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NCT04478266 · ClinicalTrials.gov registry record · Phase 3
Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer
A Phase 3 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,068
- Enrollment target
NCT04478266 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 1,068 participants.
The verdict
NCT04478266, a Phase 3 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,068 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Letrozole
- DRUG Palbociclib
- DRUG Goserelin
- DRUG Amcenestrant-matching placebo
- DRUG SAR439859
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,068 participants |
| Start Date | 2020-10-14 |
| Est. Completion | 2023-05-26 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04478266
The ClinicalTrials.gov registry entry for NCT04478266 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 1,068 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Letrozole is the first listed.
NCT04478266 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04478266 about?
NCT04478266 is a clinical study titled "Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer". 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 nega...
What is the current status of trial NCT04478266?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,068 participants. The study started on 2020-10-14. Estimated completion is 2023-05-26.
What interventions are being tested in trial NCT04478266?
The interventions under investigation include: Letrozole (DRUG), Palbociclib (DRUG), Goserelin (DRUG), Amcenestrant-matching placebo (DRUG), SAR439859 (DRUG).
Who is sponsoring clinical trial NCT04478266?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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