Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer
Status:
Recruiting
Trial end date:
2027-05-01
Target enrollment:
Participant gender:
Summary
Primary Objective:
To determine whether Amcenestrant (SAR439859) in combination with palbociclib
improvesprogression free survival (PFS) when compared with letrozole in combination with
palbociclib in participants with ER+, 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