Meta-Analysis of the Randomized Trastuzumab Trials. O'Sullivan CC, Bradbury I, Campbell C, Spielmann M, Perez EA, Joensuu H, Costantino JP, Delaloge S, Rastogi P, Zardavas D, Ballman KV, Holmes E, de Azambuja E, Piccart-Gebhart M, Zujewski JA, Gelber RD. BIG 1-01 HERA J Clin Oncol. 2015 Aug 20;33(24):2600-8. doi: 10.1200/JCO.2015.60.8620. Epub 2015 Jun 22. Journal of Clinical Oncology
2015 Impact of updated HER2 testing guidelines in breast cancer--re-evaluation of HERA trial fluorescence in situ hybridization data. Stoss OC, Scheel A, Nagelmeier I, Schildhaus HU, Henkel T, Viale G, Jasani B, Untch M, Rschoff J. BIG 1-01 HERA Mod Pathol. 2015 Dec;28(12):1528-34. doi: 10.1038/modpathol.2015.112. Modern Pathology
2015 Benefit of neadjuvant anti-human epidermal growth factor receptor 2 (HER2)-targeted therapies in HER2-positive primary breast cancer is independent of phosphatase and tensin homolog deleted from chromosome 10 (PTEN) status. Nuciforo PG, Aura C, Holmes E, Prudkin L, Jimenez J, Martinez P, Ameels H, de la Pea L, Ellis C, Eidtmann H, Piccart-Gebhart MJ, Scaltriti M, Baselga J. BIG 1-06 NeoALTTO Ann Oncol (2015) 26 (7): 1494-1500.DOI: 10.1093/ANNONC/MDV175FIRST Published online: APRIL 7, 2015. Annals of Oncology
2015 High HER2 expression correlates with response to the combination of lapatinib and trastuzumab. Scaltriti M, Nuciforo P, Bradbury I, Sperinde J, Agbor-Tarh D, Campbell C, Chenna A, Winslow J, Serra V, Parra JL, Prudkin L, Jimenez J, Aura C, Harbeck N, Pusztai L, Ellis C, Eidtmann H, Arribas J, Cortes J, de Azambuja E, Piccart M, Baselga J. BIG 1-06 NeoALTTO Clin Cancer Res. 2015 Feb 1;21(3):569-76. doi: 10.1158/1078-0432.CCR-14-1824. Epub 2014 Dec 2. Clinical Cancer Research
2015 PIK3CA mutations are associated with decreased benefit to neoadjuvant HER2-targeted therapies in breast cancer. Majewski IJ, Nuciforo P, Mittempergher L, Bosma AJ, Eidtmann H, Holmes E, Sotiriou C, Fumagalli D, Jimenez J, Aura C, Prudkin L, Daz-Delgado MC, de la Pea L, Loi S, Ellis C, Schultz N, de Azambuja E, Harbeck N, Piccart-Gebhart M, Bernards R, Baselga J. BIG 1-06 NeoALTTO J. Clin. Oncol. 2015 Janv 5. Journal of Clinical Oncology
2015 Tumor-infiltrating lymphocytes and associations with pathological complete response and event-free survival in HER2-positive early-stage breast cancer treated with Lapatinib and Trastuzumab: a secondary analysis of the NEOALTTO trial. Salgado R, Denkert C, Campbell C, Savas P, Nuciforo P, Aura C, de Azambuja E, Eidtmann H, Ellis CE, Baselga J, Piccart-Gebhart MJ, Michiels S, Bradbury I, Sotiriou C, Loi S. BIG 1-06 NeoALTTO Jama Oncol. 2015 Jul;1(4):448-54. DOI: 10.1001/JAMAONCOL.2015.0830. JAMA Oncology
2015 Relative effectiveness of letrozole compared with tamoxifen for patients with lobular carcinoma in the BIG 1-98 trial. Metzger Filho O, Giobbie-Hurder A, Mallon EA, Gusterson B, Viale G, Winer EP, Thurlimann B, Gelber RD, Colleoni M, Ejlertsen B, Debled M, Price KN, Regan MM, Coates AS, Goldhirsch A. BIG 1-98 J Clin Oncol 33:2772-2779, 2015. Journal of Clinical Oncology
2015 Predicting benefit of endocrine therapy for early breast cancer. Regan M. BIG 1-98 The Breast 2015; 24Nov 1 Supp 2:S129-S131. (IBCSG 18-98/BIG 1-98; IBCSG 24-02/BIG 2-02; IBCSG 25-02/BIG 3-02 TEXT) The Breast
2015 Outcomes of special histotypes of breast cancer after adjuvant endocrine therapy with letrozole or tamoxifen in the monotherapy cohort of the BIG 1-98 trial. Munzone E, Giobbie-Hurder A, Gusterson BA, Mallon E, Viale G, Thrlimann B, Ejlertsen B, MacGrogan G, Bibeau F, Lelkaitis G, Price KN, Gelber RD, Coates AS, Goldhirsch A, Colleoni M; International Breast Cancer Study Group and the BIG 1-98 Collaborative Group. BIG 1-98 Ann Oncol 26:2442-2449, 2015. Annals of Oncology
2015 ESR1 and ESR2 polymorphisms in the BIG 1-98 trial comparing adjuvant letrozole versus tamoxifen or their sequence for early breast cancer. Leyland-Jones B, Gray KP, Abramovitz M, Bouzyk M, Young B, Long B, Kammler R, Dell'Orto P, Biasi MO, Thrlimann B, Harvey V, Neven P, Arnould L, Maibach R, Price KN, Coates AS, Goldhirsch A, Gelber RD, Pagani O, Viale G, Rae JM, Regan MM; BIG 1-98 Collaborative Group. BIG 1-98 Breast Cancer Res Treat 154:543-555, 2015. Breast Cancer Research and Treatment
2015 Early Breast Cancer Trialists. Collaborative Group (EBCTCG). Aromatase inhibitors versus tamoxifen in early breast cancer: patient-level meta-analysis of the randomised trials. Data from the BIG 1-98 trial were included in this overview from the EBCTCG. (paper and appendix) Early Breast Cancer Trialists Collaborative Group (EBCTCG) BIG 1-98 Lancet 386:1341.1352, 2015. Lancet
2015 CYP19A1 Polymorphisms and clinical outcomes in postmenopausal women with hormone-receptor positive breast cancer in the BIG 1-98 trial Leyland-Jones B, Gray KP, Abramovitz M, Bouzyk M, Young B, Long B, Kammler R, Dell.Orto P, Biasi MO, Thrlimann B, Lyng MB, Ditzel HJ, Harvey V, Neven P, Treilleux I, Rasmussen BB, Maibach R, Price KN, Coates AS, Goldhirsch A, Pagani O, Viale G, Rae JM, Regan MM; on behalf of the BIG 1-98 Collaborative Group BIG 1-98 Breast Cancer Res Treat 151:373-84, 2015 Breast Cancer Research and Treatment
2015 Benefit/risk for adjuvant breast cancer therapy with tamoxifen or aromatase inhibitor use by age, and race/ethnicity. Chlebowski RT, Haque R, Hedlin H, Col N, Paskett E, Manson JE, Kubo JT, Johnson KC, Wactawski-Wende J, Pan K, Anderson G. BIG 1-98 Breast Cancer Res Treat. 2015 Dec;154(3):609-16. doi: 10.1007/s10549-015-3647-1. Epub 2015 Nov 24. Breast Cancer Research and Treatment
2015 Aromatase inhibitors versus tamoxifen in early breast cancer: patient-level meta-analysis of the randomised trials. Early Breast Cancer Trialists' Collaborative Group (EBCTCG), Dowsett M, Forbes JF, Bradley R, Ingle J, Aihara T, Bliss J, Boccardo F, Coates A, Coombes RC, Cuzick J, Dubsky P, Gnant M, Kaufmann M, Kilburn L, Perrone F, Rea D, Thrlimann B, van de Velde C, Pan H, Peto R, Davies C, Gray R. BIG 1-98 Lancet. 2015 Oct 3;386(10001):1341-52. doi: 10.1016/S0140-6736(15)61074-1. Epub 2015 Jul 23. The Lancet
2015 Predictive value and clinical utility of centrally assessed ER, PGR, and Ki-67 to select adjuvant endocrine therapy for premenopausal women with hormone receptor-positive, HERr2-negative early breast cancer: TEXT and SOFT trials Regan MM, Pagani O, Francis PA, Fleming GF, Walley BA, Kammler R, Dell'Orto P, Russo L, Szoke J, Doimi F, Villani L, Pizzolitto S, Ohlschlegel C, Sessa F, Peg Cmara V, Rodrguez Peralto JL, MacGrogan G, Colleoni M, Goldhirsch A, Price KN, Coates AS, Gelber RD, Viale G; SOFT and TEXT Investigators and International Breast Cancer Study Group BIG 2-02 SOFT; BIG 3-02 TEXT Breast Cancer Res Treat. 2015 Nov; doi: 10.1007/s10549-015-3612-z. Epub 2015 Oct 22. Breast Cancer Research and Treatment
2015 Predictive value and clinical utility of centrally assessed ER, PgR, and Ki-67 to select adjuvant endocrine therapy for premenopausal women with hormone receptor-positive, HER2-negative early breast cancer: TEXT and SOFT trials Regan MM, Pagani O, Francis PA, Fleming GF, Walley BA, Kammler R, Dell'Orto P, Russo L, Szo"ke J, Doimi F, Villani L, Pizzolitto S, hlschlegel C, Sessa F, Peg Cmara V, Rodrguez Peralto JL, MacGrogan G, Colleoni M, Goldhirsch A, Price KN, Coates AS, Gelber RD, Viale G; SOFT and TEXT Investigators and International Breast Cancer Study Group. BIG 2-02 SOFT; BIG 3-02 TEXT Breast Cancer Res Treat 154:275-286, 2015. (IBCSG 24-02 and 25-02) Breast Cancer Research and Treatment
2015 Predicting benefit of endocrine therapy for early breast cancer Regan MM. BIG 2-02 SOFT; BIG 3-02 TEXT Breast. Nov 1 Suppl 2:S129-31, 2015. (IBCSG 24-02 and 25-02) Breast
2015 Predicting benefit of endocrine therapy for early breast cancer Regan MM. BIG 2-02 SOFT; BIG 3-02 TEXT Breast. Nov 1 Suppl 2:S129-31, 2015. (IBCSG 24-02 and 25-02) Breast
2015 Patient-reported outcomes with adjuvant exemestane versus tamoxifen in premenopausal women with early breast cancer undergoing ovarian suppression (TEXT and SOFT): a combined analysis of two phase 3 randomised trials Bernhard J, Luo W, Ribi K, Colleoni M, Burstein HJ, Tondini C, Pinotti G, Spazzapan S, Ruhstaller T, Puglisi F, Pavesi L, Parmar V, Regan MM, Pagani O, Fleming GF, Francis PA, Price KN, Coates AS, Gelber RD, Goldhirsch A, Walley BA BIG 2-02 SOFT; BIG 3-02 TEXT Lancet Oncol. 2015 Jul;16(7):848-58. Epub 2015 Jun 16. The Lancet Oncology
2015 New insights into endocrine therapy for young women with breast cancer Lascio SD, Pagani O BIG 2-02 SOFT; BIG 3-02 TEXT Womens Health (Lond Engl). 2015 Jun;11(3):343-54 Womens Health
2015 Interpreting quality-of-life data from the SOFT and TEXT trials. Chlebowski R. BIG 2-02 SOFT; BIG 3-02 TEXT Lancet Oncology 2015; 16:749-751. (IBCSG 24-02/BIG 2-02; IBCSG 25-02/BIG 3-02 TEXT) Lancet Oncology
2015 Improved adjuvant endocrine therapy for premenopausal women with endocrine responsive disease Goldhirsch A, Colleoni M, Regan M. BIG 2-02 SOFT; BIG 3-02 TEXT 2015 Jun 9;9:544. eCollection 2015 (Review) (on-line journal) eCancer on-line journal
2015 Improved adjuvant endocrine therapy for premenopausal women with endocrine responsive disease Goldhirsch A, Colleoni M, Regan M. I BIG 2-02 SOFT; BIG 3-02 TEXT Ecancermedicalscience. 2015 Jun 9;9:544. e Collection 2015 (Review) (on-line journal). eCancer on-line journal
2015 Adjuvant ovarian suppression in premenopausal breast cancer Francis PA*, Regan MM*, Fleming GF, Lng I, Ciruelos E, Bellet M, Bonnefoi HR, Climent MA, Da Prada GA, Burstein HJ, Martino S, Davidson NE, Geyer Jr CE, Walley BA, Coleman RC, Kerbrat P, Buchholz S, Ingle JN, Winer EP, Rabaglio-Poretti M, Maibach R, Ruepp B, Giobbie-Hurder A, Price KN, Colleoni M, Viale G, Coates AS, Goldhirsch A, Gelber RD for the SOFT investigators and the International Breast Cancer Study Group. *Co-first authors BIG 2-02 SOFT; BIG 3-02 TEXT N Engl J Med. 2015 Jan 29;372(5):436-46. New England Journal of Medicine
2015 Breast Cancer Diagnosed During Pregnancy: Adapting Recent Advances in Breast Cancer Care for Pregnant Patients. Loibl S et al. BIG 2-03 Breast Cancer in Pregnancy JAMA Oncol 2015; 1(8):1145-53. (BIG 2-03) JAMA Oncology
2015 Adjuvant Lapatinib and Trastuzumab for Early Human Epidermal Growth Factor Receptor 2Positive Breast Cancer: Results From the Randomized Phase III Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization Trial Piccart-Gebhart M, Holmes E, Baselga J, de Azambuja E, Dueck AC, Viale G, Zujewski JA, Goldhirsch A, Armour A, Pritchard KI, McCullough AE, Dolci S, McFadden E, Holmes AP, Tonghua L, Eidtmann H, Dinh P, Di Cosimo S, Harbeck N, Tjulandin S, Im, JH, Huang CS, Diras V, Hillman DW, Wolff AC, Jackisch C, Lang I, Untch M, Smith I, Boyle F, Xu B, Gomez H, Suter T, Gelber RD, Perez EA. BIG 2-06 ALTTO JCO November 23, 2015 JCO621797 Journal of Clinical Oncology
2015 HLA-DRB1*07:01 biomarker characterization of hepatotoxicity during lapatinib combination therapies in ALTTO C F. Spraggs, LR Parham, L Warren, L S Williams, L P Briley, D Fraser, Z Jiang, Z Aziz, Z Tong, S D Moodley, A O. Mehta, N Jackson, J Byrne, M Andersson, M Toi, L Harris, J Gralow, R Crescenzo, A A. Armour BIG 2-06 ALTTO J Clin Oncol. doi: 10.1200/jco.2015.33.15_suppl.617 Journal of Clinical Oncology 33, no. 15_suppl (May 2015) 617-617. Journal of Clinical Oncology
2015 Prognostic and predictive value of ER?1 and ER?2 in the Intergroup Exemestane Study - first results from PathIES. V. Speirs, et al., on behalf of the PathIES Sub-Committee BIG 2-97 IES Ann Oncol (2015) 26 (9): 1890-1897. Annals of Oncology
2015 Final 10-year results of the Breast International Group 298 phase III trial and the role of Ki67 in predicting benefit of adjuvant docetaxel in patients with oestrogen receptor positive breast cancer Sonnenblick A, Francis P, Azim Jr. H, de Azambuja E, Nordenskjld B, Gutirez J, Quinaux E, Mastropasqua M, Ameye L, Anderson M, Lluch A, Gnant M, Goldhirsch A, Di Leo A, Barnadas A, Cortes-Funes H, Piccart M, Crown J BIG 2-98 TAX 315 Eur J Cancer. 2015 Aug;51(12):1481-9. Epub 2015 Jun 11 European Journal of Cancer
2015 Effect of metformin vs placebo on and metabolic factors in NCIC CTG MA.32. Goodwin PJ, Parulekar WR, Gelmon KA, Shepherd LE, Ligibel JA, Hershman DL, Rastogi P, Mayer IA, Hobday TJ, Lemieux J, Thompson AM, Pritchard KI, Whelan TJ, Mukherjee SD, Chalchal HI, Oja CD, Tonkin KS, Bernstein V, Chen BE, Stambolic V. BIG 5-11 MA.32 J Natl Cancer Inst. 2015 Mar 4;107(3). pii: djv006. doi: 10.1093/jnci/djv006. Print 2015 Mar. J Natl Cancer Inst.
