Trial Condition(s):
Vasomotor symptoms caused by adjuvant endocrine therapy in women with, or at high risk for developing hormone-receptor positive breast cancer
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 (OASIS-4)
Bayer Identifier:
21656
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
2023-508265-33-00
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
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Locations Centro Hospitalar e Universitario de Coimbra, E.P.E. | Department of Gynecology Coimbra, Portugal, 3000-075 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Clinico Academico Braga | Braga, Portugal Braga, Portugal, 4710-243 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Hospitalar de Lisboa Ocidental | Clinical Research Department Lisboa, Portugal, 1449-005 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Hospitalar Universitario do Porto Porto, Portugal, 4050-651 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fundacao Champalimaud | Centro Clinico Champalimaud - Unidade Investigacao Clinica Lisboa, Portugal, 1400-038 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica Loures, Portugal, 2674-514 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica Lisboa, Portugal, 1500-650 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHUSJ - Hospital Sao Joao Porto, Portugal, 4200-319 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medical University of Graz | Division of Gynecology and Obstetrics Graz, Austria, 8036 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Evangelisches Krankenhaus Bergisch Gladbach - Gynäkologi Bergisch Gladbach, Germany, 51465 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MedUni Innsbruck | Brust Gesundheit Zentrum Innsbruck, Austria, 6020 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Frauenarztpraxis Dr. Inka Kiesche Halle, Germany, 6110 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Praxis f. Gynäkologie und Geburtshilfe Bernburg, Germany, 6406 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Virgen del Rocio University Hospital - Oncology Department Sevilla, Spain, 41013 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital General Universitario de Valencia Valencia, Spain, 46014 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínico Universitario de Santiago de Compostela Santiago de Compostela, Spain, 15706 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Virgen de las Nieves | Oncologia Medica Granada, Spain, 18014 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eberhard-Karls-Universität Tübingen Tübingen, Germany, 72076 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Praxisklinik am Rosengarten Mannheim, Germany, 68165 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Frauenärzte am Schloss Borbeck Essen, Germany, 45355 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Praxis Hr. Dr. S. Fiedler Aachen, Germany, 52074 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital del Mar Barcelona, Spain, 08003 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital General Universitario Gregorio Maranon | Oncologia Madrid, Spain, 28009 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario La Zarzuela | Clinical Research Unit Aravaca, Spain, 28023 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Rub-Int Noi Egeszsegcentrum Szekesfehervar, Hungary, 8000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Axon Kft. Kecskemet, Hungary, 6000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AKH Wien | Allg. Gynaekologie & gynaekologische Onkologie Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Debreceni Egyetem Klinikai Kozpont Debrecen, Hungary, 4032 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Szabolcs Szatmr Bereg County University Teaching Hospital | Andras Jasa Teaching Hospital - Oncology Nyiregyhaza, Hungary, 4400 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institut Bergonié - Unicancer Nouvelle Aquitaine BORDEAUX CEDEX, France, 33076 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institut de Cancérologie de l'Ouest - Saint Herblain Saint-Herblain, France, 44800 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre de Lutte Contre le Cancer François Baclesse CAEN CEDEX 5, France, 14076 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ICO Site Paul Papin - Angers ANGERS, France, 49055 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centrum Medyczne Pratia Poznan Skorzewo, Poland, 60-185 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Salve Medica Sp. z o.o. SP.K. Lodz, Poland, 91-211 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations NZOZ MEDEM Wilk Sp. j. Katowice, Poland, 40-301 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations PRATIA MCM KRAKÓW Krakow, Poland, 30-727 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CLINICAL MEDICAL RESEARCH Sp. z o. o. Katowice, Poland, 40-156 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr. Lodz, Poland, 90-602 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gabinet Ginekologiczny Janusz Tomaszewski Bialystok, Poland, 15-224 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gynäkologisches Zentrum Bonn Bonn, Germany, 53111 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medplus Nordrhein Krefeld, Germany, 47799 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Léon Bérard lyon, France, 69008 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ICANS - Institut de Cancérologie de Strasbourg Europe STRASBOURG, France, 67033 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Azienda Ospedaliera Universitaria Integrata Verona_Borgo Trento - Ostetricia e Ginecologia B Verona, Italy, 37126 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS Fondazione Policlinico San Matteo Pavia, Italy, 27100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Istituto Europeo di Oncologia s.r.l - Ginecologia Preventiva Milano, Italy, 20141 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Ginecologia Oncologica Roma, Italy, 00168 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS Ospedale Policlinico San Martino Genova, Italy, 16132 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Health Corporation of Galilee Medical Center Nahariya, Israel, 2210001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Meir Medical Center Kfar Saba, Israel, 4428164 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chaim Sheba Medical Center Ramat Gan, Israel, 5266202 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hadassah Hebrew University Hospital Ein Kerem Jerusalem, Israel, 9112001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations