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NCT06917313 · ClinicalTrials.gov registry record · Phase 2
FLASH-Breast: Evaluating the Efficacy of Fezolinetant in Reducing Vasomotor Symptoms in Women With Breast Cancer on Endocrine Therapy
A Phase 2 study of Breast Cancer Early Stage Breast Cancer (Stage 1-3), sponsored by Yale University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 92
- Enrollment target
- 2
- Study locations
NCT06917313 is a Phase 2 study of Breast Cancer Early Stage Breast Cancer (Stage 1-3) that is actively recruiting participants, run by Yale University. The registered enrollment target is 92 participants. The trial reports 2 study locations across 2 states.
The verdict
NCT06917313, a Phase 2 study of Breast Cancer Early Stage Breast Cancer (Stage 1-3), is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 92 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a phase II, randomized, double-blinded, placebo-controlled trial designed to evaluate the efficacy of fezolinetant (45 mg a day) vs. placebo in reducing moderate to severe vasomotor symptoms (VMS) in breast cancer survivors on endocrine therapy (tamoxifen, aromatase inhibitors). The trial will proceed in a single stage, and the total of 92 participants will be randomized in 1:1 fashion to fezolinetant or placebo arm respectively.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Fezolinetant
Study Locations (2)
Connecticut
- Yale University - New Haven
Ohio
- The Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2025-12-05 |
| Est. Completion | 2028-03 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06917313
The ClinicalTrials.gov registry entry for NCT06917313 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Breast Cancer Early Stage Breast Cancer (Stage 1-3) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06917313 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Connecticut, Ohio.
Frequently Asked Questions
What is clinical trial NCT06917313 about?
NCT06917313 is a clinical study titled "FLASH-Breast: Evaluating the Efficacy of Fezolinetant in Reducing Vasomotor Symptoms in Women With Breast Cancer on Endocrine Therapy". This is a phase II, randomized, double-blinded, placebo-controlled trial designed to evaluate the efficacy of fezolinetant (45 mg a day) vs. placebo in reducing moderate to severe vasomotor symptoms (VMS) in breast cancer survivors on endocrine therapy (tamoxifen, aromatase inhibitors). The trial wi...
What is the current status of trial NCT06917313?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 92 participants. The study started on 2025-12-05. Estimated completion is 2028-03.
What conditions does trial NCT06917313 study?
This clinical trial studies the following conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3).
What interventions are being tested in trial NCT06917313?
The interventions under investigation include: Placebo (DRUG), Fezolinetant (DRUG).
Who is sponsoring clinical trial NCT06917313?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06917313 being conducted?
This trial has 2 study locations across Connecticut, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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