A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer (EMBER-3)

April 17, 2024 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

860

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: ClinicalTrials.gov@lilly.com

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1122
        • Completed
        • Instituto Argentino de Diagnóstico y Tratamiento (IADT)
      • San Juan, Argentina, 5400
        • Active, not recruiting
        • Instituto San Marcos
      • Santiago del Estero, Argentina, 4200
        • Active, not recruiting
        • Sanatorio Norte
    • Buenos Aires
      • Mar del Plata, Buenos Aires, Argentina, B7600FZO
        • Active, not recruiting
        • Instituto de Investigaciones Clínicas Mar del Plata
    • Ciudad Autónoma De Buenos Aires
      • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1061AAS
        • Active, not recruiting
        • CIPREC
      • Caba, Ciudad Autónoma De Buenos Aires, Argentina, 1125
        • Completed
        • Fundacion CENIT para la investigacion en Neurociencias
    • Córdoba
      • Capital, Córdoba, Argentina, X5008HHW
        • Active, not recruiting
        • Centro Medico Privado CEMAIC
    • Río Negro
      • Viedma, Río Negro, Argentina, 8500
        • Active, not recruiting
        • Clinica Viedma
  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Active, not recruiting
        • St Vincent's Hospital
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Completed
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Active, not recruiting
        • Cancer Research SA
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Completed
        • Box Hill Hospital
      • Melbourne, Victoria, Australia, 3135
        • Active, not recruiting
        • Maroondah Hospital
  • Austria
      • Salzburg, Austria, 5020
        • Completed
        • Uniklinikum Salzburg
    • Steiermark
      • Graz, Steiermark, Austria, 8036
        • Active, not recruiting
        • Medizinische Universität Graz
    • Wien
      • Vienna, Wien, Austria, 1090
        • Completed
        • Medizinische Universität Wien
  • Belgium
      • Namur, Belgium, 5000
        • Recruiting
        • CHU UCL Namur/Site Sainte Elisabeth
        • Contact:
          • Phone Number: 003281720531
        • Principal Investigator:
          • Stéphanie Henry
    • Antwerpen
      • Bonheiden, Antwerpen, Belgium, 2820
        • Recruiting
        • Imelda General Hospital
        • Principal Investigator:
          • Wim Wynendaele
    • Bruxelles-Capitale, Région De
      • Brussels, Bruxelles-Capitale, Région De, Belgium, 1090
        • Completed
        • UZ Brussel
      • Bruxelles, Bruxelles-Capitale, Région De, Belgium, 1000
        • Active, not recruiting
        • Institut Jules Bordet
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • Completed
        • UZ Gent
      • Sint-Niklaas, Oost-Vlaanderen, Belgium, B-9100
        • Active, not recruiting
        • AZ Nikolaas
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Active, not recruiting
        • UZ Leuven
    • West-Vlaanderen
      • Kortrijk, West-Vlaanderen, Belgium, 8500
        • Active, not recruiting
        • AZ Groeninge Campus Kennedylaan
  • Brazil
      • São Paulo, Brazil, 01246-000
        • Active, not recruiting
        • Icesp - Instituto Do Câncer Do Estado de São Paulo
      • São Paulo, Brazil, 04014-002
        • Active, not recruiting
        • Núcleo de Pesquisa Clínica da Rede São Camilo
      • São Paulo, Brazil, 01317-001
        • Active, not recruiting
        • Clínica de Pesquisa e Centro de Estudos em Ginecologia Oncológica e Mamária LTDA
    • Paraná
      • Londrina, Paraná, Brazil, 86015-520
        • Active, not recruiting
        • Hospital de Cancer de Londrina
    • São Paulo
      • Santo André, São Paulo, Brazil, 09060-650
        • Active, not recruiting
        • Faculdade de Medicina do ABC
  • China
    • Anhui
      • Bengbu, Anhui, China, 233004
        • Recruiting
        • Afflilated Hospital of Bengbu Medical College
        • Principal Investigator:
          • Ziyan Wang
    • Beijing
      • Beijing, Beijing, China, 100005
        • Recruiting
        • Beijing Hospital
        • Principal Investigator:
          • Yongqiang Zhang
      • Beijing, Beijing, China, 100039
        • Not yet recruiting
        • Fifth Medical Center of PLA General Hospital