2015 Optimal adjuvant treatment for patients with HER2-positive breast cancer in 2015. Zardavas D, Fouad TM, Piccart M. General Breast. 2015 Nov;24 Suppl 2:S143-8. doi: 10.1016/j.breast.2015.07.034. Epub 2015 Aug 5. Breast
2015 Tailoring therapies--improving the management of early breast cancer: St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2015. Coates AS, Winer EP, Goldhirsch A, Gelber RD, Gnant M, Piccart-Gebhart M, Thrlimann B, Senn HJ; Panel members. St Gallen Consensus Ann Oncol. 26: 1533-1546, 2015. Annals of Oncology
2015 Benefit to neoadjuvant anti-human epidermal growth factor receptor 2 (HER2)-targeted therapies in HER2-positive primary breast cancer is independent of phosphatase and tensin homolog deleted from chromosome 10 (PTEN) status Nuciforo PG, Aura C, Holmes E, Prudkin L, Jimenez J, Martinez P, Ameels H, de la Pea L, Ellis C, Eidtmann H, Piccart-Gebhart MJ, Scaltriti M, Baselga J BIG 1-06 NeoALTTO Ann Oncol. 2015 Jul; doi: 10.1093/annonc/mdv175. Annals of Oncology
2014 Adjuvant therapy with zoledronate in early breast cancer (AZURE BIG 01/04): final efficacy analysis R Coleman, D Cameron, D Dodwell, R Bell, C Wilson, E Rathbone, M Keane, M Gil, R Burkinshaw, S Houston, R Grieve, P Barrett-Lee, D Ritchie, V Liversedge, S Hinsley, H Marshall, on behalf of the AZURE investigators BIG 01-04 AZURE Lancet Oncol. 2014 Aug doi: 10.1016/S1470-2045(14)70302-X. Epub 2014 Jul 15. The Lancet Oncology
2014 Pathological complete response after neoadjuvant chemotherapy is an independent predictive factor irrespective of simplified breast cancer intrinsic subtypes: a landmark and two-step approach analyses from the EORTC 10994/BIG 1-00 phase III trial. Bonnefoi H, Litire S, Piccart M, MacGrogan G, Fumoleau P, Brain E, Petit T, Rouanet P, Jassem J, Moldovan C, Bodmer A, Zaman K, Cufer T, Campone M, Luporsi E, Malmstrm P, Werutsky G, Bogaerts J, Bergh J, Cameron DA; EORTC 10994/BIG 1-00 Study investigators. BIG 1-00 p53 Ann Oncol. 2014 Jun;25(6):1128-36. doi: 10.1093/annonc/mdu118. Epub 2014 Mar 11. Annals of Oncology
2014 Trastuzumab-associated cardiac events at 8 years of median follow-up in the Herceptin Adjuvant trial (BIG 1-01). de Azambuja E, Procter MJ, van Veldhuisen DJ, Agbor-Tarh D, Metzger-Filho O, Steinseifer J, Untch M, Smith IE, Gianni L, Baselga J, Jackisch C, Cameron DA, Bell R, Leyland-Jones B, Dowsett M, Gelber RD, Piccart-Gebhart MJ, Suter TM. BIG 1-01 HERA J Clin Oncol. 2014 Jul 10;32(20):2159-65. doi: 10.1200/JCO.2013.53.9288. Epub 2014 Jun 9. Journal of Clinical Oncology
2014 Chemotherapy for isolated locoregional recurrence of breast cancer (CALOR): a randomised trial Aebi S, Gelber S., Anderson SJ, Lng I, Robidoux A, Martn M, Nortier JWR, Paterson A, Rimawi MF, Baena Caada JM, Thrlimann B, Murray E, Mamounas EP, Geyer CE, Price KN, Coates AS, Gelber RD, Rastogi P, Wolmark N, Wapnir IL on behalf of the CALOR investigators BIG 1-02 CALOR Lancet Oncol 15:156-163, 2014 The Lancet Oncology
2014 Adjuvant zoledronic acid in patients with early breast cancer: final efficacy analysis of the AZURE (BIG 01/04) randomised open-label phase 3 trial. Coleman R, Cameron D, Dodwell D, Bell R, Wilson C, Rathbone E, Keane M, Gil M, Burkinshaw R, Grieve R, Barrett-Lee P, Ritchie D, Liversedge V, Hinsley S, Marshall H; AZURE investigators. BIG 1-04 AZURE Lancet Oncol. 2014 Aug;15(9):997-1006. doi: 10.1016/S1470-2045(14)70302-X. Epub 2014 Jul 15. The Lancet Oncology
2014 Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): survival outcomes of a randomised, open-label, multicentre, phase 3 trial and their association with pathological complete response. de Azambuja E, Holmes AP, Piccart-Gebhart M, Holmes E, Di Cosimo S, Swaby RF, Untch M, Jackisch C, Lang I, Smith I, Boyle F, Xu B, Barrios CH, Perez EA, Azim HA Jr, Kim SB, Kuemmel S, Huang CS, Vuylsteke P, Hsieh RK, Gorbunova V, Eniu A, Dreosti L, Tavartkiladze N, Gelber RD, Eidtmann H, Baselga J. BIG 1-06 NeoALTTO Lancet Oncol. 2014 Sep;15(10):1137-46. doi: 10.1016/S1470-2045(14)70320-1. Epub 2014 Aug 14. The Lancet Oncology
2014 The AURORA initiative for metastatic breast cancer. D. Zardavas, M. Maetens, A. Irrthum, T. Goulioti, K. Engelen, D. Fumagalli, R. Salgado, P. Aftimos, K. S. Saini, C. Sotiriou, P. Campbell, P. Dinh, G. von Minckwitz, R. D. Gelber, M. Dowsett, A. Di Leo, D. Cameron, J. Baselga, M. Gnant, A. Goldhirsch, L. Norton and M. Piccart. BIG 14-01 AURORA British Journal of Cancer (2014) 111, 18811887. doi:10.1038/bjc.2014.341 www.bjcancer.com Published online 16 September 2014. British Journal of Cancer
2014 Symptoms of endocrine treatment and outcome in the BIG 1-98 study Huober J, Cole BF, Rabaglio M, Giobbie-Hurder A, Wu J, Ejlertsen B, Bonnefoi H, Forbes JF, Neven P, Lang I, Smith I, Wardley A, Price KN, Goldhirsch A, Coates AS, Colleoni M, Gelber RD, Thurlimann B for the BIG 1-98 Collaborative and International Breast Cancer Study Groups BIG 1-98 Breast Cancer Res Treat 143:159-69, 2014 Breast Cancer Research and Treatment
2014 Elevated APOBEC3B correlates with poor outcomes for estrogen-receptor-positive breast cancers. Sieuwerts AM, Willis S, Burns MB, Look MP, Meijer-Van Gelder ME, Schlicker A, Heideman MR, Jacobs H, Wessels L, Leyland-Jones B, Gray KP, Foekens JA, Harris RS, Martens JW. BIG 1-98 Horm Cancer. 2014 Dec;5(6):405-13. doi: 10.1007/s12672-014-0196-8. Epub 2014 Aug 15. Hormones and Cancer
2014 Bone mineral density and circulating biomarkers in the BIG 1-98 trial comparing adjuvant letrozole, tamoxifen and their sequences Decensi A, Sun Z, Guerrieri-Gonzaga A, Thrlimann B, McIntosh C, Tondini C, Monnier A, Campone M, Debled M, Schnenberger A, Zaman K, Johansson H, Price KN, Gelber RD, Goldhirsch A, Coates AS, Aebi S BIG 1-98 Breast Cancer Res Treat 144:321-329, 2014 Breast Cancer Research and Treatment
2014 Adjuvant exemestane with ovarian suppression in premenopausal breast cancer Pagani O, Regan MM, Walley BA, Fleming GF, Colleoni M, Lng I, Gomez HL, Tondini C, Burstein HJ, Perez EA, Ciruelos E, Stearns V, Bonnefoi HR, Martino S, Geyer CE Jr, Pinotti G, Puglisi F, Crivellari D, Ruhstaller T,Winer EP, Rabaglio-Poretti M, Maibach R, Ruepp B, Giobbie-Hurder A, Price KN, Bernhard J, Luo W, Ribi K, Viale G, Coates AS, Gelber RD, Goldhirsch A, Francis PA; the TEXT and SOFT Investigators and the International Breast Cancer Study Group BIG 2-02 SOFT; BIG 3-02 TEXT N Engl J Med 371:107-118, 2014 New England Journal of Medicine
2014 Central pathology laboratory review of HER2 and ER in early breast cancer: an ALTTO trial [BIG 2-06/NCCTG N063D (Alliance)] ring study McCullough AE, DellOrto P, Reinholz MM, Gelber RD, Dueck AC, Russo L, Jenkins RB, Andrighetto S, Chen B, Jackisch C, Untch M, Perez EA, Piccart-Gebhart MJ, Viale G BIG 2-06 ALTTO Breast Cancer Res Treat 143:485-492, 2014 Breast Cancer Research and Treatment
2014 Quality of life (QOL) among patients (pts) with HER2+ breast cancer (bc) treated with adjuvant lapatinib and/or trastuzumab in the ALTTO study (BIG 2-06, Alliance N063D). A C. Dueck, D W. Hillman, L A. Kottschade, M Y. Halyard, J A. Sloan, L M. Flickinger, A C. Wolff, L Harris, J Gralow, K I. Pritchard, S Ellard, N Le-Lindqwister, F M. Boyle, E De Azambuja, W J. McCaskill-Stevens, JA Zujewski, M J. Piccart-Gebhart, E A. Perez BIG 2-06 ALTTO J Clin Oncol. doi: 10.1200/jco.2014.32.15_suppl.647 Journal of Clinical Oncology 32, no. 15_suppl (May 2014) 647-647. Journal of Clinical Oncology
2014 Mammographic screening detects low-risk tumor biology breast cancers. Drukker CA, Schmidt MK, Rutgers EJ, Cardoso F, Kerlikowske K, Esserman LJ, van Leeuwen FE, Pijnappel RM, Slaets L, Bogaerts J, Van't Veer LJ. BIG 3-04 MINDACT Breast Cancer Res Treat. 2014 Feb;144(1):103-11. doi: 10.1007/s10549-013-2830-5. Epub 2014 Jan 28. Breast Cancer Research and Treatment
2014 High concordance of protein (by IHC), gene (by FISH; HER2 only), and microarray readout (by TargetPrint) of ER, PgR, and HER2: results from the EORTC 10041/BIG 03-04 MINDACT trial. Viale G, Slaets L, Bogaerts J, Rutgers E, van't Veer L, Piccart-Gebhart MJ, de Snoo FA, Stork-Sloots L, Russo L, Dell'Orto P, van den Akker J, Glas A, Cardoso F; TRANSBIG Consortium & the MINDACT Investigators. BIG 3-04 MINDACT Ann Oncol. 2014 Apr;25(4):816-23. doi: 10.1093/annonc/mdu026. Annals of Oncology
2014 Attitudes of young patients with breast cancer toward fertility loss related to adjuvant systemic therapies. EORTC study 10002 BIG 3-98 Senkus E, Gomez H, Dirix L, Jerusalem G, Murray E, Van Tienhoven G, Westenberg AH, Bottomley A, Rapion J, Bogaerts J, Di Leo A, Nekovi?-Konstantinovi? Z BIG 3-98 Young patients fertility survey Psychooncology 23:173-182, 2014 Psychooncology
2014 Improving decision making about clinical trial participation - a randomised controlled trial of a decision aid for women considering participation in the IBIS-II breast cancer prevention trial. Juraskova I, Butow P, Bonner C, Bell ML, Smith AB, Seccombe M, Boyle F, Reaby L, Cuzick J, Forbes JF. BIG 5-02 IBIS-II Br J Cancer. 2014 Jul 8;111(1):1-7. doi: 10.1038/bjc.2014.144. Epub 2014 Jun 3. British Journal of Cancer
2014 Changes in bone mineral density at 3 years in postmenopausal women receiving anastrozole and risedronate in the IBIS-II bone substudy: an international, double-blind, randomised, placebo-controlled trial. Sestak I, Singh S, Cuzick J, Blake GM, Patel R, Gossiel F, Coleman R, Dowsett M, Forbes JF, Howell A, Eastell R. BIG 5-02 IBIS-II Lancet Oncol. 2014 Dec;15(13):1460-8. doi: 10.1016/S1470-2045(14)71035-6. Epub 2014 Nov 11. The Lancet Oncology
2014 Anastrozole for prevention of breast cancer in high-risk postmenopausal women (IBIS-II): an international, double-blind, randomised placebo-controlled trial. Cuzick J, Sestak I, Forbes JF, Dowsett M, Knox J, Cawthorn S, Saunders C, Roche N, Mansel RE, von Minckwitz G, Bonanni B, Palva T, Howell A; IBIS-II investigators. BIG 5-02 IBIS-II Lancet. 2014 Mar 22;383(9922):1041-8. doi: 10.1016/S0140-6736(13)62292-8. Epub 2013 Dec 12. Lancet
2013 2 years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): an open-label, randomised controlled trial Goldhirsch A, Gelber RD, Piccart-Gebhart MJ, de Azambuja E, Procter M, Suter TM, Jackisch C, Cameron D, Weber HA, Heinzmann D, Dal Lago L, McFadden E, Dowsett M, Untch M, Gianni L, Bell R, Khne CH, Vindevoghel A, Andersson M, Brunt AM, Otero-Reyes D, Song S, Smith I, Leyland-Jones B, Baselga J; Herceptin Adjuvant (HERA) Trial Study Team BIG 1-01 HERA Lancet 382:1021-1028, 2013 The Lancet
2013 Clinical practice-changing trials: the HERA study paradigm. Zardavas D, Ades F, de Azambuja E. BIG 1-01 HERA Expert Rev Anticancer Ther. 2013 Nov;13(11):1249-56. doi: 10.1586/14737140.2013.848168. Epub 2013 Oct 21. Expert Review of Anticancer Therapy
2013 CNS relapses in patients with HER2-positive early breast cancer who have and have not received adjuvant trastuzumab: a retrospective substudy of the HERA trial (BIG 1-01) Pestalozzi BC, Holmes E, de Azambuja E, Metzger-Filho O, Hogge L, Scullion M, Lng I, WardleyA, Lichinitser M, Sanchez RIL, Mller V, Dodwell D, Gelber RD, Piccart-Gebhart MJ, Cameron D BIG 1-01 HERA Lancet Oncol 14:244-248 The Lancet Oncology
