A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

874

Participants

Timeline

Start Date

October 4, 2021

Primary Completion Date

June 24, 2024

Study Completion Date

August 31, 2027

Conditions
Breast NeoplasmsNeoplasm Metastasis
Interventions
DRUG

Imlunestrant

Administered orally.

DRUG

Exemestane

Administered orally.

DRUG

Fulvestrant

Administered IM.

DRUG

Abemaciclib

Administered orally.

Trial Locations (243)

112

Koo Foundation Sun Yat-Sen Cancer Center, Taipei

407

Taichung Veterans General Hospital, Taichung

704

National Cheng Kung University Hospital, Tainan City

1000

Institut Jules Bordet, Brussels

1090

Universitaetsklinikum Allgemeines Krankenhaus Wien, Vienna

UZ Brussel, Brussels

1122

Instituto Argentino de Diagnóstico y Tratamiento (IADT), Buenos Aires

1125

Fundación Cenit Para La Investigación En Neurociencias, CABA

2010

St Vincent's Hospital, Darlinghurst

2820

Imelda General Hospital, Bonheiden

3000

UZ Leuven, Leuven

3128

Box Hill Hospital, Box Hill

3135

Maroondah Hospital, Melbourne

4102

Princess Alexandra Hospital, Woolloongabba

4200

Sanatorio Norte, Santiago del Estero

5000

CHU UCL Namur/Site Sainte Elisabeth, Namur

5020

Uniklinikum Salzburg, Salzburg

5037

Ashford Cancer Centre Research, Kurralta Park

5400

Instituto San Marcos, San Juan

8036

Medizinische Universität Graz, Graz

8500

Clinica Viedma, Viedma

AZ Groeninge Campus Kennedylaan, Kortrijk

9000

UZ Gent, Ghent

10002

National Taiwan University Hospital, Taipei

10003

Hospital San Pedro de Alcántara, Cáceres

10032

Columbia University Medical Center, New York

10034

Fakultni nemocnice Kralovske Vinohrady, Prague

14059

Fakultni Thomayerova nemocnice, Prague

14564

"General Oncology Hospital of Kifissia Agioi Anargiroi", Nea Kifissia

16132

Ospedale San Martino, Genoa

16499

Ajou University Hospital, Suwon

18016

Hospital Universitario San Cecilio, Granada

21200

Dicle Üniversitesi, Diyarbakır

21565

Gachon University Gil Medical Center, Namdong-gu

22030

Trakya University, Edirne

24105

Universitaetsklinikum Schleswig-Holstein Campus Kiel, Kiel

25000

CHU Besançon, Besançon

25198

Hospital Universitario Arnau de Vilanova de Lleida, Lleida

27010

Centro de Investigación Clínica de Alta Especialidad, Torreón

27599

University of North Carolina Medical Center, Chapel Hill

28034

Hospital Universitario Ramón y Cajal, Madrid

28040

Hospital Clinico San Carlos, Madrid

30177

Gynäkologisch-Onkologische Praxis am Pelikanplatz, Hanover

31151

Soon Chun Hyang University Cheonan Hospital, Cheonan-si

31203

Unidad de Investigación en Salud, Chihuahua City

32610

University of Florida College of Medicine, Gainesville

32763

Mid Florida Hematology and Oncology Center, Orange City

33081

Cro-Irccs, Aviano

33343

Mersin University, Mersin

33705

Florida Cancer Specialists, St. Petersburg

34070

Centre de Cancérologie du Grand Montpellier, Montpellier

34214

Medipol University Medical Faculty, Stanbul

34232

Florida Cancer Specialists, Sarasota

34457

Acıbadem Maslak Hastanesi, Istanbul

34711

Clermont Oncology Center, Clermont

34722

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi, Istanbul

35100

Ege Universitesi Hastanesi, Izmir

35128

Istituto Oncologico Veneto IRCCS, Padua

37203

Florida Cancer Specialists, Nashville

The Mark H Zangmeister Cancer Center, Nashville

38320

Hospital Universitario de Canarias, San Cristóbal de La Laguna

39202

Jackson Oncology Associates, PLLC, Jackson

40202

The University of Louisville, James Graham Brown Cancer Center, Louisville

41009

Hospital Universitario Virgen Macarena, Seville

41013

Hospital Universitario Virgen Del Rocio, Seville

41061

Evangelisches Krankenhaus Bethesda Mönchengladbach, Mönchengladbach

41110

University General Hospital of Larissa, Larissa

41260

Polyclinique De Blois, La Chaussée-Saint-Victor

41404

Kyungpook National University Chilgok Hospital, Daegu

42415

Yeungnam Univeristy Medical Center, Daegu

43018

"Municipal Enterprise Volyn Regional Medical Oncology Centre of the Volyn Regional Council", Lutsk

43608

Mercy Health - St. Vincent Medical Center, Toledo

44280

İnönü Üniversitesi Turgut Özal Tıp Merkezi, Malatya

44710

Aultman Hospital, Canton

45136

Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung, Essen

46010

Hospital Clinico de Valencia, Valencia

Hospital Quirónsalud Valencia, Valencia

47303

IU Health Ball Memorial Hospital, Inc., Muncie

49201

Dong-A University Hospital, Busan

50048

Communal Enterprise 'Kryvyi Rih Oncology Dispensary' of the Dnipropetrovsk Regional Council, Kryvyi Rih