        • Principal Investigator:
          • Zefei Jiang
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian Provincial Cancer Hospital
        • Principal Investigator:
          • Jian Liu
    • Guangdong
      • Guangzhou, Guangdong, China, 511400
        • Recruiting
        • Sun Yat-Sen University Cancer Centre
        • Principal Investigator:
          • Yanxia Shi
      • Jiangmen, Guangdong, China
        • Recruiting
        • Jiangmen Center Hospital
        • Principal Investigator:
          • XIAOPING LI
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Recruiting
        • Harbin Medical University Cancer Hospital
        • Principal Investigator:
          • Qingyuan Zhang
    • Henan
      • Luoyang, Henan, China, 471003
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science &Technology
        • Principal Investigator:
          • Xinshuai Wang
      • Nanyang, Henan, China, 473000
        • Not yet recruiting
        • Nanyang Second General Hospital
        • Principal Investigator:
          • Lina Liu
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Recruiting
        • Renmin Hospital of Wuhan University
        • Principal Investigator:
          • chuang chen
      • Wuhan, Hubei, China, 430079
        • Recruiting
        • Hubei Cancer Hospital
        • Principal Investigator:
          • Xinhong Wu
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital Tongji Medical,Science & Technology
        • Principal Investigator:
          • huihua xiong
    • Hunan
      • ChangSha, Hunan, China, 410005
        • Recruiting
        • Hunan Provincial People's Hospital
        • Principal Investigator:
          • Peizhi Fan
      • Changde, Hunan, China, 415003
        • Recruiting
        • The First People's Hospital of Changde City
        • Principal Investigator:
          • Tao Wu
      • Changsha, Hunan, China, 410008
        • Recruiting
        • Xiangya Hospital Central South University
        • Principal Investigator:
          • Juan Huang
      • Changsha, Hunan, China, 421000
        • Recruiting
        • Hunan Cancer Hospital
        • Principal Investigator:
          • Quchang Ouyang
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Jiangsu Province Hospital
        • Principal Investigator:
          • Yongmei Yin
    • Jiangxi
      • Nanchang, Jiangxi, China, 330009
        • Recruiting
        • The Third Hospital of Nanchang
        • Principal Investigator:
          • Hong Wang
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • The First Hospital of Jilin University
        • Principal Investigator:
          • Wei Li
      • Changchun, Jilin, China
        • Recruiting
        • The Second Hospital of Jilin University
        • Principal Investigator:
          • Jingwei Xu
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Principal Investigator:
          • Jin Yang
    • Shandong
      • Jinan, Shandong, China, 250013
        • Recruiting
        • Jinan Central Hospital
        • Principal Investigator:
          • Meili Sun
      • Jining, Shandong, China, 272100
        • Recruiting
        • Jining Medical University - Affiliated Hospital
        • Principal Investigator:
          • Changping Shan
      • Yantai, Shandong, China, 264000
        • Recruiting
        • Yantai Yuhuangding Hospital
        • Principal Investigator:
          • Ping Sun
    • Sichuan
      • Chengdu, Sichuan, China, 610042
        • Recruiting
        • Sichuan Cancer Hospital
        • Principal Investigator:
          • Hao Wang
      • Neijiang, Sichuan, China, 641000
        • Not yet recruiting
        • The Second People's Hospital of Neijiang
        • Principal Investigator:
          • Xujuan Wang
    • Tianjin
      • Tianjing, Tianjin, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute and Hospital
        • Principal Investigator:
          • Zhongsheng Tong
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Principal Investigator:
          • Xiaojia Wang
      • Hangzhou, Zhejiang, China, 310016
        • Recruiting
        • Sir Run Run Shaw Hospital
        • Contact:
          • Phone Number: 86 15857121122
        • Principal Investigator:
          • Xian Wang
      • Hangzhou, Zhejiang, China, 310003
        • Not yet recruiting
        • The First Affiliated Hospital, Zhejiang University
        • Principal Investigator:
