Overview

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

Status:
Terminated

Trial end date:
2021-05-28

Target enrollment:

Participant gender:

Summary

Primary Objective: To determine whether amcenestrant given at 2 different doses improves 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 ≥50% (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

Phase:

Phase 2

Details

Lead Sponsor:

Sanofi

Treatments:

Letrozole