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

Trial number: NCT04478266
Trial phase: 3 Study type: targeted, hormonal Overall status: Recruiting

Study Start Date

October, 2020

Scientific 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


Primary Objective: To determine whether Amcenestrant (SAR439859) in combination with palbociclib improvesprogression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with ER+, 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

Inclusion criteria : - Adult participants with loco-regional recurrent or metastatic disease not amenable to curative treatment - Confirmed diagnosis of ER+/HER2- breast cancer - No prior systemic treatment for loco-regional recurrent or metastatic disease - Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Participants should be willing to provide tumor tissue - Capable of giving informed consent 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 child bearing 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 patient's potential participation in a clinical trial.

Study Design

Primary purpose: Treatment , Allocation: Randomized , Intervention model: Parallel Assignment , Masking: Quadruple , Subject masked: Yes , Caregiver masked: Yes , Investigator masked: Yes , Outcomes assessor masked: Yes,


Breast Cancer

Other Study ID Numbers

EFC15935; 2020-001824-33; U1111-1233-0486


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