Phase 2 Window Study of SAR439859 (Amcenestrant) Versus Letrozole in Post-menopausal Patients With ER+, HER2- Pre-operative Post-menopausal Primary Breast Cancer (AMEERA-4)

Duration of the study, per patient, will include screening period of up to 14 days before randomization, treatment period of 14 days and post-treatment safety follow-up period of 30±7 days after last Investigational Medicinal Product (IMP) intake.

Phase 2 Window Study of Two Dose Levels of Amcenestrant [SAR439859] (SERD) Versus Letrozole in Newly Diagnosed Pre-operative Post-menopausal Patients With ER Positive, HER2 Negative Primary Breast Cancer

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

Clinical Trial: Phase 2 Window Study of SAR439859 (Amcenestrant) Versus Letrozole in Post-menopausal Patients With ER+, HER2- Pre-operative Post-menopausal Primary Breast Cancer (AMEERA-4)

Phase 2 Window Study of SAR439859 (Amcenestrant) Versus Letrozole in Post-menopausal Patients With ER+, HER2- Pre-operative Post-menopausal Primary Breast Cancer (AMEERA-4)

Recruitment

Summary

Participation Requirements

Description

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