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NCT04191382 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Window Study of SAR439859 (Amcenestrant) Versus Letrozole in Post-menopausal Patients With ER+, HER2- Pre-operative Post-menopausal Primary Breast Cancer
A Phase 2 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 2
- Development phase
- 105
- Enrollment target
NCT04191382 is a Phase 2 study that was terminated before completion, run by Sanofi. The registered enrollment target is 105 participants.
The verdict
NCT04191382, a Phase 2 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 105 participants
- Enrollment target
Study Summary
Primary Objective: To determine whether amcenestrant given at 2 different doses improved the antiproliferative activity when compared to letrozole. Secondary Objectives: * To assess the proportion of participants with a relative decrease from Baseline in percentage of positive tumor cells tested by immunohistochemistry greater than or equal to (\>=) 50 percent (%) (Ki67 \>=50%) in the three treatment arms. * To assess estrogen receptor (ER) degradation in biopsies in participants in the three treatment arms. * To assess safety in the three treatment arms.
Interventions
- DRUG Letrozole
- DRUG Amcenestrant (SAR439859)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2020-02-04 |
| Est. Completion | 2021-05-28 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04191382
The ClinicalTrials.gov registry entry for NCT04191382 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 105 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 2 interventions - of which Letrozole is the first listed.
NCT04191382 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04191382 about?
NCT04191382 is a clinical study titled "Phase 2 Window Study of SAR439859 (Amcenestrant) Versus Letrozole in Post-menopausal Patients With ER+, HER2- Pre-operative Post-menopausal Primary Breast Cancer". Primary Objective: To determine whether amcenestrant given at 2 different doses improved the antiproliferative activity when compared to letrozole. Secondary Objectives: * To assess the proportion of participants with a relative decrease from Baseline in percentage of positive tumor cells tested ...
What is the current status of trial NCT04191382?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 2020-02-04. Estimated completion is 2021-05-28.
What interventions are being tested in trial NCT04191382?
The interventions under investigation include: Letrozole (DRUG), Amcenestrant (SAR439859) (DRUG).
Who is sponsoring clinical trial NCT04191382?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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