Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer

• Status: Recruiting
• Trial end date: 2025-07-01

Summary

Primary Objective:

To determine whether amcenestrant per os improves progression free survival (PFS) when compared with a endocrine monotherapy of the choice of the physician, in participants with metastatic or locally advanced breast cancer

Secondary Objectives:

• To compare the overall survival in the 2 treatment arms

• To assess the objective response rate in the 2 treatment arms

• To evaluate the disease control rate in the 2 treatment arms

• To evaluate the clinical benefit rate in the 2 treatment arms

• To evaluate the duration of response in the 2 treatment arms

• To evaluate the PFS according to the estrogen receptor 1 gene (ESR1) mutation status in the 2 treatment arms

• To evaluate the pharmacokinetics of amcenestrant as single agent

• To evaluate health related quality of life in the 2 treatment arms

• To compare the overall safety profile in the 2 treatment arms

• Phase: Phase 2

Details

• Lead Sponsor: Sanofi
• Treatments: Anastrozole; Exemestane; Fulvestrant; Letrozole; Tamoxifen