          • Peifen Fu
      • Ningbo, Zhejiang, China, 315010
        • Recruiting
        • Hwa Mei Hospital University of Chinese Academy of Sciences
        • Principal Investigator:
          • Xujun Li
      • Ningbo, Zhejiang, China, 315048
        • Recruiting
        • Ningbo Medical Center
        • Contact:
          • Phone Number: 8605745583614
        • Principal Investigator:
          • Weizhu Wu
  • Czechia
    • Beroun
      • Horovice, Beroun, Czechia, 268 31
        • Recruiting
        • Nemocnice Horovice
        • Principal Investigator:
          • Martin Smakal
    • Praha 10
      • PRague, Praha 10, Czechia, 10034
        • Recruiting
        • Fakultní nemocnice Královské Vinohrady
        • Principal Investigator:
          • Milan Brychta
    • Praha 4
      • Prague, Praha 4, Czechia, 14059
        • Recruiting
        • Fakultni Thomayerova nemocnice
        • Principal Investigator:
          • Eugen Kubala
    • Praha 8
      • Prague, Praha 8, Czechia, 180 81
        • Recruiting
        • Fakultni nemocnice Bulovka
        • Principal Investigator:
          • Petra Beran Holeckova
    • Příbram
      • Pribram, Příbram, Czechia, 261 01
        • Completed
        • Oblastni nemocnice Pribram
  • France
      • Paris, France, 75248
        • Active, not recruiting
        • Institut Curie
      • Vandoeuvre-lès-Nancy, France, 54519
        • Completed
        • Institut de Cancérologie de Lorraine Alexis Vautrin
    • Alsace
      • Strasbourg, Alsace, France, 67033
        • Active, not recruiting
        • Institut de cancerologie Strasbourg Europe (ICANS)
    • Centre
      • La Chaussée-Saint-Victor, Centre, France, 41260
        • Completed
        • Polyclinique De Blois
    • Doubs
      • Besançon, Doubs, France, 25000
        • Active, not recruiting
        • CHU Besançon
    • Hauts-de-Seine
      • Saint-Cloud, Hauts-de-Seine, France, 92210
        • Active, not recruiting
        • Institut Curie - site Saint-Cloud
    • Languedoc-Roussillon
      • Montpellier, Languedoc-Roussillon, France, 34070
        • Active, not recruiting
        • Centre de Cancerologie du Grand Montpellier
    • Pays-de-la-Loire
      • Le Mans, Pays-de-la-Loire, France, 72000
        • Active, not recruiting
        • Clinique Victor Hugo Le Mans
    • Pyrénées-Atlantiques
      • Bayonne, Pyrénées-Atlantiques, France, 64109
        • Active, not recruiting
        • Centre Hospitalier de la Côte Basque
  • Germany
    • Baden-Württemberg
      • Ludwigsburg, Baden-Württemberg, Germany, 71640
        • Completed
        • Klinikum Ludwigsburg
    • Bayern
      • Donauwörth, Bayern, Germany, 86609
        • Completed
        • Onkologiezentrum Donauwörth
      • Erlangen, Bayern, Germany, 91054
        • Active, not recruiting
        • Universitaetsklinikum Erlangen
      • München, Bayern, Germany, 80336
        • Active, not recruiting
        • Klinikum der Ludwig-Maximilians-Universitaet Muenchen
    • Hessen
      • Frankfurt, Hessen, Germany, 60431
        • Recruiting
        • Agaplesion Markus Krankenhaus
        • Principal Investigator:
          • Marc Thill
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30177
        • Completed
        • Gynäkologisch-Onkologische Praxis am Pelikanplatz
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45136
        • Active, not recruiting
        • Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung
      • Mönchengladbach, Nordrhein-Westfalen, Germany, 41061
        • Recruiting
        • Evangelisches Krankenhaus Bethesda Mönchengladbach
        • Principal Investigator:
          • Oleg Gluz
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Completed
        • Universitaetsklinikum Schleswig-Holstein Campus Kiel
  • Greece
    • Attikí
      • Athens, Attikí, Greece, 115 22
        • Active, not recruiting
        • Agios Savvas Regional Cancer Hospital
      • Athens, Attikí, Greece, 115 28
        • Active, not recruiting
        • Alexandra Hospital
      • Nea Kifissia, Attikí, Greece, 14564
        • Recruiting
        • General Oncology Hospital of Kifissia "Agioi Anargiroi"
        • Principal Investigator:
          • Eleni Res
    • Irakleío
      • Heraklion, Irakleío, Greece, 711 10
        • Active, not recruiting
        • University General Hospital of Heraklion
    • Thessaloníki
