A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Women With Breast Cancer Who Are Having Hormone Therapy
A Randomized, Placebo-controlled, Double-blind, Phase 3 Clinical Study to Investigate the Efficacy and Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms (Hot Flashes) in Women With Stage 0 to 3 Hormone Receptor-positive Breast Cancer Who Are Receiving Adjuvant Endocrine Therapy
2 other identifiers
interventional
540
11 countries
117
Brief Summary
One of the standard treatments for women with breast cancer is hormone therapy, but this treatment can cause hot flashes. Hormone replacement therapy, or HRT, is most often prescribed for hot flashes for women in menopause but cannot be given to women on hormone therapy for breast cancer. Fezolinetant, an alternative to HRT, treats hot flashes for women in menopause. As hot flashes happen in the same way for women on hormone therapy for breast cancer, fezolinetant could help these women. In this study, women on hormone therapy for breast cancer who have moderate to severe hot flashes will take part. They will either take fezolinetant or a placebo to treat their hot flashes. The placebo looks like fezolinetant but doesn't have any medicine in it. The main aim of this study is to confirm if women who take fezolinetant have fewer hot flashes that are less severe compared to women who take the placebo. Women 18 years or older seeking treatment for hot flashes. They can take part in the study if they have an average of 7 or more moderate to severe hot flashes each day. They are having hormone therapy for breast cancer from stage 0 (cancer cells that have not spread to nearby tissue) up to stage 3+ (the cancer has spread from the breast to the lymph nodes near the breast or the chest wall). The women will be assigned 1 of 2 study treatments (fezolinetant or placebo) by chance alone. Treatment will be double-blinded. That means that the women in the study and the study doctors will not know who takes which of the study treatments (fezolinetant or placebo). Women who take part in the study will take 1 tablet every day for 52 weeks (1 year). Each woman will be given an electronic handheld device with an app to track their hot flashes on a daily basis. Some women may be able to use the app on their own smartphone. They will also use another device to answer questions about how hot flashes affect their daily life. During the study, the women will visit their study clinic about every 4 weeks for a health check. The last clinic visit will be 3 weeks after the women take their last tablet of study treatment (fezolinetant or placebo). After this visit the women will be called twice to check their health. The women will be in the study for about 2 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2024
Typical duration for phase_3
117 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2024
CompletedFirst Posted
Study publicly available on registry
June 4, 2024
CompletedStudy Start
First participant enrolled
July 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
February 19, 2026
February 1, 2026
2.1 years
May 29, 2024
February 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Mean change from Baseline to Week 4 in the frequency of moderate to severe VMS
Frequency of moderate and severe vasomotor symptoms (VMS) events will be calculated as the sum of moderate and severe VMS events per day.
Baseline to Week 4
Mean change from Baseline to Week 12 in the frequency of moderate to severe VMS
Frequency of moderate and severe VMS events will be calculated as the sum of moderate and severe VMS events per day.
Baseline to Week 12
Mean change from Baseline to Week 4 in the severity of moderate to severe VMS
The severity of VMS will be calculated using a weighted average of VMS events.
Baseline to Week 4
Mean change from Baseline to Week 12 in the severity of moderate to severe VMS
The severity of VMS will be calculated using a weighted average of VMS events.
Baseline to Week 12
Secondary Outcomes (55)
Mean change from Baseline to Week 12 in the MENQOL VMS 1 week recall domain score
Baseline to Week 12
Mean Change from Baseline to Week 12 in the PROMIS SD SF 8b Total (raw) Score
Baseline to Week 12
Mean change from Baseline to Week 24 in the frequency of moderate to severe VMS
Baseline to Week 24
Mean Change from Baseline to Week 24 in the severity of moderate to severe VMS
Baseline to Week 24
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Up to Week 55
- +50 more secondary outcomes
Study Arms (2)
Fezolinetant
EXPERIMENTALParticipants taking tamoxifen or an aromatase inhibitor will receive fezolinetant once daily for 52 weeks. After the end of the 52 week treatment period, participants will continue to participate in the extension follow up until week 104. They will continue to receive the adjuvant endocrine therapy as needed.
Placebo
PLACEBO COMPARATORParticipants taking tamoxifen or an aromatase inhibitor will receive matching placebo once daily for 52 weeks. After the end of the 52 week treatment period, participants will continue to participate in the extension follow up until week 104. They will continue to receive the adjuvant endocrine therapy as needed.
Interventions
Eligibility Criteria
You may qualify if:
- Participant has a personal history of stage 0-3 hormone receptor positive (HR+), either human epidermal growth factor receptor (HER)-2+ or HER-2- breast cancer; appropriate documentation includes a written or electronic report.
- Participant must be receiving stable maintenance adjuvant endocrine therapy (e.g., tamoxifen or aromatase inhibitors, such as anastrozole, letrozole and exemestane) with or without gonadotropin-releasing hormone (GnRH) agonists/antagonists for a minimum of 4 months prior to randomization and be planning to continue on adjuvant endocrine therapy for the duration of the trial without change to therapy, brand or dose. If the participant is taking GnRH agonists/antagonists, therapy must also be stable for a minimum of 4 months prior to randomization. Add-on therapies for breast cancer adjuvant treatment (e.g., cyclin dependent kinase-4 (CDK4) inhibitors) are allowed.
