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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

473

Participants

Timeline

Start Date

October 14, 2022

Primary Completion Date

January 29, 2024

Study Completion Date

June 25, 2027

Conditions
Vasomotor Symptoms Caused by Adjuvant Endocrine Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast CancerHot Flashes
Interventions
DRUG

Elinzanetant (BAY3427080)

120 mg elinzanetant orally once daily

DRUG

Placebo

Matching placebo orally once daily

Trial Locations (102)

1000

CHU Saint-Pierre/UMC Sint-Pieter, Bruxelles - Brussel

1070

Hôpital Erasme/Erasmus Ziekenhuis, Brussels

1200

CU Saint-Luc/UZ St-Luc, Bruxelles - Brussel

2610

ZAS Augustinus - Gynaecology department, Wilrijk

3000

UZ Leuven Gasthuisberg, Leuven

3600

Ziekenhuis Oost-Limburg - Gynecology Department, Genk

4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

6000

Axon Kft., Kecskemét

6110

Frauenarztpraxis Dr. Inka Kiesche, Halle

6406

Praxis f. Gynäkologie und Geburtshilfe, Bernburg

8000

Rub-Int Noi Egeszsegcentrum, Székesfehérvár

10117

Klinische Forschung Berlin-Mitte GmbH, Berlin

10128

Azienda Ospedaliera Ordine Mauriziano Di Torino - Ostetricia e Ginecologia, Turin

11132

Spitalul Clinic Filantropia, Bucharest

14000

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

15706

Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela

16132

IRCCS Ospedale Policlinico San Martino - Clinica ostetrica e ginecologica, Genoa

18014

Hospital Universitario Virgen De Las Nieves - Oncologia Medica, Granada

20141

Istituto Europeo di Oncologia s.r.l - Ginecologia Preventiva, Milan

27100

Fondazione IRCCS Policlinico San Matteo - Ostetricia e Ginecologia, Pavia

28023

Hospital Universitario La Zarzuela - Ginecologia, Aravaca

30159

Klinische Forschung Hannover-Mitte GmbH, Hanover

33076

Institut Bergonie - Unicancer Nouvelle Aquitaine, Bordeaux

33520

Tampereen yliopistollinen sairaala, Tampere

34090

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

37126

Azienda Ospedaliera Universitaria Integrata Verona_Borgo Trento - Ostetricia e Ginecologia B, Verona

41013

Hospital Universitario Virgen Del Rocio S.L. - Oncologia, Seville

41124

Azienda Ospedaliero Universitaria di Modena_Policlinico - Oncologia, Modena

44800

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

45355

Frauenärzte am Schloss Borbeck, Essen

46014

Hospital General Universitario de Valencia, Valencia

47799

Medplus Nordrhein, Krefeld

49100

ICO Site Paul Papin - Angers - Service Oncologie, Angers

50134

Careggi University Hospital - Ostetricia e Ginecologia, Florence

51465

Evangelisches Krankenhaus Bergisch Gladbach - Gynäkologi, Bergisch Gladbach

52074

Praxis Hr. Dr. S. Fiedler, Aachen

53111

Gynäkologisches Zentrum Bonn, Bonn

60313

Synexus Frankfurt Clinical Research Centre, Frankfurt am Main

65130

Vaasan keskussairaala, Vaasa

67033

ICANS - Institut de Cancerologie de Strasbourg Europe, Strasbourg

68165

Praxisklinik am Rosengarten, Mannheim

69373

UNICANCER - Centre Leon-Berard (CLB) - Medical oncology, Lyon

72076

Eberhard-Karls-Universität Tübingen, Tübingen

75010

Hôpital Saint Louis, Paris

75020

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

80131

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

200385

Sc Oncolab Srl, Craiova

500283

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

640000

Kazakh Institute of Oncology and Radiology - Department of Gynecology, Almaty

905900

S.C Ovidius Clinical Hospital SRL - Oncology Department, Ovidiu

2210001

Health Corporation of Galilee Medical Center, Nahariya

4428164

Meir Medical Center, Kfar Saba

5266202

Chaim Sheba Medical Center, Ramat Gan

6492601

Tel-Aviv Sourasky Medical Center, Tel Aviv

7747629

Assuta Ashdod Public Hospital (R.A), Ashdod

9112001

Hadassah Hebrew University Hospital Ein Kerem, Jerusalem

Styria

"Medical University of Graz , Division of Gynecology and Obstetrics"

Tyrol

"MedUni Innsbruck , Brust Gesundheit Zentrum"

Unknown

"AKH Wien , Allg. Gynaekologie & gynaekologische Onkologie"

"Ghent University Hospital , Women's Clinic Department"

"Femicare vzw , Tienen, BE"

"Mehilainen , Mehilainen Kuopio"

"Lääkärikeskus Gyneko, Gynaecological Medical Center , Oulu, Finland"

"Szabolcs Szatmr Bereg County University Teaching Hospital , Andras Jasa Teaching Hospital - Oncology"

"Centro Clinico Academico Braga , Braga, Portugal"

"Centro Hospitalar e Universitario de Coimbra, E.P.E. , Department of Gynecology"

"Fundacao Champalimaud , Centro Clinico Champalimaud - Unidade Investigacao Clinica"

"Centro Hospitalar de Lisboa Ocidental , Clinical Research Department"

"Luz Saude , Hospital da Luz Lisboa - Centro de Investigacao Clinica"

"Companhia Uniao Fabril , Hospital CUF Porto - Clinical Trials Department"

"Hospital General Universitario Gregorio Maranon , Oncologia"

"Hospital Clinico Universitario , Gynecology and Obstetrics Department"

"NHS Grampian , Aberdeen Royal Infirmary - Gynaecology"

"NHS Greater Glasgow and Clyde , Glasgow Royal Infirmary - Gynaecology"

"Liverpool Women's NHS Foundation Trust , Liverpool Women's Hospital - Gynaecology"

"Imperial College Healthcare NHS Trust, Queen Charlotte's and Chelsea Hospital - Gynaecology"

K1H 7W9

The Ottawa Hospital - Riverside Campus, Ottawa

H2X 0A9

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

00180

Docrates Klinikka, Helsinki

T12DC4A

Cork University Hospital, Cork

D07R2WY

Mater Misericordiae University Hospital, Dublin

D08NHY1

St James' Hospital, Dublin

TBC

St Vincents University Hospital, Dublin

H91YR71

University College Hospital Galway, Galway

X91 ER8E

University Hospital Waterford, Waterford

00168

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Ginecologia Oncologica, Rome

010000

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

15-224

Gabinet Ginekologiczny Janusz Tomaszewski, Bialystok

40-156

CLINICAL MEDICAL RESEARCH Sp. z o. o., Katowice

40-301

NZOZ MEDEM Wilk Sp. j., Katowice

30-727

Pratia McM Kraków, Krakow

90-602

Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr., Lodz

91-211

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

60-185

Centrum Medyczne Pratia Poznan, Skorzewo

02-679

Centrum Badawcze Wspolczesnej Terapii, Warsaw

Lisbon District

"Luz Saude , Hospital Beatriz Angelo - Centro de Investigacao Clinica"

1649-035

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

4050-651

Centro Hospitalar Universitario do Porto, Porto

4200-319

CHUSJ - Hospital Sao Joao, Porto

012071

S.C. Quantum Medical Center SRL, Bucharest

08003

Hospital del Mar, Barcelona

RH1 5RH

Surrey and Sussex Healthcare NHS Trust - East Surrey Hospital - Gynaecology, Redhill

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT05587296 - 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 | Biotech Hunter | Biotech Hunter