do_not_disturb_altRecruitment Complete
Vasomotor symptoms caused by adjuvant endocrine therapy in women with, or at high risk for developing hormone-receptor positive breast cancer, Hot flashes
Bayer Identifier:
21656
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
2023-508265-33-00
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 purpose
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.
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.
Key Participants Requirements
Sex
FemaleAge
18 - 70 YearsTrial summary
Enrollment Goal
473Trial Dates
October 2022 - December 2026Phase
Phase 3Could I Receive a placebo
YesProducts
Elinzanetant (BAY3427080)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Active, not recruiting | Centro Hospitalar e Universitario de Coimbra, E.P.E. | Department of Gynecology | Coimbra, 3000-075, Portugal |
Active, not recruiting | Centro Clinico Academico Braga | Braga, Portugal | Braga, 4710-243, Portugal |
Active, not recruiting | Centro Hospitalar de Lisboa Ocidental | Clinical Research Department | Lisboa, 1449-005, Portugal |
Not yet recruiting | Centro Hospitalar Universitario do Porto | Porto, 4050-651, Portugal |
Active, not recruiting | Fundacao Champalimaud | Centro Clinico Champalimaud - Unidade Investigacao Clinica | Lisboa, 1400-038, Portugal |
Completed | Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica | Loures, 2674-514, Portugal |
Active, not recruiting | Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica | Lisboa, 1500-650, Portugal |
Not yet recruiting | CHUSJ - Hospital Sao Joao | Porto, 4200-319, Portugal |
Withdrawn | Barmhzg Schwestern | Brust-Gesundheitszentrum | Linz, 4010, Austria |
Active, not recruiting | Medical University of Graz | Division of Gynecology and Obstetrics | Graz, 8036, Austria |
Active, not recruiting | Evangelisches Krankenhaus Bergisch Gladbach - Gynäkologi | Bergisch Gladbach, 51465, Germany |
Active, not recruiting | MedUni Innsbruck | Brust Gesundheit Zentrum | Innsbruck, 6020, Austria |
Active, not recruiting | Frauenarztpraxis Dr. Inka Kiesche | Halle, 6110, Germany |
Active, not recruiting | Praxis f. Gynäkologie und Geburtshilfe | Bernburg, 6406, Germany |
Withdrawn | H Univ. 12 de Octubre | Ginecología y Obstetricia | Madrid, 28041, Spain |
Active, not recruiting | Virgen del Rocio University Hospital - Oncology Department | Sevilla, 41013, Spain |
Completed | Hospital General Universitario de Valencia | Valencia, 46014, Spain |
Active, not recruiting | Hospital Clínico Universitario de Santiago de Compostela | Santiago de Compostela, 15706, Spain |
Active, not recruiting | Hospital Universitario Virgen de las Nieves | Oncologia Medica | Granada, 18014, Spain |
Completed | Eberhard-Karls-Universität Tübingen | Tübingen, 72076, Germany |
Active, not recruiting | Praxisklinik am Rosengarten | Mannheim, 68165, Germany |
Active, not recruiting | Frauenärzte am Schloss Borbeck | Essen, 45355, Germany |
Active, not recruiting | Praxis Hr. Dr. S. Fiedler | Aachen, 52074, Germany |
Active, not recruiting | Hospital del Mar | Barcelona, 08003, Spain |
Active, not recruiting | Hospital General Universitario Gregorio Maranon | Oncologia | Madrid, 28009, Spain |
Active, not recruiting | Hospital Universitario La Zarzuela | Clinical Research Unit | Aravaca, 28023, Spain |
Active, not recruiting | Rub-Int Noi Egeszsegcentrum | Szekesfehervar, 8000, Hungary |
Active, not recruiting | Axon Kft. | Kecskemet, 6000, Hungary |
Active, not recruiting | AKH Wien | Allg. Gynaekologie & gynaekologische Onkologie | Wien, 1090, Austria |
Completed | Debreceni Egyetem Klinikai Kozpont | Debrecen, 4032, Hungary |
Active, not recruiting | Szabolcs Szatmr Bereg County University Teaching Hospital | Andras Jasa Teaching Hospital - Oncology | Nyiregyhaza, 4400, Hungary |
Completed | Institut Bergonié - Unicancer Nouvelle Aquitaine | BORDEAUX CEDEX, 33076, France |
Active, not recruiting | Institut de Cancérologie de l'Ouest - Saint Herblain | Saint-Herblain, 44800, France |
Active, not recruiting | Centre de Lutte Contre le Cancer François Baclesse | CAEN CEDEX 5, 14076, France |
Active, not recruiting | ICO Site Paul Papin - Angers | ANGERS, 49055, France |
