Trial · NCT06440967
A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Women With Breast Cancer Who Are Having Hormone Therapy
NCT06440967, Phase 3, Active not recruiting, Astellas Pharma Global Development, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Women With Breast Cancer Who Are Having Hormone Therapy. Trials, record NCT06440967. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06440967
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Women With Breast Cancer Who Are Having Hormone Therapy
- NCT number
- NCT06440967
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 982 participants, actual
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Conditions
- Hot Flashes
- Interventions
- Fezolinetant, Placebo, Tamoxifen, Aromatase inhibitor
- First posted
- 2024-06-04
- Last updated
- 2026-10-27
Source ClinicalTrials.gov
Registered outcomes59
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean change from Baseline to Week 4 in the frequency of moderate to severe VMS | Baseline to Week 4 | Frequency of moderate and severe vasomotor symptoms (VMS) events will be calculated as the sum of moderate and severe VMS events per day. |
| Primary | Mean change from Baseline to Week 12 in the frequency of moderate to severe VMS | Baseline to Week 12 | Frequency of moderate and severe VMS events will be calculated as the sum of moderate and severe VMS events per day. |
| Primary | Mean change from Baseline to Week 4 in the severity of moderate to severe VMS | Baseline to Week 4 | The severity of VMS will be calculated using a weighted average of VMS events. |
| Primary | Mean change from Baseline to Week 12 in the severity of moderate to severe VMS | Baseline to Week 12 | The severity of VMS will be calculated using a weighted average of VMS events. |
| Secondary | Mean change from Baseline to Week 12 in the MENQOL VMS 1 week recall domain score | Baseline to Week 12 | The Menopause-specific Quality of Life Questionnaire (MENQOL) is a 29-item patient-reported outcome (PRO) measure that assesses the impact of 4 domains of menopausal symptoms, as experienced over the last week: vasomotor, psychosocial, physical and sexual. Each item score ranges from 1 to 8, and each domain is scored separately; each domain mean ranges from 1 to 8. The overall questionnaire score is the mean of the domain means. Higher scores represent more bothersome menopausal symptoms. A reduction (improvement) of 1 is the minimum clinically important difference in MENQoL. |
| Secondary | Mean Change from Baseline to Week 12 in the PROMIS SD SF 8b Total (raw) Score | Baseline to Week 12 | The Patient-reported Outcomes Measurement Information System Sleep Disturbance - Short Form 8b (PROMIS SD SF 8b) assesses self-reported sleep disturbance over the past 7 days and includes perceptions of: restless sleep; satisfaction with sleep; refreshing sleep; difficulties sleeping, getting to sleep or staying asleep; amount of sleep; and sleep quality. Responses to each of the 8 items range from 1 to 5 and the range of possible summed raw scores is 8 to 40. Higher scores on the PROMIS SD SF 8b indicate more of the concept measured (disturbed sleep). |
| Secondary | Mean change from Baseline to Week 24 in the frequency of moderate to severe VMS | Baseline to Week 24 | Frequency of moderate and severe VMS events will be calculated as the sum of moderate and severe VMS events per day. |
| Secondary | Mean Change from Baseline to Week 24 in the severity of moderate to severe VMS | Baseline to Week 24 | The severity of VMS will be calculated using a weighted average of VMS events. |
| Secondary | Number of participants with Treatment Emergent Adverse Events (TEAEs) | Up to Week 55 | A TEAE is defined as Adverse Event (AE) observed after starting administration of the investigational study intervention and up to 21 days after the last dose of investigational study intervention. |
| Secondary | Number of participants with Adverse Events of Special Interest (AESIs) | Up to Week 55 | AEs of special interest in this study will include: Progression of breast cancer including metastasis; Adverse events of uterine bleeding; Adverse events of liver test elevations; Any liver AE leading to discontinuation. |
1 to 10 of 59Source ClinicalTrials.gov
See all 59 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40773756 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06440967
GET https://conductscience.org/api/trials/v1/NCT06440967/registered?page=2