Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New hope for breast cancer patients: drug may tame Treatment-Linked hot flashes

NCT ID NCT05587296

Symptom relief Sponsor: Bayer 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Updated 2 times

Summary

This study tests a drug called elinzanetant to see if it can reduce hot flashes in women with hormone-receptor positive breast cancer who are on hormone-blocking therapy. About 474 women will take either the drug or a placebo for 12 weeks, then all will receive the drug for up to a year. The goal is to improve quality of life by easing these common, bothersome symptoms.

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

474 people

The number who actually took part.

Started

Oct 2022

Expected to finish

Jun 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 to 70 years

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: * Females aged 18 to 70 years of age inclusive, at the time of signing the informed consent. * Women experiencing vasomotor symptoms (VMS) caused by adjuvant endocrine therapy that they are expected to use for the duration of the study * Tamoxifen with or without the use of gonadotropin-releasing hormone (GnRH) analogues or * Aromatase inhibitors with or without the use of GnRH analogues * Women must have * a personal history of hormone-receptor positive breast cancer or * a high risk for developing breast cancer. * Participant has completed Hot Flash Daily Diary (HFDD) for at least 11 days during the two weeks preceding baseline visit, and participant has recorded at least 35 moderate to severe hot flash (HF) (including night-time HF) over the last 7 days that the HFDD was completed (assessed at the Baseline Visit). * Contraceptive use by \[women except for post-menopausal women or Women of Non childbearing potential (WONCBP)\] should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Exclusion Criteria: * Initial diagnosis of metastatic hormone-receptor positive breast cancer (stage IV) or recurrence under adjuvant endocrine therapy of hormone-receptor positive breast cancer. * Current or history (except complete remission for 5 years or more prior to signing informed consent) of any malignancy, except for hormone-receptor positive breast cancer (Stage 0-III), basal and squamous cell skin tumors. * Surgery or non-surgical (e.g., chemotherapy, radiotherapy, immunotherapy) treatment for breast cancer within the last 3 months prior to signing informed consent (except use of tamoxifen, aromatase inhibitors, GnRH analogues). * Any clinically significant prior or ongoing history of arrhythmias, heart block and QT prolongation either determined through clinical history or on electrocardiogram (ECG) evaluation. * Any active ongoing condition that could cause difficulty in interpreting VMS such as: infection that could cause pyrexia, pheochromocytoma, carcinoid syndrome. * Any unexplained vaginal bleeding. * Mammogram with clinically relevant malignant or suspicious findings that will require surgery, radiotherapy or chemotherapy as per local guidelines (mammogram should not be older than 12 months prior to signing informed consent). If a mammogram is not possible after partial mastectomy an ultrasound could be performed instead. * Disordered proliferative endometrium, endometrial hyperplasia, polyp, or endometrial cancer diagnosed based on endometrial biopsy during screening. * Current arterial or venous vascular event (e.g., Myocardial infarction (MI), Transient ischemic attack (TIA), stroke, deep vein thrombosis (DVT), i.e., within the last 6 months prior to signing informed consent.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Hormone receptor-positive breast cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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 Vasomotor symptoms caused by adjuvant endocrine therapy in women with, or at high risk for developing hormone-receptor positive breast cancer

Contacts and locations

Locations

  • AKH Wien | Allg. Gynaekologie & gynaekologische Onkologie

    Vienna, Burgenland, 7000, Austria

  • Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Tenon - Gynecologie Obstetrique Medecine de la Reproduction

    Paris, Île-de-France Region, 75020, France

  • Assuta Ashdod Public Hospital (R.A)

    Ashdod, 7747629, Israel

  • Axon Kft.

    Kecskemét, Bács-Kiskun county, 6000, Hungary

  • Azienda Ospedaliera Ordine Mauriziano Di Torino - Ostetricia e Ginecologia

    Turin, Piedmont, 10128, Italy

  • Azienda Ospedaliera Universitaria Federico II Di Napoli - DAI Materno Infantile

    Naples, Campania, 80131, Italy

  • Azienda Ospedaliera Universitaria Integrata Verona_Borgo Trento - Ostetricia e Ginecologia B

    Verona, Veneto, 37126, Italy

  • Azienda Ospedaliero Universitaria di Modena_Policlinico - Oncologia

    Modena, Emilia-Romagna, 41124, Italy

  • CHU Saint-Pierre/UMC Sint-Pieter

    Bruxelles - Brussel, 1000, Belgium

  • CHULN - H. Sta.Maria (Centro de Investigacao Clinica)

    Lisbon, 1649-035, Portugal

  • CHUSJ - Hospital Sao Joao

    Porto, 4200-319, Portugal

  • CLINICAL MEDICAL RESEARCH Sp. z o. o.

