Phase 2 Window Study of SAR439859 (Amcenestrant) Versus Letrozole in Post-menopausal Patients With ER+, HER2- Pre-operative Post-menopausal Primary Breast Cancer

Summary

Primary Objective: To determine whether amcenestrant given at 2 different doses improved the antiproliferative activity when compared to letrozole. Secondary Objectives: * To assess the proportion of participants with a relative decrease from Baseline in percentage of positive tumor cells tested by immunohistochemistry greater than or equal to (\>=) 50 percent (%) (Ki67 \>=50%) in the three treatment arms. * To assess estrogen receptor (ER) degradation in biopsies in participants in the three treatment arms. * To assess safety in the three treatment arms.

Timeline

Start

2020-02-04

Primary completion

2021-04-30

Completion

2021-05-28

Publications

• Campone M, Bidard FC, Neven P, Wang L, Ling B, Dong Y, Paux G, Herold C, De Giorgi U. AMEERA-4: a randomized, preoperative window-of-opportunity study of amcenestrant versus letrozole in early breast cancer. Breast Cancer Res. 2023 Nov 10;25(1):141. doi: 10.1186/s13058-023-01740-2.

Drugs

Indications