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

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Trial Identification

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

Official Title: EMBER-3: A Phase 3, Randomized, Open-Label Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With Endocrine Therapy

Study ID: NCT04975308

Study Description

Brief Summary: The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have breast cancer that is advanced or has spread to another part of the body. Study participation could last up to 5 years.

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Ironwood Cancer & Research Centers, Chandler, Arizona, United States

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States

Marin Cancer Care, Greenbrae, California, United States

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

Banner MD Anderson Cancer Center at McKee Medical Center, Loveland, Colorado, United States

Clermont Oncology Center, Clermont, Florida, United States

University of Florida College of Medicine, Gainesville, Florida, United States

Mid Florida Hematology and Oncology Center, Orange City, Florida, United States

Florida Cancer Specialists, Saint Petersburg, Florida, United States

Florida Cancer Specialists, Sarasota, Florida, United States

Kaiser Permanente Moanalua Medical Center, Honolulu, Hawaii, United States

University of Chicago Medical Center, Chicago, Illinois, United States

NorthShore University HealthSystem - Evanston Hospital, Evanston, Illinois, United States

IU Health Ball Memorial Hospital, Inc., Muncie, Indiana, United States

The University of Louisville, James Graham Brown Cancer Center, Louisville, Kentucky, United States

Minnesota Oncology/Hematology PA, Coon Rapids, Minnesota, United States

Jackson Oncology Associates, PLLC, Jackson, Mississippi, United States

Care Access - Clifton, Clifton, New Jersey, United States

Memorial Sloan Kettering - Bergen, Montvale, New Jersey, United States

Columbia University Medical Center, New York, New York, United States

University of North Carolina Medical Center, Chapel Hill, North Carolina, United States

Aultman Hospital, Canton, Ohio, United States

Mercy Health - St. Vincent Medical Center, Toledo, Ohio, United States

Avera Cancer Institute Sioux Falls, Sioux Falls, South Dakota, United States

Sarah Cannon Research Institute SCRI, Nashville, Tennessee, United States

Texas Oncology - Dallas Presbyterian Hospital, Dallas, Texas, United States

Texas Oncology Denton, Denton, Texas, United States

Willamette Valley Cancer Institute & Research Ctr., Houston, Texas, United States

Texas Oncology - Willowbrook, Houston, Texas, United States

Broome Oncology, The Woodlands, Texas, United States

Texas Oncology - Denison, The Woodlands, Texas, United States

Texas Oncology - McKinney, The Woodlands, Texas, United States

Texas Oncology - San Antonio Medical Center, The Woodlands, Texas, United States

Texas Oncology - The Woodlands, The Woodlands, Texas, United States

Texas Oncology Denton, The Woodlands, Texas, United States

Texas Oncology Fort Worth, The Woodlands, Texas, United States

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

US Oncology, The Woodlands, Texas, United States

Utah Cancer Specialists, Salt Lake City, Utah, United States

The University of Vermont Medical Center Inc., Burlington, Vermont, United States

Instituto de Investigaciones Clínicas Mar del Plata, Mar del Plata, Buenos Aires, Argentina

CIPREC, Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina

Fundación Cenit Para La Investigación En Neurociencias, Caba, Ciudad Autónoma De Buenos Aires, Argentina