    Katowice, 40-156, Poland

  • CU Saint-Luc/UZ St-Luc

    Bruxelles - Brussel, 1200, Belgium

  • Careggi University Hospital - Ostetricia e Ginecologia

    Florence, Tuscany, 50134, Italy

  • Centre Hospitalier de l'Universite de Montreal (CHUM) | Centre de Recherche

    Montreal, Quebec, H2X 0A9, Canada

  • Centre Paul Strauss

    Strasbourg, Grand Est, 67065, France

  • Centre de Lutte Contre le Cancer François Baclesse - Service Pathologie mammaire

    Caen, Normandy, 14000, France

  • Centro Hospitalar Universitario do Porto

    Porto, 4050-651, Portugal

  • Centrum Badawcze Wspolczesnej Terapii

    Warsaw, 02-679, Poland

  • Centrum Medyczne Pratia Poznan

    Skorzewo, 60-185, Poland

  • Chaim Sheba Medical Center

    Ramat Gan, 5266202, Israel

  • Companhia Uniao Fabril | Hospital CUF Porto - Clinical Trials Department

    Porto, 4100-180, Portugal

  • Complexo Hospitalario Universitario De Santiago | Oncologia

    Santiago de Compostela, A Coruña, 15706, Spain

  • Cork University Hospital

    Cork, Munster, T12DC4A, Ireland

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, Hajdú-Bihar, 4032, Hungary

  • Docrates Mehiläinen Syöpäsairaala

    Helsinki, Uusimaa, 00180, Finland

  • Eberhard-Karls-Universität Tübingen

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Evangelisches Krankenhaus Bergisch Gladbach - Gynäkologi

    Bergisch Gladbach, North Rhine-Westphalia, 51465, Germany

  • Femicare vzw | Tienen, BE

    Tienen, 3300, Belgium

  • Fondazione IRCCS Policlinico San Matteo - Ostetricia e Ginecologia

    Pavia, Lombardy, 27100, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Ginecologia Oncologica

    Rome, Lazio, 00168, Italy

  • Frauenarztpraxis Aurora

    Mannheim, Baden-Wurttemberg, 68163, Germany

  • Frauenarztpraxis Dr. Inka Kiesche

    Halle, Saxony-Anhalt, 6110, Germany

  • Frauenärzte am Schloss Borbeck

    Essen, North Rhine-Westphalia, 45355, Germany

  • Fundacao Champalimaud | Centro Clinico Champalimaud - Unidade Investigacao Clinica

    Lisbon, 1400-038, Portugal

  • Gabinet Ginekologiczny Janusz Tomaszewski

    Bialystok, 15-224, Poland

  • Ghent University Hospital | Women's Clinic Department

    Ghent, 9000, Belgium

  • Gynäkologisches Zentrum Bonn

    Bonn, North Rhine-Westphalia, 53111, Germany

  • Hadassah Hebrew University Hospital Ein Kerem

    Jerusalem, 9112001, Israel

  • Health Corporation of Galilee Medical Center

    Nahariya, 2210001, Israel

  • Hospital Clinico Universitario De Valencia | Ginecologia

    Valencia, 46010, Spain

  • Hospital General Universitario De Valencia | Ginecologia

    Valencia, 46014, Spain

  • Hospital General Universitario Gregorio Maranon | Oncologia

    Madrid, 28009, Spain

  • Hospital Universitario Virgen De Las Nieves | Oncologia Medica

    Granada, 18014, Spain

  • Hospital Universitario Virgen Del Rocio S.L. | Oncologia

    Seville, 41013, Spain

  • Hospital del Mar | Ginecologia

    Barcelona, 08003, Spain

  • Hôpital Erasme/Erasmus Ziekenhuis

    Brussels, 1070, Belgium

  • Hôpital Saint Louis

    Paris, Île-de-France Region, 75010, France

  • ICO Site Paul Papin - Angers - Service Oncologie

    Angers, Pays de la Loire Region, 49100, France

  • IRCCS Ospedale Policlinico San Martino - Clinica ostetrica e ginecologica

    Genoa, Liguria, 16132, Italy

  • Imperial College Healthcare NHS Trust| Queen Charlotte's and Chelsea Hospital - Gynaecology

    London, Greater London, W12 0NN, United Kingdom

  • Institut Bergonie - Unicancer Nouvelle Aquitaine

    Bordeaux, New Aquitaine, 33076, France

  • Institut de Cancerologie Ouest - Saint-Herblain - Service gynecologie medicale

    Saint-Herblain, Pays de la Loire Region, 44800, France

  • Institut du Cancer de Montpellier - Val d'Aurelle - Service Oncogynecologie et senologie

    Montpellier, Occitanie, 34090, France

  • Istituto Europeo di Oncologia s.r.l - Ginecologia Preventiva

    Milan, Lombardy, 20141, Italy

  • Kazakh Institute of Oncology and Radiology - Department of Gynecology

    Almaty, Almaty Region, 640000, Kazakhstan

  • Klinische Forschung Berlin-Mitte GmbH

    Berlin, 10117, Germany

  • Klinische Forschung Hannover-Mitte GmbH

    Hanover, Lower Saxony, 30159, Germany

  • La Zarzuela University Hospital | Ginecologia

    Aravaca, Madrid, 28023, Spain

  • Liverpool Women's NHS Foundation Trust | Liverpool Women's Hospital - Gynaecology

