OASIS-4: 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

Sponsor

Bayer (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05587296

Collaborator

(none)

405

Enrollment

Locations

Arms

25.8

Anticipated Duration (Months)

4.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

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.

Condition or Disease	Intervention/Treatment	Phase
Vasomotor Symptoms Caused by Adjuvant Endocrine Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer Hot Flashes	Drug: Elinzanetant (BAY3427080) Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

405 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 in Women With Hormone-receptor Positive Breast Cancer:

Actual Study Start Date :

Oct 14, 2022

Anticipated Primary Completion Date :

Feb 2, 2024

Anticipated Study Completion Date :

Dec 7, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Elinzanetant (BAY3427080) Participants will receive 120 mg elinzanetant orally once daily.	Drug: Elinzanetant (BAY3427080) 120 mg elinzanetant orally once daily
Placebo Comparator: Placebo Participants will receive matching placebo orally once daily.	Drug: Placebo Matching placebo orally once daily.

Arm

Intervention/Treatment

Experimental: Elinzanetant (BAY3427080)

Participants will receive 120 mg elinzanetant orally once daily.

Drug: Elinzanetant (BAY3427080)

120 mg elinzanetant orally once daily

Placebo Comparator: Placebo

Participants will receive matching placebo orally once daily.

Drug: Placebo

Matching placebo orally once daily.

Outcome Measures

Primary Outcome Measures

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]
Mean change in frequency of moderate to severe HF from baseline to Week 12 (assessed by HFDD) [Baseline to Week 12]

