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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: Recruiting Phase 2 study of Breast Cancer Early Stage Breast Cancer (Stage 1-3), sponsored by Yale University.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To evaluate the mean change reduction in frequency of moderate/severe VMS at 12 weeks of treatment with fezolinetant vs. placebo in breast cancer survivors on endocrine therapy (tamoxifen or aromatase inhibitors).
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 |
What NCT06917313 shows while recruiting
NCT06917313 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06917313's enrollment target sits among peer trials
92 767th of 2000 higher than 1,231 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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