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

EFC15935

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.

2020-10-14

2022-06-28

2023-05-26

Terminated

Early phase I

1068

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 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 1068, 'type': 'ACTUAL'}}

2023-12-08