FLASH-Breast: Evaluating the Efficacy of Fezolinetant in Reducing Vasomotor Symptoms in Women With Breast Cancer on Endocrine Therapy
NCT ID: NCT06917313
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
92 participants
INTERVENTIONAL
2025-12-05
2028-03-31
Brief Summary
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Detailed Description
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Investigators hypothesis is that neurokinin blockade by fezolinetant will significantly reduce vasomotor symptoms in breast cancer survivors on endocrine therapy (tamoxifen or aromatase inhibitor) measured by mean change in frequency of moderate to severe VMS based on patient reported data from baseline to 12-weeks.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Fezolinetant
Fezolinetant is an oral medication, and the first neurokinin 3 (NK3) receptor antagonist approved by the FDA in May 2023 for treatment of moderate to severe hot flashes due to menopause. It blocks the activities of the NK3 receptor which is involved in the brain's regulation of body temperature.
Fezolinetant
45 mg tablets, administered orally once daily with or without food, to be taken throughout the entire study phase, i.e. 12 weeks
Placebo
Patients will be given placebo tablets to compare to active comparator.
Placebo
45 mg tablets, administered orally once daily with or without food, to be taken throughout the entire study phase, i.e. 12 weeks
Interventions
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Fezolinetant
45 mg tablets, administered orally once daily with or without food, to be taken throughout the entire study phase, i.e. 12 weeks
Placebo
45 mg tablets, administered orally once daily with or without food, to be taken throughout the entire study phase, i.e. 12 weeks
Eligibility Criteria
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Inclusion Criteria
BMI of 18-38 kg/m2
Age 40-65
Currently on endocrine therapy (tamoxifen or aromatase inhibitors)
Willing and able to provide written informed consent/assent for the trial.
Postmenopausal as defined by spontaneous amenorrhea for at least 12 consecutive months, spontaneous amenorrhea for at least 6 months with biochemical criteria or menopause (FSH \> 40 IU/L), or bilateral oophorectomy for at least 6 weeks before the screening visit, or if premenopausal chemically suppressed by GnRH agonist therapy with ultrasensitive estradiol level \<10.
On endocrine therapy for a minimum of 3 months and has planned duration of 12 weeks left in the treatment regimen.
Experiencing an average of seven or more moderate to severe hot flashes per day over a 7-day period as documented by Symptom Diary during the Screening Period and seeking treatment or relief for VMS.
Able to swallow oral formulation of the study agent.
Exclusion Criteria
Receiving any other cancer treatment other than endocrine therapy. This includes chemotherapy, targeted therapies, and immunotherapy.
Receiving cytochrome CYP1A2 inhibitors
Participants who have received any treatment for vasomotor symptoms (prescription, over the counter, or herbal) for the last 28 days.
Pregnant or lactating patients
Active liver disease, jaundice, or elevated liver aminotransferases (ALT or AST) \>2x ULN, or elevated total bilirubin, OR elevated direct bilirubin, or elevated INR, or elevated alkaline phosphatase \>2x ULN
Creatinine \> 1.5 times upper limit of normal; or estimated GFR ≤ 30 mL/min per 1.73 m2 at screening.
Judgement by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
40 Years
65 Years
FEMALE
Yes
Sponsors
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Astellas Pharma US, Inc.
INDUSTRY
Yale University
OTHER
Responsible Party
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Maryam Lustberg
Professor of Internal Medicine
Principal Investigators
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Maryam Lustberg, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale University
New Haven, Connecticut, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Carl Brown
Role: primary
Cara Dauch
Role: primary
Other Identifiers
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2000037181
Identifier Type: -
Identifier Source: org_study_id