AzTrials
AzTrials

Vasomotor Symptoms Caused by Adjuvant Endocrine Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast CancerPhase 3OASIS-4NCT05587296

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

A Phase 3 study testing Elinzanetant (BAY3427080) in people with Vasomotor Symptoms Caused by Adjuvant Endocrine Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer and Hot Flashes, run by Bayer at 102 sites in 16 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
What is being tested?
Elinzanetant (BAY3427080)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
474 participants
Where
102 sitesin 16 countries
Study dates
14 Oct 2022to 5 Jun 2028
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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 locations and contacts

102 sites in 16 countries.

102 sites in 16 countries

Germany12 sites

  • Praxis Hr. Dr. S. Fiedler

    Aachen, North Rhine-Westphalia, 52074

  • Evangelisches Krankenhaus Bergisch Gladbach - Gynäkologi

    Bergisch Gladbach, North Rhine-Westphalia, 51465

  • Klinische Forschung Berlin-Mitte GmbH

    Berlin, 10117

  • Praxis f. Gynäkologie und Geburtshilfe

    Bernburg, Saxony-Anhalt, 6406

  • Gynäkologisches Zentrum Bonn

    Bonn, North Rhine-Westphalia, 53111

  • Frauenärzte am Schloss Borbeck

    Essen, North Rhine-Westphalia, 45355

  • Synexus Frankfurt Clinical Research Centre

    Frankfurt am Main, Hesse, 60313

  • Frauenarztpraxis Dr. Inka Kiesche

    Halle, Saxony-Anhalt, 6110

  • Klinische Forschung Hannover-Mitte GmbH

    Hanover, Lower Saxony, 30159

  • Medplus Nordrhein

    Krefeld, North Rhine-Westphalia, 47799

  • Frauenarztpraxis Aurora

    Mannheim, Baden-Wurttemberg, 68163

  • Eberhard-Karls-Universität Tübingen

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Portugal10 sites

  • Unidade Local de Saúde de Braga E.P.E. - Centro Clínico Académico de Braga - Serviço de Ginecologia

    Braga, 4710-243

  • Unidade Local de Saúde de Coimbra, E.P.E. - Hospitais da Universidade de Coimbra - Serviço de Ginecologia

    Coimbra, 3000-075

  • Fundacao Champalimaud | Centro Clinico Champalimaud - Unidade Investigacao Clinica

    Lisbon, 1400-038

  • Unidade Local De Saúde De Lisboa Ocidental E.P.E.

    Lisbon, 1449-005

  • Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica

    Lisbon, 1500-650

  • CHULN - H. Sta.Maria (Centro de Investigacao Clinica)

    Lisbon, 1649-035

  • Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica

    Loures, Lisbon District, 2674-514

  • Centro Hospitalar Universitario do Porto

    Porto, 4050-651

  • Companhia Uniao Fabril | Hospital CUF Porto - Clinical Trials Department

    Porto, 4100-180

  • CHUSJ - Hospital Sao Joao

    Porto, 4200-319

Other trials in Portugal

France9 sites

  • ICO Site Paul Papin - Angers - Service Oncologie

    Angers, Pays de la Loire Region, 49100

  • Institut Bergonie - Unicancer Nouvelle Aquitaine

    Bordeaux, New Aquitaine, 33076

  • Centre de Lutte Contre le Cancer François Baclesse - Service Pathologie mammaire

    Caen, Normandy, 14000

  • UNICANCER - Centre Leon-Berard (CLB) - Medical oncology

    Lyon, Auvergne-Rhône-Alpes, 69373

  • Institut du Cancer de Montpellier - Val d'Aurelle - Service Oncogynecologie et senologie

    Montpellier, Occitanie, 34090

  • Hôpital Saint Louis

    Paris, Île-de-France Region, 75010

  • Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Tenon - Gynecologie Obstetrique Medecine de la Reproduction

