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

Recruiting

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.

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
405
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
Status
LocationsStatus
Locations

CHUC - Hospitais da U. Coimbra - Servico de Ginecologia

Coimbra, Portugal, 3004-561

Status
Not yet recruiting
 
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Centro Clinico Academico - Braga

Braga, Portugal, 4710-243

Status
Not yet recruiting
 
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Centro Hospitalar de Lisboa Ocidental | Clin Res Dept

Lisboa, Portugal, 1449-005

Status
Not yet recruiting
 
Locations

Centro Hospitalar Universitario do Porto

Porto, Portugal, 4050-651

Status
Not yet recruiting
 
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Fundacao Champalimaud

Lisboa, Portugal, 1400-038

Status
Not yet recruiting
 
Locations

Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica

Loures, Portugal, 2674-514

Status
Not yet recruiting
 
Locations

Hospital da Luz - Lisboa

Lisboa, Portugal, 1500-650

Status
Not yet recruiting
 
Locations

CHUSJ - Hospital Sao Joao

Porto, Portugal, 4200-319

Status
Not yet recruiting
 
Locations

Barmhzg Schwestern | Brust-Gesundheitszentrum

Linz, Austria, 4010

Status
Not yet recruiting
 
Locations

Medizinische Univ Graz | Frauenheilkunde & Geburtshilfe

Graz, Austria, 8036

Status
Recruiting
 
Locations

Evangelisches Krankenhaus Bergisch Gladbach

Bergisch Gladbach, Germany, 51465

Status
Recruiting
 
Locations

MedUni Innsbruck | Brust Gesundheit Zentrum

Innsbruck, Austria, 6020

Status
Recruiting
 
Locations

Frauenarztpraxis Dr. Inka Kiesche

Halle, Germany, 06110

Status
Not yet recruiting
 
Locations

Praxis f. Gynäkologie und Geburtshilfe

Bernburg, Germany, 06406

Status
Recruiting
 
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H Univ. 12 de Octubre | Ginecología y Obstetricia

Madrid, Spain, 28041

Status
Not yet recruiting
 
Locations

Hospital Universitario Virgen del Rocío

Sevilla, Spain, 41013

Status
Recruiting
 
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Hospital General Universitario de Valencia

Valencia, Spain, 46014

Status
Recruiting
 
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Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, Spain, 15706

Status
Not yet recruiting
 
Locations

Hospital Universitario Virgen de las Nieves|Oncologia

Granada, Spain, 18014

Status
Recruiting
 
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Eberhard-Karls-Universität Tübingen

Tübingen, Germany, 72076

Status
Not yet recruiting
 
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Praxisklinik am Rosengarten

Mannheim, Germany, 68165

Status
Not yet recruiting
 
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Frauenärzte am Schloss Borbeck

Essen, Germany, 45355

Status
Not yet recruiting
 
Locations

Praxis Hr. Dr. S. Fiedler

Aachen, Germany, 52074

Status
Not yet recruiting
 
Locations

Hospital del Mar

Barcelona, Spain, 08003

Status
Not yet recruiting
 
Locations

Hospital General Universitario Gregorio Marañón | Oncología

Madrid, Spain, 28007

Status
Not yet recruiting
 
Locations

Hospital Sanitas La Zarzuela

Aravaca, Spain, 28023

Status
Recruiting
 
Locations

Rub-Int Noi Egeszsegcentrum

Szekesfehervar, Hungary, 8000

Status
Recruiting
 
Locations

Axon Kft.

Kecskemet, Hungary, 6000

Status
Not yet recruiting
 
Locations

AKH Wien | Allg. Gynaekologie & gynaekologische Onkologie

Wien, Austria, 1090

Status
Not yet recruiting
 
Locations

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary, 4032

Status
Not yet recruiting
 
Locations

SzSzBMK es EOK Josa Andras Oktatokorhaz

Nyiregyhaza, Hungary, 4400

Status
Recruiting
 
Locations

Institut Bergonié - Unicancer Nouvelle Aquitaine

BORDEAUX CEDEX, France, 33076

Status
Not yet recruiting
 
Locations

Institut de Cancérologie de l'Ouest - Saint Herblain

Saint-Herblain, France, 44800

Status
Recruiting
 
Locations

Centre de Lutte Contre le Cancer François Baclesse

CAEN CEDEX 5, France, 14076

Status
Not yet recruiting
 
Locations

ICO Site Paul Papin - Angers

ANGERS, France, 49055

Status
Not yet recruiting
 
Locations

PRATIA S.A

Skorzewo, Poland, 60-185

Status
Recruiting
 
Locations

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

Lodz, Poland, 91-211

Status
Not yet recruiting
 
Locations

NZOZ MEDEM Wilk Sp. j.

Katowice, Poland, 40-301

Status
Recruiting
 
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PRATIA S.A

Krakow, Poland, 30-510

Status
Not yet recruiting
 
Locations

CLINICAL MEDICAL RESEARCH Sp. z o. o.

Katowice, Poland, 40-156

Status
Recruiting
 
Locations

Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.