2013 Effect of Age on Breast Cancer Outcomes in Women With Human Epidermal Growth Factor Receptor 2Positive Breast Cancer: Results From a Herceptin Adjuvant Trial Partridge AH, Gelber S, Piccart-Gebhart MJ, Focant F, Scullion M, Holmes E, Winer EP, Gelber RD. BIG 1-01 HERA J Clin Oncol. 2013 Jul 20;31(21):2692-8. doi: 10.1200/JCO.2012.44.1956. Epub 2013 Jun 10. Journal of Clinical Oncology
2013 HER2 staining intensity in HER2-positive disease: relationship with FISH amplification and clinical outcome in the HERA trial of adjuvant trastuzumab Zabaglo L, Stoss O, Rschoff J, Zielinski D, Salter J, Arfi M, Bradbury I, Dafni U, Piccart-Gebhart M, Procter M, Dowsett M; HERA Trial Study Team. BIG 1-01 HERA Ann Oncol. 2013 Nov;24(11):2761-6. doi: 10.1093/annonc/mdt275. Epub 2013 Jul 25. Annals of Oncology
2013 Magnitude of trastuzumab benefit in patients with HER2-positive, invasive lobular breast carcinoma: results from the HERA trial. Metzger-Filho O, Procter M, de Azambuja E, Leyland-Jones B, Gelber RD, Dowsett M, Loi S, Saini KS, Cameron D, Untch M, Smith I, Gianni L, Baselga J, Jackisch C, Bell R, Sotiriou C, Viale G, Piccart-Gebhart M. BIG 1-01 HERA J Clin Oncol. 2013 Jun 1;31(16):1954-60. doi: 10.1200/JCO.2012.46.2440. Epub 2013 Apr 15. Journal of Clinical Oncology
2013 Adjuvant pegylated liposomal doxorubicin for older women with endocrine nonresponsive breast cancer who are NOT suitable for a standard chemotherapy regimen: the CASA randomized trial Crivellari D, Gray KP, Dellapasqua S, Puglisi F, Ribi K, Price KN, Lng I, Gianni L, Spazzapan S, Pinotti G, Lthi JM, Gelber RD, Regan MM, Colleoni M, Castiglione-Gertsch M, Maibach R, Rabaglio M, Coates AS, Goldhirsch A for the IBCSG BIG 1-05 CASA The Breast 22:130-137, 2013 The Breast
2013 18F-FDG PET/CT for early prediction of response to neoadjuvant lapatinib, trastuzumab, and their combination in HER2-positive breast cancer: results from Neo-ALTTO Gebhart G, Gmez C, Holmes E, Robles J, Garcia C, Corts M, de Azambuja E, Fauria K, Van Dooren V, Aktan G, Coccia-Portugal MA, Kim SB, Vuylsteke P, Cure H, Eidtmann H, Baselga J, Piccart M, Flamen P, Di Cosimo S. BIG 1-06 NeoALTTO J Nucl Med. 2013 Nov;54(11):1862-8. Epub 2013 Oct 3 Journal of Nuclear Medicine
2013 Circulating tumor cells and response to neoadjuvant paclitaxel and HER2-targeted therapy: a sub-study from the NeoALTTO phase III trial. Azim HA Jr, Roth F, Aura CM, Bavington M, Maetens M, Rouas G, Gebhart G, Gamez C, Eidtmann H, Baselga J, Piccart-Gebhart M, Ellis C, Vuylsteke P, Cure H, Domont J, Ferro A, Toral-Pea JC, de Azambuja E, Sotiriou C, Di Cosimo S, Ignatiadis M. BIG 1-06 NeoALTTO Breast. 2013 Dec;22(6):1060-5. doi: 10.1016/j.breast.2013.08.014. Epub 2013 Sep 20. Breast
2013 Factors associated with surgical management following neoadjuvant therapy in patients with primary HER2-positive breast cancer: results from the NeoALTTO phase III trial. Criscitiello C, Azim HA Jr, Agbor-tarh D, de Azambuja E, Piccart M, Baselga J, Eidtmann H, Di Cosimo S, Bradbury I, Rubio IT. BIG 1-06 NeoALTTO Ann Oncol. 2013 Aug;24(8):1980-5. doi: 10.1093/annonc/mdt129. Epub 2013 Apr 7. Annals of Oncology
2013 Pattern of rash, diarrhea, and hepatic toxicities secondary to lapatinib and their association with age and response to neoadjuvant therapy: analysis from the NeoALTTO trial. Azim HA Jr, Agbor-Tarh D, Bradbury I, Dinh P, Baselga J, Di Cosimo S, Greger JG Jr, Smith I, Jackisch C, Kim SB, Aktas B, Huang CS, Vuylsteke P, Hsieh RK, Dreosti L, Eidtmann H, Piccart M, de Azambuja E. BIG 1-06 NeoALTTO J Clin Oncol. 2013 Dec 20;31(36):4504-11. doi: 10.1200/JCO.2013.50.9448. Epub 2013 Nov 18. Journal of Clinical Oncology
2013 EGFR expression is associated with decreased response from HER2 targeted therapeutics in the neo-adjuvant setting in the NeoALTTO trial DL Rimm, E Holmes, K Schalper, I Bradbury, E Zarrella, C Ellis, J Baselga, H Eidtmann, M Piccart, N Harbeck, L Pusztai and E Perez BIG 1-06 NeoALTTO DOI: 10.1158/0008-5472.SABCS13-P1-08-09 Cancer Research
2013 Clinical application of circulating tumor cells in breast cancer: overview of the current interventional trials Bidard FC, Fehm T, Ignatiadis M, Smerage JB, Alix-Panabires C, Janni W, Messina C, Paoletti C, Mller V, Hayes DF, Piccart M, Pierga JY BIG 1-12 Treat CTC Cancer Metastasis Rev. 2013 Jun;32(1-2):179-88 Cancer and Metastasis Reviews
2013 Extended adjuvant endocrine therapy in hormone dependent breast cancer: the paradigm of the NCIC-CTG MA.17/BIG 1-97 trial. Higgins MJ1, Liedke PE, Goss PE. BIG 1-97 MA.17 Crit Rev Oncol Hematol. 2013 Apr;86(1):23-32. doi: 10.1016/j.critrevonc.2012.09.013. Epub 2012 Oct 30. Critical Reviews in Oncology/Hematology
2013 Personalized adjuvant therapies: lessons from the past: the opening address by the St. Gallen 2013 award recipient. Goldhirsch A BIG 1-98 Breast. 2013 Aug;22 Suppl 2:S3-7. doi: 10.1016/j.breast.2013.07.001. Breast
2013 Obesity and endocrine therapy: host factors and breast cancer outcome. Goodwin PJ BIG 1-98 Breast. 2013 Aug;22 Suppl 2:S44-7. doi: 10.1016/j.breast.2013.07.008. Breast
2013 Challenges of guarantee-time bias. Giobbie-Hurder A, Gelber RD, Regan MM. BIG 1-98 J Clin Oncol. 2013 Aug 10;31(23):2963-9. doi: 10.1200/JCO.2013.49.5283. Epub 2013 Jul 8. Journal of Clinical Oncology
2013 Adjuvant treatment of premenopausal women with endocrine-responsive early breast cancer: Design of the TEXT and SOFT trials Regan MM, Pagani O, Fleming GF, Walley BA, Price KN, Rabaglio M, Maibach R, Ruepp B, Coates AS, Goldhirsch A, Colleoni M, Gelber RD, Francis PA for the IBCSG and SOFT and TEXT investigators BIG 2-02 SOFT; BIG 3-02 TEXT The Breast 22 1094-1100, 2013 The Breast
2013 Adjuvant treatment of premenopausal women with endocrineresponsive early breast cancer: design of the TEXT and SOFT trials Meredith M. Regan, Olivia Pagani, Gini F. Fleming , Barbara A. Walley, Karen N. Price, Manuela Rabaglio, Rudolf Maibach, Barbara Ruepp, Alan S. Coates, Aron Goldhirsch, Marco Colleoni, Richard D. Gelber, Prudence A. Francis, on behalf of the International Breast Cancer Study Group (IBCSG) and the SOFT and TEXT Investigators BIG 2-02 SOFT; BIG 3-02 TEXT Breast. 2013 Dec;22 doi: 10.1016/j.breast.2013.08.009. Epub 2013 Oct 2. The Breast
2013 Prognosis of women with primary breast cancer diagnosed during pregnancy: results from an international collaborative study. Amant F, von Minckwitz G, Han SN, Bontenbal M, Ring AE, Giermek J, Wildiers H, Fehm T, Linn SC, Schlehe B, Neven P, Westenend PJ, Mller V, Van Calsteren K, Rack B, Nekljudova V, Harbeck N, Untch M, Witteveen PO, Schwedler K, Thomssen C, Van Calster B, Loibl S. BIG 2-03 Breast Cancer in Pregnancy J Clin Oncol. 2013 Jul 10;31(20):2532-9. doi: 10.1200/JCO.2012.45.6335. Epub 2013 Apr 22. Journal of Clinical Oncology
2013 Analysis of regional timelines to set up a global phase III clinical trial in breast cancer: the adjuvant lapatinib and/or trastuzumab treatment optimization experience. Metzger-Filho O, de Azambuja E, Bradbury I, Saini KS, Bines J, Simon SD, Dooren VV, Aktan G, Pritchard KI, Wolff AC, Smith I, Jackisch C, Lang I, Untch M, Boyle F, Xu B, Baselga J, Perez EA, Piccart-Gebhart M. BIG 2-06 ALTTO Oncologist. 2013;18(2):134-40. doi: 10.1634/theoncologist.2012-0342. Epub 2013 Jan 28. The Oncologist
2013 Overall survival benefit for sequential doxorubicindocetaxel compared with concurrent doxorubicin and docetaxel in node-positive breast cancer8-year results of the Breast International Group 02-98 phase III trial Oakman C, Francis PA, Crown J, Quinaux E, Buyse M, De Azambuja E, Margeli Vila M, Andersson, Nordenskjld B, Jakesz R, Thrlimann B, Gutirrez J, Harvey V, Punzalan L, Dellorto P, Larsimont D, Steinberg I, Gelber RD, Piccart-Gebhart M, Viale G, Di Leo A BIG 2-98 TAX 315 Ann Oncol 24: 1203-1211, 2013 Annals of Oncology
2013 Prognostic and predictive value of tumor-infiltrating lymphocytes in a phase III randomized adjuvant breast cancer trial in node-positive breast cancer comparing the addition of docetaxel to doxorubicin with doxorubicin-based chemotherapy: BIG 02-98 Loi S, Sirtaine N, Piette F, Salgado R, Viale G, Van Eenoo F, Rouas G, Francis P, Crown JP, Hitre E, de Azambuja E, Quinaux E, Di Leo A, Michiels S, Piccart MJ, Sotiriou C BIG 2-98 TAX 315 J Clin Oncol 31:860-867, 2013 Journal of Clinical Oncology
2013 Trastuzumab for patients with HER2 positive breast cancer: delivery, duration and combination therapies. Pinto AC, Ades F, de Azambuja E, Piccart-Gebhart M. General Breast. 2013 Aug;22 Suppl 2:S152-5. doi: 10.1016/j.breast.2013.07.029. Breast
2013 The 41st David A. Karnofsky Memorial Award Lecture : Academic Research Worldwide - Quo Vadis? Piccart M General J Clin Oncol. 2014 Feb 1;32(4):347-54. doi: 10.1200/JCO.2013.53.2549. Epub 2013 Dec 23. Journal of Clinical Oncology
2013 Prognostic impact of pregnancy after breast cancer according to estrogen receptor status: a multicenter retrospective study. Azim HA Jr, Kroman N, Paesmans M, Gelber S, Rotmensz N, Ameye L, De Mattos-Arruda L, Pistilli B, Pinto A, Jensen MB, Cordoba O, de Azambuja E, Goldhirsch A, Piccart MJ, Peccatori FA. BIG 8-13 POSITIVE J Clin Oncol. 2013 Jan 1;31(1):73-9. doi: 10.1200/JCO.2012.44.2285. Epub 2012 Nov 19. Journal of Clinical Oncology
2013 Perceptions and needs of women with metastatic breast cancer: A focus on clinical trials Nahleh ZA, Lin NU, Wolff AC, Cardoso F on behalf of the BIG-NABCG collaboration BIG-NABCG collaboration Breast.2013 Jun;22(3):370-3. doi: 10.1016/j.breast.2013.02.017. Epub 2013 Mar 25 The Breast
2013 An international Ki67 reproducibility study Polley MY, Leung SC, McShane LM, Gao D, Hugh JC, Mastropasqua MG, Viale G, Zabaglo LA, Penault-Llorca F, Bartlett JM, Gown AM, Symmans WF, Piper T, Mehl E, Enos RA, Hayes DF, Dowsett M, Nielsen TO; on behalf of the International Ki67 in Breast Cancer Working Group of the Breast International Group and North American Breast Cancer Group BIG-NABCG collaboration J Natl Cancer Inst. 2013 Dec 18;105(24):1897-906. doi: 10.1093/jnci/djt306. Epub 2013 Nov 7 Journal of the National Cancer Institute
2012 Making sense of clinical trial data: is inverse probability of censoring weighted analysis the answer to crossover bias? Rimawi M, Hilsenbeck SG. BIG 1-01 HERA J Clin Oncol. 2012 Feb 1;30(4):453-8. doi: 10.1200/JCO.2010.34.2808. Epub 2012 Jan 3. Journal of Clinical Oncology
2012 Pregnancy occurring during or following adjuvant trastuzumab in patients enrolled in the HERA trial (BIG 01-01). Azim HA Jr, Metzger-Filho O, de Azambuja E, Loibl S, Focant F, Gresko E, Arfi M, Piccart-Gebhart M. BIG 1-01 HERA Breast Cancer Res Treat. 2012 May;133(1):387-91. doi: 10.1007/s10549-012-1996-6. Epub 2012 Feb 26. Breast Cancer Research and Treatment
2012 Adjuvant bone-targeted therapy to prevent metastasis: lessons from the AZURE study. Coleman RE BIG 1-04 AZURE Curr Opin Support Palliat Care. 2012 Sep;6(3):322-9. doi: 10.1097/SPC.0b013e32835689cd. Current opinion in supportive and palliative care
