A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer

NCT ID: NCT05587296

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 474 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-14
• Study Completion Date: 2028-06-05

Brief Summary

Researchers are looking for a better way to treat women with, or at high risk for developing hormone-receptor positive breast cancer, who have vasomotor symptoms (VMS), a condition of having hot flashes caused by anti-cancer therapy.

VMS, also called hot flashes, are very common medical problems in women with hormone-receptor (HR)-positive breast cancer, who are receiving anti-cancer therapy. HR-positive breast cancer is a type of breast cancer, which has hormone-receptors (proteins) for female sex hormones estrogen and/or progesterone. These hormone-receptors may attach to hormones like estrogen and progesterone and thereby help cancer cells to grow and to spread. Treatments that stop these hormones from attaching to these receptors are currently used to slow or stop the growth of HR-positive breast cancer.

It is already known that women with HR-positive breast cancer benefit from this treatment. However, hot flashes are common medical problems related to this therapy. They negatively affect quality of life of many women and may lead to discontinuation (stopping) of this therapy.

The study treatment, elinzanetant is being developed to treat hot flushes. It works by blocking a substance called neurokinin from sending signals to other parts of the body, which is thought to play a role in starting hot flashes.

The main purpose of this study is to learn more about how well elinzanetant helps to treat hot flashes caused by anti-cancer therapy in women with or at high risk for developing HR-positive breast cancer compared to placebo. A placebo is a treatment that looks like a medicine but does not have any medicine in it.

To answer this, the doctors will ask the participants to record information about their hot flashes before treatment start and at certain time points during the treatment in an electronic diary. The researchers will then assess possible average changes in number and severity of hot flashes after 4 and 12 weeks of treatment.

To see how safe elinzanetant is compared to placebo. The study will collect information about the number of participants who have medical problems after taking treatment.

The study participants will be randomly (by chance) assigned to 2 treatment groups, A and B. The participants from treatment group A will take elinzanetant. The participants from treatment group B will start with placebo and then switch to elinzanetant.

All participants will continue taking the anti-cancer therapy they have been using when entering the study.

Dependent on the treatment group, the participants will either take elinzanetant or placebo as capsules by mouth once a day. After 12 weeks, the participants who have initially received placebo will switch to take elinzanetant for the remaining 40 weeks.

Each participant will be in the study for approximately 62 weeks. The treatment duration in the study will be 52 weeks. There will be up to 12 visits to the study site and 6 phone calls in between. Participants who completed the 52 weeks treatment phase, will be offered to continue treatment for another up to 2.5 years. Visit frequency: every 24 weeks until week 152.

During the study, the participants will:

• record information about their hot flashes
• answer questions about their quality of life and other symptoms.

The doctors and their study team will:

• check the participants health and vital signs
• take blood and urine samples
• examine heart health using electrocardiogram (ECG)
• examine pelvic organs like womb or ovaries using a trans vaginal ultrasound scan to see images of these organs
• make images of the breast using x-ray (mammogram), a type of radiation that passes through the body to make images of the inside and/or by using ultrasound (if applicable)
• check the health of the participant's cervix (neck of the womb) by taking a small sample of cells (smear test) for an analysis called cervical cytology (if applicable)
• take an endometrial biopsy, a small piece of tissue from the lining of the womb (called the endometrium) for analysis.
• ask the participants questions about what medicines they are taking and if they are having adverse events.

An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

About 4 weeks after the participants take their last treatment, the study doctors and their team will check the participants' health.

Conditions

Vasomotor Symptoms Caused by Adjuvant Endocrine Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer; Hot Flashes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Elinzanetant (BAY3427080)

Participants will receive 120 mg elinzanetant orally once daily.

Group Type: EXPERIMENTAL

Elinzanetant (BAY3427080)

Intervention Type: DRUG

120 mg elinzanetant orally once daily

Placebo

Participants will receive matching placebo orally once daily for 12 weeks, followed by 120 mg elinzanetant orally once daily

Group Type: PLACEBO_COMPARATOR

Elinzanetant (BAY3427080)

Intervention Type: DRUG

120 mg elinzanetant orally once daily

Placebo

Intervention Type: DRUG

Matching placebo orally once daily

Interventions

Elinzanetant (BAY3427080)

120 mg elinzanetant orally once daily

Intervention Type: DRUG

Placebo

Matching placebo orally once daily

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University of Graz | Division of Gynecology and Obstetrics