Active, not recruiting | Centrum Medyczne Pratia Poznan | Skorzewo, 60-185, Poland |
Completed | Salve Medica Sp. z o.o. SP.K. | Lodz, 91-211, Poland |
Active, not recruiting | NZOZ MEDEM Wilk Sp. j. | Katowice, 40-301, Poland |
Active, not recruiting | PRATIA MCM KRAKÓW | Krakow, 30-727, Poland |
Active, not recruiting | CLINICAL MEDICAL RESEARCH Sp. z o. o. | Katowice, 40-156, Poland |
Active, not recruiting | Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr. | Lodz, 90-602, Poland |
Active, not recruiting | Gabinet Ginekologiczny Janusz Tomaszewski | Bialystok, 15-224, Poland |
Active, not recruiting | Gynäkologisches Zentrum Bonn | Bonn, 53111, Germany |
Withdrawn | Uniklinik Ulm / Klinik für Frauenheilkunde und Geburtshilfe | Ulm, 89075, Germany |
Active, not recruiting | Medplus Nordrhein | Krefeld, 47799, Germany |
Active, not recruiting | Centre Leon Berard | lyon, 69008, France |
Active, not recruiting | ICANS - Institut de Cancérologie de Strasbourg Europe | STRASBOURG, 67033, France |
Active, not recruiting | Azienda Ospedaliera Universitaria Integrata Verona_Borgo Trento - Ostetricia e Ginecologia B | Verona, 37126, Italy |
Active, not recruiting | IRCCS Fondazione Policlinico San Matteo | Pavia, 27100, Italy |
Active, not recruiting | Istituto Europeo di Oncologia s.r.l - Ginecologia Preventiva | Milano, 20141, Italy |
Active, not recruiting | Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Ginecologia Oncologica | Roma, 00168, Italy |
Active, not recruiting | IRCCS Ospedale Policlinico San Martino - Clinica ostetrica e ginecologica | Genova, 16132, Italy |
Active, not recruiting | Health Corporation of Galilee Medical Center | Nahariya, 2210001, Israel |
Active, not recruiting | Meir Medical Center | Kfar Saba, 4428164, Israel |
Active, not recruiting | Chaim Sheba Medical Center | Ramat Gan, 5266202, Israel |
Active, not recruiting | Hadassah Hebrew University Hospital Ein Kerem | Jerusalem, 9112001, Israel |
Completed | S.C. Quantum Medical Center SRL | Bucuresti, 012071, Romania |
Completed | Spitalul Clinic Filantropia | Bucuresti, 11132, Romania |
Not yet recruiting | CHULN - H. Sta.Maria (Centro de Investigacao Clinica) | Lisboa, 1649-035, Portugal |
Active, not recruiting | Companhia Uniao Fabril | Hospital CUF Porto - Clinical Trials Department | Porto, 4100-180, Portugal |
Active, not recruiting | Institut du Cancer de Montpellier - Val d'Aurelle | MONTPELLIER CEDEX, 34298, France |
Completed | Hôpital Saint Louis | PARIS, 75010, France |
Active, not recruiting | A.O. Ordine Mauriziano | Torino, 10128, Italy |
Withdrawn | Sf. Nectarie Oncology Center | Craiova, 200542, Romania |
Active, not recruiting | SC ONCOLAB SRL | Craiova, 200385, Romania |
Active, not recruiting | Docrates Klinikka | Helsinki, 00180, Finland |
Active, not recruiting | Tampereen yliopistollinen sairaala | Tampere, 33520, Finland |
Active, not recruiting | Vaasan keskussairaala | Vaasa, 65130, Finland |
Active, not recruiting | Mehilainen | Mehilainen Kuopio | Kuopio, 70100, Finland |
Active, not recruiting | Lääkärikeskus Gyneko, Gynaecological Medical Center | Oulu, Finland | Oulu, 90100, Finland |
Active, not recruiting | A.O.U. di Modena - Policlinico | Modena, 41100, Italy |
Withdrawn | Oncocenter | Timisoara, 300166, Romania |
Active, not recruiting | Hôpital Tenon | PARIS, 75020, France |
Active, not recruiting | Liverpool Women's NHS Foundation Trust | Liverpool Women's Hospital | Gynaecology | Liverpool, L8 7SS, United Kingdom |
Active, not recruiting | Imperial College Healthcare NHS Trust| Queen Charlotte's and Chelsea Hospital - Gynaecology | London, W12 0NN, United Kingdom |
Active, not recruiting | NHS Greater Glasgow and Clyde | Glasgow Royal Infirmary - Gynaecology | Glasgow, G4 0SF, United Kingdom |
Active, not recruiting | Surrey and Sussex Healthcare NHS Trust | Redhill, RH1 5RH, United Kingdom |
Active, not recruiting | Aberdeen Royal Infirmary | Aberdeen, AB25 2ZN, United Kingdom |
Active, not recruiting | Tel-Aviv Sourasky Medical Center | Tel-Aviv-Jaffa, 6492601, Israel |
Active, not recruiting | Assuta Ashdod Public Hospital (R.A) | Ashdod, 7747629, Israel |
Active, not recruiting | University College Hospital Galway | Galway, H91YR71, Ireland |
