Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer — AMEERA-5  

Breast Cancer Clinical Trial

Official title: A Randomized, Multicenter, Double-blind Phase 3 Study of Amcenestrant (SAR439859) Plus Palbociclib Versus Letrozole Plus Palbociclib for the Treatment of Patients With ER (+), HER2 (-) Breast Cancer Who Have Not Received Prior Systemic Anti-cancer Treatment for Advanced Disease

Status Terminated

Clinical Trial Summary

Primary Objective:

To determine whether Amcenestrant (SAR439859) in combination with palbociclib improves progression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease.

Secondary Objective:

• To compare the overall survival in both treatment arms.

• To evaluate the objective response rate in both treatment arms.

• To evaluate the duration of response in both treatment arms.

• To evaluate the clinical benefit rate in both treatment arms.

• To evaluate progression-free survival on next line of therapy.

• To evaluate the pharmacokinetics of amcenestrant, and palbociclib.

• To evaluate health-related quality of life in both treatment arms.

• To evaluate the time to first chemotherapy in both treatment arms.

• To evaluate safety in both treatment arms.

Clinical Trial Description

Study duration per participant was approximately 59 months, which includes a 33- month treatment period. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT04478266
• Study type: Interventional
• Source: Sanofi
• Status: Terminated
• Phase: Phase 3
• Start date: October 14, 2020
• Completion date: May 26, 2023