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

Trial Title: 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

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

Conditions: Official terms:
Breast Neoplasms
Hot Flashes

Study type: Interventional

Study phase: Phase 3

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Investigator)

Intervention:

Intervention type: Drug
Intervention name: Elinzanetant (BAY3427080)
Description: 120 mg elinzanetant orally once daily
Arm group label: Elinzanetant (BAY3427080)

Intervention type: Drug
Intervention name: Placebo
Description: Matching placebo orally once daily.
Arm group label: Placebo

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 2 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.

Criteria for 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.

Gender: Female

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Medical University of Graz | Division of Gynecology and Obstetrics

Address:
City: Graz
Zip: 8036
Country: Austria

Facility:
Name: MedUni Innsbruck | Brust Gesundheit Zentrum

Address:
City: Innsbruck
Zip: 6020
Country: Austria

Facility:
Name: AKH Wien | Allg. Gynaekologie & gynaekologische Onkologie

Address:
City: Wien
Zip: 1090
Country: Austria

Facility:
Name: ZAS Augustinus - Gynaecology department

Address:
City: Wilrijk
Zip: 2610
Country: Belgium

Facility:
Name: Hôpital Erasme/Erasmus Ziekenhuis

Address:
City: Brussels
Zip: 1070
Country: Belgium

Facility:
Name: CHU Saint-Pierre/UMC Sint-Pieter

Address:
City: Bruxelles - Brussel
Zip: 1000
Country: Belgium

Facility:
Name: CU Saint-Luc/UZ St-Luc

Address:
City: Bruxelles - Brussel
Zip: 1200
Country: Belgium

Facility:
Name: Ziekenhuis Oost-Limburg - Gynecology Department

Address:
City: Genk
Zip: 3600
Country: Belgium

Facility:
Name: Ghent University Hospital | Women's Clinic Department

Address:
City: Gent
Zip: 9000
Country: Belgium

Facility:
Name: UZ Leuven Gasthuisberg

Address:
City: Leuven
Zip: 3000
Country: Belgium

Facility:
Name: Femicare vzw | Tienen, BE

Address:
City: Tienen
Zip: 3300
Country: Belgium

Facility:
Name: The Ottawa Hospital - Riverside Campus

Address:
City: Ottawa
Zip: K1H 7W9
Country: Canada

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

Address:
City: Montreal
Zip: H2X 0A9
Country: Canada

Facility:
Name: Docrates Klinikka

Address:
City: Helsinki
Zip: 00180
Country: Finland

Facility:
Name: Mehilainen | Mehilainen Kuopio

Address:
City: Kuopio
Zip: 70100
Country: Finland

Facility:
Name: Lääkärikeskus Gyneko, Gynaecological Medical Center | Oulu, Finland

