This international study will compare the efficacy and tolerability of amcenestrant versus tamoxifen in patients with hormone receptor-positive, HER2-negative early breast cancer who experienced burdensome side effects with aromatase inhibitors and have therefore prematurely ended their adjuvant therapy.
Adjuvant therapy is given after surgery with or without radiotherapy to help prevent and delay the progression of the disease into a more advanced and incurable form. However, current adjuvant therapies, like aromatase inhibitors, can have side effects for patients, which may cause them to discontinue the medication prematurely. As a result, many of these patients experience disease recurrence.
The objective of AMEERA-6 is to investigate another treatment option for these patients in order to prevent them from developing advanced, incurable disease.
The study opened in January 2022 and will enrol 3,738 patients from 650 hospitals and cancer centres in about 29 countries worldwide.
18 academic research groups from the BIG network are participating in the study, making this international research effort possible.
The AMEERA-6 trial is a partnership coordinated by BIG Headquarters in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC) and Alliance Foundation Trials (AFT). Sanofi is the pharmaceutical partner and sponsor of the study, providing funding and study drugs.