    Paris, Île-de-France Region, 75020

  • Institut de Cancerologie Ouest - Saint-Herblain - Service gynecologie medicale

    Saint-Herblain, Pays de la Loire Region, 44800

  • Centre Paul Strauss

    Strasbourg, Grand Est, 67065

Other trials in France

Italy9 sites

  • Careggi University Hospital - Ostetricia e Ginecologia

    Florence, Tuscany, 50134

  • IRCCS Ospedale Policlinico San Martino - Clinica ostetrica e ginecologica

    Genoa, Liguria, 16132

  • Istituto Europeo di Oncologia s.r.l - Ginecologia Preventiva

    Milan, Lombardy, 20141

  • Azienda Ospedaliero Universitaria di Modena_Policlinico - Oncologia

    Modena, Emilia-Romagna, 41124

  • Azienda Ospedaliera Universitaria Federico II Di Napoli - DAI Materno Infantile

    Naples, Campania, 80131

  • Fondazione IRCCS Policlinico San Matteo - Ostetricia e Ginecologia

    Pavia, Lombardy, 27100

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Ginecologia Oncologica

    Rome, Lazio, 00168

  • Azienda Ospedaliera Ordine Mauriziano Di Torino - Ostetricia e Ginecologia

    Turin, Piedmont, 10128

  • Azienda Ospedaliera Universitaria Integrata Verona_Borgo Trento - Ostetricia e Ginecologia B

    Verona, Veneto, 37126

Other trials in Italy

Belgium8 sites

  • Hôpital Erasme/Erasmus Ziekenhuis

    Brussels, 1070

  • CHU Saint-Pierre/UMC Sint-Pieter

    Bruxelles - Brussel, 1000

  • CU Saint-Luc/UZ St-Luc

    Bruxelles - Brussel, 1200

  • Ziekenhuis Oost-Limburg - Gynecology Department

    Genk, 3600

  • Ghent University Hospital | Women's Clinic Department

    Ghent, 9000

  • UZ Leuven Gasthuisberg

    Leuven, 3000

  • Femicare vzw | Tienen, BE

    Tienen, 3300

  • ZAS Augustinus - Gynaecology department

    Wilrijk, Antwerpen, 2610

Other trials in Belgium

Poland8 sites

  • Gabinet Ginekologiczny Janusz Tomaszewski

    Bialystok, 15-224

  • CLINICAL MEDICAL RESEARCH Sp. z o. o.

    Katowice, 40-156

  • NZOZ MEDEM Wilk Sp. j.

    Katowice, 40-301

  • Pratia McM Kraków

    Krakow, 30-727

  • Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.

    Lodz, 90-602

  • Salve Medica Sp. z o.o. SP.K.

    Lodz, 91-211

  • Centrum Medyczne Pratia Poznan

    Skorzewo, 60-185

  • Centrum Badawcze Wspolczesnej Terapii

    Warsaw, 02-679

Other trials in Poland

Spain8 sites

  • La Zarzuela University Hospital | Ginecologia

    Aravaca, Madrid, 28023

  • Hospital del Mar | Ginecologia

    Barcelona, 08003

  • Hospital Universitario Virgen De Las Nieves | Oncologia Medica

    Granada, 18014

  • Hospital General Universitario Gregorio Maranon | Oncologia

    Madrid, 28009

  • Complexo Hospitalario Universitario De Santiago | Oncologia

    Santiago de Compostela, A Coruña, 15706

  • Hospital Universitario Virgen Del Rocio S.L. | Oncologia

    Seville, 41013

  • Hospital Clinico Universitario De Valencia | Ginecologia

    Valencia, 46010

  • Hospital General Universitario De Valencia | Ginecologia

    Valencia, 46014

Other trials in Spain

Ireland6 sites

  • Cork University Hospital

    Cork, Munster, T12DC4A

  • St Vincents University Hospital

    Dublin, Leinster, D04 TC63

  • Mater Misericordiae University Hospital

    Dublin, Leinster, D07R2WY

  • St James' Hospital

    Dublin, Leinster, D08NHY1

  • University College Hospital Galway

    Galway, Connacht, H91YR71

  • University Hospital Waterford

    Waterford, Munster, X91 ER8E

Other trials in Ireland

Israel6 sites

  • Assuta Ashdod Public Hospital (R.A)

