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; 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 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, 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: 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 ; 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. 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. 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. 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, 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. 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: 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 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 : 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 ; 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: 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