      • Thessaloniki, Thessaloníki, Greece, 546 45
        • Active, not recruiting
        • EUROMEDICA General Clinic of Thessaloniki
      • Thessaloniki, Thessaloníki, Greece, 564 29
        • Completed
        • Papageorgiou General Hospital of Thessaloniki
      • Thessaloniki, Thessaloníki, Greece, 570 01
        • Active, not recruiting
        • European Interbalkan Medical Center
    • Thessalía
      • Larissa, Thessalía, Greece, 41110
        • Completed
        • University General Hospital of Larissa
  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560092
        • Active, not recruiting
        • Medstar Speciality Hospital
    • Kerala
      • Thiruvananthapuram, Kerala, India, 695011
        • Completed
        • Regional Cancer Centre - Thiruvananthapuram
    • Maharashtra
      • Mumbai, Maharashtra, India, 400092
        • Completed
        • HCG Cancer Centre
      • Nagpur, Maharashtra, India, 440003
        • Active, not recruiting
        • Government Medical College And Hospital - Nagpur
      • Nagpur, Maharashtra, India, 440027
        • Active, not recruiting
        • Rashtrasant Tukdoji Regional Cancer Hospital
      • Nashik, Maharashtra, India, 422002
        • Active, not recruiting
        • HCG Manavata Cancer Centre
      • Pune, Maharashtra, India, 411004
        • Active, not recruiting
        • Deenanath Mangeshkar Hospital & Research Centre
      • Pune, Maharashtra, India, 411057
        • Active, not recruiting
        • Lifepoint Multispeciality Hospital
    • Telangana
      • Hyderabad, Telangana, India, 500082
        • Completed
        • Yashoda Hospitals
  • Italy
      • Padova, Italy, 35128
        • Active, not recruiting
        • Istituto Oncologico Veneto IRCCS
    • Campania
      • Naples, Campania, Italy, 80100
        • Active, not recruiting
        • University of Naples Federico II
      • Napoli, Campania, Italy, 80131
        • Active, not recruiting
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale
    • Friuli-Venezia Giulia
      • Aviano, Friuli-Venezia Giulia, Italy, 33081
        • Completed
        • Cro-Irccs
    • Lazio
      • Roma, Lazio, Italy, 00168
        • Active, not recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli
    • Liguria
      • Genova, Liguria, Italy, 16132
        • Active, not recruiting
        • Ospedale San Martino
    • Toscana
      • Firenze, Toscana, Italy, 50134
        • Active, not recruiting
        • Azienda Ospedaliera Universitaria Careggi
  • Japan
      • Fukuoka, Japan, 811-1395
        • Recruiting
        • National Hospital Organization Kyushu Cancer Center
        • Principal Investigator:
          • Eriko Tokunaga
      • Hiroshima, Japan, 730-8518
        • Recruiting
        • Hiroshima City Hospital
        • Principal Investigator:
          • Mitsuya Itoh
      • Kagoshima, Japan, 892-0833
        • Recruiting
        • Sagara Hospital
        • Principal Investigator:
          • Tetsuhiko Taira
      • Kumamoto, Japan, 862-8655
        • Recruiting
        • Kumamoto Shinto General hospital
        • Principal Investigator:
          • Tomofumi Osako
      • Osaka, Japan, 541-8567
        • Recruiting
        • Osaka International Cancer Institute
        • Principal Investigator:
          • Takahiro Nakayama
      • Shizuoka, Japan, 420-8527
        • Recruiting
        • Shizuoka General Hospital
        • Principal Investigator:
          • Michiko Tsuneizumi
      • Tokyo, Japan, 113-8431
        • Recruiting
        • Juntendo University Hospital
        • Principal Investigator:
          • Junichiro Watanabe
    • Aichi
      • Nagoya, Aichi, Japan, 466-8560
        • Recruiting
        • Nagoya University Hospital
        • Principal Investigator:
          • Norikazu Masuda
    • Chiba
      • Chiba-shi, Chiba, Japan, 260-8717
        • Recruiting
        • Chiba Cancer Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Rikiya Nakamura
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0280
        • Recruiting
        • National Hospital Organization Shikoku Cancer Center
        • Principal Investigator:
          • Kenjiro Aogi
    • Fukuoka
      • Kurume, Fukuoka, Japan, 830-0013
        • Recruiting
        • Kurume General Hospital
        • Principal Investigator:
          • Miki Yamaguchi
    • Gunma
      • Otashi, Gunma, Japan, 373-8550
        • Recruiting
