ASCO 2022 | AMEERA-6: Amcenestrant, a novel SERD, in HR+ breast cancer

The trial I will be presenting at the poster session during the upcoming ASCO meeting is the AMEERA-6 trial, which is a Sanofi sponsored trial in collaboration with EORTC, with AFT and with BIC. So I, myself am a medical fellow and part of the medical team at EORTC supporting this trial. So most people treating patients with endocrine therapy for hormone receptor positive early breast cancer know from experience that this therapy is not always well tolerated. And we have seen in large registry studies that up to 30% of patients discontinue their treatments earlier than planned. The majority, even in the first year, so about 20% actually discontinued their treatment within the first year of initiation, especially the treatment with aromatase inhibitors. So the AMEERA-6 trial is a Phase III randomized, double blind, double dummy study, where patients, so pre or postmenopausal women or men, who have discontinued their aromatase inhibitor therapy within 30 months of initiation are randomized to receive either tamoxifen, which is actually at this point the standard therapy for these patients, or to receive amcenestrant, which is an oral SERD.

So a selective estrogen receptor degrader with a dual mechanism, so this both inhibits and degrades the estrogen receptor. And amcenestrant has shown in a phase 1/2 trial that it has meaningful clinical activity in patients with advanced breast cancer, as well as a tolerable safety profile. So the purpose of our trial is to investigate whether treatment with amcenestrant during five years in these patients who have to discontinue their aromatase inhibitor therapy cannot be more efficient than treatment with tamoxifen in this setting.