Clinical Research Directory
Browse clinical research sites, groups, and studies.
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
Sponsor: Bayer
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.
Official title: A Double-blind, Randomized, Placebo-controlled Multicenter Study to Investigate Efficacy and Safety of Elinzanetant for the Treatment of Vasomotor Symptoms Induced by Adjuvant Endocrine Therapy, Over 52 Weeks and Optionally for an Additional up to 2.5 Years in Women With Hormone-receptor Positive Breast Cancer:
Key Details
Gender
FEMALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
474
Start Date
2022-10-14
Completion Date
2028-06-05
Last Updated
2026-02-03
Healthy Volunteers
No
Conditions
Interventions
Elinzanetant (BAY3427080)
120 mg elinzanetant orally once daily
Placebo
Matching placebo orally once daily
Locations (102)
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
Mehiläinen Kuopio
Kuopio, Finland
Lääkärikeskus Gyneko Oy
Oulu, Finland
Tampere University Hospital, Tampereen yliopistollinen sairaala (TAYS)
Tampere, Finland
Vaasa Central Hospital, Vaasan keskussairaala - Syöpätaudit
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
Naples, 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 | Ginecologia
Valencia, Spain
Imperial College Healthcare NHS Trust| Queen Charlotte's and Chelsea Hospital - Gynaecology
London, Greater London, United Kingdom
Liverpool Women's NHS Foundation Trust | Liverpool Women's Hospital - Gynaecology
Liverpool, Merseyside, United Kingdom
NHS Greater Glasgow and Clyde | Glasgow Royal Infirmary - Gynaecology
Glasgow, Scotland, United Kingdom
Surrey and Sussex Healthcare NHS Trust - East Surrey Hospital - Gynaecology
Redhill, Surrey, United Kingdom
NHS Grampian | Aberdeen Royal Infirmary - Gynaecology
Aberdeen, United Kingdom