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.
Study duration per participant was approximately 59 months, which includes a 33- month treatment period.
Pharmaceutical form: Tablets Route of Administration: Oral
Pharmaceutical form: Tablets Route of Administration: Oral
Pharmaceutical form: Capsules/Tablets Route of Administration: Oral
Pharmaceutical form: Capsules Route of Administration: Orally
Pharmaceutical form: Depot Injection Route of Administration: Subcutaneous
Pharmaceutical form: Capsules Route of Administration: Orally
CABA, Buenos Aires, Argentina
CABA, Buenos Aires, Argentina
Capital Federal, Buenos Aires, Argentina
Pergamino, Buenos Aires, Argentina
Córdoba, Córdoba Province, Argentina
Rosario, Santa Fe Province, Argentina
Buenos Aires, Argentina
La Rioja, Argentina
Mar del Plata, Argentina
Salta, Argentina