50134

Azienda Ospedaliera Universitaria Careggi, Florence

54519

Institut de Cancérologie de Lorraine Alexis Vautrin, Vandœuvre-lès-Nancy

57105

Avera Cancer Institute Sioux Falls, Sioux Falls

60201

NorthShore University HealthSystem - Evanston Hospital, Evanston

60431

Agaplesion Markus Krankenhaus, Frankfurt am Main

60637

University of Chicago Medical Center, Chicago

61070

"CNPE Regional Center of Oncology", Kharkiv

64109

Centre Hospitalier de la Côte Basque, Bayonne

64320

Private Practice - Dr. Joaquin Reinoso, Monterrey

64460

Filios Alta Medicina, Monterrey

65025

Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council, Odesa

66278

Centro Medico Zambrano Hellion, San Pedro Garza García

67033

Institut de cancérologie Strasbourg Europe (ICANS), Strasbourg

68000

Oaxaca Site Management Organization, Oaxaca City

71640

Klinikum Ludwigsburg, Ludwigsburg

72000

Clinique Victor Hugo Le Mans, Le Mans

72424

Unidad Médica Onco-hematológica, Puebla City

73657

Chi Mei Hospital - Liouying Branch, Tainan City

75013

USO - Texas Oncology - Allen, Allen

75020

Texas Oncology - Denison, The Woodlands

75056

Texas Oncology - Carrollton, Lewisville

75231

Texas Oncology - Dallas Presbyterian Hospital, Dallas

75248

Institut Curie, Paris

75460

Texas Oncology - Paris, The Woodlands

77070

Willamette Valley Cancer Institute & Research Ctr., Houston

77380

Blue Ridge Cancer Care, The Woodlands

Broome Oncology, The Woodlands

Minnesota Oncology/Hematology PA, The Woodlands

Texas Oncology - Carrollton, The Woodlands

Texas Oncology - McKinney, The Woodlands

Texas Oncology - Medical City Dallas, The Woodlands

Texas Oncology - Methodist Charlton Cancer Center, The Woodlands

Texas Oncology - San Antonio Medical Center, The Woodlands

Texas Oncology - The Woodlands, The Woodlands

Texas Oncology - Willowbrook, The Woodlands

Texas Oncology Fort Worth, The Woodlands

Texas Oncology-Baylor Charles A. Sammons Cancer Center, The Woodlands

USO-Rocky Mountain Cancer Center, The Woodlands

78731

Texas Oncology - Austin Central, The Woodlands

80100

University of Naples Federico II, Naples

80131

Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli

80336

Klinikum der Ludwig-Maximilians-Universitaet Muenchen, München

80538

Banner MD Anderson Cancer Center at McKee Medical Center, Loveland

84106

Utah Cancer Specialists, Salt Lake City

85224

Ironwood Cancer & Research Centers, Chandler

85234

Banner MD Anderson Cancer Center, Gilbert

86609

Onkologiezentrum Donauwörth, Donauwörth

88000

Uzhgorod Central City Clinical Hospital, Uzhhorod

91054

Universitaetsklinikum Erlangen, Erlangen

92123

Sharp Memorial Hospital, San Diego

92210

Hôpital René Huguenin, Saint-Cloud

94904

Marin Cancer Care, Greenbrae

95817

University of California Davis (UC Davis) Comprehensive Cancer Center, Sacramento

96819

Kaiser Permanente Moanalua Medical Center, Honolulu

100005