2012 Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial Baselga J, Bradbury I, Eidtmann H, Di Cosimo S, de Azambuja E, Aura C, Gmez H, Dinh P, Fauria K, Van Dooren V, Aktan G, Goldhirsch A, Chang T-W, Horvth Z, Coccia-Portugal M, Domont J, Tseng L-M, Kunz G, Sohn JH, Semiglazov V, Lerzo G, Palacova M, Probachai V, Pusztai L, Untch M, Gelber RD, Piccart-Gebhart M, on behalf of the NeoALTTO Study Team BIG 1-06 NeoALTTO Lancet. 2012 Feb 18;379(9816):633-40. Epub 2012 Jan 17 The Lancet
2012 Longer-term outcomes of letrozole versus placebo after 5 years of tamoxifen in the NCIC CTG MA.17 trial: analyses adjusting for treatment crossover. Jin H, Tu D, Zhao N, Shepherd LE, Goss PE. BIG 1-97 MA.17 J Clin Oncol. 2012 Mar 1;30(7):718-21. doi: 10.1200/JCO.2010.34.4010. Epub 2011 Oct 31. Journal of Clinical Oncology
2012 Lipid concentrations in postmenopausal women on letrozole after 5 years of tamoxifen: an NCIC CTG MA.17 sub-study. Wasan KM, Goss PE, Pritchard PH, Shepherd L, Tu D, Ingle JN. BIG 1-97 MA.17 Breast Cancer Res Treat. 2012 Dec;136(3):769-76. doi: 10.1007/s10549-012-2294-z. Epub 2012 Oct 23. Breast Cancer Research and Treatment
2012 The advantage of letrozole over tamoxifen in the BIG 1-98 trial is consistent in younger postmenopausal women and in those with chemotherapy-induced menopause Chirgwin J, Sun Z, Smith I, Price KN, Thrlimann B, Ejlertsen B, Bonnefoi H, Regan MM, Goldhirsch A, Coates AS BIG 1-98 Breast Cancer Res Treat. 2012 Jan;131(1):295-306. Epub 2011 Sep 4 Breast Cancer Research and Treatment
2012 Subjective cognitive complaints one year after ceasing adjuvant endocrine treatment for early-stage breast cancer Ribi K, Aldridge J, Phillips K-A, Thompson A, Harvey V, Thrlimann B, Cardoso F, Pagani O, Coates AS, Goldhirsch A, Price KN, Gelber RD, Bernhard J for the IBCSG BIG 1-98 Br J Cancer. 2012 May 8;106(10):1618-25. Epub 2012 Apr 24 British Journal of Cancer
2012 Prognostic value of Bcl-2 in two independent populations of estrogen receptor positive breast cancer patients treated with adjuvant endocrine therapy. Larsen MS, Bjerre K, Giobbie-Hurder A, Lnkholm AV, Henriksen KL, Ejlertsen B, Lykkesfeldt AE, Rasmussen BB. BIG 1-98 Acta Oncol. 2012 Jul;51(6):781-9. doi: 10.3109/0284186X.2011.653009. Epub 2012 Mar 30. ACTA Oncologica
2012 Prognostic and predictive role of ESR1 status for postmenopausal patients with endocrine-responsive early breast cancer in the Danish cohort of the BIG 1-98 trial Ejlertsen B, Aldridge J, Nielsen KV, Regan MM, Henriksen KL, Lykkesfeldt AE, Mller S, Gelber RD, Price KN, Rasmussen BB, Viale G, Mouridsen H for the Danish Breast Cancer Cooperative Group, the BIG 1-98 Collaborative Group and the International Breast Cancer Study Group BIG 1-98 Ann Oncol. 2012 May;23(5):1138-44. Epub 2011 Oct 10 Annals of Oncology
2012 Obesity and risk of recurrence or death after adjuvant endocrine therapy with letrozole or tamoxifen in the Breast International Group 1-98 Trial. Ewertz M, Gray KP, Regan MM, Ejilertsen B, Price KN, Thrlimann B, Bonnefoi H, Forbes JFF, Paridaens R, Rabaglio M, Gelber RD, Colleoni M, Lng I, Smith I, Coates AS, Goldhirsch A, Mouridsen H for BIG 1-98 Collaborative and International Breast Cancer Study Groups BIG 1-98 J Clin Oncol 30:3967-3975, 2012 Journal of Clinical Oncology
2012 Making sense of clinical trial data: is inverse probability of censoring weighted analysis the answer to crossover bias? Rimawi M, Hilsenbeck SG. BIG 1-98 J Clin Oncol. 2012 Feb 1;30(4):453-8. doi: 10.1200/JCO.2010.34.2808. Epub 2012 Jan 3. Journal of Clinical Oncology
2012 CYP2D6 Genotype and Tamoxifen Response in Postmenopausal Women with Endocrine-Responsive Breast Cancer: The Breast International Group 1-98 Trial Regan MM, Leyland-Jones B, Bouzyk M, Pagani O, Tang W, Kammler R, Dell'orto P, Biasi MO, Thrlimann B, Lyng MB, Ditzel HJ, Neven P, Debled M, Maibach R, Price KN, Gelber RD, Coates AS, Goldhirsch A, Rae JM, Viale G; on behalf of the Breast International Group (BIG) 1-98 Collaborative Group BIG 1-98 J Natl Cancer Inst. 2012 Mar 21;104(6):441-451. Epub 2012 Mar 6 Journal of the National Cancer Institute
2012 Bone mineral density in breast cancer patients treated with adjuvant letrozole, tamoxifen, or sequences of letrozole and tamoxifen in the BIG 1-98 study (SAKK 21/07) Zaman K, Thrlimann B, Huober J, Schnenberger A, Pagani O, Lthi J, Simcock M, Giobbie-Hurder A, Berthod G, Genton C, Brauchli P, Aebi S; on behalf of the Swiss Group for Clinical Cancer Research (SAKK) BIG 1-98 Ann Oncol. 2012 Jun;23(6):1474-1481. Epub 2011 Oct 14 Annals of Oncology
2012 Treatment of breast cancer during pregnancy: an observational study. Loibl S, Han SN, von Minckwitz G, Bontenbal M, Ring A, Giermek J, Fehm T, Van Calsteren K, Linn SC, Schlehe B, Gziri MM, Westenend PJ, Mller V, Heyns L, Rack B, Van Calster B, Harbeck N, Lenhard M, Halaska MJ, Kaufmann M, Nekljudova V, Amant F. BIG 2-03 Breast Cancer in Pregnancy Lancet Oncol. 2012 Sep;13(9):887-96. doi: 10.1016/S1470-2045(12)70261-9. Epub 2012 Aug 16. The Lancet Oncology
2012 Disease-related outcomes with long-term follow-up: an updated analysis of the intergroup exemestane study Bliss JM, Kilburn LS, Coleman RE, Forbes JF, Coates AS, Jones SE, Jassem J, Delozier T, Andersen J, Paridaens R, van de Velde CJ, Lnning PE, Morden J, Reise J, Cisar L, Menschik T, Coombes RC BIG 2-97 IES J Clin Oncol. 2012 Mar 1;30(7):709-17. Epub 2011 Oct 31 Journal of Clinical Oncology
2012 Prognostic and predictive value of TP53 mutations in node-positive breast cancer patients treated with anthracycline- or anthracycline/taxane based adjuvant therapy: results from the BIG 02-98 phase III trial Fernandez-Cuesta L, Oakman C, Falagan-Lotsch P, Smoth K, Quinaux E, Buyse M, Dolci S, De Azambuja E, Hainaut P, Dell'Orto P, Larsimont D, Francis PA, Crown J, Piccart-Gebhart M, Viale G, Di Leo A, Olivier M BIG 2-98 TAX 315 Breast Cancer Res. 2012 May 2;14(3):R70. Breast Cancer Research
2012 Effect of baseline serum vitamin D levels on aromatase inhibitors induced musculoskeletal symptoms: results from the IBIS-II, chemoprevention study using anastrozole. Singh S, Cuzick J, Mesher D, Richmond B, Howell A. BIG 5-02 IBIS-II Breast Cancer Res Treat. 2012 Apr;132(2):625-9. doi: 10.1007/s10549-011-1911-6. Epub 2011 Dec 25. Breast Cancer Research and Treatment
2012 Role of the multidisciplinary team in breast cancer management: results from a large international survey involving 39 countries. Saini KS, Taylor C, Ramirez AJ, Palmieri C, Gunnarsson U, Schmoll HJ, Dolci SM, Ghenne C, Metzger-Filho O, Skrzypski M, Paesmans M, Ameye L, Piccart-Gebhart MJ, de Azambuja E. General Ann Oncol. 2012 Apr;23(4):853-9. doi: 10.1093/annonc/mdr352. Epub 2011 Aug 4. Annals of Oncology
2012 A common language in neoadjuvant breast cancer clinical trials: proposals for standard definitions and endpoints. Fumagalli D, Bedard PL, Nahleh Z, Michiels S, Sotiriou C, Loi S, Sparano JA, Ellis M, Hylton N, Zujewski JA, Hudis C, Esserman L, Piccart M; BIG-NABCG collaboration BIG-NABCG collaboration Lancet Oncol. 2012 Jun;13(6):e240-8 The Lancet
2011 Safety of zoledronic acid and incidence of osteonecrosis of the jaw (ONJ) during adjuvant therapy in a randomised phase III trial (AZURE: BIG 0104) for women with stage II/III breast cancer Coleman R, Woodward E, Brown J, Cameron D, Bell R, Dodwell D, Keane M, Gil M, Davies C, Burkinshaw R, Houston S J, Grieve R J, Barrett-Lee P J, Thorpe H. BIG 01-04 AZURE Breast Cancer Res Treat. 2011 Jun; doi: 10.1007/s10549-011-1429-y. Epub 2011 Mar 11. Breast Cancer Research and Treatment
2011 A phase III, multicenter, double-blind, randomized trial of celecoxib versus placebo in primary breast cancer patients: Randomized European Celecoxib Trial (REACT) R. C. Coombes, G. Von Minckwitz, J. Hicks, P. Klare, A. A. Evans, M. Schmidt, A. Makris, R. Grieve, S. Loibl, L. Maher, K. Mousa, K. Buchsenscuhtz, R. A'Hern, J. M. Bliss BIG 1-03 REACT DOI: 10.1200/jco.2011.29.15_suppl.tps115 Journal of Clinical Oncology 29, no. 15_suppl Journal of Clinical Oncology
2011 TP53 status for prediction of sensitivity to taxane versus non-taxane neoadjuvant chemotherapy in breast cancer (EORTC 10994/BIG 1-00): a randomised phase 3 trial. Bonnefoi H, Piccart M, Bogaerts J, Mauriac L, Fumoleau P, Brain E, Petit T, Rouanet P, Jassem J, Blot E, Zaman K, Cufer T, Lortholary A, Lidbrink E, Andr S, Litire S, Lago LD, Becette V, Cameron DA, Bergh J, Iggo R; EORTC 10994/BIG 1-00 Study Investigators. BIG 1-00 p53 Lancet Oncol. 2011 Jun;12(6):527-39. Epub 2011 May 11 The Lancet Oncology
2011 Multifactorial approach to predicting resistance to anthracyclines. Desmedt C, Di Leo A, de Azambuja E, Larsimont D, Haibe-Kains B, Selleslags J, Delaloge S, Duhem C, Kains JP, Carly B, Maerevoet M, Vindevoghel A, Rouas G, Lallemand F, Durbecq V, Cardoso F, Salgado R, Rovere R, Bontempi G, Michiels S, Buyse M, Nogaret JM, Qi Y, Symmans F, Pusztai L, D'Hondt V, Piccart-Gebhart M, Sotiriou C. BIG 1-00 p53 J Clin Oncol. 2011 Apr 20;29(12):1578-86. doi: 10.1200/JCO.2010.31.2231. Epub 2011 Mar 21. Journal of Clinical Oncology
2011 Treatment with trastuzumab for 1 year after adjuvant chemotherapy in patients with HER2-positive early breast cancer: a 4-year follow-up of a randomised controlled trial Gianni L, Dafni U, Gelber RD, Azambuja E, Muehlbauer S, Goldhirsch A, Untch M, Smith I, Baselga J, Jackisch C, Cameron D, Mano M, Pedrini JL, Veronesi A, Mendiola C, Pluzanska A, Semiglazov V, Vrdoljak E, Eckart MJ, Shen Z, Skiadopoulos G, Procter M, Pritchard KI, Piccart-Gebhart MJ, Bell R. Herceptin Adjuvant (HERA) Trial Study Team BIG 1-01 HERA Lancet Oncol. 2011 Mar;12(3):236-44. Epub 2011 Feb 25 The Lancet Oncology
2011 Safety of zoledronic acid and incidence of osteonecrosis of the jaw (ONJ) during adjuvant therapy in a randomised phase III trial (AZURE: BIG 01-04) for women with stage II/III breast cancer. Coleman R, Woodward E, Brown J, Cameron D, Bell R, Dodwell D, Keane M, Gil M, Davies C, Burkinshaw R, Houston SJ, Grieve RJ, Barrett-Lee PJ, Thorpe H. BIG 1-04 AZURE Breast Cancer Res Treat. 2011 Jun;127(2):429-38. doi: 10.1007/s10549-011-1429-y. Epub 2011 Mar 11. Breast Cancer Research and Treatment
2011 Breast-Cancer Adjuvant Therapy with Zoledronic Acid Coleman RE, Marshall H, Cameron D, Dodwell D, Burkinshaw R, Keane M, Gil M, Houston SJ, Grieve RJ, Barrett-Lee PJ, Ritchie D, Pugh J, Gaunt C, Rea U, Peterson J, Davies C, Hiley V, Gregory W, Bell R for the AZURE Investigators BIG 1-04 AZURE N Engl J Med 2011; 365:1396-1405 October 13, 2011 New England Journal of Medicine
2011 Which patients benefit most from adjuvant aromatase inhibitors? Results using a composite measure of prognostic risk in the BIG 1-98 randomized trial Viale G, Regan MM, Dell'orto P, Mastropasqua MG, Maiorano E, Rasmussen BB, Macgrogan G, Forbes JF, Paridaens RJ, Colleoni M, Lng I, Thrlimann B, Mouridsen H, Mauriac L, Gelber RD, Price KN, Goldhirsch A, Gusterson BA, Coates AS; for the BIG 1-98 Collaborative and International Breast Cancer Study Groups. BIG 1-98 Ann Oncol. 2011 Oct;22(10):2201-7. Epub 2011 Feb 18 Annals of Oncology
