Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

435

Participants

Timeline

Start Date

January 24, 2023

Primary Completion Date

December 27, 2026

Study Completion Date

December 28, 2028

Conditions
Breast CancerMetastatic Breast Cancer
Interventions
DRUG

Elacestrant

Elacestrant 86 mg, 172 mg, 258 mg or 345 mg once daily in cycles of 28 days

DRUG

Alpelisib

Alpelisib 150 mg or 250 mg once daily in cycles of 28 days

DRUG

Everolimus

Everolimus 5 mg, 7.5 mg, or 10 mg once daily in cycles of 28 days

DRUG

Ribociclib

Ribociclib 400 mg or 600 mg once daily for 21 days followed by 7 days off in cycles of 28 days

DRUG

Palbociclib

Palbociclib 100 mg or 125 mg once daily for 21 days followed by 7 days off in cycles of 28 days

DRUG

Capivasertib

Capivasertib 200 mg or 320 mg or 400 mg twice daily for 4 days on, 3 days off in cycles of 28 days

DRUG

Abemaciclib

Abemaciclib 100 mg or 150 mg twice daily in cycles of 28 consecutive days

Trial Locations (118)

2113

RECRUITING

Macquarie University, Sydney

10016

RECRUITING

NYU Langone Health, New York

11776

RECRUITING

New York Cancer and Blood Specialists, Port Jefferson Station

13620

RECRUITING

Seoul National University Bundang Hospital, Seongnam-si

15006

RECRUITING

Complejo Hospitalario Universitario A Coruna, A Coruña

20037

RECRUITING

George Washington Cancer Center, Washington D.C.

20141

RECRUITING

Istituto Europeo di Oncologia (IEO), Milan

21287

RECRUITING

Johns Hopkins School of Medicine, Baltimore

22031

RECRUITING

Inova Schar Cancer Institute, Fairfax

RECRUITING

Virginia Cancer Specialists, Fairfax

23502

RECRUITING

Virginia Oncology Associates, Norfolk

25123

RECRUITING

ASST degli Spedali Civili di Brescia, Brescia

26100

WITHDRAWN

"Azienda Ospedaliera Istituti Ospitalieri Di Cremona", Cremona

26831

WITHDRAWN

Nemocnice Horovice Hospital, Hořovice

28007

RECRUITING

Hospital General Universitario Gregorio Maranon, Madrid

RECRUITING

IOB Madrd Institute of Oncology Hospital Beata Maria Ana de Jesus, Madrid

28040

RECRUITING

Hospital Clinico San Carlos, Madrid

28041

RECRUITING

Hospital Universitario 12 de Octubre, Madrid

28046

RECRUITING

Hospital Universitario La Paz, Madrid

28223

RECRUITING

NEXT Madrid, Pozuelo de Alarcón

29010

RECRUITING

Hospital Universitario Virgen de la Victoria, Málaga

30041

WITHDRAWN

Northside Hospital Atlanta Cancer Care, Cumming

32224

RECRUITING

Mayo Clinic - Jacksonville, Jacksonville

32701

RECRUITING

Advent Health (Florida Hospital) - Altamonte Springs, Altamonte Springs

34070

RECRUITING

Centre de Cancérologie du Grand Montpellier, Montpellier

34125

WITHDRAWN

Gesundheit Nordhessen Klinikum Kassel, Kassel

34474

RECRUITING

Ocala Oncology, Ocala

36303

RECRUITING

Dothan Hematology and Oncology, Dothan

37203

RECRUITING

Sarah Cannon Research Institute / Tennessee Oncology, Nashville

44033

WITHDRAWN

Ulsan University Hospital, Ulsan

45136

WITHDRAWN

Kliniken Essen-Mitte (KEM), Essen

46009

RECRUITING

Fundacion Instituto Valeciano De Oncologia, Valencia

46010

RECRUITING

Hospital Clinico Universitario de Valencia, Valencia

46015

RECRUITING

Hospital Arnau De Vilanova, Valencia

46236

WITHDRAWN

Marienhospital Bottrop, Bottrop

46804

WITHDRAWN

Fort Wayne Medical Oncology and Hematology, Fort Wayne

47923

RECRUITING

Ospedale Infermi di Rimini - Azienda Unita Sanitaria Locale Della Romagna, Rimini