Active, not recruiting | Mater Misericordiae University Hospital | Dublin, D07R2WY, Ireland |
Active, not recruiting | St Vincents University Hospital | Dublin 4, TBC, Ireland |
Active, not recruiting | St James' Hospital | Dublin, D08NHY1, Ireland |
Not yet recruiting | Cork University Hospital | Cork, T12DC4A, Ireland |
Active, not recruiting | S.C Ovidius Clinical Hospital SRL - Oncology Department | Ovidiu, 905900, Romania |
Withdrawn | Spitalul Municipal Ploiesti | Ploiesti, 100337, Romania |
Active, not recruiting | Ghent University Hospital | Women's Clinic Department | Gent, 9000, Belgium |
Active, not recruiting | UZ Leuven Gasthuisberg | LEUVEN, 3000, Belgium |
Active, not recruiting | Hôpital Erasme/Erasmus Ziekenhuis | Brussels, 1070, Belgium |
Active, not recruiting | CHU Saint-Pierre/UMC Sint-Pieter | BRUXELLES - BRUSSEL, 1000, Belgium |
Completed | CU Saint-Luc/UZ St-Luc | BRUXELLES - BRUSSEL, 1200, Belgium |
Active, not recruiting | Femicare vzw | Tienen, BE | Tienen, 3300, Belgium |
Active, not recruiting | ZAS Augustinus - Gynaecology department | Wilrijk, 2610, Belgium |
Completed | Kazakh Institute of Oncology and Radiology - Department of Gynecology | Almaty, 640000, Kazakhstan |
Completed | Multidisciplinary Medical Center of the Akimat of Astana - Department of Chemotherapy No1 | Astana, 010000, Kazakhstan |
Completed | Centrum Badawcze Wspolczesnej Terapii | Warszawa, 02-679, Poland |
Withdrawn | Hamilton Health Sciences-Juravinski Cancer Centre | Hamilton, L8V 5C2, Canada |
Active, not recruiting | Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM) | Montreal, H2X 0A9, Canada |
Withdrawn | Women's College Hospital | Toronto, M5S 1B2, Canada |
Completed | Careggi University Hospital - Ostetricia e Ginecologia | Firenze, 50134, Italy |
Active, not recruiting | Azienda Ospedaliera Universitaria Federico II Di Napoli - DAI Materno Infantile | Napoli, 80131, Italy |
Active, not recruiting | The Ottawa Hospital - Riverside Campus | Ottawa, K1H 7W9, Canada |
Active, not recruiting | Ziekenhuis Oost-Limburg - Gynecology Department | Genk, 3600, Belgium |
Active, not recruiting | Synexus Frankfurt Clinical Research Centre | Frankfurt, 60313, Germany |
Withdrawn | Hospital Universitario La Paz | Ginecology Department | Madirid, 28046, Spain |
Terminated | Hospital Clinico Universitario | Gynecology and Obstetrics Department | Valencia, 46010, Spain |
Completed | S.C. Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL | Brasov, 500283, Romania |
Active, not recruiting | Klinische Forschung Hannover-Mitte GmbH | Hannover, 30159, Germany |
Active, not recruiting | University Hospital Waterford | Waterford, X91 ER8E, Ireland |
Completed | Klinische Forschung Berlin-Mitte GmbH | Berlin, 10117, Germany |
Primary Outcome
- Mean change in frequency of moderate to severe hot flash (HF) from baseline to Week 4 (assessed by hot flash daily diary [HFDD])date_rangeTime Frame:Baseline to Week 4
- Mean change in frequency of moderate to severe HF from baseline to Week 12 (assessed by HFDD)date_rangeTime Frame:Baseline to Week 12
Secondary Outcome
- Mean change in severity of moderate to severe HF from baseline to Week 4 (assessed by HFDD).date_rangeTime Frame:Baseline to Week 4
- Mean change in severity of moderate to severe HF from baseline to Week 12 (assessed by HFDD)date_rangeTime Frame:Baseline to Week 12
- Mean change in frequency of moderate to severe HF from baseline to Week 1 (assessed by HFDD)date_rangeTime Frame:Baseline to Week 1
- Mean change in frequency of moderate to severe HF from baseline over time (assessed by HFDD)date_rangeTime Frame:Baseline to Week 52
- Mean change in patient-reported outcomes measurement information system sleep disturbance short form 8b (PROMIS SD SF 8b) total score from baseline to Week 12The 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 disturbancedate_rangeTime Frame:Baseline to Week 12
- Mean change in menopause specific quality of life scale (MENQOL) total score from baseline to Week 12The 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.date_rangeTime Frame:Baseline to Week 12
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
2