    Liverpool, Merseyside, L8 7SS, United Kingdom

  • Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica

    Loures, Lisbon District, 2674-514, Portugal

  • Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica

    Lisbon, 1500-650, Portugal

  • Lääkärikeskus Gyneko Oy

    Oulu, North Ostrobothnia, 90100, Finland

  • Mater Misericordiae University Hospital

    Dublin, Leinster, D07R2WY, Ireland

  • MedUni Innsbruck | Brust Gesundheit Zentrum

    Vienna, State of Vienna, 1140, Austria

  • Medical University of Graz | Division of Gynecology and Obstetrics

    Salzburg, 5020, Austria

  • Medplus Nordrhein

    Krefeld, North Rhine-Westphalia, 47799, Germany

  • Mehiläinen Kuopio

    Kuopio, Northern Savonia, 70100, Finland

  • Meir Medical Center

    Kfar Saba, 4428164, Israel

  • Multidisciplinary Medical Center of the Akimat of Astana - Department of Chemotherapy No1

    Astana, Aqmola, 010000, Kazakhstan

  • NHS Grampian | Aberdeen Royal Infirmary - Gynaecology

    Aberdeen, AB25 2ZN, United Kingdom

  • NHS Greater Glasgow and Clyde | Glasgow Royal Infirmary - Gynaecology

    Glasgow, Scotland, G4 0SF, United Kingdom

  • NZOZ MEDEM Wilk Sp. j.

    Katowice, 40-301, Poland

  • Pratia McM Kraków

    Krakow, 30-727, Poland

  • Praxis Hr. Dr. S. Fiedler

    Aachen, North Rhine-Westphalia, 52074, Germany

  • Praxis f. Gynäkologie und Geburtshilfe

    Bernburg, Saxony-Anhalt, 6406, Germany

  • Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.

    Lodz, 90-602, Poland

  • Rub-Int Noi Egeszsegcentrum

    Székesfehérvár, Fejér, 8000, Hungary

  • S.C Ovidius Clinical Hospital SRL - Oncology Department

    Ovidiu, 905900, Romania

  • S.C. Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL

    Brasov, 500283, Romania

  • S.C. Quantum Medical Center SRL

    Bucharest, 012071, Romania

  • Salve Medica Sp. z o.o. SP.K.

    Lodz, 91-211, Poland

  • Sc Oncolab Srl

    Craiova, Dolj, 200385, Romania

  • Spitalul Clinic Filantropia

    Bucharest, 11132, Romania

  • St James' Hospital

    Dublin, Leinster, D08NHY1, Ireland

  • St Vincents University Hospital

    Dublin, Leinster, D04 TC63, Ireland

  • Surrey and Sussex Healthcare NHS Trust - East Surrey Hospital - Gynaecology

    Redhill, Surrey, RH1 5RH, United Kingdom

  • Synexus Frankfurt Clinical Research Centre

    Frankfurt am Main, Hesse, 60313, Germany

  • Szabolcs Szatmr Bereg County University Teaching Hospital | Andras Jasa Teaching Hospital - Oncology

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary

  • Tampere University Hospital, Tampereen yliopistollinen sairaala (TAYS)

    Tampere, Pirkanmaa, 33520, Finland

  • Tel- Aviv Sourasky Medical Center - Nephrology

    Tel Aviv, 6492601, Israel

  • The Ottawa Hospital - Riverside Campus

    Ottawa, Ontario, K1H 7W9, Canada

  • UNICANCER - Centre Leon-Berard (CLB) - Medical oncology

    Lyon, Auvergne-Rhône-Alpes, 69373, France

  • UZ Leuven Gasthuisberg

    Leuven, 3000, Belgium

  • Unidade Local De Saúde De Lisboa Ocidental E.P.E.

    Lisbon, 1449-005, Portugal

  • Unidade Local de Saúde de Braga E.P.E. - Centro Clínico Académico de Braga - Serviço de Ginecologia

    Braga, 4710-243, Portugal

  • Unidade Local de Saúde de Coimbra, E.P.E. - Hospitais da Universidade de Coimbra - Serviço de Ginecologia

    Coimbra, 3000-075, Portugal

  • University College Hospital Galway

    Galway, Connacht, H91YR71, Ireland

  • University Hospital Waterford

    Waterford, Munster, X91 ER8E, Ireland

  • Vaasa Central Hospital, Vaasan keskussairaala - Syöpätaudit

    Vaasa, Pohjanmaa, 65130, Finland

  • ZAS Augustinus - Gynaecology department

    Wilrijk, Antwerpen, 2610, Belgium

  • Ziekenhuis Oost-Limburg - Gynecology Department

    Genk, 3600, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.