Beijing Hospital, Beijing

100039

Fifth Medical Center of PLA General Hospital, Beijing

150081

Harbin Medical University Cancer Hospital, Harbin

197758

N.N.Petrov Research Institute of Oncology, Saint Petersburg

210029

Jiangsu Province Hospital, Nanjing

233004

Afflilated Hospital of Bengbu Medical College, Bengbu

248007

Kaluga Regional Clinical Oncology Center, Kaluga

250013

Jinan Central Hospital, Jinan

300060

Tianjin Medical University Cancer Institute and Hospital, Tianjin

310016

Sir Run Run Shaw Hospital, Hangzhou

310022

Zhejiang Cancer Hospital, Hangzhou

315010

Hwa Mei Hospital University of Chinese Academy of Sciences, Ningbo

315048

Ningbo Medical Center, Ningbo

330009

The Third Hospital of Nanchang, Nanchang

350014

Fujian Provincial Cancer Hospital, Fuzhou

400092

HCG Cancer Centre, Mumbai

400138

Volgograd Regional Clinical Cancer Clinic No.1, Volgograd

410008

Xiangya Hospital Central South University, Changsha

411004

Deenanath Mangeshkar Hospital & Research Centre, Pune

411057

Lifepoint Multispeciality Hospital, Pune

415003

The First People's Hospital of Changde City, Changde

421000

Hunan Cancer Hospital, Changsha

422002

HCG Manavata Cancer Centre, Nashik

430030

Tongji Hospital Tongji Medical,Science & Technology, Wuhan

430060

Renmin Hospital of Wuhan University, Wuhan

430079

Hubei Cancer Hospital, Wuhan

440003

Government Medical College And Hospital - Nagpur, Nagpur

440027

Rashtrasant Tukdoji Regional Cancer Hospital, Nagpur

471003

The First Affiliated Hospital of Henan University of Science &Technology, Luoyang

473000

Nanyang Second General Hospital, Nanyang

500082

Yashoda Hospitals, Hyderabad

511400

Sun Yat-Sen University Cancer Centre, Guangzhou

518035

Shenzhen Second People's Hospital, Shenzhen

519000

The Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai

524001

Affiliated Hospital of Guangdong Medical University, Zhanjiang

528403

Zhongshan Peoples Hospital, Zhongshan

560092

Medstar Speciality Hospital, Bangalore

610042

Sichuan Cancer hospital, Chengdu

641000

The Second People's Hospital of Neijiang, Neijiang

695011

Regional Cancer Centre - Thiruvananthapuram, Thiruvananthapuram

710061

The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an

2418515

Kanagawa cancer center, Yokohama

07013

Care Access - Clifton, Clifton

07645

Memorial Sloan Kettering - Bergen, Montvale

05401

The University of Vermont Medical Center Inc., Burlington

B7600FZO

Instituto de Investigaciones Clínicas Mar del Plata, Mar del Plata

C1061AAS

CIPREC, Buenos Aires

X5008HHW

Centro Medico Privado CEMAIC, Capital

B-9100

AZ Nikolaas, Sint-Niklaas

86015-520

Hospital de Cancer de Londrina, Londrina

09060-650

Faculdade de Medicina do ABC, Santo André

01246-000

Icesp - Instituto Do Câncer Do Estado de São Paulo, São Paulo

01317-001

Clínica de Pesquisa e Centro de Estudos em Ginecologia Oncológica e Mamária LTDA, São Paulo

