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

Hot Flashes Clinical Trial

— OASIS-4  

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 Additional 2 Years in Women With Hormone-receptor Positive Breast Cancer:

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05587296
• Other study ID #: 21656
• Secondary ID: 2023-508265-33-0
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 14, 2022
• Est. completion date: December 4, 2026

Study information

• Verified date: June 2024
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 473
• Est. completion date: December 4, 2026
• Est. primary completion date: January 29, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Hot Flashes

Intervention

Drug:
• Elinzanetant (BAY3427080)
120 mg elinzanetant orally once daily
• Placebo
Matching placebo orally once daily.

Locations

Country	Name	City	State
Austria	Medizinische Univ Graz | Frauenheilkunde & Geburtshilfe	Graz	Steiermark
Austria	MedUni Innsbruck | Brust Gesundheit Zentrum	Innsbruck	Tirol
Austria	AKH Wien | Allg. Gynaekologie & gynaekologische Onkologie	Wien
Belgium	Hôpital Erasme/Erasmus Ziekenhuis	Brussels
Belgium	CHU Saint-Pierre/UMC Sint-Pieter	Bruxelles - Brussel
Belgium	CU Saint-Luc/UZ St-Luc	Bruxelles - Brussel
Belgium	Ziekenhuis Oost-Limburg - Gynecology Department	Genk
Belgium	Ghent University Hospital | Women's Clinic Department	Gent
Belgium	UZ Leuven Gasthuisberg	Leuven
Belgium	Femicare vzw	Tienen
Belgium	GZA Ziekenhuizen	Wilrijk	Antwerpen
Canada	Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)	Montreal	Quebec
Canada	The Ottawa Hospital - Riverside Campus	Ottawa
Finland	Docrates Klinikka	Helsinki
Finland	Mehiläinen Kuopio	Kuopio
Finland	Lääkärikeskus Gyneko	Oulu
Finland	Tampereen yliopistollinen sairaala, keskussairaala	Tampere
Finland	Vaasan keskussairaala	Vaasa
France	ICO Site Paul Papin - Angers	Angers
France	Institut Bergonié - Unicancer Nouvelle Aquitaine	Bordeaux
France	Centre de Lutte Contre le Cancer François Baclesse	Caen Cedex 5
France	Centre Léon Bérard	Lyon
France	Institut du Cancer de Montpellier - Val d'Aurelle	Montpellier Cedex
France	Hôpital Saint Louis	Paris
France	Hôpital Tenon	Paris
France	Institut de Cancérologie de l'Ouest - Saint Herblain	Saint-Herblain
France	ICANS - Institut de Cancérologie de Strasbourg Europe	Strasbourg
Germany	Praxis Hr. Dr. S. Fiedler	Aachen	Nordrhein-Westfalen
Germany	Evangelisches Krankenhaus Bergisch Gladbach	Bergisch Gladbach	Nordrhein-Westfalen
Germany	Klinische Forschung Berlin-Mitte GmbH	Berlin
Germany	Praxis f. Gynäkologie und Geburtshilfe	Bernburg	Sachsen-Anhalt
Germany	Gynäkologisches Zentrum	Bonn	Nordrhein-Westfalen
Germany	Frauenärzte am Schloss Borbeck	Essen	Nordrhein-Westfalen
Germany	Synexus Frankfurt Clinical Research Centre	Frankfurt	Hessen
Germany	Frauenarztpraxis Dr. Inka Kiesche	Halle	Sachsen-Anhalt
Germany	Klinische Forschung Hannover-Mitte GmbH	Hannover	Niedersachsen
Germany	Medplus Nordrhein	Krefeld	Nordrhein-Westfalen
Germany	Praxisklinik am Rosengarten	Mannheim	Baden-Württemberg
Germany	Eberhard-Karls-Universität Tübingen	Tübingen	Baden-Württemberg
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Axon Kft.	Kecskemet
Hungary	Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz	Nyiregyhaza
Hungary	Rub-Int Noi Egeszsegcentrum	Szekesfehervar
Ireland	Mater Misericordiae University Hospital	Dublin
Ireland	St James' Hospital	Dublin
Ireland	St Vincents University Hospital	Dublin 4
Ireland	University College Hospital Galway	Galway
Ireland	University Hospital Waterford	Waterford
Israel	Assuta Ashdod	Ashdod
Israel	Hadassah Hebrew University Hospital Ein Kerem	Jerusalem
Israel	Meir Medical Center	Kfar Saba
Israel	Health Corporation of Galilee Medical Center	Nahariya
Israel	Chaim Sheba Medical Center	Ramat Gan
Israel	Tel-Aviv Sourasky Medical Center	Tel Aviv
Italy	A.O.U. Careggi	Firenze	Toscana
Italy	IRCCS Ospedale Policlinico San Martino	Genova	Liguria
Italy	IRCCS Istituto Europeo di Oncologia s.r.l. (IEO)	Milano	Lombardia
