Fezolinetant for hot flashes in women with early-stage, hormone receptor–positive breast cancer on endocrine therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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, regardless of HER2 status.

Age 18 years and older.

Currently on endocrine therapy (tamoxifen or aromatase inhibitors) as part of standard of care treatment for HR+ breast cancer. Endocrine therapy may be administered with or without ovarian suppression and/or CDK4/6 inhibitors as permitted in Section 7.1.1. Participants with HER2-positive disease are eligible and may receive concurrent HER2 monoclonal antibody therapy (e.g., trastuzumab or pertuzumab), but not HER2 antibody-drug conjugates (e.g., ado-trastuzumab emtansine T-DM1, or trastuzumab deruxtecan T-DXd).

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.

-Premenopausal participants receiving ovarian suppression must agree to use an effective non-hormonal method of contraception during study participation and for the longest period required after the last dose of study treatment based on the contraception requirements for all anticancer therapies the participant is receiving.

o Acceptable methods of contraception include: Intrauterine device (IUD), Total hysterectomy or bilateral tubal ligation, Sexual abstinence (the reliability of abstinence must be evaluated concerning the duration of the clinical study and the participant's lifestyle), A vasectomized partner (provided the partner is the sole sexual partner of the study participant and that the vasectomized partner has received medical confirmation of the surgical success).

On endocrine therapy for a minimum of 3 months and has planned duration of 12 weeks left in the treatment regimen. Participants receiving a CDK4/6 inhibitor must have been on treatment for at least 4 weeks prior to enrollment.

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 initiated, discontinued, or had a dose adjustment of treatment for vasomotor symptoms (prescription, over the counter, or herbal) within 28 days prior to screening.

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.