Phase 2 Breast Cancer Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- Women who have been diagnosed with hormone receptor-positive (HR+) invasive breast cancer at an early to intermediate stage (stage I, II, or III), confirmed by a tissue biopsy, for whom hormone-blocking treatment has been recommended.
- People aged 18 years or older.
- People currently taking hormone-blocking medication (such as tamoxifen or aromatase inhibitors) as part of their standard breast cancer treatment, which may also include ovarian suppression and/or certain targeted medicines called CDK4/6 inhibitors. People with HER2-positive breast cancer may also be eligible if they are receiving certain HER2-targeting antibody medicines (such as trastuzumab or pertuzumab), but not HER2 antibody-drug conjugates.
- People willing and able to sign a written consent form to take part in the trial.
- People who are postmenopausal (either naturally, through surgery, or through hormone-suppressing injections that bring estrogen levels low enough to meet the trial's definition).
- People who have been on hormone-blocking treatment for at least 3 months and have at least 12 weeks of treatment still planned. People also taking a CDK4/6 inhibitor must have been on it for at least 4 weeks before joining.
- People experiencing an average of seven or more moderate to severe hot flashes per day over a 7-day period, recorded in a symptom diary during the screening period, who are looking for relief from these symptoms.
- People who are able to swallow the study medicine in tablet or capsule form.
Who may not be able to join:
- People whose breast cancer has spread to other parts of the body (stage IV or metastatic disease).
- People currently receiving any other cancer treatment beyond hormone-blocking therapy, such as chemotherapy, targeted therapy, or immunotherapy.
- People currently taking a type of medication known as a CYP1A2 inhibitor (confirm with trial site for specific medicines that fall into this category).
- People who have started, stopped, or changed the dose of any treatment for hot flashes or similar symptoms — whether prescription, over-the-counter, or herbal — within 28 days before screening.
- People who are pregnant or currently breastfeeding.
- People with known liver cirrhosis, active liver disease, jaundice, or certain abnormal liver or bile-related blood test results above the levels set by the trial.
- People with certain abnormal kidney function test results at screening.
- People whom the trial investigator believes are unlikely to follow the study procedures and requirements.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Maryam Lustberg, MD, Yale University
Phone: 773-369-6904
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Frequency of moderate/severe VMS at 12 weeks of treatment with fezolinetant vs. placebo
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.