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
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:
3 other identifiers
interventional
474
16 countries
102
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2022
Longer than P75 for phase_3
102 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 14, 2022
CompletedFirst Submitted
Initial submission to the registry
October 17, 2022
CompletedFirst Posted
Study publicly available on registry
October 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 29, 2024
CompletedResults Posted
Study results publicly available
October 29, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 5, 2028
ExpectedApril 16, 2026
April 1, 2026
1.3 years
October 17, 2022
September 9, 2025
April 14, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Mean Change in Frequency of Moderate to Severe Hot Flashes (HF) From Baseline to Week 4 (Assessed by Hot Flash Daily Diary [HFDD])
Participants' assessments of HF were recorded electronically twice daily using the sponsor developed Hot Flash Daily Diary (HFDD). The HFDD was completed in the morning after waking up (morning diary) and each evening at bedtime (evening diary) on the hand-held device. The HFDD items assessed the number of mild, moderate, and severe HF experienced during the day and during the night. Mild HF was defined as a "sensation of heat without sweating", moderate HF was defined as a "sensation of heat with sweating, but able to continue activity", and severe HF was defined as a "sensation of heat with sweating, causing cessation (stopping) of activity". Mean daily frequency is calculated as total number of moderate to severe HF during that week divided by the total number of available days with data during that week.
Baseline to Week 4
Mean Change in Frequency of Moderate to Severe HFs From Baseline to Week 12 (Assessed by HFDD)
Participants' assessments of HF were recorded electronically twice daily using the sponsor developed Hot Flash Daily Diary (HFDD). The HFDD was completed in the morning after waking up (morning diary) and each evening at bedtime (evening diary) on the hand-held device. The HFDD items assessed the number of mild, moderate, and severe HF experienced during the day and during the night. Mild HF was defined as a "sensation of heat without sweating", moderate HF was defined as a "sensation of heat with sweating, but able to continue activity", and severe HF was defined as a "sensation of heat with sweating, causing cessation (stopping) of activity". Mean daily frequency is calculated as total number of moderate to severe HF during that week divided by the total number of available days with data during that week.
Baseline to Week 12
Secondary Outcomes (6)
Mean Change in Severity of Moderate to Severe HF From Baseline to Week 4 (Assessed by HFDD).
Baseline to Week 4
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 Frequency of Moderate to Severe HF From Baseline Over Time (Assessed by HFDD)
Baseline to Week 50
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
- +1 more secondary outcomes
Study Arms (2)
Elinzanetant (BAY3427080)
EXPERIMENTALParticipants will receive 120 mg elinzanetant orally once daily.
Placebo
PLACEBO COMPARATORParticipants will receive matching placebo orally once daily for 12 weeks, followed by 120 mg elinzanetant orally once daily
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (102)
AKH Wien | Allg. Gynaekologie & gynaekologische Onkologie
Vienna, Burgenland, 7000, Austria
MedUni Innsbruck | Brust Gesundheit Zentrum
Vienna, State of Vienna, 1140, Austria
Medical University of Graz | Division of Gynecology and Obstetrics
Salzburg, 5020, Austria
ZAS Augustinus - Gynaecology department
Wilrijk, Antwerpen, 2610, Belgium
Hôpital Erasme/Erasmus Ziekenhuis
Brussels, 1070, Belgium
CHU Saint-Pierre/UMC Sint-Pieter
Bruxelles - Brussel, 1000, Belgium
CU Saint-Luc/UZ St-Luc
Bruxelles - Brussel, 1200, Belgium
Ziekenhuis Oost-Limburg - Gynecology Department
Genk, 3600, Belgium
Ghent University Hospital | Women's Clinic Department
Ghent, 9000, Belgium
UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
Femicare vzw | Tienen, BE
Tienen, 3300, Belgium
The Ottawa Hospital - Riverside Campus
Ottawa, Ontario, K1H 7W9, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM) | Centre de Recherche
Montreal, Quebec, H2X 0A9, Canada
Lääkärikeskus Gyneko Oy
Oulu, North Ostrobothnia, 90100, Finland
Mehiläinen Kuopio
