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NCT04059484 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer
A Phase 2 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 2
- Development phase
- 367
- Enrollment target
NCT04059484 is a Phase 2 study that was terminated before completion, run by Sanofi. The registered enrollment target is 367 participants.
The verdict
NCT04059484, a Phase 2 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 367 participants
- Enrollment target
Study Summary
Primary Objective: To determine whether amcenestrant per overall survival (os) improves progression free survival (PFS) when compared with an endocrine monotherapy of the choice of the physician, in participants with metastatic or locally advanced breast cancer Secondary Objectives: * To compare the overall survival in the 2 treatment arms * To assess the objective response rate in the 2 treatment arms * To evaluate the disease control rate in the 2 treatment arms * To evaluate the clinical benefit rate in the 2 treatment arms * To evaluate the duration of response in the 2 treatment arms * To evaluate the PFS according to the estrogen receptor 1 gene (ESR1) mutation status in the 2 treatment arms * To evaluate the pharmacokinetics of amcenestrant as single agent * To evaluate health-related quality of life in the 2 treatment arms * To compare the overall safety profile in the 2 treatment arms
Interventions
- DRUG Anastrozole
- DRUG Letrozole
- DRUG Exemestane
- DRUG Fulvestrant
- DRUG Amcenestrant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 367 participants |
| Start Date | 2019-10-22 |
| Est. Completion | 2025-01-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04059484
The ClinicalTrials.gov registry entry for NCT04059484 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 367 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 Anastrozole is the first listed.
NCT04059484 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04059484 about?
NCT04059484 is a clinical study titled "Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer". Primary Objective: To determine whether amcenestrant per overall survival (os) improves progression free survival (PFS) when compared with an endocrine monotherapy of the choice of the physician, in participants with metastatic or locally advanced breast cancer Secondary Objectives: * To compare ...
What is the current status of trial NCT04059484?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 367 participants. The study started on 2019-10-22. Estimated completion is 2025-01-02.
What interventions are being tested in trial NCT04059484?
The interventions under investigation include: Anastrozole (DRUG), Letrozole (DRUG), Exemestane (DRUG), Fulvestrant (DRUG), Amcenestrant (DRUG).
Who is sponsoring clinical trial NCT04059484?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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