Graz, Styria, Austria

MedUni Innsbruck | Brust Gesundheit Zentrum

Innsbruck, Tyrol, Austria

AKH Wien | Allg. Gynaekologie & gynaekologische Onkologie

Vienna, , Austria

ZAS Augustinus - Gynaecology department

Wilrijk, Antwerpen, Belgium

Hôpital Erasme/Erasmus Ziekenhuis

Brussels, , Belgium

CHU Saint-Pierre/UMC Sint-Pieter

Bruxelles - Brussel, , Belgium

CU Saint-Luc/UZ St-Luc

Bruxelles - Brussel, , Belgium

Ziekenhuis Oost-Limburg - Gynecology Department

Genk, , Belgium

Ghent University Hospital | Women's Clinic Department

Ghent, , Belgium

UZ Leuven Gasthuisberg

Leuven, , Belgium

Femicare vzw | Tienen, BE

Tienen, , Belgium

The Ottawa Hospital - Riverside Campus

Ottawa, Ontario, Canada

Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)

Montreal, Quebec, Canada

Docrates Mehiläinen Syöpäsairaala

Helsinki, , Finland

Mehilainen | Mehilainen Kuopio

Kuopio, , Finland

Lääkärikeskus Gyneko, Gynaecological Medical Center | Oulu, Finland

Oulu, , Finland

Tampere University Hospital, Tampereen yliopistollinen sairaala (TAYS)

Tampere, , Finland

Vaasan keskussairaala

Vaasa, , Finland

ICO Site Paul Papin - Angers - Service Oncologie

Angers, , France

Institut Bergonie - Unicancer Nouvelle Aquitaine

Bordeaux, , France

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

Caen, , France

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

Lyon, , France

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

Montpellier, , France

Hôpital Saint Louis

Paris, , France

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

Paris, , France

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

Saint-Herblain, , France

ICANS - Institut de Cancerologie de Strasbourg Europe

Strasbourg, , France

Praxisklinik am Rosengarten

Mannheim, Baden-Wurttemberg, Germany

Eberhard-Karls-Universität Tübingen

Tübingen, Baden-Wurttemberg, Germany

Synexus Frankfurt Clinical Research Centre

Frankfurt am Main, Hesse, Germany

Klinische Forschung Hannover-Mitte GmbH

Hanover, Lower Saxony, Germany

Praxis Hr. Dr. S. Fiedler

Aachen, North Rhine-Westphalia, Germany

Evangelisches Krankenhaus Bergisch Gladbach - Gynäkologi

Bergisch Gladbach, North Rhine-Westphalia, Germany

Gynäkologisches Zentrum Bonn

Bonn, North Rhine-Westphalia, Germany

Frauenärzte am Schloss Borbeck

Essen, North Rhine-Westphalia, Germany

Medplus Nordrhein

Krefeld, North Rhine-Westphalia, Germany

Praxis f. Gynäkologie und Geburtshilfe

Bernburg, Saxony-Anhalt, Germany

Frauenarztpraxis Dr. Inka Kiesche

Halle, Saxony-Anhalt, Germany

Klinische Forschung Berlin-Mitte GmbH

Berlin, , Germany

Debreceni Egyetem Klinikai Kozpont

Debrecen, , Hungary

Axon Kft.

Kecskemét, , Hungary

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

Nyíregyháza, , Hungary

Rub-Int Noi Egeszsegcentrum

Székesfehérvár, , Hungary

Cork University Hospital

Cork, , Ireland

Mater Misericordiae University Hospital

Dublin, , Ireland

St James' Hospital

Dublin, , Ireland

St Vincents University Hospital

Dublin, , Ireland

University College Hospital Galway

Galway, , Ireland

University Hospital Waterford

Waterford, , Ireland

Assuta Ashdod Public Hospital (R.A)

Ashdod, , Israel

Hadassah Hebrew University Hospital Ein Kerem

Jerusalem, , Israel

Meir Medical Center

Kfar Saba, , Israel

Health Corporation of Galilee Medical Center

Nahariya, , Israel

Chaim Sheba Medical Center

Ramat Gan, , Israel

Tel-Aviv Sourasky Medical Center

Tel Aviv, , Israel

Azienda Ospedaliera Universitaria Federico II Di Napoli - DAI Materno Infantile

Napoli, Campania, Italy

Azienda Ospedaliero Universitaria di Modena_Policlinico - Oncologia

Modena, Emilia-Romagna, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Ginecologia Oncologica