2011 Interpreting Breast International Group (BIG) 1-98: a randomized, double-blind, phase III trial comparing letrozole and tamoxifen as adjuvant endocrine therapy for postmenopausal women with hormone receptor-positive, early breast cancer. Regan MM, Price KN, Giobbie-Hurder A, Thrlimann B, Gelber RD; International Breast Cancer Study Group and BIG 1-98 Collaborative Group. BIG 1-98 Breast Cancer Res. 2011 May 26;13(3):209. doi: 10.1186/bcr2837. Breast Cancer Research and Treatment
2011 Initialization of adjuvant hormonal treatment for breast cancer. Martnez Guisado A, Snchez Muoz A, de la Cabeza Lomas Garrido M, Ruz Borrego M, Bayo Calero J, de Toro Salas R, Gonzlez Mancha R, de la Haba Rodrguez J, Alba Conejo E. BIG 1-98 Adv Ther. 2011 Sep;28 Suppl 6:66-84. doi: 10.1007/s12325-011-0039-8. Epub 2011 Sep 16. Advances in Therapy
2011 Cost-Benefit Analysis of Endocrine Therapy in the Adjuvant Setting for Postmenopausal Patients with Hormone Receptor-Positive Breast Cancer, Based on Survival Data and Future Prices for Generic Drugs in the Context of the German Health Care System. Lux MP, Reichelt C, Karnon J, Tnzer TD, Radosavac D, Fasching PA, Beckmann MW, Thiel FC. BIG 1-98 Breast Care (Basel). 2011 Oct;6(5):381-389. Epub 2011 Oct 13. Breast Care
2011 Correcting for discretionary treatment crossover in an analysis of survival in the Breast International Group BIG 1-98 trial by using the inverse probability of censoring weighted method. Finkelstein DM, Schoenfeld DA. BIG 1-98 J Clin Oncol. 2011 Mar 20;29(9):1093-5. doi: 10.1200/JCO.2010.33.9374. Epub 2011 Feb 14. Journal of Clinical Oncology
2011 Cognitive function in postmenopausal breast cancer patients one year after completing adjuvant endocrine therapy with letrozole and/or tamoxifen in the BIG 1-98 trial Phillips KA, Aldridge J, Ribi K, Sun Z, Thompson A, Harvey V, Thrlimann B, Cardoso F, Pagani O, Coates AS, Goldhirsch A, Price KN, Gelber RD, Bernhard J BIG 1-98 Breast Cancer Res Treat 2011 Feb;126(1):221-6. Epub 2010 Nov 3 Breast Cancer Research and Treatment
2011 Assessment of letrozole and tamoxifen alone and in sequence for postmenopausal women with steroid hormone receptor-positive breast cancer: the BIG 1-98 randomised clinical trial at 81 years median follow-up Regan MM, Neven P, Giobbie-Hurder A, Goldhirsch A, Ejlertsen B, Mauriac L, Forbes JF, Smith I, Lng I, Wardley A, Rabaglio M, Price KN, Gelber RD, Coates AS, Thrlimann B, for the members of the BIG 1-98 Collaborative Group and the International Breast Cancer Study Group (IBCSG). BIG 1-98 Lancet Oncology 12:1101-1108, 2011 plus webappendix The Lancet Oncology
2011 Analyses Adjusting for Selective Crossover Show Improved Overall Survival With Adjuvant Letrozole Compared With Tamoxifen in the BIG 1-98 Study Colleoni M, Giobbie-Hurder A, Regan MM, Thrlimann B, Mouridsen H, Mauriac L, Forbes JF, Paridaens R, Lng I, Smith I, Chirgwin J, Pienkowski T, Wardley A, Price KN, Gelber RD, Coates AS, Goldhirsch A BIG 1-98 J Clin Oncol. 2011 Mar 20;29(9):1117-24. Epub 2011 Feb 14 Journal of Clinical Oncology
2011 An overview of letrozole in postmenopausal women with hormone-responsive breast cancer. Barnadas A, Estvez LG, Lluch-Hernndez A, Rodriguez-Lescure A, Rodriguez-Sanchez C, Sanchez-Rovira P. BIG 1-98 Adv Ther. 2011 Dec;28(12):1045-58. doi: 10.1007/s12325-011-0075-4. Epub 2011 Nov 7. Advances in Therapy
2011 The EORTC 10041/BIG 03-04 MINDACT trial is feasible: results of the pilot phase Rutgers E, Piccart M, Bogaerts J, Delaloge S, Van't Veer L, Rubio I, Viale G, Thompson A, Passalacqua R, Nitz U, Vindevoghel A, Pierga J-Y, Ravdin P, Werutsky G, Cardoso F. BIG 3-04 MINDACT Eur J Cancer. 2011 Dec;47(18):2742-9. Epub 2011 Nov 1 Journal of Clinical Oncology
2011 Evaluation of metformin in early breast cancer: a modification of the traditional paradigm for clinical testing of anti-cancer agents. Goodwin PJ, Stambolic V, Lemieux J, Chen BE, Parulekar WR, Gelmon KA, Hershman DL, Hobday TJ, Ligibel JA, Mayer IA, Pritchard KI, Whelan TJ, Rastogi P, Shepherd LE. BIG 5-11 MA.32 Breast Cancer Res Treat. 2011 Feb;126(1):215-20. doi: 10.1007/s10549-010-1224-1. Epub 2010 Oct 26. Breast Cancer Research and Treatment
2011 Developing an international network for breast cancer research: the BIG experience Gnant M, Piccart-Gebhart M, Goldhirsch A, Baselga J, Cameron D, Di Leo A, Dowsett M, Gelber R, von Minckwitz G, Waldvogel C & Straehle C General Clinical Investigation May 2011, Vol. 1, No. 5, Pages 623-628 Clinical Investigation
2011 Proposals for uniform collection of biospecimens from neoadjuvant breast cancer clinical trials: timing and specimen types Loi S, Symmans WF, Bartlett JM, Fumagalli D, Vant Veer L, Forbes JF, Bedard P, Denkert C, Zujewski J, Viale G, Pusztai L, Esserman LJ, Leyland-Jones BR BIG-NABCG collaboration Lancet Oncol. 2011 Nov;12(12):1162-8. The Lancet Oncology
2011 Pregnancy after breast cancer: if you wish, ma'am. Pagani O, Partridge A, Korde L, Badve S, Bartlett J, Albain K, Gelber R, Goldhirsch A; Breast International Group; North American Breast Cancer Group Endocrine Working Group. BIG-NABCG collaboration Breast Cancer Res Treat. 2011 Sep;129(2):309-17. doi: 10.1007/s10549-011-1643-7. Epub 2011 Jun 23. Breast Cancer Research and Treatment
2011 Assessment of Ki67 in Breast Cancer: Recommendations from the International Ki67 in Breast Cancer Working Group Dowsett M, Nielsen TO, A'hern R, Bartlett J, Coombes RC, Cuzick J, Ellis M, Henry NL, Hugh JC, Lively T, McShane L, Paik S, Penault-Llorca F, Prudkin L, Regan M, Salter J, Sotiriou C, Smith IE, Viale G, Zujewski JA, Hayes DF BIG-NABCG collaboration J Natl Cancer Inst. 2011 Nov 16;103(22):1656-64. Epub 2011 Sep 29 Journal of the National Cancer Institute
2010 The effects of adding zoledronic acid to neoadjuvant chemotherapy on tumour response: exploratory evidence for direct anti-tumour activity in breast cancer Coleman RE, Winter MC, Cameron D, Bell R, Dodwell D, Keane MM, Gil M, Ritchie D, Passos-Coelho JL, Wheatley D, Burkinshaw R, Marshall SJ, Thorpe H on behalf of the AZURE (BIG01/04) Investigators. BIG 01-04 AZURE Br J Cancer. 2010 Mar 30, doi: 10.1038/sj.bjc.6605604. Epub 2010 Mar 16. British Journal of Cancer
2010 Longer-term assessment of trastuzumab-related cardiac adverse events in the Herceptin Adjuvant (HERA) trial. Procter M, Suter TM, de Azambuja E, Dafni U, van Dooren V, Muehlbauer S, Climent MA, Rechberger E, Liu WT, Toi M, Coombes RC, Dodwell D, Pagani O, Madrid J, Hall M, Chen SC, Focan C, Muschol M, van Veldhuisen DJ, Piccart-Gebhart MJ. BIG 1-01 HERA J Clin Oncol. 2010 Jul 20;28(21):3422-8. doi: 10.1200/JCO.2009.26.0463. Epub 2010 Jun 7. Journal of Clinical Oncology
2010 A novel interaction between HER2/neu and cyclin E in breast cancer Mittendorf EA, Liu Y, Tucker SL, McKenzie T, Qiao N, Akli S, Biernacka A, Liu Y, Meijer L, Keyomarsi K, Hunt KK BIG 14-04 PYTHIA Oncogene. 2010 Jul 8 doi: 10.1038/onc.2010.151. Oncogene
2010 The differences in outcome between ATAC and BIG 1-98 suggest efficacy differences between these two nonsteroidal AIs. Mouridsen HT. BIG 1-98 Cancer Invest. 2010;28 Suppl 1:1-3. doi: 10.3109/07357907.2010.501632. Cancer Investigation
2010 Tailoring adjuvant endocrine therapy for postmenopausal breast cancer: a CYP2D6 multiple-genotype-based modeling analysis and validation. Yu KD, Huang AJ, Shao ZM. BIG 1-98 PLoS One. 2010 Dec 20;5(12):e15649. doi: 10.1371/journal.pone.0015649. PLoS One
2010 Switching from tamoxifen to aromatase inhibitors for adjuvant endocrine therapy in postmenopausal patients with early breast cancer. van de Velde CJ, Verma S, van Nes JG, Masterman C, Pritchard KI. BIG 1-98 Cancer Treat Rev. 2010 Feb;36(1):54-62. doi: 10.1016/j.ctrv.2009.10.003. Epub 2009 Nov 26. Cancer Treatment Reviews
2010 Molecular risk assessment of BIG 1-98 participants by expression profiling using RNA from archival tissue. Antonov J, Popovici V, Delorenzi M, Wirapati P, Baltzer A, Oberli A, Thrlimann B, Giobbie-Hurder A, Viale G, Altermatt HJ, Aebi S, Jaggi R. BIG 1-98 BMC Cancer. 2010 Feb 9;10:37. doi: 10.1186/1471-2407-10-37. BMC Cancer
2010 Meta-analysis of breast cancer outcomes in adjuvant trials of aromatase inhibitors versus tamoxifen Dowsett M, Cuzick J, Ingle J, Coates A, Forbes J, Bliss J, Buyse M, Baum M, Buzdar A, Colleoni M, Coombes C, Snowdon C, Gnant M, Jakesz R, Kaufmann M, Boccardo F, Godwin J, Davies C, Peto R BIG 1-98 J Clin Oncol 28:509-518, 2010 Journal of Clinical Oncology
2010 FACE: the barefaced facts of AI potency. Monnier A BIG 1-98 Cancer Manag Res. 2010 Oct 27;2:267-76. doi: 10.2147/CMR.S13511. Cancer Management and Research
2010 Evaluation of treatment-effect heterogeneity using biomarkers measured on a continuous scale: subpopulation treatment effect pattern plot. Lazar AA, Cole BF, Bonetti M, Gelber RD. BIG 1-98 J Clin Oncol. 2010 Oct 10;28(29):4539-44. doi: 10.1200/JCO.2009.27.9182. Epub 2010 Sep 13. Journal of Clinical Oncology
2010 Cost effectiveness of letrozole versus anastrozole in postmenopausal women with HR+ early-stage breast cancer. Lipsitz M, Delea TE, Guo A. BIG 1-98 Curr Med Res Opin. 2010 Oct;26(10):2315-28. doi: 10.1185/03007995.2010.510784. Current Medical Research and Opinion
2010 Cognitive function in postmenopausal women receiving adjuvant letrozole or tamoxifen for breast cancer in the BIG 1-98 randomized trial Phillips KA, Ribi K, Sun Z, Stephens A, Thompson A, Harvey V, Thrlimann B, Cardoso F, Pagani O, Coates AS, Goldhirsch A, Price KN, Gelber RD, Bernhard J BIG 1-98 The Breast 19:388-395, 2010 The Breast
2010 Cognitive changes associated with endocrine therapy for breast cancer. Agrawal K, Onami S, Mortimer JE, Pal SK. BIG 1-98 Maturitas. 2010 Nov;67(3):209-14. doi: 10.1016/j.maturitas.2010.07.004. Epub 2010 Aug 4. Maturitas
2010 Benefits and adverse effects of endocrine therapy. Colleoni M, Giobbie-Hurder A BIG 1-98 Ann Oncol 21 (Suppl 7) : vii107-vii111, 2010 Annals of Oncology
2010 Aromatase inhibitors alone or in sequence with tamoxifen - clinical evaluation of the BIG 1-98 trial. Kelly CM, Buzdar AU. BIG 1-98 Expert Opin Pharmacother. 2010 Feb;11(3):489-92. doi: 10.1517/14656560903501551. Expert Opinion on Pharmacotherapy
2010 Death due to liver failure during endocrine therapy for premenopausal breast cancer Rabaglio M, Ruepp B, for the STP Steering Committee BIG 2-02 SOFT; BIG 3-02 TEXT ACTA Oncologica 49:874-876, 2010 ACTA Oncologica
2010 Breast cancer in pregnancy: recommendations of an international consensus meeting. Amant F, Deckers S, Van Calsteren K, Loibl S, Halaska M, Brepoels L, Beijnen J, Cardoso F, Gentilini O, Lagae L, Mir O, Neven P, Ottevanger N, Pans S, Peccatori F, Rouzier R, Senn HJ, Struikmans H, Christiaens MR, Cameron D, Du Bois A. BIG 2-03 Breast Cancer in Pregnancy Eur J Cancer. 2010 Dec;46(18):3158-68. doi: 10.1016/j.ejca.2010.09.010. European Journal of Cancer
2010 The effect of body mass index on overall and disease-free survival in node-positive breast cancer patients treated with docetaxel and doxorubicin-containing adjuvant chemotherapy: the experience of the BIG 02-98 trial de Azambuja E, McCaskill-Stevens W, Francis P, Quinaux E, Crown JPA, Vicente M, Giuliani R, Nordenskjld B, Gutirez J, Andersson M, Vila MM, Jakesz R, Demol J, Dewar J, Santoro A, Lluch A, Olsen S, Gelber RD, Angelo Di Leo A, Piccart-Gebhart M BIG 2-98 TAX 315 Breast Cancer Res Treat. 2010 Jan;119(1):145-53 Breast Cancer Research and Treatment
