Trial Condition(s):

Vasomotor symptoms caused by adjuvant endocrine therapy in women with, or at high risk for developing hormone-receptor positive breast cancer, Hot Flashes

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:

NCT05587296

EudraCT Number:

2022-000095-18

EU CT Number:

2023-508265-33-00

Recruitment Complete

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
473
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Elinzanetant (BAY3427080)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
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CHUC - Hospitais da U. Coimbra - Servico de Ginecologia

Coimbra, Portugal, 3004-561

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Centro Clinico Academico Braga | Braga, Portugal

Braga, Portugal, 4710-243

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Centro Hospitalar de Lisboa Ocidental | Clin Res Dept

Lisboa, Portugal, 1449-005

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Centro Hospitalar Universitario do Porto

Porto, Portugal, 4050-651

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Fundacao Champalimaud | Centro Clinico Champalimaud - Unidade Investigacao Clinica

Lisboa, Portugal, 1400-038

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Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica

Loures, Portugal, 2674-514

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

Lisboa, Portugal, 1500-650

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CHUSJ - Hospital Sao Joao

Porto, Portugal, 4200-319

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Medizinische Univ Graz | Frauenheilkunde & Geburtshilfe

Graz, Austria, 8036

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Evangelisches Krankenhaus Bergisch Gladbach

Bergisch Gladbach, Germany, 51465

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MedUni Innsbruck | Brust Gesundheit Zentrum

Innsbruck, Austria, 6020

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Frauenarztpraxis Dr. Inka Kiesche

Halle, Germany, 06110

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Praxis f. Gynäkologie und Geburtshilfe

Bernburg, Germany, 06406

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Virgen del Rocio University Hospital - Oncology Department

Sevilla, Spain, 41013

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Hospital General Universitario de Valencia

Valencia, Spain, 46014

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Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, Spain, 15706

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Hospital Universitario Virgen de las Nieves|Oncologia

Granada, Spain, 18014

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Eberhard-Karls-Universität Tübingen

Tübingen, Germany, 72076

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Praxisklinik am Rosengarten

Mannheim, Germany, 68165

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Frauenärzte am Schloss Borbeck

Essen, Germany, 45355

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Praxis Hr. Dr. S. Fiedler

Aachen, Germany, 52074

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Hospital del Mar

Barcelona, Spain, 08003

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Hospital General Universitario Gregorio Maranon | Oncologia

Madrid, Spain, 28007

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Hospital Sanitas La Zarzuela

Aravaca, Spain, 28023

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Rub-Int Noi Egeszsegcentrum

Szekesfehervar, Hungary, 8000

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Axon Kft.

Kecskemet, Hungary, 6000

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AKH Wien | Allg. Gynaekologie & gynaekologische Onkologie

Wien, Austria, 1090

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Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary, 4032

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SzSzBMK es EOK Josa Andras Oktatokorhaz

Nyiregyhaza, Hungary, 4400

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Institut Bergonié - Unicancer Nouvelle Aquitaine

Bordeaux, France, 33076

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Institut de Cancérologie de l'Ouest - Saint Herblain

Saint-Herblain, France, 44800

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Centre de Lutte Contre le Cancer François Baclesse

CAEN CEDEX 5, France, 14076

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ICO Site Paul Papin - Angers

ANGERS, France, 49055

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PRATIA S.A

Skorzewo, Poland, 60-185

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Salve Medica Sp. z o.o. SP.K.

Lodz, Poland, 91-211

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NZOZ MEDEM Wilk Sp. j.

Katowice, Poland, 40-301

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PRATIA S.A

Krakow, Poland, 30-510

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CLINICAL MEDICAL RESEARCH Sp. z o. o.

Katowice, Poland, 40-156

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Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.

