A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Women With Breast Cancer Who Are Having Hormone Therapy
NCT ID: NCT06440967
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
540 participants
INTERVENTIONAL
2024-07-31
2027-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Fezolinetant
Participants 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.
Fezolinetant
oral
Tamoxifen
oral
Aromatase inhibitor
oral
Placebo
Participants 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.
Placebo
oral
Tamoxifen
oral
Aromatase inhibitor
oral
Interventions
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Fezolinetant
oral
Placebo
oral
Tamoxifen
oral
Aromatase inhibitor
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
18 Years
FEMALE
No
Sponsors
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Astellas Pharma Global Development, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development, Inc.
Locations
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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 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 DK45002
Næstved, , Denmark
Site DE45008
Sønderborg, , Denmark
Site FR33003
Angers, , France
Site FR33001
Bayonne, , France
Site FR33005
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 DE49009
Leipzig, , Germany
Site DE49007
Mönchengladbach, , Germany
Site DE49010
München, , Germany
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 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 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 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
Countries
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Central Contacts
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References
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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.
Other Identifiers
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2024-510719-31-00
Identifier Type: OTHER
Identifier Source: secondary_id
2693-CL-1303
Identifier Type: -
Identifier Source: org_study_id