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New hope for breast cancer patients: drug may tame hot flashes without hormones

NCT ID NCT06440967

Symptom relief Sponsor: Astellas Pharma Global Development, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests fezolinetant, a non-hormonal drug, for treating hot flashes in women with hormone-positive breast cancer who are on hormone therapy. About 984 women will take either fezolinetant or a placebo daily for a year. The goal is to see if fezolinetant reduces the number and severity of hot flashes compared to placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

982 people

The number who actually took part.

Started

Jul 2024

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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). Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

hormone receptor-positive breast cancer Hot Flashes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hot flashes

Contacts and locations

Locations

  • Site CA15001

    Québec, Quebec, Canada

  • Site CA15002

    Montreal, Quebec, Canada

  • Site CA15003

    Sherbrooke, Quebec, Canada

  • Site CA15004

    Québec, Quebec, Canada

  • Site CA15007

    Trois-Rivières, Canada

  • Site CA15016

    Sault Ste. Marie, Ontario, Canada

  • Site CA15019

    Sarnia, Ontario, Canada

  • Site CA15020

    Victoriaville, Quebec, Canada

  • Site CZ42001

    Olomouc, Czechia

  • Site CZ42002

    Hradec Králové, Czechia

  • Site CZ42003

    Hořovice, Czechia

  • Site CZ42004

    Tábor, Czechia

  • Site CZ42005

    Prague, Czechia

  • Site CZ42006

    České Budějovice, Czechia

  • Site CZ42007

    Vodňany, Czechia

  • Site CZ42008

    Prague, Czechia

  • Site CZ42009

    Vsetín, Czechia

  • Site CZ42011

    Nový Jičín, Czechia

  • Site CZ42013

    Prague, Czechia

  • Site DE45003

    Esbjerg, Denmark

  • Site DE45008

    Sønderborg, Denmark

  • Site DE49001

    Bottrop, Germany

  • Site DE49007

    Mönchengladbach, Germany

  • Site DE49009

    Leipzig, Germany

  • Site DE49010

    München, Germany

  • Site DK45002

    Næstved, Denmark

  • Site DK45007

    Aalborg, Denmark

  • Site DK45009

    Hillerød, Denmark

  • Site ES34002

    Murcia, Spain

  • Site ES34003

    Girona, Spain

  • Site ES34005

    Granada, Spain

  • Site ES34006

    Jaén, Spain

  • Site ES34007

    Madrid, Spain

  • Site ES34008

    Palma, Spain

  • Site ES34009

    Seville, Spain

  • Site ES34010

    Elche, Spain

  • Site ES34011

    Barcelona, Spain

  • Site ES34013

    Valencia, Spain

  • Site ES34014

    Murcia, Spain

  • Site ES34015

    Majadahonda, Spain

  • Site ES34017

    León, Spain

  • Site ES34019

    Madrid, Spain

  • Site ES34020

    Barcelona, Spain

  • Site ES34022

    Madrid, Spain

  • Site ES34023

    Madrid, Spain

  • Site ES34024

    Seville, Spain

  • Site ES34025

    Rivas-Vaciamadrid, Spain

  • Site FR33001

    Bayonne, France

  • Site FR33002

    Saint-Herblain, France

  • Site FR33003

    Angers, France

  • Site FR33005

    Bordeaux, France

  • Site FR33007

    Lille, France

  • Site FR33008

    Montpellier, France

  • Site FR33012

    Lyon, France

  • Site FR33013

    Le Mans, France

  • Site FR33016

    Dijon, France

  • Site FR33017

    Caen, France

  • Site FR33018

    Bordeaux, France

  • Site GB44001

    Preston Lancashire, United Kingdom

  • Site GB44002

    Liverpool, United Kingdom

  • Site GB44003

    Bristol, United Kingdom

  • Site GB44005

    London, United Kingdom

  • Site GB44006

    Glasgow, United Kingdom

  • Site GB44008

    Bebington, Birkenhead, United Kingdom

  • Site GB44009

    Guildford, Surrey, United Kingdom

  • Site GB44010

    Stroke on Trent, United Kingdom

  • Site GB44012

    Redhill, United Kingdom

  • Site GB44016

    Cambridge, United Kingdom

  • Site GB44017

    Oxford, United Kingdom

  • Site GB44018

    Aberdeen, United Kingdom

  • Site GB44019

    Birmingham, United Kingdom

  • Site GB44020

    Liverpool, United Kingdom

  • Site GR49003

    Münster, Germany

  • Site GR49005

    Essen, North Rhine-Westphalia, Germany

  • Site GR49013

    Dresden, Germany

  • Site GR49014

    Wolfsburg, Germany

  • Site HU36001

    Eger, Hungary

  • Site HU36002

    Kecskemét, Hungary

  • Site HU36003

    Székesfehérvár, Hungary

  • Site HU36006

    Debrecen, Hungary

  • Site HU36008

    Budapest, Hungary

  • Site HU36010

    Salgótarján, Hungary

  • Site IT39003

    Milan, Italy

  • Site IT39011

    Bologna, Italy

  • Site IT39012

    Terni, Italy

  • Site IT39013

    Mirano, Italy

  • Site IT39015

    Genova, Italy

  • Site IT39017

    Pavia, Italy

  • Site IT39018

    Reggio Emilia, Italy

  • Site NL31001

    Haarlem, Netherlands

  • Site NL31002

    Rotterdam, Netherlands

  • Site NL31004

    Rotterdam, Netherlands

  • Site NL31006

    Dirksland, Netherlands

  • Site NL31009

    Terneuzen, Netherlands

  • Site NL31010

    Breda, Netherlands

  • Site NL31012

    Rotterdam, Netherlands

  • Site PO48001

    Warsaw, Poland

  • Site PO48002

    Poznan, Poland

  • Site PO48003

    Świdnik, Poland

  • Site PO48004

    Katowice, Poland

  • Site PO48005

    Bialystok, Poland

  • Site PO48006

    Bydgoszcz, Poland

  • Site PO48007

    Lodz, Poland

  • Site PO48010

    Szczecin, Poland

  • Site PO48012

    Lodz, Poland

  • Site PO48015

    Krakow, Poland

  • Site PO48017

    Katowice, Poland

  • Site PO48018

    Poznan, Poland

  • Site PO48019

    Poznan, Skorzewo, Poland

  • Site PO48021

    Krakow, Poland

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