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FLASH-Breast: Evaluating the Efficacy of Fezolinetant in Reducing Vasomotor Symptoms in Women With Breast Cancer on Endocrine Therapy

ConditionBreast Cancer Early Stage Breast Cancer (Stage 1-3)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorYale University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fezolinetant

    Drug

    45 mg tablets, administered orally once daily with or without food, to be taken throughout the entire study phase, i.e. 12 weeks

  • Placebo

    Drug

    45 mg tablets, administered orally once daily with or without food, to be taken throughout the entire study phase, i.e. 12 weeks

Treatment groups

92 Participants
are divided into 2 treatment groups
Group A: FezolinetantActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Frequency of moderate/severe VMS at 12 weeks of treatment with fezolinetant vs. placebo

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).

Time frame
Baseline to 12 weeks

Secondary outcomes

1

Efficacy of fezolinetant vs. placebo in reducing the mean daily frequency of moderate/severe VMS

To evaluate the efficacy of fezolinetant vs. placebo in reducing the mean daily frequency of moderate/severe VMS

Time frame
At week 4, after treatment initiation
2

Regression of mean daily frequency of moderate/severe VMS average

To evaluate treatment activity among breast cancer survivors treated with fezolinetant vs placebo over the entire course of the study duration - measure by regression of mean daily frequency of moderate/severe VMS average every week of treatment (weeks 0-12)

Time frame
Study duration: weeks 0-12
3

Change in global quality of life using Functional Assessment of Cancer Therapy - Breast, Endocrine Therapy Symptoms (FACT-B ES)

To evaluate the difference in global quality of life in breast cancer survivors treated with fezolinetant vs placebo using FACT-B ES. The total score range is 0 to 164, with higher scores indicating better quality of life

Time frame
Baseline to week 12
4

Differences in sleep quality using PROMIS Sleep Disturbance-Short Form 8b (PROMIS SD SF 8b)

To evaluate the differences in sleep quality in breast cancer survivors' treatment with fezolinetant vs placebo using patient-reported outcomes measurement information System Sleep Disturbance - Short Form 8b (PROMIS SD SF 8b. Total score is calculated by summing the items (range: 8-40), with a higher score meaning more disturbed sleep.

Time frame
Baseline, week 4 and week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

Astellas Pharma US, Inc.

Collaborator

Source ClinicalTrials.gov
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