        • Gunma Prefectural Cancer Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yasuhiro Yanagita
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 003-0804
        • Recruiting
        • National Hospital Organization Hokkaido Cancer Center
        • Principal Investigator:
          • Mitsugu Yamamoto
    • Hyogo
      • Akashi, Hyogo, Japan, 673-8558
        • Recruiting
        • Hyogo Cancer Center
        • Principal Investigator:
          • Koji Matsumoto
      • Kobe, Hyogo, Japan, 651-0072
        • Recruiting
        • Shinko Hospital
        • Principal Investigator:
          • Kazuhiko Yamagami
    • Ibaraki
      • Tsuchiura, Ibaraki, Japan, 300-0028
        • Recruiting
        • Tsuchiura Kyodo General Hospital
        • Principal Investigator:
          • Tsuyoshi Nakagawa
      • Tsukuba, Ibaraki, Japan, 305-8576
        • Recruiting
        • Tsukuba University Hospital
        • Principal Investigator:
          • Hiroko Bando
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 216-8511
        • Recruiting
        • St. Marianna University School of Medicine Hospital
        • Principal Investigator:
          • Koichiro Tsugawa
      • Yokohama, Kanagawa, Japan, 2418515
        • Recruiting
        • Kanagawa Cancer Center
        • Principal Investigator:
          • Toshinari Yamashita
    • Nagano
      • Tomitake, Nagano, Japan, 381-8551
        • Recruiting
        • Nagano Municipal Hospital
        • Principal Investigator:
          • Hideki Nishimura
    • Niigata
      • Niigata-shi, Niigata, Japan, 951-8566
        • Recruiting
        • Niigata Cancer Center Hospital
        • Principal Investigator:
          • Koji Kaneko
    • Tokyo
      • Shinagawa, Tokyo, Japan, 142-8555
        • Recruiting
        • Showa University Hospital
        • Principal Investigator:
          • Hitomi Sakai
  • Korea, Republic of
    • Chungcheongnam-do [Chungnam]
      • Cheonan-si, Chungcheongnam-do [Chungnam], Korea, Republic of, 31151
        • Active, not recruiting
        • Soon Chun Hyang University Cheonan Hospital
    • Incheon-gwangyeoksi [Incheon]
      • Namdong-gu, Incheon-gwangyeoksi [Incheon], Korea, Republic of, 21565
        • Completed
        • Gachon University Gil Medical Center
    • Kyǒnggi-do
      • Suwon-si, Kyǒnggi-do, Korea, Republic of, 16499
        • Completed
        • Ajou University Hospital
    • Kyǒngsangbuk-do
      • Daegu, Kyǒngsangbuk-do, Korea, Republic of, 42415
        • Active, not recruiting
        • Yeungnam Univeristy Medical Center
    • Pusan-Kwangyǒkshi
      • Busan, Pusan-Kwangyǒkshi, Korea, Republic of, 49201
        • Active, not recruiting
        • Dong-A University Hospital
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 05505
        • Active, not recruiting
        • Asan Medical Center
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 06351
        • Active, not recruiting
        • Samsung Medical Center
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 03722
        • Active, not recruiting
        • Severance Hospital, Yonsei University Health System
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 03080
        • Completed
        • Seoul National University Hospital
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 03181
        • Completed
        • Kangbuk Samsung Hospital
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 06273
        • Active, not recruiting
        • Gangnam Severance Hospital
    • Taegu-Kwangyǒkshi
      • Daegu, Taegu-Kwangyǒkshi, Korea, Republic of, 41404
        • Active, not recruiting
        • Kyungpook National University Chilgok Hospital
  • Mexico
      • Chihuahua, Mexico, 31203
        • Completed
        • Unidad de Investigación en Salud
      • Oaxaca, Mexico, 68000
        • Completed
        • Oaxaca Site Management Organization
      • Puebla, Mexico, 72424
        • Active, not recruiting
        • Unidad Médica Onco-hematológica
    • Coahuila
      • Torreón, Coahuila, Mexico, 27010
        • Completed
        • Centro de Investigación Clínica de Alta Especialidad
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 03310
        • Active, not recruiting
        • Grupo Medico Camino Sc
      • Álvaro Obregón, Distrito Federal, Mexico, 01330
        • Active, not recruiting
        • COI Centro Oncologico Internacional S.A.P.I. de C.V.