Secondary Outcome Measures

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 52]
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]
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
Mean change in menopause specific quality of life scale (MENQOL) total score from baseline to Week 12 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Barmhzg Schwestern \| Brust-Gesundheitszentrum	Linz	Oberösterreich	Austria	4010
2	Medizinische Univ Graz \| Frauenheilkunde & Geburtshilfe	Graz	Steiermark	Austria	8036
3	MedUni Innsbruck \| Brust Gesundheit Zentrum	Innsbruck	Tirol	Austria	6020
4	AKH Wien \| Allg. Gynaekologie & gynaekologische Onkologie	Wien		Austria	1090
5	GZA Ziekenhuizen	Wilrijk	Antwerpen	Belgium	2610
6	CHU Saint-Pierre/UMC Sint-Pieter	Bruxelles - Brussel		Belgium	1000
7	Hôpital Erasme/Erasmus Ziekenhuis	Bruxelles - Brussel		Belgium	1070
8	CU Saint-Luc/UZ St-Luc	Bruxelles - Brussel		Belgium	1200
9	UZ Gent	Gent		Belgium	9000
10	UZ Leuven Gasthuisberg	Leuven		Belgium	3000
11	Femicare vzw	Tienen		Belgium	3300
12	Docrates Klinikka	Helsinki		Finland	00180
13	Mehiläinen Kuopio	Kuopio		Finland	70100
14	Lääkärikeskus Gyneko	Oulu		Finland	90100
15	Tampereen yliopistollinen sairaala, keskussairaala	Tampere		Finland	33521
16	Vaasan keskussairaala	Vaasa		Finland	65130
17	ICO Site Paul Papin - Angers	Angers		France	49055
18	Institut Bergonié - Unicancer Nouvelle Aquitaine	Bordeaux Cedex		France	33076
19	Centre de Lutte Contre le Cancer François Baclesse	Caen Cedex 5		France	14076
20	Centre Léon Bérard	Lyon		France	69008
21	Institut du Cancer de Montpellier - Val d'Aurelle	Montpellier Cedex		France	34298
22	Hôpital Saint Louis	Paris		France	75010
23	Hôpital Tenon	Paris		France	75020
24	Institut de Cancérologie de l'Ouest - Saint Herblain	Saint-Herblain		France	44800
25	ICANS - Institut de Cancérologie de Strasbourg Europe	Strasbourg		France	67033
26	Praxisklinik am Rosengarten	Mannheim	Baden-Württemberg	Germany	68165
27	Eberhard-Karls-Universität Tübingen	Tübingen	Baden-Württemberg	Germany	72076
28	Uniklinik Ulm / Klinik für Frauenheilkunde und Geburtshilfe	Ulm	Baden-Württemberg	Germany	89075
29	Praxis Hr. Dr. S. Fiedler	Aachen	Nordrhein-Westfalen	Germany	52074
30	Evangelisches Krankenhaus Bergisch Gladbach	Bergisch Gladbach	Nordrhein-Westfalen	Germany	51465
31	Gynäkologisches Zentrum	Bonn	Nordrhein-Westfalen	Germany	53111
32	Frauenärzte am Schloss Borbeck	Essen	Nordrhein-Westfalen	Germany	45355
33	Medplus Nordrhein	Krefeld	Nordrhein-Westfalen	Germany	47799
34	Praxis f. Gynäkologie und Geburtshilfe	Bernburg	Sachsen-Anhalt	Germany	06406
35	Frauenarztpraxis Dr. Inka Kiesche	Halle		Germany	06110
36	Debreceni Egyetem Klinikai Kozpont	Debrecen		Hungary	4032
37	Axon Kft.	Kecskemet		Hungary	6000
38	SzSzBMK es EOK Josa Andras Oktatokorhaz	Nyiregyhaza		Hungary	4400
39	Rub-Int Noi Egeszsegcentrum	Szekesfehervar		Hungary	8000
40	Cork University Hospital	Cork		Ireland
41	Mater Misericordiae University Hospital	Dublin		Ireland	7
42	St James' Hospital	Dublin		Ireland	D08 NHY1
43	St Vincents University Hospital	Dublin		Ireland	DUBLIN 4
44	University College Hospital Galway	Galway		Ireland
45	Assuta Ashdod	Ashdod		Israel	7747629
46	Hadassah Hebrew University Hospital Ein Kerem	Jerusalem		Israel	9112001
47	Meir Medical Center	Kfar Saba		Israel	4428164
48	Health Corporation of Galilee Medical Center	Nahariya		Israel	2210001
49	Chaim Sheba Medical Center	Ramat Gan		Israel	5262000
50	Tel-Aviv Sourasky Medical Center	Tel Aviv		Israel	6423906
51	A.O.U. di Modena - Policlinico	Modena	Emilia-Romagna	Italy	41124
52	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma	Lazio	Italy	00168
53	IRCCS Ospedale Policlinico San Martino	Genova	Liguria	Italy	16132
54	IRCCS Istituto Europeo di Oncologia s.r.l. (IEO)	Milano	Lombardia	Italy	20141
55	Fondazione IRCCS Policlinico San Matteo	Pavia	Lombardia	Italy	27100
56	A.O. Ordine Mauriziano	Torino	Piemonte	Italy	10128
57	A.O.U.I. Verona	Verona	Veneto	Italy	37126
58	Kaz. Inst. of oncology and radiology \| Dept. of gynecology	Almaty		Kazakhstan	50000
59	Multifield medical center \| Chemotherapy department No 1	Nur-Sultan		Kazakhstan	010009
60	Gabinet Ginekologiczny Janusz Tomaszewski	Bialystok		Poland	15-244
61	CLINICAL MEDICAL RESEARCH Sp. z o. o.	Katowice		Poland	40-156
62	NZOZ MEDEM Wilk Sp. j.	Katowice		Poland	40-301
63	Pratia S.A	Krakow		Poland	30-510
64	Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.	Lodz		Poland	90-602
65	Salve Medica Sp. z o.o. SP.K.	Lodz		Poland	91-211
66	Pratia S.A	Skorzewo		Poland	60-185
67	Centrum Badawcze Wspolczesnej Terapii	Warszawa		Poland	02-679
68	Luz Saude \| Hospital Beatriz Angelo - Centro de Investigacao Clinica	Loures	Lisboa	Portugal	2674-514
69	Centro Clinico Academico - Braga	Braga		Portugal	4710-243
70	CHUC - Hospitais da U. Coimbra - Servico de Ginecologia	Coimbra		Portugal	3004-561
71	Fundacao Champalimaud	Lisboa		Portugal	1400-038
72	Centro Hospitalar de Lisboa Ocidental \| Clin Res Dept	Lisboa		Portugal	1449-005
73	Hospital da Luz - Lisboa	Lisboa		Portugal	1500-650
74	CHULN - H. Sta.Maria (Centro de Investigacao Clinica)	Lisboa		Portugal	1649-035
75	Centro Hospitalar Universitario do Porto	Porto		Portugal	4050-651
76	Hospital CUF Porto	Porto		Portugal	4100-180
77	CHUSJ - Hospital Sao Joao	Porto		Portugal	4200-319
78	S.C. Quantum Medical Center S.R.L	Bucuresti		Romania	012071
79	Spitalul Clinic Filantropia	Bucuresti		Romania	11132
80	Sc Oncolab Srl	Craiova		Romania	200385
81	Sf. Nectarie Oncology Center	Craiova		Romania	200542
82	S.C Ovidius Clinical Hospital SRL - Oncology Department	Ovidiu		Romania	905900
83	Spitalul Municipal Ploiesti	Ploiesti		Romania	100337
84	Oncocenter	Timisoara		Romania	300166
85	Hospital Clínico Universitario de Santiago de Compostela	Santiago de Compostela	A Coruña	Spain	15706
86	Hospital Sanitas La Zarzuela	Aravaca	Madrid	Spain	28023
87	Hospital del Mar	Barcelona		Spain	08003
88	Hospital Universitario Virgen de las Nieves\|Oncologia	Granada		Spain	18014
89	Hospital General Universitario Gregorio Marañón \| Oncología	Madrid		Spain	28007
90	H Univ. 12 de Octubre \| Ginecología y Obstetricia	Madrid		Spain	28041
91	Hospital Universitario Virgen del Rocío	Sevilla		Spain	41013
92	Hospital General Universitario de Valencia	Valencia		Spain	46014
93	Surrey and Sussex Healthcare NHS Trust	Redhill	Surrey	United Kingdom	RH1 5RH
94	Aberdeen Royal Infirmary	Aberdeen		United Kingdom	AB25 2ZN
95	Glasgow Royal Infirmary \| Haematology	Glasgow		United Kingdom	G4 0SF
96	Liverpool Womens Hospital	Liverpool		United Kingdom	L8 7SS
97	Queen Charlottes & Chelseas Hospital	London		United Kingdom	W12 0NN

Sponsors and Collaborators

Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Bayer

ClinicalTrials.gov Identifier:

NCT05587296

Other Study ID Numbers:

21656
2022-000095-18

First Posted:

Oct 20, 2022

Last Update Posted:

Jan 12, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Breast Neoplasms

Hot Flashes

Study Results

No Results Posted as of Jan 12, 2023