Address:
City: Oulu
Zip: 90100
Country: Finland

Facility:
Name: Tampereen yliopistollinen sairaala

Address:
City: Tampere
Zip: 33520
Country: Finland

Facility:
Name: Vaasan keskussairaala

Address:
City: Vaasa
Zip: 65130
Country: Finland

Facility:
Name: ICO Site Paul Papin - Angers

Address:
City: Angers
Zip: 49055
Country: France

Facility:
Name: Institut Bergonié - Unicancer Nouvelle Aquitaine

Address:
City: Bordeaux Cedex
Zip: 33076
Country: France

Facility:
Name: Centre de Lutte Contre le Cancer François Baclesse

Address:
City: Caen Cedex 5
Zip: 14076
Country: France

Facility:
Name: Centre Léon Bérard

Address:
City: Lyon
Zip: 69008
Country: France

Facility:
Name: Institut du Cancer de Montpellier - Val d'Aurelle

Address:
City: Montpellier Cedex
Zip: 34298
Country: France

Facility:
Name: Hôpital Saint Louis

Address:
City: Paris
Zip: 75010
Country: France

Facility:
Name: Hôpital Tenon

Address:
City: Paris
Zip: 75020
Country: France

Facility:
Name: Institut de Cancérologie de l'Ouest - Saint Herblain

Address:
City: Saint-Herblain
Zip: 44800
Country: France

Facility:
Name: ICANS - Institut de Cancérologie de Strasbourg Europe

Address:
City: Strasbourg
Zip: 67033
Country: France

Facility:
Name: Praxisklinik am Rosengarten

Address:
City: Mannheim
Zip: 68165
Country: Germany

Facility:
Name: Eberhard-Karls-Universität Tübingen

Address:
City: Tübingen
Zip: 72076
Country: Germany

Facility:
Name: Synexus Frankfurt Clinical Research Centre

Address:
City: Frankfurt
Zip: 60313
Country: Germany

Facility:
Name: Klinische Forschung Hannover-Mitte GmbH

Address:
City: Hannover
Zip: 30159
Country: Germany

Facility:
Name: Praxis Hr. Dr. S. Fiedler

Address:
City: Aachen
Zip: 52074
Country: Germany

Facility:
Name: Evangelisches Krankenhaus Bergisch Gladbach - Gynäkologi

Address:
City: Bergisch Gladbach
Zip: 51465
Country: Germany

Facility:
Name: Gynäkologisches Zentrum Bonn

Address:
City: Bonn
Zip: 53111
Country: Germany

Facility:
Name: Frauenärzte am Schloss Borbeck

Address:
City: Essen
Zip: 45355
Country: Germany

Facility:
Name: Medplus Nordrhein

Address:
City: Krefeld
Zip: 47799
Country: Germany

Facility:
Name: Praxis f. Gynäkologie und Geburtshilfe

Address:
City: Bernburg
Zip: 6406
Country: Germany

Facility:
Name: Frauenarztpraxis Dr. Inka Kiesche

Address:
City: Halle
Zip: 6110
Country: Germany

Facility:
Name: Klinische Forschung Berlin-Mitte GmbH

Address:
City: Berlin
Zip: 10117
Country: Germany

Facility:
Name: Debreceni Egyetem Klinikai Kozpont

Address:
City: Debrecen
Zip: 4032
Country: Hungary

Facility:
Name: Axon Kft.

Address:
City: Kecskemet
Zip: 6000
Country: Hungary

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

Address:
City: Nyiregyhaza
Zip: 4400
Country: Hungary

Facility:
Name: Rub-Int Noi Egeszsegcentrum

Address:
City: Szekesfehervar
Zip: 8000
Country: Hungary

Facility:
Name: Cork University Hospital

Address:
City: Cork
Zip: T12DC4A
Country: Ireland

Facility:
Name: St Vincents University Hospital

Address:
City: Dublin 4
Zip: TBC
Country: Ireland

Facility:
Name: Mater Misericordiae University Hospital

Address:
City: Dublin
Zip: D07R2WY
Country: Ireland

Facility:
Name: St James' Hospital

Address:
City: Dublin
Zip: D08NHY1
Country: Ireland

Facility:
Name: University College Hospital Galway

Address:
City: Galway
Zip: H91YR71
Country: Ireland

Facility:
Name: University Hospital Waterford

Address:
City: Waterford
Zip: X91 ER8E
Country: Ireland

Facility:
Name: Assuta Ashdod Public Hospital (R.A)

Address:
City: Ashdod
Zip: 7747629
Country: Israel

Facility:
Name: Hadassah Hebrew University Hospital Ein Kerem

Address:
City: Jerusalem
Zip: 9112001
Country: Israel

Facility:
Name: Meir Medical Center

Address:
City: Kfar Saba
Zip: 4428164
Country: Israel

Facility:
Name: Health Corporation of Galilee Medical Center

Address:
City: Nahariya
Zip: 2210001
Country: Israel

Facility:
Name: Chaim Sheba Medical Center

Address:
City: Ramat Gan
Zip: 5266202
Country: Israel

Facility:
Name: Tel-Aviv Sourasky Medical Center

Address:
City: Tel-Aviv-Jaffa
Zip: 6492601
Country: Israel

Facility:
Name: A.O.U. Policlinico Federico II Napoli

Address:
City: Naples
Zip: 80131
Country: Italy

Facility:
Name: A.O.U. di Modena - Policlinico

Address:
City: Modena
Zip: 41100
Country: Italy

Facility:
Name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Ginecologia Oncologica

Address:
City: Roma
Zip: 00168
Country: Italy

Facility:
Name: IRCCS Ospedale Policlinico San Martino - Clinica ostetrica e ginecologica

Address:
City: Genova
Zip: 16132
Country: Italy

Facility:
Name: Istituto Europeo di Oncologia s.r.l - Ginecologia Preventiva

Address:
City: Milano
Zip: 20141
Country: Italy

Facility:
Name: IRCCS Fondazione Policlinico San Matteo

Address:
City: Pavia
Zip: 27100
Country: Italy

Facility:
Name: A.O. Ordine Mauriziano

Address:
City: Torino
Zip: 10128
Country: Italy

Facility:
Name: Careggi University Hospital - Ostetricia e Ginecologia

Address:
City: Firenze
Zip: 50134
Country: Italy

Facility:
Name: Azienda Ospedaliera Universitaria Integrata Verona_Borgo Trento - Ostetricia e Ginecologia B

Address:
City: Verona
Zip: 37126
Country: Italy

Facility:
Name: Kazakh Institute of Oncology and Radiology - Department of Gynecology

Address:
City: Almaty
Zip: 640000
Country: Kazakhstan

Facility:
Name: Multidisciplinary Medical Center of the Akimat of Astana - Department of Chemotherapy No1

Address:
City: Astana
Zip: 010000
Country: Kazakhstan

Facility:
Name: Gabinet Ginekologiczny Janusz Tomaszewski

Address:
City: Bialystok
Zip: 15-224
Country: Poland

Facility:
Name: CLINICAL MEDICAL RESEARCH Sp. z o. o.

