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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
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
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
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