2010 Multidisciplinary meeting on male breast cancer: summary and research recommendations. Korde LA, Zujewski JA, Kamin L, Giordano S, Domchek S, Anderson WF, Bartlett JM, Gelmon K, Nahleh Z, Bergh J, Cutuli B, Pruneri G, McCaskill-Stevens W, Gralow J, Hortobagyi G, Cardoso F. BIG 2-07 Male BC J Clin Oncol. 2010 Apr 20;28(12):2114-22. doi: 10.1200/JCO.2009.25.5729. Epub 2010 Mar 22. Journal of Clinical Oncology
2010 Multidisciplinary meeting on male breast cancer: summary and research recommendations. Korde LA, Zujewski JA, Kamin L, Giordano S, Domchek S, Anderson WF, Bartlett JM, Gelmon K, Nahleh Z, Bergh J, Cutuli B, Pruneri G, McCaskill-Stevens W, Gralow J, Hortobagyi G, Cardoso F. BIG-NABCG collaboration J Clin Oncol. 2010 Apr 20;28(12):2114-22. doi: 10.1200/JCO.2009.25.5729. Epub 2010 Mar 22. Journal of Clinical Oncology
2009 Disease-free survival according to degree of HER2 amplification for patients treated with adjuvant chemotherapy with or without 1 year of trastuzumab: the HERA Trial. Dowsett M, Procter M, McCaskill-Stevens W, de Azambuja E, Dafni U, Rueschoff J, Jordan B, Dolci S, Abramovitz M, Stoss O, Viale G, Gelber RD, Piccart-Gebhart M, Leyland-Jones B. BIG 1-01 HERA J Clin Oncol. 2009 Jun 20;27(18):2962-9. doi: 10.1200/JCO.2008.19.7939. Epub 2009 Apr 13. Journal of Clinical Oncology
2009 Update of the BIG 1-98 Trial: Where do we stand? Joerger M, Thuerlimann B BIG 1-98 The Breast 18 (2009) S3, S78S82 The Breast
2009 The gene expression grade index: a potential predictor of relapse for endocrine-treated breast cancer patients in the BIG 198 trial Desmedt C, Giobbie-Hurder A, Neven P, Paridaens R, Christiaens M-R, Smeets A, Lallemand F, Haibe-Kains B, Viale G, Gelber RD, Piccart M, Sotiriou C BIG 1-98 BMC Med Genomics 2009, 2:40 BMC Medical Genomics
2009 Letrozole therapy alone or in sequence with tamoxifen in women with breast cancer BIG 1-98 Collaborative Group, Mouridsen H, Giobbie-Hurder A, Goldhirsch A, Thrlimann B, Paridaens R, Smith I, Mauriac L, Forbes J, Price KN, Regan MM, Gelber RD, Coates AS. BIG 1-98 N Engl J Med Volume 361:766-776 August 20, 2009 Number 8 New England Journal of Medicine
2009 Design, conduct, and analyses of Breast International Group (BIG) 1-98: a randomized, double-blind, phase-III study comparing letrozole and tamoxifen as adjuvant endocrine therapy for postmenopausal women with receptor-positive, early breast cancer. Giobbie-Hurder A, Price KN, Gelber RD; International Breast Cancer Study Group; BIG 1-98 Collaborative Group. BIG 1-98 Clin Trials. 2009 Jun;6(3):272-87 Clinical Trials
2009 Breast cancer patients on endocrine therapy reveal more symptoms when self-reporting than in pivotal trials: an outcome research study. Ruhstaller T, von Moos R, Rufibach K, Ribi K, Glaus A, Spaeti B, Koeberle D, Mueller U, Hoefliger M, Hess D, Boehme C, Thuerlimann B. BIG 1-98 Oncology 2009;76(2):142-8. Epub 2009 Jan 22 Oncology
2009 Bone Quality Test (BQT) scores of fingernails in postmenopausal patients treated with adjuvant letrozole or tamoxifen for early breast cancer. Sun Z, Goldhirsch A, Price KN, Colleoni M, Ravaioli A, Simoncini E, Campbell I, Gelber RD, Towler M. BIG 1-98 Breast. 2009 Apr;18(2):84-8. doi: 10.1016/j.breast.2009.01.003. Epub 2009 Feb 24. Breast
2009 Bone fractures among postmenopausal patients with endocrine-responsive early breast cancer treated with 5 years of letrozole or tamoxifen in the BIG 1-98 trial. Rabaglio M, Sun Z, Price KN, Castiglione-Gertsch M, Hawle H, Thrlimann B, Mouridsen H, Campone M, Forbes JF, Paridaens RJ, Colleoni M, Pienkowski T, Nogaret JM, Lng I, Smith I, Gelber RD, Goldhirsch A, Coates AS; BIG 1-98 Collaborative and International Breast Cancer Study Groups. BIG 1-98 Ann Oncol. 2009 Sep;20(9):1489-98. doi: 10.1093/annonc/mdp033. Epub 2009 May 27. Annals of Oncology
2009 Daily clinical practice of fresh tumour tissue freezing and gene expression profiling; logistics pilot study preceding the MINDACT trial Mook S, Bonnefoi H, Pruneri G, Larsimont D, Jaskiewicz J, Sabadell MD, Macgrogan G, Van't Veer LJ, Cardoso F, Rutgers EJ BIG 3-04 MINDACT Eur J Cancer. 2009 May;45(7):1201-8. Epub 2009 Feb 14 European Journal of Cancer
2009 Facilitating consensus by examining patterns of treatment effects Gelber R, Gelber S, for the International Breast Cancer Study Group (IBCSG) and the Breast International Group (BIG) General The Breast 18 (2009) S3, S2S8 The Breast
2009 Better translation from bench to bedside: breakthroughs in the individualized treatment of cancer Straehle C, Cardoso F, de Azambuja E, Dolci S, Meisman L, Vantongelen K, Ignatiadis M, Sotiriou C, Piccart-Gebhart MJ General Crit Care Med. 2009 Jan;37(1 Suppl):S22-9 Critical Care Medicine
2008 Estimating the magnitude of trastuzumab effects within patient subgroups in the HERA trial Untch M, Gelber RD, Jackisch C, Procter M, Baselga J, Bell R, Cameron D, Bari M, Smith I, Leyland-Jones B, de Azambuja E, Wermuth P, Khasanov R, Feng-yi F, Constantin C, Mayordomo JI, Su CH, Yu SY, Lluch A, Senkus-Konefka E, Price C, Haslbauer F, Suarez Sahui T, Srimuninnimit V, Colleoni M, Coates AS, Piccart-Gebhart MJ, Goldhirsch A for the HERA Study Team BIG 1-01 HERA Ann Oncol 18:909-916, 2008 Annals of Oncology
2008 Progress on BIG 1-02/IBCSG 27-02/NSABP B-37, a prospective randomized trial evaluating chemotherapy after local therapy for isolated locoregional recurrences of breast cancer Wapnir IL, Aebi S, Gelber S, Anderson SJ, Lng I, Robidoux A, Mamounas EP, Wolmark N BIG 1-02 CALOR Ann Surg Oncol 15:3227-3231, 2008 Annals of Surgical Oncology
2008 A randomized clinical trial of adjuvant chemotherapy for radically resected locoregional relapse of breast cancer: IBCSG 27-02, BIG 1-02, and NSABP B-37 Wapnir IL, Aebi S, Geyer CE, Zahrieh D, Gelber RD, Anderson SJ, Robidoux A, Bernhard J, Maibach R, Castiglione-Gertsch M, Coates AS, Piccart MJ, Clemons MJ, Costantino JP, Wolmark N BIG 1-02 CALOR Clin Breast Cancer. 2008 Jun;8(3):287-92. Clinical Breast Cancer
2008 Intent-to-treat analysis of the placebo-controlled trial of letrozole for extended adjuvant therapy in early breast cancer: NCIC CTG MA.17 Ingle JN, Tu D, Pater JL, Muss HB, Martino S, Robert NJ, Piccart MJ, Castiglione M, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Cameron DA, Palmer MJ, Goss PE BIG 1-97 MA.17 Ann Oncol May 2008; 19: 877 - 882 Annals of Oncology
2008 Extending the benefits of adjuvant therapy in early HR+ breast cancer. Goss PE BIG 1-97 MA.17 Breast Cancer Res Treat. 2008 Dec;112 Suppl 1:45-52. doi: 10.1007/s10549-008-0129-8. Epub 2008 Sep 11. Breast Cancer Research and Treatment
2008 Extended adjuvant endocrine therapy in breast cancer: current status and future directions. Goss PE, Muss HB, Ingle JN, Whelan TJ, Wu M. BIG 1-97 MA.17 Clin Breast Cancer. 2008 Oct;8(5):411-7. doi: 10.3816/CBC.2008.n.049. Clinical Breast Cancer
2008 Efficacy, toxicity, and quality of life in older women with early-stage breast cancer treated with letrozole or placebo after 5 years of tamoxifen: NCIC CTG Intergroup trial MA.17 Muss HB, Tu D, Ingle JN, Martino S, Robert NJ, Pater JL, Whelan TJ, Palmer MJ, Piccart MJ, Shepherd LE, Pritchard KI, He Z, Goss PE BIG 1-97 MA.17 JCO Apr 20 2008: 1956-1964 Journal of Clinical Oncology
2008 Decision making in adjuvant trials in breast cancer: the NCIC CTG MA.17 trial as an example. Pater J, Tu D, Shepherd L, Ingle JN, Goss PE. BIG 1-97 MA.17 Breast Cancer Res Treat. 2008 Mar;108(2):265-9. Epub 2007 May 3. Breast Cancer Research and Treatment
2008 Competing causes of death from a randomized trial of extended adjuvant endocrine therapy for breast cancer. Chapman JA, Meng D, Shepherd L, Parulekar W, Ingle JN, Muss HB, Palmer M, Yu C, Goss PE. BIG 1-97 MA.17 J Natl Cancer Inst. 2008 Feb 20;100(4):252-60. doi: 10.1093/jnci/djn014. Epub 2008 Feb 12. Journal of National Cancer Institute
2008 Understanding the BIG results: Insights from the BIG 1-98 trial analyses. Wardley AM. BIG 1-98 Adv Ther. 2008 Dec;25(12):1257-75. doi: 10.1007/s12325-008-0128-5. Advances in Therapy
2008 Prognostic and predictive value of centrally reviewed Ki-67 labeling index in postmenopausal women with endocrine-responsive breast cancer: results from Breast International Group trial 1-98 comparing adjuvant tamoxifen with letrozole Viale G, Giobbie-Hurder A, Regan MM, Coates AS, Mastropasqua MG, Dell'Orto P, Maiorano M, MacGrogan G, Braye SG, hlschlegel C, Neven P, Orosz Z, Olszewski WP, Knox F, Thrlimann B, Price KN, Castiglione-Gertsch M, Gelber RD, Gusterson BA, Goldhirsch A BIG 1-98 JCO Nov 3 2008 Journal of Clinical Oncology
2008 Letters to editor: inappropriate ATAC on Tamoxifen Coates A, Mouridsen H, Thrlimann B, for the BIG 1-98 Collaborative group BIG 1-98 Lancet Oncol Vol 9, April 2008 The Lancet Oncology
2008 Letrozole compared with tamoxifen for elderly patients with endocrine-responsive early breast cancer: the BIG 1-98 Trial Crivellari D, Sun Z, Coates AS, Price KN, Thrlimann B, Mouridsen H, Mauriac L, Forbes JF, Paridaens RJ, Castiglione-Gertsch M, Gelber RD, Colleoni M, Lng I, Del Mastro L, Gladieff L, Rabaglio M, Smith IE, Chirgwin JH, Goldhirsch A BIG 1-98 JCO Apr 20 2008: 1972-1979 Journal of Clinical Oncology
2008 Inappropriate ATAC on tamoxifen. Coates A, Mouridsen H, Thrlimann B; BIG 1-98 Collaborative Group. BIG 1-98 Lancet Oncol. 2008 Apr;9(4):315-6. doi: 10.1016/S1470-2045(08)70085-8. The Lancet Oncology
2008 Cost-effectiveness of letrozole versus tamoxifen as initial adjuvant therapy in postmenopausal women with hormone-receptor positive early breast cancer from a Canadian perspective. Delea TE, El-Ouagari K, Karnon J, Sofrygin O. BIG 1-98 Breast Cancer Res Treat. 2008 Apr;108(3):375-87. Epub 2007 Jul 26. Breast Cancer Research and Treatment
2008 Adjuvant letrozole versus tamoxifen according to centrally-assessed ERBB2 status for postmenopausal women with endocrine-responsive early breast cancer: supplementary results from the BIG 1-98 randomised trial Rasmussen BB, Regan MM, Lykkesfeldt AE, DellOrto P, Del Curto B, Henriksen KL, Mastropasqua MG, Price KN, Mry E, Lacroix-Triki M, Braye S, Altermatt HJ, Gelber RD, Castiglione-Gertsch M, Goldhirsch A, Gusterson BA, Thrlimann B, Coates AS, Viale G for the BIG 1-98 Collaborative and International Breast Cancer Study Groups BIG 1-98 Lancet 9:23-28, 2008. The Lancet Oncology
2008 A review of the BIG results: the Breast International Group 1-98 trial analyses. Doughty JC. BIG 1-98 Breast. 2008 Jan;17 Suppl 1:S9-S14. doi: 10.1016/S0960-9776(08)70003-1. Breast
2008 Premenopausal endocrine-responsive early breast cancer: who receives chemotherapy? Regan MM, Pagani O, Walley B, Torrisi R, Perez EA, Francis P, Fleming GF, Price KN, Thrlimann B, Maibach R, Castiglione-Gertsch M, Coates AS, Goldhirsch A, Gelber RD; SOFT/TEXT/PERCHE Steering Committee; International Breast Cancer Study Group BIG 2-02 SOFT; BIG 3-02 TEXT Ann Oncol. 2008 Jul;19(7):1231-41. Epub 2008 Mar 5. Annals of Oncology