Lodz, Poland, 90-602

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Gabinet Ginekologiczny Janusz Tomaszewski

Bialystok, Poland, 15-244

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Gynäkologisches Zentrum

Bonn, Germany, 53111

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Medplus Nordrhein

Krefeld, Germany, 47799

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Centre Léon Bérard

lyon, France, 69008

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ICANS - Institut de Cancérologie de Strasbourg Europe

STRASBOURG, France, 67033

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A.O.U.I. Verona

Verona, Italy, 37126

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Fondazione IRCCS Policlinico San Matteo

Pavia, Italy, 27100

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IRCCS Istituto Europeo di Oncologia s.r.l. (IEO)

Milano, Italy, 20141

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy, 00168

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IRCCS Ospedale Policlinico San Martino

Genova, Italy, 16132

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Health Corporation of Galilee Medical Center

Nahariya, Israel, 2210001

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Meir Medical Center

Kfar Saba, Israel, 4428164

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Chaim Sheba Medical Center

Ramat Gan, Israel, 5262000

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Hadassah Hebrew University Hospital Ein Kerem

Jerusalem, Israel, 9112001

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S.C. Quantum Medical Center S.R.L

Bucuresti, Romania, 012071

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Spitalul Clinic Filantropia

Bucuresti, Romania, 11132

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

Lisboa, Portugal, 1649-035

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Companhia Uniao Fabril | Hospital CUF Porto - Clinical Trials Department

Porto, Portugal, 4100-180

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Institut du Cancer de Montpellier - Val d'Aurelle

MONTPELLIER CEDEX, France, 34298

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Hôpital Saint Louis

PARIS, France, 75010

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A.O. Ordine Mauriziano

Torino, Italy, 10128

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SC ONCOLAB SRL

Craiova, Romania, 200385

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Docrates Klinikka

Helsinki, Finland, 00180

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Tampereen yliopistollinen sairaala, keskussairaala

Tampere, Finland, 33521

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Vaasan keskussairaala

Vaasa, Finland, 65130

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Mehiläinen Kuopio

Kuopio, Finland, 70100

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Lääkärikeskus Gyneko

Oulu, Finland, 90100

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A.O.U. di Modena - Policlinico

Modena, Italy, 41124

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Hôpital Tenon

PARIS, France, 75020

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Liverpool Womens Hospital

Liverpool, United Kingdom, L8 7SS

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Queen Charlottes & Chelseas Hospital

London, United Kingdom, W12 0NN

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Glasgow Royal Infirmary | Haematology

Glasgow, United Kingdom, G4 0SF

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Surrey and Sussex Healthcare NHS Trust

Redhill, United Kingdom, RH1 5RH

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Aberdeen Royal Infirmary

Aberdeen, United Kingdom, AB25 2ZN

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Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel, 6423906

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Assuta Ashdod

Ashdod, Israel, 7747629

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University College Hospital Galway

Galway, Ireland, H91YR71

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Mater Misericordiae University Hospital

Dublin, Ireland, 7

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St Vincents University Hospital

Dublin, Ireland, D04T6F4

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St James' Hospital

Dublin, Ireland, D08NHY1

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S.C Ovidius Clinical Hospital SRL - Oncology Department

Ovidiu, Romania, 905900

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Ghent University Hospital | Women's Clinic Department

Gent, Belgium, 9000

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UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

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Hôpital Erasme/Erasmus Ziekenhuis

Brussels, Belgium, 1070

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CHU Saint-Pierre/UMC Sint-Pieter

BRUXELLES - BRUSSEL, Belgium, 1000

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CU Saint-Luc/UZ St-Luc

BRUXELLES - BRUSSEL, Belgium, 1200

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Femicare vzw

Tienen, Belgium, 3300

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GZA Ziekenhuizen

Wilrijk, Belgium, 2610

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Kaz. Inst. of oncology and radiology | Dept. of gynecology

Almaty, Kazakhstan, 50000

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Multifield medical center | Chemotherapy department No 1

Nur-Sultan, Kazakhstan, 010009

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Centrum Badawcze Wspolczesnej Terapii

Warszawa, Poland, 02-679

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Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)

Montreal, Canada, H2X 0A9

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A.O.U. Careggi

Firenze, Italy, 50134

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A.O.U. Policlinico Federico II Napoli

Naples, Italy, 80131

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The Ottawa Hospital - Riverside Campus

Ottawa, Canada, K1H 7W9

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Ziekenhuis Oost-Limburg - Gynecology Department

Genk, Belgium, 3600

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Synexus Frankfurt Clinical Research Centre

Frankfurt, Germany, 60313

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S.C. Centrul Medical de Diagn si Tratam Ambulator Neomed SRL

Brasov, Romania, 500283

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Klinische Forschung Hannover-Mitte GmbH

Hannover, Germany, 30159

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University Hospital Waterford

Waterford, Ireland, X91ER8E

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Klinische Forschung Berlin-Mitte GmbH

Berlin, Germany, 10117

Trial Design