APPALACHES

BIG 18-01

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A phase II study of Adjuvant Palbociclib as an Alternative to CHemotherapy in Elderly patients with high-risk ER+/HER2- early breast cancer

APPALACHES aims to test the efficacy of at least 5 years of endocrine therapy combined with 2 years of palbociclib as post-surgery (adjuvant) treatment compared with adjuvant chemotherapy followed by endocrine  therapy in older patients with stage II-III ER-positive/HER2-negative (ER+/HER2-) early breast cancer.

Palbociclib has already been approved for use as a standard therapy in combination with endocrine therapy in many countries for treating ER+ HER2-metastatic breast cancer.

Palbociclib is generally well tolerated and expected to have fewer side effects than chemotherapy. The APPALACHES study aims to find out if this treatment of endocrine therapy combined with palbociclib will be at least as efficient as the standard chemotherapy followed by anti-hormonal therapy in patients with stage II-III ER+-HER2- early breast cancer.

Patients will be randomly assigned to two different groups. After a surgical procedure to remove the primary breast tumour, patients will receive either:
– Standard adjuvant endocrine therapy for at least 5 years in combination with palbociclib for up to 2 years.

OR

– Standard adjuvant chemotherapy followed by standard adjuvant endocrine therapy for at least 5 years.

The trial recruited 372 patients (women and men) aged 70 years and older who have been diagnosed with stage II or III early invasive ER-positive/HER2-negative breast cancer.

The APPALACHES study is coordinated and sponsored by the EORTC (European Organisation for Research and Treatment of Cancer) under the BIG umbrella.

In addition to the GBG (German Breast Group), 5 BIG groups are participating:  .

Pfizer is the pharmaceutical partner of the study, providing funding and study drugs.

The study started recruitment in September 2019 and reached its accrual goal in Q4 2022.  Expected study completion date: September 30, 2032.

74 sites in 9 countries:

  • België
  • Italië
  • UK
  • Frankrijk
  • Portugal
  • Spanje
  • Germany
  • Poland
  • Jordan

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APPALACHES is made possible by a research grant and study drugs provided by Pfizer and is run according to BIG’s Principles of Research Conduct.

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