- Participant has a minimum average of 7 moderate to severe hot flashes (HFs) (vasomotor symptoms (VMS)) per day as recorded in the electronic daily diary (data must be available for at least 7 of the last 10 days prior to randomization).
- Has an European Cooperative Oncology Group (ECOG) score 0 or 1.
- Has at least 12-month life expectation.
- Participant is born female.
- Female participant: Is not pregnant and at least 1 of the following conditions apply:
- Not a woman of childbearing potential (WOCBP)
- WOCBP who has a negative urine or serum pregnancy test at screening and day 1 and agrees to follow the contraceptive guidance from the time of informed consent through at least 30 days after final investigational study intervention administration.
- Female participant: Must not be breastfeeding or lactating starting at screening and while the participant is taking investigational study intervention and for 30 days after final investigational study intervention administration.
- Female participant: Must not donate ova starting at first administration of study intervention and while the participant is taking investigational study intervention and for 30 days after final investigational study intervention administration.
- Participant agrees not to participate in another interventional study while participating in the present study until the end of the 1-year extension follow-up period.
- Participant's condition is stable as determined on the basis of medical history and general physical examination, hematology and biochemistry parameters, pulse rate and/or blood pressure and electrocardiogram (ECG) (or showing no clinically relevant deviations obtained within the last 3 months or at screening).
- Participant has no new clinically significant findings on breast examination or from imaging (mammogram, breast ultrasound or equivalent). Results indicate that the participant is a good candidate for the study. Appropriate documentation includes a written or electronic report. In case of double mastectomy, imaging is not needed.
- Participant has a negative serology panel (including hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody and human immunodeficiency virus (HIV) antibody screens).
You may not qualify if:
- Participant has diagnosis of metastatic breast cancer (stage 4).
- Participant has current or history (except complete remission for 5 years or more prior to signing informed consent) of any malignancy except for HR+ breast cancer (stage 0 to 3) or basal cell carcinoma.
- Participant has had surgery or non-surgical (chemotherapy or radiotherapy) treatment for breast cancer within the last 3 months prior to signing informed consent.
- Participant has active liver disease, jaundice, or elevated liver aminotransferases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST)), elevated total bilirubin (TBL) or direct bilirubin (DBL), or elevated alkaline phosphatase (ALP) at screening. A participant with mildly elevated ALT or AST up to \< 2 × upper limit of normal (ULN) can be enrolled if TBL and DBL are normal. Participant with mildly elevated ALP (up to \< 1.5 × ULN) can be enrolled if cholestatic liver disease is excluded and no cause other than fatty liver is diagnosed. Participant with Gilbert's syndrome with elevated TBL may be enrolled as long as DBL, hemoglobin and reticulocytes are normal.
- Participant has creatinine \> 1.5 x ULN; or estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease formula \< 30 mL/min/1.73 m2 at the screening visit.
- Participant has a history of endometrial hyperplasia (participant can be enrolled if she has undergone a hysterectomy) or uterine/endometrial cancer.
- Participant has a medical condition or chronic disease (including history of neurological \[including cognitive\], hepatic, renal, cardiovascular, gastrointestinal, pulmonary \[e.g., moderate asthma\], endocrine, or gynecological disease) or malignancy that could confound interpretation of the study outcome.
- Participant uses a prohibited therapy (menopause hormone therapy (MHT), estradiol-containing hormonal contraceptive progestin and progesterone-only medicines, any treatment for VMS \[prescription medications, over-the-counter, or herbal\] or CYP1A2 (cytochrome P450) inhibitors) or is not willing to wash out such drugs; in addition, medications that are contraindicated due to underlying breast cancer diagnosis and the adjuvant endocrine therapy.
- Participant has a known substance abuse or alcohol addiction within 6 months of screening.
- Participant has received any investigational therapy within 90 days or 5 half-lives, whichever is longer, prior to screening.
- Participant has any condition, which makes the participant unsuitable for study participation.