Centro Medico Privado CEMAIC, Capital, Córdoba, Argentina

Clinica Viedma, Viedma, Río Negro, Argentina

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

Instituto San Marcos, San Juan, , Argentina

Sanatorio Norte, Santiago del Estero, , Argentina

St Vincent's Hospital, Darlinghurst, New South Wales, Australia

Princess Alexandra Hospital, Woolloongabba, Queensland, Australia

Cancer Research SA, Adelaide, South Australia, Australia

Box Hill Hospital, Box Hill, Victoria, Australia

Maroondah Hospital, Melbourne, Victoria, Australia

Medizinische Universität Graz, Graz, Steiermark, Austria

Medizinische Universität Wien, Vienna, Wien, Austria

Uniklinikum Salzburg, Salzburg, , Austria

Imelda General Hospital, Bonheiden, Antwerpen, Belgium

UZ Brussel, Brussels, Bruxelles-Capitale, Région De, Belgium

Institut Jules Bordet, Bruxelles, Bruxelles-Capitale, Région De, Belgium

UZ Gent, Gent, Oost-Vlaanderen, Belgium

AZ Nikolaas, Sint-Niklaas, Oost-Vlaanderen, Belgium

UZ Leuven, Leuven, Vlaams-Brabant, Belgium

AZ Groeninge Campus Kennedylaan, Kortrijk, West-Vlaanderen, Belgium

CHU UCL Namur/Site Sainte Elisabeth, Namur, , Belgium

Hospital de Cancer de Londrina, Londrina, Paraná, Brazil

Faculdade de Medicina do ABC, Santo André, São Paulo, Brazil

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

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

Núcleo de Pesquisa Clínica da Rede São Camilo, São Paulo, , Brazil

Afflilated Hospital of Bengbu Medical College, Bengbu, Anhui, China

Beijing Hospital, Beijing, Beijing, China

Fifth Medical Center of PLA General Hospital, Beijing, Beijing, China

Fujian Provincial Cancer Hospital, Fuzhou, Fujian, China

Sun Yat-Sen University Cancer Centre, Guangzhou, Guangdong, China

Jiangmen Center Hospital, Jiangmen, Guangdong, China

Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China

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

Nanyang Second General Hospital, Nanyang, Henan, China

Tongji Hospital Tongji Medical,Science & Technology, Wuhan, Hubei, China

Renmin Hospital of Wuhan University, Wuhan, Hubei, China

Hubei Cancer Hospital, Wuhan, Hubei, China

The First People's Hospital of Changde City, Changde, Hunan, China

Hunan Provincial People's Hospital, ChangSha, Hunan, China

Xiangya Hospital Central South University, Changsha, Hunan, China

Hunan Cancer Hospital, Changsha, Hunan, China

Jiangsu Province Hospital, Nanjing, Jiangsu, China

The Third Hospital of Nanchang, Nanchang, Jiangxi, China

The First Hospital of Jilin University, Changchun, Jilin, China

The Second Hospital of Jilin University, Changchun, Jilin, China

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

Jinan Central Hospital, Jinan, Shandong, China

Jining Medical University - Affiliated Hospital, Jining, Shandong, China

Yantai Yuhuangding Hospital, Yantai, Shandong, China

Sichuan Cancer hospital, Chengdu, Sichuan, China

The Second People's Hospital of Neijiang, Neijiang, Sichuan, China

Tianjin Medical University Cancer Institute and Hospital, Tianjing, Tianjin, China

The First Affiliated Hospital, Zhejiang University, Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital, Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China

Hwa Mei Hospital University of Chinese Academy of Sciences, Ningbo, Zhejiang, China

Ningbo Medical Center, Ningbo, Zhejiang, China

Nemocnice Horovice, Horovice, Beroun, Czechia

Fakultni nemocnice Kralovske Vinohrady, PRague, Praha 10, Czechia

Fakultni Thomayerova nemocnice, Prague, Praha 4, Czechia

Fakultni nemocnice Bulovka, Prague, Praha 8, Czechia

Oblastni nemocnice Pribram, Pribram, Příbram, Czechia

Institut de cancérologie Strasbourg Europe (ICANS), Strasbourg, Alsace, France

Polyclinique De Blois, La Chaussée-Saint-Victor, Centre, France

CHU Besançon, Besançon, Doubs, France

Institut Curie - site Saint-Cloud, Saint-Cloud, Hauts-de-Seine, France

Centre de Cancérologie du Grand Montpellier, Montpellier, Languedoc-Roussillon, France

Clinique Victor Hugo Le Mans, Le Mans, Pays-de-la-Loire, France

Centre Hospitalier de la Côte Basque, Bayonne, Pyrénées-Atlantiques, France

Institut Curie, Paris, , France

Institut de Cancérologie de Lorraine Alexis Vautrin, Vandoeuvre-lès-Nancy, , France

Klinikum Ludwigsburg, Ludwigsburg, Baden-Württemberg, Germany

Onkologiezentrum Donauwörth, Donauwörth, Bayern, Germany

Universitaetsklinikum Erlangen, Erlangen, Bayern, Germany

Klinikum der Ludwig-Maximilians-Universitaet Muenchen, München, Bayern, Germany

Agaplesion Markus Krankenhaus, Frankfurt, Hessen, Germany

Gynäkologisch-Onkologische Praxis am Pelikanplatz, Hannover, Niedersachsen, Germany

Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung, Essen, Nordrhein-Westfalen, Germany

Evangelisches Krankenhaus Bethesda Mönchengladbach, Mönchengladbach, Nordrhein-Westfalen, Germany

Universitaetsklinikum Schleswig-Holstein Campus Kiel, Kiel, Schleswig-Holstein, Germany

Agios Savvas Regional Cancer Hospital, Athens, Attikí, Greece

Alexandra Hospital, Athens, Attikí, Greece

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

University General Hospital of Heraklion, Heraklion, Irakleío, Greece

Euromedica General Clinic of Thessaloniki, Thessaloniki, Thessaloníki, Greece

Papageorgiou General Hospital of Thessaloniki, Thessaloniki, Thessaloníki, Greece

European Interbalkan Medical Center, Thessaloniki, Thessaloníki, Greece

University General Hospital of Larissa, Larissa, Thessalía, Greece

Medstar Speciality Hospital, Bangalore, Karnataka, India

Regional Cancer Centre - Thiruvananthapuram, Thiruvananthapuram, Kerala, India

HCG Cancer Centre, Mumbai, Maharashtra, India

Government Medical College And Hospital - Nagpur, Nagpur, Maharashtra, India

Rashtrasant Tukdoji Regional Cancer Hospital, Nagpur, Maharashtra, India

HCG Manavata Cancer Centre, Nashik, Maharashtra, India

Deenanath Mangeshkar Hospital & Research Centre, Pune, Maharashtra, India

Lifepoint Multispeciality Hospital, Pune, Maharashtra, India

Yashoda Hospitals, Hyderabad, Telangana, India

University of Naples Federico II, Naples, Campania, Italy

Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Campania, Italy

Cro-Irccs, Aviano, Friuli-Venezia Giulia, Italy

Fondazione Policlinico Universitario Agostino Gemelli, Roma, Lazio, Italy

Ospedale San Martino, Genova, Liguria, Italy

Azienda Ospedaliera Universitaria Careggi, Firenze, Toscana, Italy

Istituto Oncologico Veneto IRCCS, Padova, , Italy

Nagoya University Hospital, Nagoya, Aichi, Japan

Chiba cancer center, Chiba-shi, Chiba, Japan

National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, Japan

Kurume General Hospital, Kurume, Fukuoka, Japan

Gunma Prefectural Cancer Center, Otashi, Gunma, Japan

National Hospital Organization Hokkaido Cancer Center, Sapporo, Hokkaido, Japan

Hyogo Cancer Center, Akashi, Hyogo, Japan

Shinko Hospital, Kobe, Hyogo, Japan

Tsuchiura Kyodo General Hospital, Tsuchiura, Ibaraki, Japan

Tsukuba University Hospital, Tsukuba, Ibaraki, Japan

St. Marianna University School of Medicine Hospital, Kawasaki, Kanagawa, Japan

Kanagawa cancer center, Yokohama, Kanagawa, Japan

Nagano Municipal Hospital, Tomitake, Nagano, Japan

Niigata Cancer Center Hospital, Niigata-shi, Niigata, Japan

Showa University Hospital, Shinagawa, Tokyo, Japan

National Hospital Organization Kyushu Cancer Center, Fukuoka, , Japan

Hiroshima City Hospital, Hiroshima, , Japan

Sagara Hospital, Kagoshima, , Japan

Kumamoto Shinto General Hospital, Kumamoto, , Japan

Osaka International Cancer Institute, Osaka, , Japan

Shizuoka General Hospital, Shizuoka, , Japan

Juntendo University Hospital, Tokyo, , Japan

Soon Chun Hyang University Cheonan Hospital, Cheonan-si, Chungcheongnam-do [Chungnam], Korea, Republic of

Gachon University Gil Medical Center, Namdong-gu, Incheon-gwangyeoksi [Incheon], Korea, Republic of

Ajou University Hospital, Suwon-si, Kyǒnggi-do, Korea, Republic of

Yeungnam Univeristy Medical Center, Daegu, Kyǒngsangbuk-do, Korea, Republic of

Dong-A University Hospital, Busan, Pusan-Kwangyǒkshi, Korea, Republic of

Seoul National University Hospital, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of

