Fezolinetant for hot flashes in women with early-stage, hormone receptor–positive breast cancer on endocrine therapy
A Randomized Phase II Study to Evaluate the Efficacy of Fezolinetant in Reducing Vasomotor Symptoms in Women With Breast Cancer on Endocrine Therapy
This trial will test whether taking fezolinetant 45 mg daily can reduce moderate-to-severe hot flashes in women with early-stage, HR+ breast cancer who are on tamoxifen or aromatase inhibitors.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 40 Years to 65 Years |
| Sex | Female |
| Sponsor | Yale University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 2 sites (New Haven, Connecticut and 1 other locations) |
| Trial ID | NCT06917313 on ClinicalTrials.gov |
What this trial studies
This is a phase II, randomized, double-blind, placebo-controlled trial enrolling 92 participants randomized 1:1 to fezolinetant 45 mg daily or placebo for 12 weeks. After a 7–14 day screening period with baseline measures, participants will record daily frequency and severity of vasomotor symptoms and weekly averages will be calculated. The primary efficacy endpoint compares the change in weekly average daily frequency of moderate-to-severe hot flashes from baseline to week 12 between arms. After the week-12 assessment participants will be unblinded and may cross over to the alternate treatment if they choose.
Who should consider this trial
Good fit: Postmenopausal women aged 40–65 with stage I–III, hormone receptor–positive breast cancer who are currently on tamoxifen or an aromatase inhibitor, have at least seven moderate-to-severe hot flashes per day, a BMI of 18–40 kg/m2, and meet the trial's menopause and treatment-duration criteria.
Not a fit: People who are not on endocrine therapy, have fewer than seven moderate-to-severe hot flashes per day, are outside the specified age or BMI ranges, or who are premenopausal and not chemically suppressed are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, fezolinetant could meaningfully reduce hot flash frequency and severity, improving quality of life and adherence to endocrine therapy for breast cancer survivors.
How similar studies have performed: Neurokinin 3 receptor antagonists like fezolinetant have shown clear benefit for menopausal vasomotor symptoms in the general population, but data specifically in breast cancer patients on endocrine therapy are more limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Women with diagnosed, histologically confirmed, clinical stage I-III, HR+ invasive breast cancer as defined by ASCO CAP guidelines for whom adjuvant endocrine therapy would be indicated. BMI of 18-40 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: Participants who have a diagnosis of stage IV metastatic disease. 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. Known cirrhosis or 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.
Where this trial is running
New Haven, Connecticut and 1 other locations
- Yale University — New Haven, Connecticut, United States (Recruiting)
- The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Maryam Lustberg, MD — Yale University
- Study coordinator: Laura Kane
- Email: laura.kane@yale.edu
- Phone: 773-369-6904
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.