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
- Conditions
- Vasomotor Symptoms Caused by Adjuvant Endocrine Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast CancerHot Flashes
- Interventions
- Drug: Elinzanetant (BAY3427080)Drug: Placebo
- Registration Number
- NCT05587296
- Lead Sponsor
- Bayer
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 473
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Elinzanetant (BAY3427080) Elinzanetant (BAY3427080) Participants will receive 120 mg elinzanetant orally once daily. Placebo Elinzanetant (BAY3427080) Participants will receive matching placebo orally once daily for 12 weeks, followed by 120 mg elinzanetant orally once daily Placebo Placebo Participants will receive matching placebo orally once daily for 12 weeks, followed by 120 mg elinzanetant orally once daily
- Primary Outcome Measures
Name Time Method Mean change in frequency of moderate to severe hot flash (HF) from baseline to Week 4 (assessed by hot flash daily diary [HFDD]) Baseline to Week 4 Mean change in frequency of moderate to severe HF from baseline to Week 12 (assessed by HFDD) Baseline to Week 12
- Secondary Outcome Measures
Name Time Method Mean change in severity of moderate to severe HF from baseline to Week 4 (assessed by HFDD). Baseline to Week 4 Mean change in frequency of moderate to severe HF from baseline over time (assessed by HFDD) Baseline to Week 52 Mean change in menopause specific quality of life scale (MENQOL) total score from baseline to Week 12 Baseline to Week 12 The MENQOL questionnaire is comprised of 29 items assessing the presence of menopausal symptoms and the impact of menopause on health-related quality of life over the past week. The items assess four domains of symptoms and functioning: VMS, psychosocial functioning, physical functioning, and sexual functioning. For each item, the participant indicates if they have experienced the symptom (yes/no). If participants select yes, participants rate how bothered they were by the symptom using a six-point verbal descriptor scale, with response options ranging from 0 'not at all bothered' to 6 'extremely bothered'. Based on the individual responses, item scores, domain scores, and a total MENQOL score are calculated. Each score ranges from 1-8, higher scores indicate greater bother.
Mean change in severity of moderate to severe HF from baseline to Week 12 (assessed by HFDD) Baseline to Week 12 Mean change in frequency of moderate to severe HF from baseline to Week 1 (assessed by HFDD) Baseline to Week 1 Mean change in patient-reported outcomes measurement information system sleep disturbance short form 8b (PROMIS SD SF 8b) total score from baseline to Week 12 Baseline to Week 12 The PROMIS SD SF 8b includes 8 items assessing sleep disturbance over the past 7 days. Items assess sleep quality, sleep depth and restoration associated with sleep, perceived difficulties with getting to sleep or staying asleep and perceptions of the adequacy of and satisfaction with sleep. Participants respond to the items on a 5-point scale from not at all, never or very poor to very much, always or very good. Four of the items are scored reversely. Total scores range from 8 to 40, with higher scores indicating greater severity of sleep disturbance
Trial Locations
- Locations (102)
Institut Bergonie - Unicancer Nouvelle Aquitaine
🇫🇷Bordeaux Cedex, France
Institut de Cancerologie Ouest - Saint-Herblain - Service gynecologie medicale
🇫🇷Saint-Herblain, France
Meir Medical Center
🇮🇱Kfar Saba, Israel
Salve Medica Sp. z o.o. SP.K.
🇵🇱Lodz, Poland
Centro Hospitalar e Universitario de Coimbra, E.P.E. | Department of Gynecology
🇵🇹Coimbra, Portugal
Fundacao Champalimaud | Centro Clinico Champalimaud - Unidade Investigacao Clinica
🇵🇹Lisboa, Portugal
Centro Hospitalar de Lisboa Ocidental | Clinical Research Department
🇵🇹Lisboa, Portugal
Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica
🇵🇹Lisboa, Portugal
Centrum Badawcze Wspolczesnej Terapii
🇵🇱Warszawa, Poland
S.C. Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL
🇷🇴Brasov, Romania
S.C. Quantum Medical Center SRL
🇷🇴Bucuresti, Romania
Spitalul Clinic Filantropia
🇷🇴Bucuresti, Romania
S.C Ovidius Clinical Hospital SRL - Oncology Department
🇷🇴Ovidiu, Romania
Hospital Clínico Universitario de Santiago de Compostela
🇪🇸Santiago de Compostela, A Coruña, Spain
Hospital Universitario La Zarzuela | Clinical Research Unit
🇪🇸Aravaca, Madrid, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Universitario Virgen de las Nieves | Oncologia Medica