Kangbuk Samsung Hospital, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of

Severance Hospital, Yonsei University Health System, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of

Asan Medical Center, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of

Gangnam Severance Hospital, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of

Samsung Medical Center, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of

Kyungpook National University Chilgok Hospital, Daegu, Taegu-Kwangyǒkshi, Korea, Republic of

Centro de Investigación Clínica de Alta Especialidad, Torreón, Coahuila, Mexico

Grupo Medico Camino Sc, Mexico City, Distrito Federal, Mexico

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

Private Practice - Dr. Joaquin Reinoso, Monterrey, Nuevo León, Mexico

Filios Alta Medicina, Monterrey, Nuevo León, Mexico

Centro Medico Zambrano Hellion, San Pedro Garza Garcia, Nuevo León, Mexico

Unidad de Investigación en Salud, Chihuahua, , Mexico

Oaxaca Site Management Organization, Oaxaca, , Mexico

Unidad Médica Onco-hematológica, Puebla, , Mexico

Medische Centrum Leeuwarden, Leeuwarden, Fryslân, Netherlands

Maastricht UMC+, Maastricht, Limburg, Netherlands

Haga Ziekenhuis locatie Leyweg, Den Haag, Zuid-Holland, Netherlands

Kaluga Regional Clinical Oncology Center, Kaluga, Kalužskaja Oblast', Russian Federation

Volgograd Regional Clinical Cancer Clinic No.1, Volgograd, Volgogradskaya Oblast', Russian Federation

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

Hospital Universitari Vall d'Hebron, Barcelona, Barcelona [Barcelona], Spain

Hospital Universitari Dexeusa, Barcelona, Catalunya [Cataluña], Spain

Hospital de la Santa Creu i Sant Pau, Barcelona, Catalunya [Cataluña], Spain

Hospital San Pedro de Alcántara, Cáceres, Extremadura, Spain

Hospital Universitario Arnau de Vilanova de Lleida, Lleida, Lleida [Lérida], Spain

Hospital Universitario Ramón y Cajal, Madrid, Madrid, Comunidad De, Spain

Hospital Universitario de Canarias, La Laguna, Santa Cruz De Tenerife, Spain

Hospital Clinico de Valencia, Valencia, Valenciana, Comunitat, Spain

Hospital Quirónsalud Valencia, Valencia, València, Spain

Hospital Universitario San Cecilio, Granada, , Spain

Hospital Clinico San Carlos, Madrid, , Spain

Hospital Universitario Virgen Macarena, Sevilla, , Spain

Hospital Universitario Virgen Del Rocio, Sevilla, , Spain

Chi Mei Hospital - Liouying Branch, Tainan City, Tainan, Taiwan

Taichung Veterans General Hospital, Taichung, , Taiwan

National Cheng Kung University Hospital, Tainan, , Taiwan

National Taiwan University Hospital, Taipei, , Taiwan

Koo Foundation Sun Yat-Sen Cancer Center, Taipei, , Taiwan

Medipol Mega Universite Hastanesi, Stanbul, İstanbul, Turkey

Acibadem Altunizade Hospital, Üsküdar / Stanbul, İstanbul, Turkey

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

Sbü Gülhane Eğitim Ve Araştirma Hastanesi, Ankara, , Turkey

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi, Ankara, , Turkey

Hacettepe Universitesi, Ankara, , Turkey

Memorial Ankara Hastanesi, Ankara, , Turkey

Ankara City Hospital, Ankara, , Turkey

Akdeniz Universitesi Hastanesi, Antalya, , Turkey

Dicle Üniversitesi, Diyarbakir, , Turkey

Trakya University, Edirne, , Turkey

Acıbadem Maslak Hastanesi, İstanbul, , Turkey

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

Ege Universitesi Hastanesi, Izmir, , Turkey

İnönü Üniversitesi Turgut Özal Tıp Merkezi, Malatya, , Turkey

Mersin University, Mersin, , Turkey

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

CNPE "Regional Center of Oncology", Kharkiv, Kharkivska Oblast, Ukraine

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

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

Uzhgorod Central City Clinical Hospital, Uzhhorod, Zakarpatska Oblast, Ukraine

Contact Details

Name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Affiliation: Eli Lilly and Company

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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