S.C. Quantum Medical Center SRL Bucuresti, Romania, 012071 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Spitalul Clinic Filantropia Bucuresti, Romania, 11132 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHULN - H. Sta.Maria (Centro de Investigacao Clinica) Lisboa, Portugal, 1649-035 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Companhia Uniao Fabril | Hospital CUF Porto - Clinical Trials Department Porto, Portugal, 4100-180 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institut du Cancer de Montpellier - Val d'Aurelle MONTPELLIER CEDEX, France, 34298 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Saint Louis PARIS, France, 75010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O. Ordine Mauriziano Torino, Italy, 10128 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SC ONCOLAB SRL Craiova, Romania, 200385 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Docrates Klinikka Helsinki, Finland, 00180 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tampereen yliopistollinen sairaala Tampere, Finland, 33520 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vaasan keskussairaala Vaasa, Finland, 65130 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mehilainen | Mehilainen Kuopio Kuopio, Finland, 70100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Lääkärikeskus Gyneko, Gynaecological Medical Center | Oulu, Finland Oulu, Finland, 90100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. di Modena - Policlinico Modena, Italy, 41100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Tenon PARIS, France, 75020 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Liverpool Womens Hospital Liverpool, United Kingdom, L8 7SS | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Queen Charlottes & Chelseas Hospital London, United Kingdom, W12 0NN | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Glasgow Royal Infirmary | Haematology Glasgow, United Kingdom, G4 0SF | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Surrey and Sussex Healthcare NHS Trust Redhill, United Kingdom, RH1 5RH | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Aberdeen Royal Infirmary Aberdeen, United Kingdom, AB25 2ZN | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tel-Aviv Sourasky Medical Center Tel-Aviv-Jaffa, Israel, 6492601 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Assuta Ashdod Ashdod, Israel, 7747629 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University College Hospital Galway Galway, Ireland, H91YR71 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mater Misericordiae University Hospital Dublin, Ireland, D07R2WY | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St Vincents University Hospital Dublin 4, Ireland, TBC | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St James' Hospital Dublin, Ireland, D08NHY1 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cork University Hospital Cork, Ireland, T12DC4A | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations S.C Ovidius Clinical Hospital SRL - Oncology Department Ovidiu, Romania, 905900 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ghent University Hospital | Women's Clinic Department Gent, Belgium, 9000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Erasme/Erasmus Ziekenhuis Brussels, Belgium, 1070 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHU Saint-Pierre/UMC Sint-Pieter BRUXELLES - BRUSSEL, Belgium, 1000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CU Saint-Luc/UZ St-Luc BRUXELLES - BRUSSEL, Belgium, 1200 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Femicare vzw | Tienen, BE Tienen, Belgium, 3300 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ZAS Augustinus - Gynaecology department Wilrijk, Belgium, 2610 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kazakh Institute of Oncology and Radiology - Department of Gynecology Almaty, Kazakhstan, 640000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Multidisciplinary Medical Center of the Akimat of Astana - Department of Chemotherapy No1 Astana, Kazakhstan, 010000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centrum Badawcze Wspolczesnej Terapii Warszawa, Poland, 02-679 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM) Montreal, Canada, H2X 0A9 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Careggi Firenze, Italy, 50134 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Policlinico Federico II Napoli Naples, Italy, 80131 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Ottawa Hospital - Riverside Campus Ottawa, Canada, K1H 7W9 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ziekenhuis Oost-Limburg - Gynecology Department Genk, Belgium, 3600 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Synexus Frankfurt Clinical Research Centre Frankfurt, Germany, 60313 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clinico Universitario | Gynecology and Obstetrics Department Valencia, Spain, 46010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations S.C. Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL Brasov, Romania, 500283 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinische Forschung Hannover-Mitte GmbH Hannover, Germany, 30159 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University Hospital Waterford Waterford, Ireland, X91 ER8E | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinische Forschung Berlin-Mitte GmbH Berlin, Germany, 10117 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
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 additional 2 years in women with hormone-receptor positive breast cancer:
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
2
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])Timeframe: Baseline to Week 4
- Mean change in frequency of moderate to severe HF from baseline to Week 12 (assessed by HFDD)Timeframe: Baseline to Week 12
Secondary Outcome
- Mean change in severity of moderate to severe HF from baseline to Week 4 (assessed by HFDD).Timeframe: Baseline to Week 4
- Mean change in severity of moderate to severe HF from baseline to Week 12 (assessed by HFDD)Timeframe: Baseline to Week 12
- Mean change in frequency of moderate to severe HF from baseline to Week 1 (assessed by HFDD)Timeframe: Baseline to Week 1
- Mean change in frequency of moderate to severe HF from baseline over time (assessed by HFDD)Timeframe: 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 disturbanceTimeframe: 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.Timeframe: Baseline to Week 12
Additional Information
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