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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT04478266

Run by

Sanofi

People needed

1068

Starts

2020-10-14

Expected to finish

2023-05-26

Last updated by the study team

2025-09-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigational Site Number :8400083 — Glendale, Arizona, United States
• Investigational Site Number :8400066 — Tucson, Arizona, United States
• Investigational Site Number :8400038 — Fullerton, California, United States
• Investigational Site Number :8400056 — Los Alamitos, California, United States
• Investigational Site Number :8400029 — Santa Monica, California, United States
• Investigational Site Number :8400025 — Denver, Colorado, United States
• Investigational Site Number :8400059 — Lakeland, Florida, United States
• Investigational Site Number :8400053 — Orlando, Florida, United States
• Investigational Site Number :8400081 — Palm Bay, Florida, United States
• Investigational Site Number :8400055 — Athens, Georgia, United States
• Investigational Site Number :8400016 — Atlanta, Georgia, United States
• Investigational Site Number :8400034 — Savannah, Georgia, United States
• Investigational Site Number :8400035 — Thomasville, Georgia, United States
• Investigational Site Number :8400039 — Chicago, Illinois, United States
• Investigational Site Number :8400008 — Fort Wayne, Indiana, United States
• Investigational Site Number :8400006 — Iowa City, Iowa, United States
• Investigational Site Number :8400013 — Westwood, Kansas, United States
• Investigational Site Number :8400028 — Scarborough, Maine, United States
• Investigational Site Number :8400017 — Boston, Massachusetts, United States
• Investigational Site Number :8400076 — Danvers, Massachusetts, United States
• Investigational Site Number :8400077 — Newton, Massachusetts, United States
• Investigational Site Number :8400002 — Ann Arbor, Michigan, United States
• Investigational Site Number :8400005 — Kansas City, Missouri, United States
• Investigational Site Number :8400004 — St Louis, Missouri, United States
• Investigational Site Number :8400075 — Daphne, Alabama, United States

Full record on ClinicalTrials.gov

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