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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: Clinical Trial Phase 2 study, sponsored by Sanofi.
NCT04059484 is a Phase 2 study that was terminated before completion, run by Sanofi. The registered enrollment target is 367 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (176% higher). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
PFS is defined as the time in months interval from the date of randomization to the date of first documented tumor progression as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) assessed by independent central review (ICR) or death (due to any cause), whichever comes first. Progressive Disease (PD) as per RECIST 1.1: at least a 20 percent (%) increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meie
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 |
Why NCT04059484 stopped before completion
NCT04059484 is an interventional study that assigns participants to a tested intervention. The registered 367 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (176% higher).
The record links to 0 conditions, and to 5 interventions - of which Anastrozole is the first listed.
NCT04059484 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04059484's enrollment target sits among peer trials
367 121st of 2000 higher than 1,880 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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