Terminated • Phase III • Stage III, IV • ER positive • PR positive • HER2 negative • CDK4/6 inhibitor absent • Post-Menopausal • Interventional

The following is imported from ClinicalTrials.gov:

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

Brief 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.

Description

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

Study Design

Eligibility Criteria

Arms and Intervention

• Amcenestrant-matching placebo

• SAR439859

• Palbociclib

• Letrozole

• Goserelin

• Letrozole-matching placebo

Exclusion criteria

• known active brain metastases.

• prior neo (adjuvant) treatment with any selective estrogen receptor degrader (serd).

• inadequate organ and marrow function.

• disease recurrence while on, or within 12 months of completion of (neo)adjuvant endocrine therapy.

• pregnant, breastfeeding, or woman of childbearing potential unwilling to use recommended contraception methods.

• male participants who disagree to follow contraception.

• participants with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term.

• participants with significant concomitant illness.

• the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.