Kuopio, Northern Savonia, 70100, Finland
Tampere University Hospital, Tampereen yliopistollinen sairaala (TAYS)
Tampere, Pirkanmaa, 33520, Finland
Vaasa Central Hospital, Vaasan keskussairaala - Syöpätaudit
Vaasa, Pohjanmaa, 65130, Finland
Docrates Mehiläinen Syöpäsairaala
Helsinki, Uusimaa, 00180, Finland
UNICANCER - Centre Leon-Berard (CLB) - Medical oncology
Lyon, Auvergne-Rhône-Alpes, 69373, France
Centre Paul Strauss
Strasbourg, Grand Est, 67065, France
Centre de Lutte Contre le Cancer François Baclesse - Service Pathologie mammaire
Caen, Normandy, 14000, France
Institut Bergonie - Unicancer Nouvelle Aquitaine
Bordeaux, Nouvelle-Aquitaine, 33076, France
Institut du Cancer de Montpellier - Val d'Aurelle - Service Oncogynecologie et senologie
Montpellier, Occitanie, 34090, France
ICO Site Paul Papin - Angers - Service Oncologie
Angers, Pays de la Loire Region, 49100, France
Institut de Cancerologie Ouest - Saint-Herblain - Service gynecologie medicale
Saint-Herblain, Pays de la Loire Region, 44800, France
Hôpital Saint Louis
Paris, Île-de-France Region, 75010, France
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Tenon - Gynecologie Obstetrique Medecine de la Reproduction
Paris, Île-de-France Region, 75020, France
Praxisklinik am Rosengarten
Mannheim, Baden-Wurttemberg, 68165, Germany
Eberhard-Karls-Universität Tübingen
Tübingen, Baden-Wurttemberg, 72076, Germany
Synexus Frankfurt Clinical Research Centre
Frankfurt am Main, Hesse, 60313, Germany
Klinische Forschung Hannover-Mitte GmbH
Hanover, Lower Saxony, 30159, Germany
Praxis Hr. Dr. S. Fiedler
Aachen, North Rhine-Westphalia, 52074, Germany
Evangelisches Krankenhaus Bergisch Gladbach - Gynäkologi
Bergisch Gladbach, North Rhine-Westphalia, 51465, Germany
Gynäkologisches Zentrum Bonn
Bonn, North Rhine-Westphalia, 53111, Germany
Frauenärzte am Schloss Borbeck
Essen, North Rhine-Westphalia, 45355, Germany
Medplus Nordrhein
Krefeld, North Rhine-Westphalia, 47799, Germany
Praxis f. Gynäkologie und Geburtshilfe
Bernburg, Saxony-Anhalt, 6406, Germany
Frauenarztpraxis Dr. Inka Kiesche
Halle, Saxony-Anhalt, 6110, Germany
Klinische Forschung Berlin-Mitte GmbH
Berlin, 10117, Germany
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Axon Kft.
Kecskemét, 6000, Hungary
Szabolcs Szatmr Bereg County University Teaching Hospital | Andras Jasa Teaching Hospital - Oncology
Nyíregyháza, 4400, Hungary
Rub-Int Noi Egeszsegcentrum
Székesfehérvár, 8000, Hungary
University College Hospital Galway
Galway, Connacht, H91YR71, Ireland
St Vincents University Hospital
Dublin, Leinster, D04 TC63, Ireland
Mater Misericordiae University Hospital
Dublin, Leinster, D07R2WY, Ireland
St James' Hospital
Dublin, Leinster, D08NHY1, Ireland
Cork University Hospital
Cork, Munster, T12DC4A, Ireland
University Hospital Waterford
Waterford, Munster, X91 ER8E, Ireland
Assuta Ashdod Public Hospital (R.A)
Ashdod, 7747629, Israel
Hadassah Hebrew University Hospital Ein Kerem
Jerusalem, 9112001, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Health Corporation of Galilee Medical Center
Nahariya, 2210001, Israel
Chaim Sheba Medical Center
Ramat Gan, 5266202, Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, 6492601, Israel
Azienda Ospedaliera Universitaria Federico II Di Napoli - DAI Materno Infantile
Naples, Campania, 80131, Italy
Azienda Ospedaliero Universitaria di Modena_Policlinico - Oncologia
Modena, Emilia-Romagna, 41124, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Ginecologia Oncologica
Rome, Lazio, 00168, Italy
IRCCS Ospedale Policlinico San Martino - Clinica ostetrica e ginecologica
Genoa, Liguria, 16132, Italy
Istituto Europeo di Oncologia s.r.l - Ginecologia Preventiva
Milan, Lombardy, 20141, Italy
Fondazione IRCCS Policlinico San Matteo - Ostetricia e Ginecologia
Pavia, Lombardy, 27100, Italy
Azienda Ospedaliera Ordine Mauriziano Di Torino - Ostetricia e Ginecologia
Turin, Piedmont, 10128, Italy
Careggi University Hospital - Ostetricia e Ginecologia
Florence, Tuscany, 50134, Italy
Azienda Ospedaliera Universitaria Integrata Verona_Borgo Trento - Ostetricia e Ginecologia B
Verona, Veneto, 37126, Italy
Kazakh Institute of Oncology and Radiology - Department of Gynecology
Almaty, Almaty Region, 640000, Kazakhstan
Multidisciplinary Medical Center of the Akimat of Astana - Department of Chemotherapy No1
Astana, Aqmola, 010000, Kazakhstan
Gabinet Ginekologiczny Janusz Tomaszewski
Bialystok, 15-224, Poland
CLINICAL MEDICAL RESEARCH Sp. z o. o.