Lodz, Poland, 90-602

Status
Recruiting
 
Locations

Gabinet Ginekologiczny Janusz Tomaszewski

Bialystok, Poland, 15-244

Status
Recruiting
 
Locations

Gynäkologisches Zentrum

Bonn, Germany, 53111

Status
Not yet recruiting
 
Locations

Uniklinik Ulm / Klinik für Frauenheilkunde und Geburtshilfe

Ulm, Germany, 89075

Status
Not yet recruiting
 
Locations

Medplus Nordrhein

Krefeld, Germany, 47799

Status
Not yet recruiting
 
Locations

Centre Léon Bérard

lyon, France, 69008

Status
Recruiting
 
Locations

ICANS - Institut de Cancérologie de Strasbourg Europe

STRASBOURG, France, 67033

Status
Not yet recruiting
 
Locations

A.O.U.I. Verona

Verona, Italy, 37126

Status
Not yet recruiting
 
Locations

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy, 27100

Status
Not yet recruiting
 
Locations

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

Milano, Italy, 20141

Status
Not yet recruiting
 
Locations

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy, 00168

Status
Not yet recruiting
 
Locations

IRCCS Ospedale Policlinico San Martino

Genova, Italy, 16132

Status
Not yet recruiting
 
Locations

Health Corporation of Galilee Medical Center

Nahariya, Israel, 2210001

Status
Not yet recruiting
 
Locations

Meir Medical Center

Kfar Saba, Israel, 4428164

Status
Not yet recruiting
 
Locations

Chaim Sheba Medical Center

Ramat Gan, Israel, 5262000

Status
Not yet recruiting
 
Locations

Hadassah Hebrew University Hospital Ein Kerem

Jerusalem, Israel, 9112001

Status
Not yet recruiting
 
Locations

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

Bucuresti, Romania, 012071

Status
Not yet recruiting
 
Locations

Spitalul Clinic Filantropia

Bucuresti, Romania, 11132

Status
Not yet recruiting
 
Locations

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

Lisboa, Portugal, 1649-035

Status
Not yet recruiting
 
Locations

Hospital CUF Porto

Porto, Portugal, 4100-180

Status
Not yet recruiting
 
Locations

Institut du Cancer de Montpellier - Val d'Aurelle

MONTPELLIER CEDEX, France, 34298

Status
Not yet recruiting
 
Locations

Hôpital Saint Louis

PARIS, France, 75010

Status
Not yet recruiting
 
Locations

A.O. Ordine Mauriziano

Torino, Italy, 10128

Status
Not yet recruiting
 
Locations

Sf. Nectarie Oncology Center

Craiova, Romania, 200542

Status
Not yet recruiting
 
Locations

SC ONCOLAB SRL

Craiova, Romania, 200385

Status
Not yet recruiting
 
Locations

Docrates Klinikka

Helsinki, Finland, 00180

Status
Not yet recruiting
 
Locations

Tampereen yliopistollinen sairaala, keskussairaala

Tampere, Finland, 33521

Status
Not yet recruiting
 
Locations

Vaasan keskussairaala

Vaasa, Finland, 65130

Status
Not yet recruiting
 
Locations

Mehiläinen Kuopio

Kuopio, Finland, 70100

Status
Not yet recruiting
 
Locations

Lääkärikeskus Gyneko

Oulu, Finland, 90100

Status
Not yet recruiting
 
Locations

A.O.U. di Modena - Policlinico

Modena, Italy, 41124

Status
Not yet recruiting
 
Locations

Oncocenter

Timisoara, Romania, 300166

Status
Not yet recruiting
 
Locations

Hôpital Tenon

PARIS, France, 75020

Status
Not yet recruiting
 
Locations

Liverpool Womens Hospital

Liverpool, United Kingdom, L8 7SS

Status
Not yet recruiting
 
Locations

Queen Charlottes & Chelseas Hospital

London, United Kingdom, W12 0NN

Status
Not yet recruiting
 
Locations

Glasgow Royal Infirmary | Haematology

Glasgow, United Kingdom, G4 0SF

Status
Not yet recruiting
 
Locations

Surrey and Sussex Healthcare NHS Trust

Redhill, United Kingdom, RH1 5RH

Status
Not yet recruiting
 
Locations

Aberdeen Royal Infirmary

Aberdeen, United Kingdom, AB25 2ZN

Status
Not yet recruiting
 
Locations

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel, 6423906

Status
Not yet recruiting
 
Locations

Assuta Ashdod

Ashdod, Israel, 7747629

Status
Not yet recruiting
 
Locations

University College Hospital Galway

Galway, Ireland

Status
Not yet recruiting
 
Locations

Mater Misericordiae University Hospital

Dublin, Ireland, 7

Status
Not yet recruiting
 
Locations

St Vincents University Hospital

Dublin, Ireland, DUBLIN 4

Status
Not yet recruiting
 
Locations

St James' Hospital

Dublin, Ireland, D08 NHY1

Status
Not yet recruiting
 
Locations

Cork University Hospital

Cork, Ireland

Status
Not yet recruiting
 
Locations

S.C Ovidius Clinical Hospital SRL - Oncology Department

Ovidiu, Romania, 905900

Status
Not yet recruiting
 
Locations

Spitalul Municipal Ploiesti

Ploiesti, Romania, 100337

Status
Not yet recruiting
 
Locations

UZ Gent

GENT, Belgium, 9000

Status
Not yet recruiting
 
Locations

UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

Status
Not yet recruiting
 
Locations

Hôpital Erasme/Erasmus Ziekenhuis

BRUXELLES - BRUSSEL, Belgium, 1070

Status
Not yet recruiting
 
Locations

CHU Saint-Pierre/UMC Sint-Pieter

BRUXELLES - BRUSSEL, Belgium, 1000

Status
Recruiting
 
Locations

CU Saint-Luc/UZ St-Luc

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Not yet recruiting
 
Locations

Femicare vzw

Tienen, Belgium, 3300

Status
Recruiting
 
Locations

GZA Ziekenhuizen

Wilrijk, Belgium, 2610

Status
Not yet recruiting
 
Locations

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

Almaty, Kazakhstan, 50000

Status
Not yet recruiting
 
Locations

Multifield medical center | Chemotherapy department No 1

Nur-Sultan, Kazakhstan, 010009

Status
Not yet recruiting
 
Locations

Centrum Badawcze Wspolczesnej Terapii

Warszawa, Poland, 02-679

Status
Not yet recruiting
 

Trial Design