    Ashdod, 7747629

  • Hadassah Hebrew University Hospital Ein Kerem

    Jerusalem, 9112001

  • Meir Medical Center

    Kfar Saba, 4428164

  • Health Corporation of Galilee Medical Center

    Nahariya, 2210001

  • Chaim Sheba Medical Center

    Ramat Gan, 5266202

  • Tel- Aviv Sourasky Medical Center - Nephrology

    Tel Aviv, 6492601

Other trials in Israel

Finland5 sites

  • Docrates Mehiläinen Syöpäsairaala

    Helsinki, Uusimaa, 00180

  • Mehiläinen Kuopio

    Kuopio, Northern Savonia, 70100

  • Lääkärikeskus Gyneko Oy

    Oulu, North Ostrobothnia, 90100

  • Tampere University Hospital, Tampereen yliopistollinen sairaala (TAYS)

    Tampere, Pirkanmaa, 33520

  • Vaasa Central Hospital, Vaasan keskussairaala - Syöpätaudit

    Vaasa, Pohjanmaa, 65130

Other trials in Finland

Romania5 sites

  • S.C. Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL

    Brasov, 500283

  • S.C. Quantum Medical Center SRL

    Bucharest, 012071

  • Spitalul Clinic Filantropia

    Bucharest, 11132

  • Sc Oncolab Srl

    Craiova, Dolj, 200385

  • S.C Ovidius Clinical Hospital SRL - Oncology Department

    Ovidiu, 905900

Other trials in Romania

United Kingdom5 sites

  • NHS Grampian | Aberdeen Royal Infirmary - Gynaecology

    Aberdeen, AB25 2ZN

  • NHS Greater Glasgow and Clyde | Glasgow Royal Infirmary - Gynaecology

    Glasgow, Scotland, G4 0SF

  • Liverpool Women's NHS Foundation Trust | Liverpool Women's Hospital - Gynaecology

    Liverpool, Merseyside, L8 7SS

  • Imperial College Healthcare NHS Trust| Queen Charlotte's and Chelsea Hospital - Gynaecology

    London, Greater London, W12 0NN

  • Surrey and Sussex Healthcare NHS Trust - East Surrey Hospital - Gynaecology

    Redhill, Surrey, RH1 5RH

Other trials in United Kingdom

Hungary4 sites

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, Hajdú-Bihar, 4032

  • Axon Kft.

    Kecskemét, Bács-Kiskun county, 6000

  • Szabolcs Szatmr Bereg County University Teaching Hospital | Andras Jasa Teaching Hospital - Oncology

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400

  • Rub-Int Noi Egeszsegcentrum

    Székesfehérvár, Fejér, 8000

Other trials in Hungary

Austria3 sites

  • Medical University of Graz | Division of Gynecology and Obstetrics

    Salzburg, 5020

  • AKH Wien | Allg. Gynaekologie & gynaekologische Onkologie

    Vienna, Burgenland, 7000

  • MedUni Innsbruck | Brust Gesundheit Zentrum

    Vienna, State of Vienna, 1140

Other trials in Austria

Canada2 sites

  • Centre Hospitalier de l'Universite de Montreal (CHUM) | Centre de Recherche

    Montreal, Quebec, H2X 0A9

  • The Ottawa Hospital - Riverside Campus

    Ottawa, Ontario, K1H 7W9

Other trials in Canada

Kazakhstan2 sites

  • Kazakh Institute of Oncology and Radiology - Department of Gynecology

    Almaty, Almaty Region, 640000

  • Multidisciplinary Medical Center of the Akimat of Astana - Department of Chemotherapy No1

    Astana, Aqmola, 010000

Other trials in Kazakhstan

About this study

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 3.5 Years in Women With Hormone-receptor Positive Breast Cancer:

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.

Read more

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 3.5 years.

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.