2008 Elucidating the role of chest wall irradiation in 'intermediate-risk' breast cancer: the MRC/EORTC SUPREMO trial. Kunkler IH, Canney P, van Tienhoven G, Russell NS; MRC/EORTC (BIG 2-04) SUPREMO Trial Management Group. BIG 2-04 SUPREMO Clin Oncol (R Coll Radiol). 2008 Feb;20(1):31-4. Clinical Oncology
2008 Elucidating the Role of Chest Wall Irradiation in Intermediate-risk Breast Cancer: the MRC/EORTC SUPREMO Trial Kunkler IH, Canney P, van Tienhoven G, Russell NS; MRC/EORTC (BIG 2-04) SUPREMO Trial Management Group. BIG 2-04 SUPREMO Clin Oncol (R Coll Radiol). 2008 Feb;20(1):31-4. Clinical Oncology
2008 Is risk of central nervous system (CNS) relapse related to adjuvant taxane treatment in node-positive breast cancer? Results of the CNS substudy in the intergroup phase III BIG 02-98 trial Pestalozzi BC, Francis P, Quinaux E, Dolci S, de Azambuja E, Gelber RD, Viale G, Balil A, Andersson M, Nordenskjld B, Gnant M, Gutierrez J, Lng I, Crown JPA, Piccart-Gebhart M on behalf of the BIG 02-98 Collaborative Group BIG 2-98 TAX 315 Ann Oncol, November 2008; 19: 1837 - 1841 Annals of Oncology
2008 Adjuvant chemotherapy with sequential or concurrent antracycline and docetaxel: Breast International Group 02-98 randomized trial Francis P, Crown J, Di Leo A, Buyse M, Balil A, Andersson M, Nordeskjold B, Lang I, Jasesz R, Vorobiof D, Gutirrez J, van Hazel G, Dolci S, Jamin S, Bendahmane B, Gelber RD, Goldhirsch A, Castiglione-Gertsch M, Piccart-Gebhart M BIG 2-98 TAX 315 J Natl Cancer Inst 100:121-133, 2008 Journal of the National Cancer Institute
2008 Clinical application of the 70-gene profile: the MINDACT trial Cardoso F, Van't Veer L, Rutgers E, Loi S, Mook S, Piccart-Gebhart MJ on behalf of the TRANSBIG Consortium BIG 3-04 MINDACT J Clin Oncol. 2008 Feb 10;26(5):729-35 Journal of Clinical Oncology
2008 IBIS II: a breast cancer prevention trial in postmenopausal women using the aromatase inhibitor anastrozole. Cuzick J. BIG 5-02 IBIS-II Expert Rev Anticancer Ther. 2008 Sep;8(9):1377-85. doi: 10.1586/14737140.8.9.1377. Expert Review of Anticancer Therapy
2008 Effects of anastrozole on cognitive performance in postmenopausal women: a randomised, double-blind chemoprevention trial (IBIS II). Jenkins VA, Ambroisine LM, Atkins L, Cuzick J, Howell A, Fallowfield LJ. BIG 5-02 IBIS-II Lancet Oncol. 2008 Oct;9(10):953-61. doi: 10.1016/S1470-2045(08)70207-9. Epub 2008 Sep 1. The Lancet Oncology
2008 Chemoprevention of breast cancer. Cuzick J. BIG 5-02 IBIS-II Breast Cancer. 2008;15(1):10-6. doi: 10.1007/s12282-007-0006-z. Breast Cancer
2008 The new generation of breast cancer clinical trials: the right drug for the right target de Azambuja E1, Cardoso F, Meirsman L, Straehle C, Dolci S, Vantongelen K, Piccart-Gebhart M. General Bull Cancer. 2008 Mar;95(3):352-7. doi: 10.1684/bdc.2008.0587. Bull Cancer
2008 La nouvelle gnration des tudes cliniques sur le cancer du sein: la bonne drogue et la bonne cible de Azambuja E, Cardoso F, Meirsman L, Straehle C, Dolci S, Vantongelen K, Piccart-Gebhart M General Bulletin du Cancer. Volume 95, Numro 3, 352-7, mars 2008 Le Bulletin du Cancer
2008 The 70-gene prognosis-signature predicts disease outcome in breast cancer patients with 1-3 positive lymph nodes in an independent validation study Mook S, Schmidt MK, Viale G, Pruneri G, Eekhout I, Floore A, Glas AM, Bogaerts J, Cardoso F, Piccart-Gebhart MJ, Rutgers ET, Van't Veer LJ; TRANSBIG Consortium TRANSBIG Breast Cancer Res Treat. 2009 Jul;116(2):295-302. Epub 2008 Jul 27 Breast Cancer Research and Treatment
2008 Personalized medicine by the use of microarray gene expression profiling Mook S, Cardoso F, van t Veer L TRANSBIG In: Pharmacogenetics of Breast Cancer: towards the Individualization of Therapy. Translational Medecine Series 7. Editor Leyland-Jones B; Informa Healthcare USA, Inc, 123-134, 2008 Pharmacogenetics of Breast Cancer
2008 New tools for assessing breast cancer recurrence Dinh P, Cardoso F, Sotiriou C, Piccart-Gebhart MJ TRANSBIG Cancer Treat Res. 2008;141:99-118 Cancer Treatment and Research
2008 Inconsistent criteria used in American Society of Clinical Oncology 2007 update of recommendations for the use of tumor markers in breast cancer Cardoso F, Saghatchian M, Thompson A, Rutgers E; TRANSBIG Consortium Steering Committee. TRANSBIG J Clin Oncol. 2008 Apr 20;26(12):2058-9; author reply 2060-1 Journal of Clinical Oncology
2008 Comparison of prognostic gene expression signatures for breast cancer Haibe-Kains B, Desmedt C, Piette F, Buyse M, Cardoso F, Van't Veer L, Piccart M, Bontempi G, Sotiriou C TRANSBIG BMC Genomics. 2008 Aug 21;9:394 BMC Genomics
2008 Recommendations for collection and handling of specimens from group breast cancer clinical trials & Appendix: Recommendations for collection and handling of specimens from group breast cancer clinical trials Leyland-Jones BR, Ambrosone CB, Bartlett JMS, Ellis MJC, Enos RA, Raji A, Pins MR, Zujewski JA, Hewitt SM, Forbes JF, Abramovitz M, Braga S, Cardoso F, Harbeck N, Denkert C, Jewell SD BIG-NABCG collaboration J Clin Oncol. 2008 Dec 1;26(34):5638-44. Epub 2008 Oct 27 Journal of Clinical Oncology
2007 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial Smith I, Procter M, Gelber RD, Guillaume S, Feyereislova A, Dowsett M, Goldhirsch A, Untch M, Mariani G, Baselga J, Kaufmann M, Cameron D, Bell R, Bergh J, Coleman R, Wardley A, Harbeck N, Lopez RI, Mallmann P, Gelmon K, Wilcken N, Wist E, Snchez Rovira P, Piccart-Gebhart MJ, for the HERA study team BIG 1-01 HERA Lancet 369:29-36, 2007 The Lancet
2007 Trastuzumab-associated cardiac adverse effects in the herceptin adjuvant trial Suter TM, Procter M, van Veldhuisen DJ, Muscholl M, Bergh J, Carlomagno C, Perren T, Passalacqua R, Bighin C, Klijn JG, Ageev FT, Hitre E, Groetz J, Iwata H, Knap M, Gnant M, Muehlbauer S, Spence A, Gelber RD, Piccart-Gebhart MJ BIG 1-01 HERA J Clin Oncol 25:3859-65, 2007. Epub 2007 Jul 23 Journal of Clinical Oncology
2007 Using clinical trial data to tailor adjuvant treatments for individual patients. Regan MM, Gelber RD; International Breast Cancer Study Group (IBCSG) and the Breast International Group (BIG). BIG 1-01 HERA Breast. 2007 Dec;16 Suppl 2:S98-104. Epub 2007 Aug 23 Breast
2007 Bisphosphonates and prevention of metastases: the AZURE study Burkinshaw R, Thorpe H, Coleman R BIG 1-04 AZURE BCO Volume 10, Issue 11, Nov 2007 BCO
2007 Letrozole in the extended adjuvant setting: MA.17. Goss PE BIG 1-97 MA.17 Breast Cancer Res Treat. 2007;105 Suppl 1:45-53. Epub 2007 Oct 3. Breast Cancer Research and Treatment
2007 Efficacy of letrozole extended adjuvant therapy according to estrogen receptor and progesterone receptor status of the primary tumor: National Cancer Institute of Canada clinicals trials group MA.17 Goss PE, Ingle JN, Martino S, Robert NJ, Muss HB, Piccart MJ, Castiglione M, Tu D, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Cameron DA, Palmer MJ, Pater JL. BIG 1-97 MA.17 JCO 25:15:2006-2011, 2007 Journal of Clinical Oncology
2007 Using clinical trial data to tailor adjuvant treatments for individual patients. Regan MM, Gelber RD; International Breast Cancer Study Group (IBCSG) and the Breast International Group (BIG). BIG 1-98 Breast. 2007 Dec;16 Suppl 2:S98-104. Epub 2007 Aug 23 Breast
2007 The Breast International Group 1-98 trial: big results for women with hormone-sensitive early breast cancer. Monnier AM BIG 1-98 Expert Rev Anticancer Ther. 2007 May;7(5):627-34. Expert Review of Anticancer Therapy
2007 Prognostic and predictive value of centrally reviewed expression of estrogen and progesterone receptors in a randomized trial comparing letrozole and tamoxifen adjuvant therapy for postmenopausal women with early breast cancer: results from the BIG 1-98 Viale G, Regan MM, Maiorano E, Mastropasqua MG, DellOrto P, Rasmussen BB, Raffoul J, Neven P, Orosz Z, Braye S, hlschlegel C, Thrlimann B, Gelber RD, Castiglione-Gertsch M, Price KN, Goldhirsch A, Gusterson BA, Coates AS BIG 1-98 J Clin Oncol 25:25:3846-3852, 2007 Journal of Clinical Oncology
2007 Predictors of early relapse in postmenopausal women with hormone receptor-positive breast cancer in the BIG 1-98 trial Mauriac L, Keshaviah A, Debled M, Mouridsen H, Forbes JF, Thrlimann BB, Paridaens R, Monnier A, Lng I, Wardley A, Nogaret J-M, Gelber RD, Castiglione-Gertsch M, Price KN, Coates AS, Smith I, Viale G, Rabaglio M, Zabaznyi N, Goldhirsch A BIG 1-98 Ann Oncol 18:859-867, 2007 Annals of Oncology
2007 Letrozole as upfront endocrine therapy for postmenopausal women with hormone-sensitive breast cancer: BIG 1-98 Koeberle D, Thuerlimann B BIG 1-98 Breast Cancer Res and Treat 105 Supple 1:55-66, 2007 Breast Cancer Research and Treatment
2007 Five years of letrozole compared with tamoxifen as initial adjuvant therapy for postmenopausal women with endocrine-responsive early breast cancer: update of study BIG 1-98 Coates AS, Keshaviah A, Thrlimann B, Mouridsen H, Mauriac L, Forbes JF, Paridaens R, Castiglione-Gertsch M, Gelber RD, Colleoni M, Lng I, Del Mastro L, Smith I, Chirgwin J, Nogaret JM, Pienkowski T, Wardley A, Jakobsen EH, Price KN, Goldhirsch A. BIG 1-98 J Clin Oncol 25:486-492, 2007 Journal of Clinical Oncology
2007 Cost-effectiveness of letrozole versus tamoxifen as initial adjuvant therapy in hormone receptor-positive postmenopausal women with early-stage breast cancer. Delea TE, Karnon J, Sofrygin O, Thomas SK, Papo NL, Barghout V. BIG 1-98 Clin Breast Cancer. 2007 Jun;7(8):608-18. Clinical Cancer Research
2007 Cardiovascular adverse events during adjuvant endocrine therapy for early breast cancer using letrozole or tamoxifen: safety analysis of BIG 1-98 Trial Mouridsen H, Keshaviah A, Coates AS, Rabaglio M, Castiglione-Gertsch M, Sun Z, Thrlimann B, Mauriac L, Forbes JF, Paridaens R, Gelber RD, Colleoni M, Smith I, Price KN, Goldhirsch A BIG 1-98 J Clin Oncol 25:5715-5722, 2007 Journal of Clinical Oncology
2007 Survival and safety of exemestane versus tamoxifen after 23 years' tamoxifen treatment (Intergroup Exemestane Study): a randomised controlled trial Coombes R, Kilburn L, Snowdon C, Paridaens R, Coleman R, Jones S, Jassem J, Van de Velde C, Delozier T, Alvarez I, Del Mastro L, Ortmann O, Diedrich K, Coates A, Bajetta E, Holmberg S, Dodwell D, Mickiewicz E, Andersen J, Lnning P, Cocconi G, Forbes J, Castiglione M, Stuart N, Stewart A, Fallowfield L, Bertelli G, Hall E, Bogle R, Carpentieri M, Colajori E, Subar M, Ireland E, Bliss J, on behalf of the Intergroup Exemestane Study BIG 2-97 IES Lancet 369:9561:559-570, 2007 The Lancet Oncology
2007 The MINDACT trial: the first prospective clinical validation of a genomic tool Cardoso F, Piccart-Gebhart M, Van't Veer L, Rutgers E; TRANSBIG Consortium BIG 3-04 MINDACT Mol Oncol. 2007 Dec;1(3):246-51. Epub 2007 Oct 22 Molecular Oncology
2007 Breast International Group MINDACT trial: a prospective trial to validate the Amsterdam signature Rutgers EJ BIG 3-04 MINDACT ASCO 43rd Annual meeting 2007 - Educational Book ASCO (Abstract)
2007 Using clinical trial data to tailor adjuvant treatments for individual patients. Regan MM1, Gelber RD; International Breast Cancer Study Group (IBCSG) and the Breast International Group (BIG). General Breast. 2007 Dec;16 Suppl 2:S98-104. Epub 2007 Aug 23 Breast