48201

RECRUITING

Barbara Ann Karmanos Cancer Institute, Detroit

49100

RECRUITING

Davidoff Rabin Medical Center, Petah Tikva

53792

RECRUITING

University of WI - Carbone Cancer Center (Phase II only), Madison

55404

WITHDRAWN

Minnesota Oncology Hematology, Minneapolis

55905

RECRUITING

Mayo Clinic - Rochester, Rochester

56124

WITHDRAWN

Azienda Ospedaliero-Universitaria Pisana, Pisa

60611

RECRUITING

Northwestern Feinberg Scholl of Medicine Prentice Women's Hospital, Chicago

63110

RECRUITING

Washington University School of Medicine in St. Louis, St Louis

66204

RECRUITING

MD Alliance for Multispecialty Research, LLC, Merriam

68167

RECRUITING

Universitaetsklinikum Mannheim, Mannheim

69495

RECRUITING

Centre Hospitalier Lyon SUD- HCL, Lyon

72076

WITHDRAWN

Universitaetsklinikum Tuebingen, Tübingen

72762

RECRUITING

Highlands Oncology Group, Springdale

75246

RECRUITING

Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas

77030

RECRUITING

MD Anderson Cancer Center Texas, Houston

77900

WITHDRAWN

Fakultni Nemocnice Olomouc, Olomouc

78229

RECRUITING

UT Health San Antonio, San Antonio

80124

RECRUITING

Rocky Mountain Cancer Centers, Lone Tree

80131

RECRUITING

"Istituto Nazionale Tumori Fondazione PASCALE", Napoli

81675

WITHDRAWN

Technischen Universitaet Muenchen (TUM), Klinikum Rechts der Isar, Munich

85054

RECRUITING

Mayo Clinic - Arizona, Phoenix

90048

RECRUITING

Cedars Sinai, Los Angeles

90095

RECRUITING

UCLA UCLA Hem/Onc - Clinical Research Unit, Los Angeles

90603

COMPLETED

TOI Clinical Research, Whittier

90720

RECRUITING

OPN Healthcare (Los Alamitos Location), Los Alamitos

91007

RECRUITING

OPN Healthcare (Arcadia Location), Arcadia

91010

NOT_YET_RECRUITING

City of Hope National Medical Center, Duarte

91206

WITHDRAWN

Glendale Adventist, Glendale

94158

RECRUITING

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco

94805

RECRUITING

Institut Gustave-Roussy-Umr 981, Villejuif

98405

RECRUITING

Northwest Medical Specialties (Nwms) - Puyallup - Medical Oncology (Rainier Hematology-Oncology)/Exigent Research Network; LLC, Tacoma

99216

RECRUITING

Cancer Care Northwest, Spokane Valley

352408

RECRUITING

Rambam Heath, Haifa

5265601

RECRUITING

Sheba Medical Center; Center Israel, Ramat Gan

7747629

RECRUITING

Samson Assuta Ashdod University Hospital - The Institute of Oncology, Ashdod

9103102

RECRUITING

Shaare Zedek Medical Center, Jerusalem

06519

WITHDRAWN

Yale School Of Medicine - Smilow Cancer Hospital - Breast Center, New Haven

04074

WITHDRAWN

New England Cancer Specialists, Scarborough

02114

RECRUITING

Massachusetts General Hospital, Boston

02215

RECRUITING

Dana Farber Cancer Institute, Boston

08816

RECRUITING

Astera Cancer Care, East Brunswick

07932

RECRUITING

Summit Medical Group, Florham Park

08901

RECRUITING

Cooperman Barnabas Medical Center, New Brunswick

02905

RECRUITING

W&IH of RI Breast Health Center of Women and Infants Hospital of Rhode Island, Providence

