TERMINATED • Phase III • Stage III, IV • ER positive • PR positive • HER2 negative • CDK4/6 inhibitor absent • Medical Oncology • 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 was 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 was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.