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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: Clinical Trial Phase 2 study, sponsored by Sanofi.
NCT04191382 is a Phase 2 study that was terminated before completion, run by Sanofi. The registered enrollment target is 105 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Tumor tissue collected through a core-cut biopsy at Baseline and Day 15 was used to determine Ki67 expression. Ki67 expression was defined as the percentage of positive tumor cells assessed by central reading. Ki67 percent change from Baseline for a given participant was defined as 100\*(Ki67pre - Ki67post) / Ki67pre, where Ki67pre and Ki67post were pre-treatment and post-treatment Ki67 value of the participant. Adjusted geometric least square (LS) means and 95 percentage (%) confidence interval
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 |
Why NCT04191382 stopped before completion
NCT04191382 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% lower).
The record links to 0 conditions, and to 2 interventions - of which Letrozole is the first listed.
NCT04191382 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04191382's enrollment target sits among peer trials
105 650th of 2000 higher than 1,341 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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