Being tested
Elinzanetant (BAY3427080), Placebo
Medical subject headings
Hot Flashes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Elinzanetant (BAY3427080)Drug

    120 mg elinzanetant orally once daily

  • PlaceboDrug

    Matching placebo orally once daily

Study groups in NCT05587296
Study groupRoleWhat they receive
Elinzanetant (BAY3427080)ExperimentalParticipants will receive 120 mg elinzanetant orally once daily.
Receives: Drug: Elinzanetant (BAY3427080)
PlaceboPlacebo comparatorParticipants will receive matching placebo orally once daily for 12 weeks, followed by 120 mg elinzanetant orally once daily
Receives: Drug: Elinzanetant (BAY3427080); Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to Week 4

  2. 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.

    Measured: Baseline to Week 12

Secondary outcomes (6)

  1. Mean Change in Severity of Moderate to Severe HF From Baseline to Week 4 (Assessed by HFDD).

    In the HFDD, the severity of HFs was categorized as: 1 = mild, 2 = moderate, and 3 = severe; therefore, a decrease in the HF severity score indicates an improvement.

    The mean daily severity during treatment was calculated for the available days as [(1 x number of mild HF) + (2 x number of moderate HF) + (3 x number of severe HF)] / (total number of mild, moderate and severe hot flashes on that day). When no HFs were reported for a particular day, the mean severity for that day was set to 0. The mean daily severity during baseline was calculated for the available days as [(2 x number of moderate HF) + (3 x number of severe HF)] / (total number of moderate to severe hot flashes on that day).

    Measured: Baseline to Week 4

  2. Mean Change in Severity of Moderate to Severe HF From Baseline to Week 12 (Assessed by HFDD)

    In the HFDD, the severity of HFs was categorized as: 1 = mild, 2 = moderate, and 3 = severe; therefore, a decrease in the HF severity score indicates an improvement.

    The mean daily severity during treatment was calculated for the available days as [(1 x number of mild HF) + (2 x number of moderate HF) + (3 x number of severe HF)] / (total number of mild, moderate and severe hot flashes on that day). When no HFs were reported for a particular day, the mean severity for that day was set to 0. The mean daily severity during baseline was calculated for the available days as [(2 x number of moderate HF) + (3 x number of severe HF)] / (total number of moderate to severe hot flashes on that day).

    Measured: Baseline to Week 12

  3. Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 1 (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.

    Measured: Baseline to Week 1

  4. Mean Change in Frequency of Moderate to Severe HF From Baseline Over Time (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.

    Measured: Baseline to Week 50

  5. 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

    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. Individual item scores are aggregated to total raw scores which range from 8 to 40. Total raw scores are converted into T-scores for comparison with population norms, with a mean of 50 and standard deviation of 10. T-scores range from 28.9 to 76.5. For both raw and T-scores higher scores indicate greater severity of sleep disturbance. According to available score cut points from PROMIS developers, T-scores can be interpreted as indicating mild (55-59), moderate (60-69), or severe (>70) sleep disturbance.

    Measured: Baseline to Week 12

  6. Mean Change in Menopause Specific Quality of Life Scale (MENQOL) Total Score From 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. For a MENQOL total score, the aggregated mean of the mean domain scores is calculated.

    Measured: Baseline to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2022
  2. Study start14 Oct 2022
  3. Primary completion29 Jan 2024
  4. Study completion5 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
474 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05587296
Sponsor's protocol ID
21656
Other IDs
2023-508265-33-00, 2022-000095-18, 2023
Acronym
OASIS-4
Status last verified
Jun 2026
First submitted
17 Oct 2022
Last updated
9 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 40454634

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Elinzanetant (BAY3427080) in people with Vasomotor Symptoms Caused by Adjuvant Endocrine Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer and Hot Flashes, run by Bayer at 102 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 102 sites in Germany, Portugal, France, Italy, Belgium and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in Frequency of Moderate to Severe Hot Flashes (HF) From Baseline to Week 4 (Assessed by Hot Flash Daily Diary [HFDD]) (time frame: Baseline to Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05587296, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.

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