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Sponsor: Sanofi
Conditions: Breast Cancer
Interventions: Amcenestrant-matching placebo, SAR439859, Palbociclib, Letrozole, Goserelin
Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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.
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- + 219 more on CT.gov