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64320
        • Active, not recruiting
        • Private Practice - Dr. Joaquin Reinoso
      • Monterrey, Nuevo León, Mexico, 64460
        • Active, not recruiting
        • Filios Alta Medicina
      • San Pedro Garza Garcia, Nuevo León, Mexico, 66278
        • Active, not recruiting
        • Centro Medico Zambrano Hellion
  • Netherlands
    • Fryslân
      • Leeuwarden, Fryslân, Netherlands, 8934 AD
        • Completed
        • Medische Centrum Leeuwarden
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
        • Active, not recruiting
        • Maastricht UMC+
    • Zuid-Holland
      • Den Haag, Zuid-Holland, Netherlands, 2545 AA
        • Recruiting
        • Haga Ziekenhuis locatie Leyweg
        • Principal Investigator:
          • Danny Houtsma
  • Russian Federation
      • Saint Petersburg, Russian Federation, 197758
        • Recruiting
        • N.N.Petrov Research Institute of Oncology
        • Principal Investigator:
          • Petr Vladimirovich Krivorotko
    • Kalužskaja Oblast'
      • Kaluga, Kalužskaja Oblast', Russian Federation, 248007
        • Completed
        • Kaluga Regional Clinical Oncology Center
    • Volgogradskaya Oblast'
      • Volgograd, Volgogradskaya Oblast', Russian Federation, 400138
        • Recruiting
        • Volgograd Regional Clinical Cancer Clinic No.1
        • Principal Investigator:
          • Nadezhda Vitalievna Kovalenko
  • Spain
      • Granada, Spain, 18016
        • Active, not recruiting
        • Hospital Universitario San Cecilio
      • Madrid, Spain, 28040
        • Active, not recruiting
        • Hospital Clinico San Carlos
      • Sevilla, Spain, 41013
        • Active, not recruiting
        • Hospital Universitario Virgen del Rocío
      • Sevilla, Spain, 41009
        • Completed
        • Hospital Universitario Virgen Macarena
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Active, not recruiting
        • Hospital Universitari Vall d'Hebron
    • Catalunya [Cataluña]
      • Barcelona, Catalunya [Cataluña], Spain, 08041
        • Active, not recruiting
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Catalunya [Cataluña], Spain, 08028
        • Active, not recruiting
        • Hospital Universitari Dexeusa
    • Extremadura
      • Cáceres, Extremadura, Spain, 10003
        • Active, not recruiting
        • Hospital San Pedro de Alcantara
    • Lleida [Lérida]
      • Lleida, Lleida [Lérida], Spain, 25198
        • Completed
        • Hospital Universitario Arnau de Vilanova de Lleida
    • Madrid, Comunidad De
      • Madrid, Madrid, Comunidad De, Spain, 28034
        • Active, not recruiting
        • Hospital Universitario Ramon y Cajal
    • Santa Cruz De Tenerife
      • La Laguna, Santa Cruz De Tenerife, Spain, 38320
        • Completed
        • Hospital Universitario de Canarias
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46010
        • Active, not recruiting
        • Hospital Clinico de Valencia
    • València
      • Valencia, València, Spain, 46010
        • Active, not recruiting
        • Hospital Quirónsalud Valencia
  • Taiwan
      • Taichung, Taiwan, 407
        • Active, not recruiting
        • Taichung Veterans General Hospital
      • Tainan, Taiwan, 704
        • Active, not recruiting
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 10002
        • Active, not recruiting
        • National Taiwan University Hospital
      • Taipei, Taiwan, 112
        • Active, not recruiting
        • Koo Foundation Sun Yat-Sen Cancer Center
    • Tainan
      • Tainan City, Tainan, Taiwan, 73657
        • Completed
        • Chi Mei Hospital - Liouying Branch
  • Turkey
      • Adana, Turkey, 01250
        • Active, not recruiting
        • Baskent University Dr. Turgut Noyan Research and Training Center
      • Ankara, Turkey, 06520
        • Completed
        • Memorial Ankara Hastanesi
      • Ankara, Turkey, 06800
        • Active, not recruiting
        • Ankara City Hospital
      • Ankara, Turkey, 06200
        • Active, not recruiting
        • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi
      • Ankara, Turkey, 06010
        • Active, not recruiting
        • Sbü Gülhane Eğitim Ve Araştirma Hastanesi
      • Ankara, Turkey, 06230
        • Completed
        • Hacettepe Universitesi
      • Antalya, Turkey, 07059
        • Active, not recruiting
        • Akdeniz Universitesi Hastanesi
      • Diyarbakir, Turkey, 21200
        • Completed
        • Dicle Üniversitesi
      • Edirne, Turkey, 22030
        • Completed
        • Trakya University
      • Istanbul, Turkey, 34722
