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
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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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