🇪🇸Granada, Spain
Hospital General Universitario Gregorio Maranon | Oncologia
🇪🇸Madrid, Spain
Virgen del Rocio University Hospital - Oncology Department
🇪🇸Sevilla, Spain
Hôpital Erasme/Erasmus Ziekenhuis
🇧🇪Brussels, Belgium
CHU Saint-Pierre/UMC Sint-Pieter
🇧🇪Bruxelles - Brussel, Belgium
CU Saint-Luc/UZ St-Luc
🇧🇪Bruxelles - Brussel, Belgium
CHUSJ - Hospital Sao Joao
🇵🇹Porto, Portugal
Medical University of Graz | Division of Gynecology and Obstetrics
🇦🇹Graz, Steiermark, Austria
MedUni Innsbruck | Brust Gesundheit Zentrum
🇦🇹Innsbruck, Tirol, Austria
AKH Wien | Allg. Gynaekologie & gynaekologische Onkologie
🇦🇹Wien, Austria
Ghent University Hospital | Women's Clinic Department
🇧🇪Gent, Belgium
The Ottawa Hospital - Riverside Campus
🇨🇦Ottawa, Ontario, Canada
ZAS Augustinus - Gynaecology department
🇧🇪Wilrijk, Antwerpen, Belgium
Ziekenhuis Oost-Limburg - Gynecology Department
🇧🇪Genk, Belgium
UZ Leuven Gasthuisberg
🇧🇪Leuven, Belgium
Femicare vzw | Tienen, BE
🇧🇪Tienen, Belgium
Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)
🇨🇦Montreal, Quebec, Canada
Sc Oncolab Srl
🇷🇴Craiova, Dolj, Romania
Docrates Klinikka
🇫🇮Helsinki, Finland
Mehilainen | Mehilainen Kuopio
🇫🇮Kuopio, Finland
Lääkärikeskus Gyneko, Gynaecological Medical Center | Oulu, Finland
🇫🇮Oulu, Finland
Tampereen yliopistollinen sairaala
🇫🇮Tampere, Finland
Vaasan keskussairaala
🇫🇮Vaasa, Finland
ICO Site Paul Papin - Angers - Service Oncologie
🇫🇷Angers, France
Eberhard-Karls-Universität Tübingen
🇩🇪Tübingen, Baden-Württemberg, Germany
Centre de Lutte Contre le Cancer François Baclesse - Service Pathologie mammaire
🇫🇷Caen Cedex 5, France
UNICANCER - Centre Leon Berard (CLB)
🇫🇷Lyon, France
Synexus Frankfurt Clinical Research Centre
🇩🇪Frankfurt, Hessen, Germany
Klinische Forschung Hannover-Mitte GmbH
🇩🇪Hannover, Niedersachsen, Germany
Praxis Hr. Dr. S. Fiedler
🇩🇪Aachen, Nordrhein-Westfalen, Germany
Evangelisches Krankenhaus Bergisch Gladbach - Gynäkologi
🇩🇪Bergisch Gladbach, Nordrhein-Westfalen, Germany
Gynäkologisches Zentrum Bonn
🇩🇪Bonn, Nordrhein-Westfalen, Germany
Frauenärzte am Schloss Borbeck
🇩🇪Essen, Nordrhein-Westfalen, Germany
ICM - Institut du Cancer de Montpellier - Val d'Aurelle
🇫🇷Montpellier Cedex, France
Hôpital Saint Louis
🇫🇷Paris, France
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Tenon
🇫🇷Paris, France
ICANS - Institut de Cancerologie de Strasbourg Europe
🇫🇷Strasbourg, France
Praxisklinik am Rosengarten
🇩🇪Mannheim, Baden-Württemberg, Germany
Medplus Nordrhein
🇩🇪Krefeld, Nordrhein-Westfalen, Germany
Praxis f. Gynäkologie und Geburtshilfe
🇩🇪Bernburg, Sachsen-Anhalt, Germany
Frauenarztpraxis Dr. Inka Kiesche
🇩🇪Halle, Sachsen-Anhalt, Germany
Klinische Forschung Berlin-Mitte GmbH
🇩🇪Berlin, Germany
Debreceni Egyetem Klinikai Kozpont
🇭🇺Debrecen, Hungary
Axon Kft.
🇭🇺Kecskemet, Hungary
Szabolcs Szatmr Bereg County University Teaching Hospital | Andras Jasa Teaching Hospital - Oncology
🇭🇺Nyiregyhaza, Hungary
Rub-Int Noi Egeszsegcentrum
🇭🇺Szekesfehervar, Hungary
Cork University Hospital
🇮🇪Cork, Ireland
St Vincents University Hospital
🇮🇪Dublin 4, Ireland
Mater Misericordiae University Hospital
🇮🇪Dublin, Ireland
St James' 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
Health Corporation of Galilee Medical Center
🇮🇱Nahariya, Israel
Chaim Sheba Medical Center
🇮🇱Ramat Gan, Israel
Tel-Aviv Sourasky Medical Center
🇮🇱Tel-Aviv-Jaffa, 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
🇮🇹Roma, Lazio, Italy
IRCCS Ospedale Policlinico San Martino - Clinica ostetrica e ginecologica
🇮🇹Genova, Liguria, Italy
Istituto Europeo di Oncologia s.r.l - Ginecologia Preventiva
🇮🇹Milano, Lombardia, Italy
Fondazione IRCCS Policlinico San Matteo - Ostetricia e Ginecologia
🇮🇹Pavia, Lombardia, Italy
Azienda Ospedaliera Ordine Mauriziano Di Torino - Ostetricia e Ginecologia
🇮🇹Torino, Piemonte, Italy
Careggi University Hospital - Ostetricia e Ginecologia
🇮🇹Firenze, Toscana, 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
Centrum Medyczne Pratia Poznan
🇵🇱Skorzewo, Poland
Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica
🇵🇹Loures, Lisboa, Portugal
Centro Clinico Academico Braga | Braga, Portugal
🇵🇹Braga, Portugal
CHULN - H. Sta.Maria (Centro de Investigacao Clinica)
🇵🇹Lisboa, Portugal
Centro Hospitalar Universitario do Porto
🇵🇹Porto, Portugal
Companhia Uniao Fabril | Hospital CUF Porto - Clinical Trials Department
🇵🇹Porto, Portugal
Hospital Clinico Universitario | Gynecology and Obstetrics Department
🇪🇸Valencia, Spain
Hospital General Universitario de Valencia
🇪🇸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