- Participant has a known or suspected hypersensitivity to fezolinetant, the adjuvant endocrine therapy being used, or any components of the formulations used.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (117)
Site CA15019
Sarnia, Ontario, Canada
Site CA15016
Sault Ste. Marie, Ontario, Canada
Site CA15002
Montreal, Quebec, Canada
Site CA15001
Québec, Quebec, Canada
Site CA15004
Québec, Quebec, Canada
Site CA15003
Sherbrooke, Quebec, Canada
Site CA15020
Victoriaville, Quebec, Canada
Site CA15018
Barrie, Canada
Site CA15007
Trois-Rivières, Canada
Site CZ42006
České Budějovice, Czechia
Site CZ42003
Hořovice, Czechia
Site CZ42002
Hradec Králové, Czechia
Site CZ42011
Nový Jičín, Czechia
Site CZ42001
Olomouc, Czechia
Site CZ42005
Prague, Czechia
Site CZ42008
Prague, Czechia
Site CZ42013
Prague, Czechia
Site CZ42004
Tábor, Czechia
Site CZ42007
Vodňany, Czechia
Site CZ42009
Vsetín, Czechia
Site DK45007
Aalborg, Denmark
Site DE45003
Esbjerg, Denmark
Site DK45009
Hillerød, Denmark
Site DK45002
Næstved, Denmark
Site DE45008
Sønderborg, Denmark
Site FR33003
Angers, France
Site FR33001
Bayonne, France
Site FR33005
Bordeaux, France
Site FR33018
Bordeaux, France
Site FR33017
Caen, France
Site FR33016
Dijon, France
Site FR33013
Le Mans, France
Site FR33007
Lille, France
Site FR33012
Lyon, France
Site FR33008
Montpellier, France
Site FR33002
Saint-Herblain, France
Site GR49005
Essen, North Rhine-Westphalia, Germany
Site DE49001
Bottrop, Germany
Site GR49013
Dresden, Germany
Site DE49009
Leipzig, Germany
Site DE49007
Mönchengladbach, Germany
Site DE49010
München, Germany
Site GR49003
Münster, Germany
Site GR49011
Witten, Germany
Site GR49014
Wolfsburg, Germany
Site HU36007
Budapest, Hungary
Site HU36008
Budapest, Hungary
Site HU36006
Debrecen, Hungary
Site HU36001
Eger, Hungary
Site HU36002
Kecskemét, Hungary
Site HU36010
Salgótarján, Hungary
Site HU36003
Székesfehérvár, Hungary
Site IT39011
Bologna, Italy
Site IT39015
Genova, Italy
Site IT39003
Milan, Italy
Site IT39013
Mirano, Italy
Site IT39017
Pavia, Italy
Site IT39018
Reggio Emilia, Italy
Site IT39012
Terni, Italy
Site IT39014
Tricase, Italy
Site NL31014
Amsterdam, Netherlands
Site NL31010
Breda, Netherlands
Site NL31006
Dirksland, Netherlands
Site NL31001
Haarlem, Netherlands
Site NL31002
Rotterdam, Netherlands
Site NL31004
Rotterdam, Netherlands
Site NL31012
Rotterdam, Netherlands
Site NL31009
Terneuzen, Netherlands
Site PO48019
Poznan, Skorzewo, Poland
Site PO48005
Bialystok, Poland
Site PO48006
Bydgoszcz, Poland
Site PO48004
Katowice, Poland
Site PO48017
Katowice, Poland
Site PO48015
Krakow, Poland
Site PO48021
Krakow, Poland
Site PO48007
Lodz, Poland
Site PO48012
Lodz, Poland
Site PO48020
Piła, Poland
Site PO48002
Poznan, Poland
Site PO48018
Poznan, Poland
Site PO48010
Szczecin, Poland
Site PO48003
Świdnik, Poland
Site PO48001
Warsaw, Poland
Site ES34011
Barcelona, Spain
Site ES34020
Barcelona, Spain
Site ES34021
Barcelona, Spain
Site ES34010
Elche, Spain
Site ES34003
Girona, Spain
Site ES34005
Granada, Spain
Site ES34006
Jaén, Spain
Site ES34017
León, Spain
Site ES34007
Madrid, Spain
Site ES34019
Madrid, Spain
Site ES34022
Madrid, Spain
Site ES34023
Madrid, Spain
Site ES34015
Majadahonda, Spain
Site ES34002
Murcia, Spain
Site ES34014
Murcia, Spain
Site ES34008
Palma, Spain
Site ES34025
Rivas-Vaciamadrid, Spain
Site ES34009
Seville, Spain
Site ES34024
Seville, Spain
Site ES34013
Valencia, Spain
Site GB44008
Bebington, Birkenhead, United Kingdom
Site GB44009
Guildford, Surrey, United Kingdom
Site GB44018
Aberdeen, United Kingdom
Site GB44019
Birmingham, United Kingdom
Site GB44003
Bristol, United Kingdom
Site GB44016
Cambridge, United Kingdom
Site GB44006
Glasgow, United Kingdom
Site GB44002
Liverpool, United Kingdom
Site GB44020
Liverpool, United Kingdom
Site GB44005
London, United Kingdom
Site GB44017
Oxford, United Kingdom
Site GB44001
Preston Lancashire, United Kingdom
Site GB44012
Redhill, United Kingdom
Site GB44010
Stroke on Trent, United Kingdom
Related Publications (1)
Liao C, Pal L. Novel Pharmacotherapies for Menopausal Symptoms. Obstet Gynecol. 2025 Oct 1;146(4):473-486. doi: 10.1097/AOG.0000000000006025. Epub 2025 Aug 7.
PMID: 40773756DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Global Development, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2024
First Posted
June 4, 2024
Study Start
July 31, 2024
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
June 30, 2027
Last Updated
February 19, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.