Italy	A.O.U. di Modena - Policlinico	Modena	Emilia-Romagna
Italy	A.O.U. Policlinico Federico II Napoli	Naples	Campania
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia	Lombardia
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma	Lazio
Italy	A.O. Ordine Mauriziano	Torino	Piemonte
Italy	A.O.U.I. Verona	Verona	Veneto
Kazakhstan	Kazakh Institute of Oncology and Radiology - Department of Gynecology	Almaty
Kazakhstan	Multidisciplinary Medical Center of the Akimat of Astana - Department of Chemotherapy No1	Nur-Sultan
Poland	Gabinet Ginekologiczny Janusz Tomaszewski	Bialystok
Poland	CLINICAL MEDICAL RESEARCH Sp. z o. o.	Katowice
Poland	NZOZ MEDEM Wilk Sp. j.	Katowice
Poland	Pratia S.A	Krakow
Poland	Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.	Lodz
Poland	Salve Medica Sp. z o.o. SP.K.	Lodz
Poland	Pratia S.A	Skorzewo
Poland	Centrum Badawcze Wspolczesnej Terapii	Warszawa
Portugal	Centro Clinico Academico Braga | Braga, Portugal	Braga
Portugal	CHUC - Hospitais da U. Coimbra - Servico de Ginecologia	Coimbra
Portugal	Centro Hospitalar de Lisboa Ocidental | Clin Res Dept	Lisboa
Portugal	CHULN - H. Sta.Maria (Centro de Investigacao Clinica)	Lisboa
Portugal	Fundacao Champalimaud | Centro Clinico Champalimaud - Unidade Investigacao Clinica	Lisboa
Portugal	Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica	Lisboa
Portugal	Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica	Loures	Lisboa
Portugal	Centro Hospitalar Universitario do Porto	Porto
Portugal	CHUSJ - Hospital Sao Joao	Porto
Portugal	Companhia Uniao Fabril | Hospital CUF Porto - Clinical Trials Department	Porto
Romania	S.C. Centrul Medical de Diagn si Tratam Ambulator Neomed SRL	Brasov
Romania	S.C. Genesys Fertility Center S.R.L	Bucuresti
Romania	Spitalul Clinic Filantropia	Bucuresti
Romania	Sc Oncolab Srl	Craiova
Romania	S.C Ovidius Clinical Hospital SRL - Oncology Department	Ovidiu
Spain	Hospital Sanitas La Zarzuela	Aravaca	Madrid
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitario Virgen de las Nieves | Oncologia Medica	Granada
Spain	Hospital General Universitario Gregorio Maranon | Oncologia	Madrid
Spain	Hospital Clínico Universitario de Santiago de Compostela	Santiago de Compostela	A Coruña
Spain	Virgen del Rocio University Hospital - Oncology Department	Sevilla
Spain	Hospital General Universitario de Valencia	Valencia
United Kingdom	Aberdeen Royal Infirmary	Aberdeen
United Kingdom	Glasgow Royal Infirmary | Haematology	Glasgow
United Kingdom	Liverpool Womens Hospital	Liverpool
United Kingdom	Queen Charlottes & Chelseas Hospital	London
United Kingdom	Surrey and Sussex Healthcare NHS Trust	Redhill	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Austria,  Belgium,  Canada,  Finland,  France,  Germany,  Hungary,  Ireland,  Israel,  Italy,  Kazakhstan,  Poland,  Portugal,  Romania,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in frequency of moderate to severe hot flash (HF) from baseline to Week 4 (assessed by hot flash daily diary [HFDD])		Baseline to Week 4
Primary	Mean change in frequency of moderate to severe HF from baseline to Week 12 (assessed by HFDD)		Baseline to Week 12
Secondary	Mean change in severity of moderate to severe HF from baseline to Week 4 (assessed by HFDD).		Baseline to Week 4
Secondary	Mean change in severity of moderate to severe HF from baseline to Week 12 (assessed by HFDD)		Baseline to Week 12
Secondary	Mean change in frequency of moderate to severe HF from baseline to Week 1 (assessed by HFDD)		Baseline to Week 1
Secondary	Mean change in frequency of moderate to severe HF from baseline over time (assessed by HFDD)		Baseline to Week 52
Secondary	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. Total scores range from 8 to 40, with higher scores indicating greater severity of sleep disturbance	Baseline to Week 12
Secondary	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.	Baseline to Week 12

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