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Fezolinetant for the Improvement of Vasomotor Symptoms in Breast Cancer Patients Taking Endocrine Therapy, VENT Trial | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Fezolinetant for the Improvement of Vasomotor Symptoms in Breast Cancer Patients Taking Endocrine Therapy, VENT Trial

Phase 2 Randomized, Cross-over Trial of Fezolinetant for Treatment of Vasomotor Symptoms in Patients Taking Endocrine Therapy (VEnT)

NCT06617455•University of Michigan Rogel Cancer Center

View on ClinicalTrials.gov

Summary

This phase II trial tests how well fezolinetant works in improving vasomotor symptoms (VMS) in breast cancer patients taking endocrine therapy (ET). Anti-hormone treatments are effective for lowering the risk of breast cancer but can cause bothersome VMS, such as hot flashes and night sweats. Fezolinetant inhibits the activity of the neurokinin type 3 receptor and has shown activity against VMS in postmenopausal women. Taking fezolinetant may work well at improving VMS in breast cancer patients taking ET.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Female subject aged ≥ 18 years
•Taking endocrine therapy (tamoxifen, anastrozole, exemestane, or letrozole) for adjuvant treatment of stage 1-3 breast cancer or for chemoprevention (breast ductal carcinoma in situ \[DCIS\] or high risk)
•Planning to take the same endocrine therapy for at least 10 weeks after study drug initiation
•Report 28 or more VMS episodes, at least some of which are severe or bothersome, during the 7-day screening period
•Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2 x upper limit of normal (ULN) within 28 days prior to randomization
•Total bilirubin \< 2 x ULN within 28 days prior to randomization
•Completion of chemotherapy, if given. Concurrent use of gonadotropin releasing hormone agonist (GnRHa) therapy, anti-HER2 therapy, bisphosphonate therapy, poly adenosine diphosphate-ribose polymerase (PARP) inhibitor therapy, and abemaciclib therapy is permitted
•Patients receiving treatment with selective serotonin reuptake inhibitor (SSRIs), serotonin and norepinephrine reuptake inhibitor (SNRIs), gabapentinoids, clonidine, or oxybutynin must have been taking a stable dose for at least 30 days prior to enrollment if they plan to continue the drug during study participation, and willing to remain on the treatment for the duration of study participation. If they do not plan to take the medication during study participation, they should stop the medication at least 7 days before the start of the VMS screening period
•Patients taking over-the-counter supplements or herbal medications for treatment of VMS must stop the medication at least 7 days before the start of the VMS screening period
•Able to self-complete questionnaires in English
+2 more criteria

Exclusion Criteria

•Metastatic breast cancer
•Prior treatment with fezolinetant
•Known severe renal disease (estimated glomerular filtration rate \[eGFR\] less than 30 mL/min/1.73 m\^2)
•Known cirrhosis
•Pregnant or breast feeding, or plan to become pregnant during the study period or within 3 months of completing study medication
•Concomitant use of CYP1A2 inhibitors, including but not limited to fluvoxamine, ciprofloxacin, cimetidine, citalopram, and ribociclib
•Concomitant use of systemic or transdermal estrogen products
•Known allergy or hypersensitivity to fezolinetant or any of the excipients in the medication
•Unable to take oral medications
•Any medical condition that would interfere with the absorption of study medication. Prior gastric bypass is permitted
+3 more criteria

Locations (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Key Dates

Start Date

October 31, 2024

Primary Completion Date

October 22, 2025

Completion Date

November 21, 2025

Last Updated

March 2, 2026

Enrollment

ACTUAL participants

Conditions

Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Breast Ductal Carcinoma In SituLocalized Breast Carcinoma

Interventions

Biospecimen Collection

PROCEDURE

Fezolinetant

DRUG

Placebo Administration

DRUG

Quality-of-Life Assessment

OTHER

Questionnaire Administration

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Fezolinetant for the Improvement of Vasomotor Symptoms in Breast Cancer Patients Taking Endocrine Therapy, VENT Trial

Inclusion Criteria

Exclusion Criteria

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