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

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.