2007 Keeping faith with trial volunteers Piccart M, Goldhirsch A, Wood W, Pritchard K, Baselga J, Reaby L, Kssler I, Kyriakides S, Norton L, Coates A General Nature 446:137-138, 2007 Nature
2007 Breast cancer in elderly Crivellari D, Aapro M, Leonard R, Von Minckwitz G, Brain E, Goldhirsh A, Veronesi A, Muss H General J Clin Oncol 25:1882-1890, 2007 Journal of Clinical Oncology
2007 Adjuvant chemotherapy--yes or no? Prognostic markers in early breast cancer. Piccart-Gebhart MJ, Sotiriou C. General Ann Oncol. 2007 Dec;18 Suppl 12:xii2-7. doi: 10.1093/annonc/mdm532. Annals of Oncology
2007 Strong time dependence of the 76-gene prognostic signature for node-negative breast cancer patients in the TRANSBIG multicenter independent validation series Desmedt C, Piette F, Loi S, Wang Y, Lallemand F, Haibe-Kains B, Viale G, Delorenzi M, Zhang Y, d'Assignies MS, Bergh J, Lidereau R, Ellis P, Harris AL, Klijn JG, Foekens JA, Cardoso F, Piccart MJ, Buyse M, Sotiriou C; TRANSBIG Consortium TRANSBIG Clin Cancer Res. 2007 Jun 1;13(11):3207-14 Clinical Cancer Research
2006 The extended adjuvant NCIC CTG MA.17 trials: initial and rerandomization studies. Pritchard KI, Goss PE, Shepherd L. BIG 1-97 MA.17 Breast. 2006 Feb;15 Suppl 1:S14-20. Breast
2006 Quality of life in a randomized control trial? Comments concerning MA.17 This P, de la Rochefordire A, Bredart A, Asselain B, Poinsot R, Dolbeault S, Sigal-Zafrani B BIG 1-97 MA.17 J Clin Oncol. 2006 Aug 20;24(24):4038; author reply 4038-9 Comment on Assessment of quality of life in MA.17: a randomized, placebo-controlled trial of letrozole after 5 years of tamoxifen in postmenopausal women. [J Clin Oncol. 2005] Journal of Clinical Oncology
2006 Preventing relapse beyond 5 years: the MA.17 extended adjuvant trial. Goss PE BIG 1-97 MA.17 Semin Oncol. 2006 Apr;33(2 Suppl 7):S8-12. Seminars in Oncology
2006 Emerging data on optimal adjuvant endocrine therapy: Breast International Group trial 1-98/MA.17. Wardley AM BIG 1-97 MA.17 Clin Breast Cancer. 2006 Feb;6 Suppl 2:S45-50. Clinical Breast Cancer
2006 Effect of letrozole versus placebo on bone mineral density in women with primary breast cancer completing 5 or more years of adjuvant tamoxifen: a comparison study to NCIC CTG MA.17 Perez EA, Josse RG, Pritchard KI, Ingle NJ, Martino S, Findlay BP, Shenkier TN, Tozer RG, Palmer MJ, Shepherd EL, Liu S, Tu D, Goss PE BIG 1-97 MA.17 J Clin Oncol 24: 3629-3635, 2006 Journal of Clinical Oncology
2006 Duration of letrozole treatment and outcomes in the placebo-controlled NCIC CTG MA.17 extended adjuvant therapy trial Ingle JN, Tu D, Pater JL, Martino S, Robert NJ, Muss HB, Piccart MJ, Castiglione M, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Cameron DA, Palmer MJ, Goss PE BIG 1-97 MA.17 Breast Cancer Research and Treatment 99:295-300, 2006 Breast Cancer Research and Treatment
2006 Clinical outcomes of ethnic minority women in MA.17: a trial of letrozole after 5 years of tamoxifen in postmenopausal women with early stage breast cancer. Moy B, Tu D, Pater JL, Ingle JN, Shepherd LE, Whelan TJ, Goss PE. BIG 1-97 MA.17 Ann Oncol. 2006 Nov;17(11):1637-43. Epub 2006 Aug 25. Annals of Oncology
2006 The use of early adjuvant aromatase inhibitor therapy: contributions from the BIG 1-98 letrozole trial. Forbes JF BIG 1-98 Semin Oncol. 2006 Apr;33(2 Suppl 7):S2-7. Seminars in Oncology
2006 The evolving role of letrozole in the adjuvant setting: first results from the large, phase III, randomized trial BIG 1-98. Monnier A BIG 1-98 Breast. 2006 Feb;15 Suppl 1:S21-9. The Breast
2006 Letrozole or tamoxifen in early breast cancer Buzdar AU, Baum M, Cusick J BIG 1-98 N Engl J Med 354:14:1528-1530, 2006 New England Journal of Medicine
2006 Breast carcinoma during pregnancy. International recommendations from an expert meeting. Loibl S, von Minckwitz G, Gwyn K, Ellis P, Blohmer JU, Schlegelberger B, Keller M, Harder S, Theriault RL, Crivellari D, Klingebiel T, Louwen F, Kaufmann M. BIG 2-03 Breast Cancer in Pregnancy Cancer. 2006 Jan 15;106(2):237-46. Cancer
2006 Quality of life in the intergroup exemestane study: a randomized trial of exemestane versus continued tamoxifen after 2 or 3 years of tamoxifen in post meanopausal women with primary breast cancer Fallowfield LJ, Bliss JM, Porter LS, Price MH, Snowdon CF, Jones SE, Coombes RC, Hall E BIG 2-97 IES J Clin Oncol 24:910-917, 2006 Journal of Clinical Oncology
2021 Niraparib for Advanced Breast Cancer with Germline BRCA1 and BRCA2 Mutations: the EORTC 1307-BCG/BIG513/TESARO PR-305010-C BRAVO Study. Turner NC, Balmaa J, Poncet C et al. BIG 5-13 BRAVO Clin Cancer Res. 2021 Oct 15;27(20):5482-5491. doi: 10.1158/1078-0432.CCR-21-0310. Epub 2021 Jul 22. Clinical Cancer Research
2021 Adjuvant Palbociclib for Early Breast Cancer: The PALLAS Trial Results (ABCSG-42/AFT-05/BIG-14-03). Gnant M, Dueck AC, Frantal S et al. BIG 14-03 PALLAS J Clin Oncol. 2022 Jan 20;40(3):282-293. doi: 10.1200/JCO.21.02554. Epub 2021 Dec 7 Journal of Clinical Oncology
2006 Gene signature evaluation as a prognostic tool: challenges in the design of the MINDACT trial Bogaerts J, Cardoso F, Buyse M, Braga S, Loi S, Harrison JA, Bines J, Mook S, Decker N, Ravdin P, Therasse P, Rutgers E, van 't Veer LJ, Piccart M; TRANSBIG consortium BIG 3-04 MINDACT Nat Clin Pract Oncol. 2006 Oct;3(10):540-51 Nature Clinical Practice Oncology
2006 Validation and clinical utility of a 70-gene prognostic signature for women with node-negative breast cancer Buyse M, Loi S, van't Veer L, Viale G, Delorenzi M, Glas AM, d'Assignies MS, Bergh J, Lidereau R, Ellis P, Harris A, Bogaerts J, Therasse P, Floore A, Amakrane M, Piette F, Rutgers E, Sotiriou C, Cardoso F, Piccart MJ; TRANSBIG Consortium TRANSBIG J Natl Cancer Inst. 2006 Sep 6;98(17):1183-92 Journal of the National Cancer Institute
2021 Stambolic V. Cancer antigen 15-3/mucin 1 levels in CCTG MA.32: A breast cancer randomized trial of metformin vs placebo Goodwin PJ, Dowling RJO, Ennis M et al. BIG 5-11 MA.32 JNCI Cancer Spectr 2021;5(5):pkab066. doi: 10.1093/jncics/pkab066. Epub 2021 July 28 JNCI Cancer Spectrum
2005 Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer Piccart-Gebhart MJ1, Procter M, Leyland-Jones B, et al. BIG 1-01 HERA NEJM 353:1659- 1672, 2005 New England Journal of Medicine
2005 The influence of letrozole on serum lipid concentrations in postmenopausal women with primary breast cancer who have completed 5 years of adjuvant tamoxifen (NCIC CTG MA.17L). Wasan KM, Goss PE, Pritchard PH, Shepherd L, Palmer MJ, Liu S, Tu D, Ingle JN, Heath M, Deangelis D, Perez EA. BIG 1-97 MA.17 Ann Oncol. 2005 May;16(5):707-15. Epub 2005 Apr 7. Annals of Oncology
2021 Adjuvant olaparib for patients with BRCA1- or BRCA2-mutated Breast Cancer Tutt ANJ, Garber JE, Kaufman B et al. BIG 6-13 OlympiA N Engl J Med 384(25):2394-2405, 2021. New England Journal of Medicine
2005 Randomized trial of letrozole following tamoxifen as extended adjuvant therapy in receptor-positive breast cancer: updated findings from NCIC CTG MA.17 Goss PE, Ingle JN, Martino S, et al. BIG 1-97 MA.17 J Natl Cancer Inst 97:1262-1271, 2005 Journal of the National Cancer Institute
2005 Benefit with aromatase inhibitors in the adjuvant setting for postmenopausal women with breast cancer. Mouridsen HT, Robert NJ. BIG 1-97 MA.17 MedGenMed. 2005 Aug 24;7(3):20. Medscape general medicine
2005 Assessment of quality of life in MA.17: a randomized, placebo-controlled trial of letrozole after 5 years of tamoxifen in postmenopausal women Whelan TJ , Goss EP, Ingle JN, Pater JL, Tu D, Pritchard K, Liu S, Shepherd LE, Palmer M, Nicholas NJ, Martino S, Muss SH BIG 1-97 MA.17 J Clin Oncol 23:6931-6940, 2005 Journal of Clinical Oncology
2005 Benefit with aromatase inhibitors in the adjuvant setting for postmenopausal women with breast cancer. Mouridsen HT, Robert NJ. BIG 1-98 MedGenMed. 2005 Aug 24;7(3):20. Medscape general medicine
2005 Aromatase inhibitors - A triumph of translational oncology Swain SM BIG 1-98 N Engl J Med. 2005 Dec 29;353(26):2807-9 Erratum in: N Engl J Med. 2006 Aug 3;355(5):533 New England Journal of Medicine
2005 A Comparison of Letrozole and Tamoxifen postmenopausal women with early breast cancer Thrlimann B, Keshaviah A, Coates AS et al. BIG 1-98 NEJM 353:26 2747- 2757, 2005 New England Journal of Medicine
2005 A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer. Breast International Group (BIG) 1-98 Collaborative Group, Thrlimann B, Keshaviah A, Coates AS, Mouridsen H, Mauriac L, Forbes JF, Paridaens R, Castiglione-Gertsch M, Gelber RD, Rabaglio M, Smith I, Wardley A, Price KN, Goldhirsch A. BIG 1-98 N Engl J Med. 2005 Dec 29;353(26):2747-57. The New England Journal of Medicine
2005 Moving away from the "One shoe fits all" strategy: the key to future progress in chemotherapy Piccart-Gebhart MJ General J Clin Oncol 23:8:1611-1613, 2005 Journal of Clinical Oncology
2004 Letrozole vs. placebo after adjuvant tamoxifen in postmenopausal breast cancer: the MA-17 study Gori S, Anastasi P, Marrocolo F. BIG 1-97 MA.17 Suppl Tumori. 2004 Jul-Aug;3(4):S27-31. Tumori Journal
2004 Current status of aromatase inhibitors in the management of breast cancer and critique of the NCIC MA-17 trial. Baum M BIG 1-97 MA.17 Cancer Control. 2004 Jul-Aug;11(4):217-21. Cancer Control
2004 Changing clinical practice: extending the benefits of adjuvant endocrine therapy in breast cancer. Goss PE BIG 1-97 MA.17 Semin Oncol. 2004 Dec;31(6 Suppl 12):15-22. Seminars in Oncology
2004 Adjuvant chemotherapy in elderly patients with breast cancer: a survey of the Breast International Group (BIG) Biganzoli L, Goldhirsch A, Straehle C, Castiglione-Gertsch M, Therasse P, Aapro M, Minisini A, Piccart MJ General Ann Oncol 15:2:207-210, 2004 Annals of Oncology
2004 A big trial for a new technology: TransBIG Project takes microarrays into clinical trials Tuma RS TRANSBIG J Natl Cancer Inst. 2004 May 5;96(9):648-9. Journal of the National Cancer Institute
2003 A randomized trial of letrozole in postmenopausal women after five years of tamoxifen therapy for early-stage breast cancer Goss PE, Ingle JN, Martino S, Robert NJ, Muss HB, Piccart MJ, Castiglione M, Tu D, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Therasse P, Palmer MJ, Pater JL BIG 1-97 MA.17 N Engl J Med 349-19:1793-1802, 2003 New England Journal of Medicine
2003 Aromatase inhibitors in prevention--data from the ATAC (arimidex, tamoxifen alone or in combination) trial and the design of IBIS-II (the second International Breast Cancer Intervention Study). Cuzick J. BIG 5-02 IBIS-II Recent Results Cancer Res. 2003;163:96-103; discussion 264-6. Recent Results Cancer Research
2002 Moving forward: Herceptin in the adjuvant setting. Tan-Chiu E, Piccart M. BIG 1-01 HERA Oncology. 2002;63 Suppl 1:57-63. Oncology
2000 The Breast International Group : a new spirit of collaboration in breast cancer research for the new millennium Piccart M, Goldhirsch A, Straehle C General Eur J Cancer. 2000 Sep;36(14):1733-6. The European Journal of Cancer