Study Sponsor: Sanofi

Study Drug Name: Amcenestrant

Drug Class: Amcenestrant is a type of hormone therapy called a selective estrogen receptor degrader/down regulator with possible anti-cancer properties. This means it specifically targets

Route of administration: Amcenestrant, Palbociclib, and Letrozole are oral medications. Goserelin is given as an injection under the skin (subcutaneous).

Duration of Study: This trial is about 64 months long with a treatment period of about 33 months.

Target Patient Cancer Type: ER (+) HER2(-) Advanced Breast Cancer

Key Inclusion Criteria:

• ER+/HER2- breast cancer
• Recurrent or metastatic disease not responsive to curative treatment
• No prior systemic treatment for recurrent or metastatic disease

Key Exclusion Criteria:

• Active brain metastases
• Prior treatment with any selective estrogen receptor degrader (SERD)
• Impaired organ or marrow function
• Disease recurrence while on, or within 12 months of completion of (neo)adjuvant endocrine therapy
• Pregnant, breastfeeding, or planning to become pregnant during trial participation

Diversity Statement:

Sanofi respects the diversity of its people and works to create an inclusive workplace where everyone can be their true selves. Its employees represent the variety of Sanofi’s patients, customers and partners, which builds a better understanding of needs and forges stronger connections. Sanofi people dare to be themselves and to celebrate their differences, be it race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; or veteran or military status, in an environment that helps them achieve their full potential.

Brief Summary:

This study is being conducted to determine whether Amcenestrant given with palbociclib improves progression free survival (PFS) when compared with letrozole given with palbociclib for participants with ER+, HER2- advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease.

Full Protocol Title: Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer (AMEERA-5)

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