C1017AAS

RECRUITING

Centro Medico Austral, Buenos Aires

C1280 AEB

WITHDRAWN

Hospital Britanico De Buenos Aires, Buenos Aires

X5008HHW

RECRUITING

Cemaic - Centro De Especialidades Medicas Ambulatorias E Investigacion Clinica, Córdoba

01122

RECRUITING

Centro Oncologico Riojano Integral (Cori), La Rioja

WITHDRAWN

Orszagos Onkologiai Intezet, Budapest

01070

RECRUITING

Institut Jules Bordet, Anderlecht

06000

RECRUITING

Grand Hôpital de Charleroi - Site Notre Dame, Charleroi

03000

RECRUITING

Universitaire Ziekenhuizen (Uz) Leuven - Campus Gasthuisberg - Multidisciplinair Borstcentrum (Multidisciplinary Breast Center) (Mbc), Leuven

09100

WITHDRAWN

Algemeen Ziekenhuis Nikolaas; VITAZ; Oncologie Klinisch Studiecentrum, Sint-Niklaas

74605-070

RECRUITING

ACCG - Hospital Araujo Jorge, Goiânia

88301-220

RECRUITING

Clinica Neoplasias Litoral, Itajaí

90610-000

RECRUITING

Hospital Sao Lucas da PUCRS, Porto Alegre

90850-170

RECRUITING

Centro Gaucho Integrado de Oncologia; Hematologia; Ensino e Pesquisa - Hospital Mae de Deus/AESC, Porto Alegre

01308-050

RECRUITING

Hospital Sirio-Libanes (HSL) - Centro De Oncologia - Sao Paulo, São Paulo

76038 Cedex 1

RECRUITING

Centre de Cancérologie du Grand Montpellier, Rouen

31059 Cedex 09

RECRUITING

Centre Hospitalier Universitaire (Chu) De Toulouse - Institut Universitaire Du Cancer De Toulouse-Oncopole (Iuct-Oncopole) (Institut Claudius Regaud), Toulouse

01307

WITHDRAWN

Universitatskinikum Carl Gustav Carus Dresden, Dresden

WITHDRAWN

Universitatskinikum Carl Gustav Carus Dresden, Dresden

01083

WITHDRAWN

Semmelweis Egyetem Klinikai Kozpont - Onkologiai Intezet, Budapest

06800

RECRUITING

Centre Hospitalier De L'Ardenne, Libramont

04-141

WITHDRAWN

Klinika Onkologii; Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy, Warsaw

62-500

WITHDRAWN

"Przychodnia Lekarska Komed Roman Karaszewski", Konin

93-338

WITHDRAWN

Instytut Centrum Zdrowia Matki Polki, Lodz

60-693

WITHDRAWN

Med-Polonia Sp. Z o.o., Poznan

05505

RECRUITING

Asan Medical Center, Seoul

06273

RECRUITING

Gangnam Severance Hospital, Seoul

06591

WITHDRAWN

The Catholic University of Korea - Seoul St. Mary's Hospital, Seoul

136-705

WITHDRAWN

Korea University Anam Hospital, Seoul

08035

RECRUITING

Hospital Universitari Vall d'Hebron, Barcelona

08036

RECRUITING

Hospital Clinic Barcelona, Barcelona

0*6200

RECRUITING

Abdurrahman Yurtaslan Oncology Hospital, Ankara

6001CD

WITHDRAWN

Ankara Bilkent City Hospital, Bilkent Campus, Universiteler Mh. (old: Ankara Yildirim Beyazit Universitesi), Ankara

L7 8YA

RECRUITING

The Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool

NSW 2170

WITHDRAWN

Liverpool Hospital, Liverpool

N18 1QX

RECRUITING

North Middlesex University Hospital, London

W1G 6AD

RECRUITING

Sarah Cannon Research Institute UK; Ltd, London

W1T 7HA

RECRUITING

University College London Hospitals NHS Foundation Trust; The London Clinic - Main Hospital, London

All Listed Sponsors
lead

Stemline Therapeutics, Inc.

INDUSTRY