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Anatomic Stage I Breast Cancer AJCC v8Phase 2VEnTNCT06617455

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

A Phase 2 study testing Biospecimen Collection, Fezolinetant and Quality-of-Life Assessment in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by University of Michigan Rogel Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Biospecimen Collection, Fezolinetant and Quality-of-Life Assessment
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
9 participants
Where
1 siteUnited States
Study dates
31 Oct 2024to 21 Nov 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines
  • For women of childbearing potential, participants must agree to use an effective contraceptive method during protocol therapy and for 3 months following completion of protocol therapy with details provided as a part of the consent process and must have a negative pregnancy test at screening. In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, and bilateral tubal ligation/occlusion

Who cannot join

  • 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
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  • 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
  • Concurrent medical disease that could confound or interfere with evaluation of VMS
  • Patients with a prior or concurrent malignancy whose natural history or treatment, in the opinion of the treating investigator, has the potential to interfere with the safety or efficacy assessment of the investigational regimen
  • Patients who are participating concurrently in another interventional study (actually receiving a study medication) or participated in an interventional study within 30 days prior to screening or received any investigational drug within 30 days or within 5 half-lives prior to screening, whichever is longer

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

Other trials in United States

About this study

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

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.

Read the detailed description

15APR2026- Amendment processed to revise the statistical analysis plan, because the trial is being terminated early due to poor accrual. We are switching the analysis plan to be descriptive because of poor accrual. Additionally, we are removing the exploratory analyses.

Being tested
Biospecimen Collection, Fezolinetant, Placebo Administration, Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings
Carcinoma, Intraductal, Noninfiltrating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo collection of blood samples

  • FezolinetantDrug

    Given PO

  • Placebo AdministrationDrug

    Given PO

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT06617455
Study groupRoleWhat they receive
Arm I (fezolinetant, placebo)ExperimentalPatients receive fezolinetant PO QD for 28 days in the absence of unacceptable toxicity. Patients then go through a washout period and take no study medication for the next 14 days. Following the washout, patients receive placebo PO QD for 28 days in the absence of unacceptable toxicity. Patients undergo collection of blood samples throughout the study.
Receives: Procedure: Biospecimen Collection; Drug: Fezolinetant; Drug: Placebo Administration; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Arm II (placebo, fezolinetant)ExperimentalPatients receive placebo PO QD for 28 days in the absence of unacceptable toxicity. Patients then go through a washout period and take no study medication for the next 14 days. Following the washout, patients receive fezolinetant PO QD for 28 days in the absence of unacceptable toxicity. Patients undergo collection of blood samples throughout the study.
Receives: Procedure: Biospecimen Collection; Drug: Fezolinetant; Drug: Placebo Administration; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in frequency of vasomotor symptoms (VMS)

    Will perform an intent-to-treat analysis. The mean change in frequency of VMS with 4 weeks of fezolinetant versus placebo will be reported with the corresponding 95% confidence interval. Initial analysis will use a paired t-test of the mean change in frequency of VMS with 4 weeks of treatment with drug and placebo.

    Measured: Baseline to day 71

Secondary outcomes (6)

  1. Change of the severity of VMS

    The mean change of the severity of VMS, as assessed with the hot flash log, with 4 weeks of fezolinetant versus placebo. Will perform an intent-to-treat analysis. Will be reported with corresponding 95% confidence intervals. Initial analysis will use a paired t-test of the mean change in severity of VMS from baseline to week 4 between drug and placebo.

    Measured: Baseline to day 71

  2. Change of the hot flash score

    The mean change of the hot flash score, as assessed with the hot flash log and calculated by multiplying VMS frequency by severity, with 4 weeks of fezolinetant versus placebo. Will perform an intent-to-treat analysis. Will be reported with corresponding 95% confidence intervals. Initial analysis will use a paired t-test of the mean change in hot flash score from baseline to week 4 between drug and placebo.

    Measured: Baseline to day 71

  3. Change of the Menopause-Specific Quality of Life (MENQOL) hot flash subscore

    The mean change of the MENQOL hot flash subscore with 4 weeks of fezolinetant versus placebo. Will perform an intent-to-treat analysis. Will be reported with corresponding 95% confidence intervals. Initial analysis will use a paired t-test of the mean change in MENQOL hot flash subscore from baseline to week 4 between drug and placebo.

    Measured: Baseline to day 71

  4. Patient Global Impression of Change (PGIC) for hot flashes and night sweats

    The mean PGIC for hot flashes and for night sweats after 4 weeks of fezolinetant versus placebo. Will perform an intent-to-treat analysis. Will be reported with corresponding 95% confidence intervals. Initial analysis will use a paired t-test of PGIC score from baseline to week 4 between drug and placebo.

    Measured: Baseline to day 71

  5. Change of the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance

    The mean change of the PROMIS Sleep Disturbance T score with 4 weeks of fezolinetant versus placebo. Will perform an intent-to-treat analysis. Will be reported with corresponding 95% confidence intervals. Initial analysis will use a paired t-test of the mean change in PROMIS Sleep Disturbance from baseline to week 4 between drug and placebo.

    Measured: Baseline to day 71

  6. Incidence of adverse events

    Safety will be assessed throughout the trial and adverse events during the 10 weeks of study participation will be reported using descriptive statistics for fezolinetant and for placebo. Assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

    Measured: Baseline through 30 days after the last dose of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2024
  2. Study start31 Oct 2024
  3. Primary completion22 Oct 2025
  4. Study completion21 Nov 2025

Why it stopped: Lack of Patient Interest

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06617455
Sponsor's protocol ID
UMCC 2024.059
Other IDs
NCI-2024-06543, HUM00256706
Acronym
VEnT
Status last verified
May 2026
First submitted
24 Sep 2024
Last updated
6 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: participant demographics and patient-reported outcomes data will be available to researchers upon reasonable request

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Fezolinetant and Quality-of-Life Assessment in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by University of Michigan Rogel Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Lack of Patient Interest). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in frequency of vasomotor symptoms (VMS) (time frame: Baseline to day 71). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06617455.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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