Katowice, 40-156, Poland
NZOZ MEDEM Wilk Sp. j.
Katowice, 40-301, Poland
Pratia McM Kraków
Krakow, 30-727, Poland
Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.
Lodz, 90-602, Poland
Salve Medica Sp. z o.o. SP.K.
Lodz, 91-211, Poland
Centrum Medyczne Pratia Poznan
Skorzewo, 60-185, Poland
Centrum Badawcze Wspolczesnej Terapii
Warsaw, 02-679, Poland
Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica
Loures, Lisbon District, 2674-514, Portugal
Centro Clinico Academico Braga | Braga, Portugal
Braga, 4710-243, Portugal
Unidade Local de Saúde de Coimbra, E.P.E. - Hospitais da Universidade de Coimbra - Serviço de Ginecologia
Coimbra, 3000-075, Portugal
Fundacao Champalimaud | Centro Clinico Champalimaud - Unidade Investigacao Clinica
Lisbon, 1400-038, Portugal
Unidade Local De Saúde De Lisboa Ocidental E.P.E.
Lisbon, 1449-005, Portugal
Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica
Lisbon, 1500-650, Portugal
CHULN - H. Sta.Maria (Centro de Investigacao Clinica)
Lisbon, 1649-035, Portugal
Centro Hospitalar Universitario do Porto
Porto, 4050-651, Portugal
Companhia Uniao Fabril | Hospital CUF Porto - Clinical Trials Department
Porto, 4100-180, Portugal
CHUSJ - Hospital Sao Joao
Porto, 4200-319, Portugal
Sc Oncolab Srl
Craiova, Dolj, 200385, Romania
S.C. Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL
Brasov, 500283, Romania
S.C. Quantum Medical Center SRL
Bucharest, 012071, Romania
Spitalul Clinic Filantropia
Bucharest, 11132, Romania
S.C Ovidius Clinical Hospital SRL - Oncology Department
Ovidiu, 905900, Romania
Complexo Hospitalario Universitario De Santiago | Oncologia
Santiago de Compostela, A Coruña, 15706, Spain
La Zarzuela University Hospital | Ginecologia
Aravaca, Madrid, 28023, Spain
Hospital del Mar I Ginecologia
Barcelona, 08003, Spain
Hospital Universitario Virgen De Las Nieves | Oncologia Medica
Granada, 18014, Spain
Hospital General Universitario Gregorio Maranon | Oncologia
Madrid, 28009, Spain
Hospital Universitario Virgen Del Rocio S.L. | Oncologia
Seville, 41013, Spain
Hospital Clinico Universitario De Valencia | Ginecologia
Valencia, 46010, Spain
Hospital General Universitario De Valencia | Ginecologia
Valencia, 46014, Spain
Imperial College Healthcare NHS Trust| Queen Charlotte's and Chelsea Hospital - Gynaecology
London, Greater London, W12 0NN, United Kingdom
Liverpool Women's NHS Foundation Trust | Liverpool Women's Hospital - Gynaecology
Liverpool, Merseyside, L8 7SS, United Kingdom
NHS Greater Glasgow and Clyde | Glasgow Royal Infirmary - Gynaecology
Glasgow, Scotland, G4 0SF, United Kingdom
Surrey and Sussex Healthcare NHS Trust - East Surrey Hospital - Gynaecology
Redhill, Surrey, RH1 5RH, United Kingdom
NHS Grampian | Aberdeen Royal Infirmary - Gynaecology
Aberdeen, AB25 2ZN, United Kingdom
Related Publications (1)
Cardoso F, Parke S, Brennan DJ, Briggs P, Donders G, Panay N, Haseli-Mashhadi N, Block M, Caetano C, Francuski M, Haberland C, Laapas K, Seitz C, Zuurman L. Elinzanetant for Vasomotor Symptoms from Endocrine Therapy for Breast Cancer. N Engl J Med. 2025 Aug 21;393(8):753-763. doi: 10.1056/NEJMoa2415566. Epub 2025 Jun 2.
PMID: 40454634DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2022
First Posted
October 20, 2022
Study Start
October 14, 2022
Primary Completion
January 29, 2024
Study Completion (Estimated)
June 5, 2028
Last Updated
April 16, 2026
Results First Posted
October 29, 2025
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
There are no current plans to share data. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.