SAR439859 Plus Palbociclib as First Line Therapy for Patients With ER(+) HER2(-) Advanced Breast Cancer
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- STATUS
- Recruiting
-
- End date
- Sep 12, 2026
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- participants needed
- 810
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- sponsor
- Sanofi
Summary
Primary Objective:
To determine whether SAR439859 in combination with palbociclib improves progression 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 the pharmacokinetics of SAR439859, goserelin, 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
Description
Study duration per participant is approximately 57 months, which includes a 24-month treatment period
Details
| Condition | Breast Cancer, Breast Cancer |
|---|---|
| Age | 18-100 years |
| Treatment | Goserelin, Letrozole, SAR439859, Letrozole-matching placebo, SAR439859-matching placebo, Ibrance |
| Clinical Study Identifier | NCT04478266 |
| Sponsor | Sanofi |
| Last Modified on | 19 February 2024 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
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