Address:
City: Katowice
Zip: 40-156
Country: Poland

Facility:
Name: NZOZ MEDEM Wilk Sp. j.

Address:
City: Katowice
Zip: 40-301
Country: Poland

Facility:
Name: Pratia McM Kraków

Address:
City: Krakow
Zip: 30-727
Country: Poland

Facility:
Name: Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.

Address:
City: Lodz
Zip: 90-602
Country: Poland

Facility:
Name: Salve Medica Sp. z o.o. SP.K.

Address:
City: Lodz
Zip: 91-211
Country: Poland

Facility:
Name: Centrum Medyczne Pratia Poznan

Address:
City: Skorzewo
Zip: 60-185
Country: Poland

Facility:
Name: Centrum Badawcze Wspolczesnej Terapii

Address:
City: Warszawa
Zip: 02-679
Country: Poland

Facility:
Name: Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica

Address:
City: Loures
Zip: 2674-514
Country: Portugal

Facility:
Name: Centro Clinico Academico Braga | Braga, Portugal

Address:
City: Braga
Zip: 4710-243
Country: Portugal

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

Address:
City: Coimbra
Zip: 3000-075
Country: Portugal

Facility:
Name: Fundacao Champalimaud | Centro Clinico Champalimaud - Unidade Investigacao Clinica

Address:
City: Lisboa
Zip: 1400-038
Country: Portugal

Facility:
Name: Centro Hospitalar de Lisboa Ocidental | Clinical Research Department

Address:
City: Lisboa
Zip: 1449-005
Country: Portugal

Facility:
Name: Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica

Address:
City: Lisboa
Zip: 1500-650
Country: Portugal

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

Address:
City: Lisboa
Zip: 1649-035
Country: Portugal

Facility:
Name: Centro Hospitalar Universitario do Porto

Address:
City: Porto
Zip: 4050-651
Country: Portugal

Facility:
Name: Companhia Uniao Fabril | Hospital CUF Porto - Clinical Trials Department

Address:
City: Porto
Zip: 4100-180
Country: Portugal

Facility:
Name: CHUSJ - Hospital Sao Joao

Address:
City: Porto
Zip: 4200-319
Country: Portugal

Facility:
Name: Sc Oncolab Srl

Address:
City: Craiova
Zip: 200385
Country: Romania

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

Address:
City: Brasov
Zip: 500283
Country: Romania

Facility:
Name: S.C. Quantum Medical Center SRL

Address:
City: Bucuresti
Zip: 012071
Country: Romania

Facility:
Name: Spitalul Clinic Filantropia

Address:
City: Bucuresti
Zip: 11132
Country: Romania

Facility:
Name: S.C Ovidius Clinical Hospital SRL - Oncology Department

Address:
City: Ovidiu
Zip: 905900
Country: Romania

Facility:
Name: Hospital Clínico Universitario de Santiago de Compostela

Address:
City: Santiago de Compostela
Zip: 15706
Country: Spain

Facility:
Name: Hospital Universitario La Zarzuela | Clinical Research Unit

Address:
City: Aravaca
Zip: 28023
Country: Spain

Facility:
Name: Hospital del Mar

Address:
City: Barcelona
Zip: 08003
Country: Spain

Facility:
Name: Hospital Universitario Virgen de las Nieves | Oncologia Medica

Address:
City: Granada
Zip: 18014
Country: Spain

Facility:
Name: Hospital General Universitario Gregorio Maranon | Oncologia

Address:
City: Madrid
Zip: 28009
Country: Spain

Facility:
Name: Virgen del Rocio University Hospital - Oncology Department

Address:
City: Sevilla
Zip: 41013
Country: Spain

Facility:
Name: Hospital Clinico Universitario | Gynecology and Obstetrics Department

Address:
City: Valencia
Zip: 46010
Country: Spain

Facility:
Name: Hospital General Universitario de Valencia

Address:
City: Valencia
Zip: 46014
Country: Spain

Facility:
Name: Surrey and Sussex Healthcare NHS Trust

Address:
City: Redhill
Zip: RH1 5RH
Country: United Kingdom

Facility:
Name: Aberdeen Royal Infirmary

Address:
City: Aberdeen
Zip: AB25 2ZN
Country: United Kingdom

Facility:
Name: Glasgow Royal Infirmary | Haematology

Address:
City: Glasgow
Zip: G4 0SF
Country: United Kingdom

Facility:
Name: Liverpool Womens Hospital

Address:
City: Liverpool
Zip: L8 7SS
Country: United Kingdom

Facility:
Name: Queen Charlottes & Chelseas Hospital

Address:
City: London
Zip: W12 0NN
Country: United Kingdom

Start date: October 14, 2022

Completion date: December 4, 2026

Lead sponsor:
Agency: Bayer
Agency class: Industry

Source: Bayer

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05587296
http://clinicaltrials.bayer.com