04014-002

Núcleo de Pesquisa Clínica da Rede São Camilo, São Paulo

Unknown

Jiangmen Center Hospital, Jiangmen

The Second Hospital of Jilin University, Changchun

Acibadem Altunizade Hospital, Üsküdar / Stanbul

268 31

Nemocnice Horovice, Hořovice

180 81

Nemocnice Na Bulovce, Prague

261 01

Oblastni nemocnice Pribram, Příbram

115 22

Agios Savvas Regional Cancer Hospital, Athens

115 28

Alexandra Hospital, Athens

711 10

University General Hospital of Heraklion, Heraklion

546 45

Euromedica General Clinic of Thessaloniki, Thessaloniki

564 29

Papageorgiou General Hospital of Thessaloniki, Thessaloniki

570 01

European Interbalkan Medical Center, Thessaloniki

00168

Fondazione Policlinico Universitario Agostino Gemelli, Rome

466-8560

Nagoya University Hospital, Nagoya

260-8717

Chiba cancer center, Chiba

791-0280

National Hospital Organization Shikoku Cancer Center, Matsuyama

830-0013

Kurume General Hospital, Kurume

373-8550

Gunma Prefectural Cancer Center, Otashi

003-0804

National Hospital Organization Hokkaido Cancer Center, Sapporo

673-8558

Hyogo Cancer Center, Akashi

651-0072

Shinko Hospital, Kobe

300-0028

Tsuchiura Kyodo General Hospital, Tsuchiura

305-8576

Tsukuba University Hospital, Tsukuba

216-8511

St. Marianna University School of Medicine Hospital, Kawasaki

381-8551

Nagano Municipal Hospital, Tomitake

951-8566

Niigata Cancer Center Hospital, Niigata

142-8555

Showa University Hospital, Shinagawa

811-1395

National Hospital Organization Kyushu Cancer Center, Fukuoka

730-8518

Hiroshima City Hospital, Hiroshima

892-0833

Sagara Hospital, Kagoshima

862-8655

Kumamoto Shinto General Hospital, Kumamoto

541-8567

Osaka International Cancer Institute, Osaka

420-8527

Shizuoka General Hospital, Shizuoka

113-8431

Juntendo University Hospital, Tokyo

01330

COI Centro Oncologico Internacional S.A.P.I. de C.V., Álvaro Obregón

03310

Grupo Medico Camino Sc, Mexico City

6229 HX

Maastricht UMC+, Maastricht

8934 AD

Medische Centrum Leeuwarden, Leeuwarden

2545 AA

Haga Ziekenhuis locatie Leyweg, The Hague

03080

Seoul National University Hospital, Seoul

03181

Kangbuk Samsung Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06273

Gangnam Severance Hospital, Seoul

06351

Samsung Medical Center, Seoul

08035

Hospital Universitari Vall d'Hebron, Barcelona

08028

Hospital Universitari Dexeusa, Barcelona

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

01250

Baskent University Dr. Turgut Noyan Research and Training Center, Adana

06010

University of Health Sciences,Gulhane School of Medicine, Ankara

06200

Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital, Ankara

06230

Hacettepe Universitesi, Ankara

06520

Memorial Ankara Hastanesi, Ankara

06800

Ankara Bilkent Şehir Hastanesi, Ankara

07059

Akdeniz Universitesi Hastanesi, Antalya

All Listed Sponsors
lead

Eli Lilly and Company

INDUSTRY