Rome, Lazio, Italy

IRCCS Ospedale Policlinico San Martino - Clinica ostetrica e ginecologica

Genoa, Liguria, Italy

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

Milan, Lombardy, Italy

Fondazione IRCCS Policlinico San Matteo - Ostetricia e Ginecologia

Pavia, Lombardy, Italy

Azienda Ospedaliera Ordine Mauriziano Di Torino - Ostetricia e Ginecologia

Turin, Piedmont, Italy

Careggi University Hospital - Ostetricia e Ginecologia

Florence, Tuscany, Italy

Azienda Ospedaliera Universitaria Integrata Verona_Borgo Trento - Ostetricia e Ginecologia B

Verona, Veneto, Italy

Kazakh Institute of Oncology and Radiology - Department of Gynecology

Almaty, , Kazakhstan

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

Astana, , Kazakhstan

Gabinet Ginekologiczny Janusz Tomaszewski

Bialystok, , Poland

CLINICAL MEDICAL RESEARCH Sp. z o. o.

Katowice, , Poland

NZOZ MEDEM Wilk Sp. j.

Katowice, , Poland

Pratia McM Kraków

Krakow, , Poland

Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.

Lodz, , Poland

Salve Medica Sp. z o.o. SP.K.

Lodz, , Poland

Centrum Medyczne Pratia Poznan

Skorzewo, , Poland

Centrum Badawcze Wspolczesnej Terapii

Warsaw, , Poland

Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica

Loures, Lisbon District, Portugal

Centro Clinico Academico Braga | Braga, Portugal

Braga, , Portugal

Centro Hospitalar e Universitario de Coimbra, E.P.E. | Department of Gynecology

Coimbra, , Portugal

Fundacao Champalimaud | Centro Clinico Champalimaud - Unidade Investigacao Clinica

Lisbon, , Portugal

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

Lisbon, , Portugal

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

Lisbon, , Portugal

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

Lisbon, , Portugal

Centro Hospitalar Universitario do Porto

Porto, , Portugal

Companhia Uniao Fabril | Hospital CUF Porto - Clinical Trials Department

Porto, , Portugal

CHUSJ - Hospital Sao Joao

Porto, , Portugal

Sc Oncolab Srl

Craiova, Dolj, Romania

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

Brasov, , Romania

S.C. Quantum Medical Center SRL

Bucharest, , Romania

Spitalul Clinic Filantropia

Bucharest, , Romania

S.C Ovidius Clinical Hospital SRL - Oncology Department

Ovidiu, , Romania

Complexo Hospitalario Universitario De Santiago | Oncologia

Santiago de Compostela, A Coruña, Spain

La Zarzuela University Hospital | Ginecologia

Aravaca, Madrid, Spain

Hospital del Mar I Ginecologia

Barcelona, , Spain

Hospital Universitario Virgen De Las Nieves | Oncologia Medica

Granada, , Spain

Hospital General Universitario Gregorio Maranon | Oncologia

Madrid, , Spain

Hospital Universitario Virgen Del Rocio S.L. | Oncologia

Seville, , Spain

Hospital Clinico Universitario De Valencia | Ginecologia

Valencia, , Spain

Hospital General Universitario De Valencia I Ginecologia

Valencia, , Spain

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

Redhill, Surrey, United Kingdom

NHS Grampian | Aberdeen Royal Infirmary - Gynaecology

Aberdeen, , United Kingdom

NHS Greater Glasgow and Clyde | Glasgow Royal Infirmary - Gynaecology

Glasgow, , United Kingdom

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

Liverpool, , United Kingdom

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

London, , United Kingdom

Countries

Austria; Belgium; Canada; Finland; France; Germany; Hungary; Ireland; Israel; Italy; Kazakhstan; Poland; Portugal; Romania; Spain; United Kingdom

References

Cardoso F, Parke S, Brennan DJ, Briggs P, Donders G, Panay N, Haseli-Mashhadi N, Block M, Caetano C, Francuski M, Haberland C, Laapas K, Seitz C, Zuurman L. Elinzanetant for Vasomotor Symptoms from Endocrine Therapy for Breast Cancer. N Engl J Med. 2025 Aug 21;393(8):753-763. doi: 10.1056/NEJMoa2415566. Epub 2025 Jun 2.

Reference Type: DERIVED

PMID: 40454634 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://clinicaltrials.bayer.com

Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Other Identifiers

2023-508265-33-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

2022-000095-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

21656

Identifier Type: -

Identifier Source: org_study_id