        • Completed
        • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
      • Izmir, Turkey, 35100
        • Completed
        • Ege Universitesi Hastanesi
      • Malatya, Turkey, 44280
        • Completed
        • İnönü Üniversitesi Turgut Özal Tıp Merkezi
      • Mersin, Turkey, 33343
        • Active, not recruiting
        • Mersin University
      • İstanbul, Turkey, 34457
        • Completed
        • Acıbadem Maslak Hastanesi
    • İstanbul
      • Stanbul, İstanbul, Turkey, 34214
        • Active, not recruiting
        • Medipol Mega Universite Hastanesi
      • Üsküdar / Stanbul, İstanbul, Turkey
        • Active, not recruiting
        • Acibadem Altunizade Hospital
  • Ukraine
    • Dnipropetrovska Oblast
      • Kryvyi Rih, Dnipropetrovska Oblast, Ukraine, 50048
        • Recruiting
        • Communal Enterprise 'Kryvyi Rih Oncology Dispensary' of the Dnipropetrovsk Regional Council
        • Principal Investigator:
          • Hryhoriy Adamchuk
    • Kharkivska Oblast
      • Kharkiv, Kharkivska Oblast, Ukraine, 61070
        • Recruiting
        • CNPE "Regional Center of Oncology"
        • Principal Investigator:
          • Dmytro Bukhtieiev
    • Odeska Oblast
      • Odesa, Odeska Oblast, Ukraine, 65025
        • Recruiting
        • Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council
        • Principal Investigator:
          • Oleksandr Berzoy
    • Volynska Oblast
      • Lutsk, Volynska Oblast, Ukraine, 43018
        • Recruiting
        • Municipal Enterprise "Volyn Regional Medical Oncology Centre" of the Volyn Regional Council
        • Principal Investigator:
          • Ivan Sinielnikov
    • Zakarpatska Oblast
      • Uzhhorod, Zakarpatska Oblast, Ukraine, 88000
        • Recruiting
        • Uzhgorod Central City Clinical Hospital
        • Principal Investigator:
          • Iryna Hotko
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Completed
        • Ironwood Cancer & Research Centers
      • Gilbert, Arizona, United States, 85234
        • Active, not recruiting
        • Banner MD Anderson Cancer Center
    • California
      • Greenbrae, California, United States, 94904
        • Completed
        • Marin Cancer Care
      • Sacramento, California, United States, 95817
        • Active, not recruiting
        • University of California Davis (UC Davis) Comprehensive Cancer Center
    • Colorado
      • Loveland, Colorado, United States, 80538
        • Completed
        • Banner MD Anderson Cancer Center at McKee Medical Center
    • Florida
      • Clermont, Florida, United States, 34711
        • Recruiting
        • Clermont Oncology Center
        • Contact:
          • Phone Number: 352-242-1366
        • Principal Investigator:
          • Gopal Kunta
      • Gainesville, Florida, United States, 32610
        • Active, not recruiting
        • University of Florida College of Medicine
      • Orange City, Florida, United States, 32763
        • Active, not recruiting
        • Mid Florida Hematology and Oncology Center
      • Saint Petersburg, Florida, United States, 33705
        • Active, not recruiting
        • Florida Cancer Specialists
      • Sarasota, Florida, United States, 34232
        • Active, not recruiting
        • Florida Cancer Specialists
    • Hawaii
      • Honolulu, Hawaii, United States, 96819
        • Completed
        • Kaiser Permanente Moanalua Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Active, not recruiting
        • University of Chicago Medical Center
      • Evanston, Illinois, United States, 60201
        • Recruiting
        • NorthShore University HealthSystem - Evanston Hospital
        • Principal Investigator:
          • Poornima Saha
    • Indiana
      • Muncie, Indiana, United States, 47303
        • Completed
        • IU Health Ball Memorial Hospital, Inc.
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • The University of Louisville, James Graham Brown Cancer Center
        • Principal Investigator:
          • Brian Dong
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Completed
        • Minnesota Oncology/Hematology PA
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Recruiting
        • Jackson Oncology Associates, PLLC
        • Principal Investigator:
          • Natale T Sheehan
    • New Jersey
      • Clifton, New Jersey, United States, 07013
        • Recruiting
        • Care Access - Clifton
        • Principal Investigator:
          • Richards Afonja
      • Montvale, New Jersey, United States, 07645
        • Active, not recruiting
        • Memorial Sloan Kettering - Bergen
    • New York
      • New York, New York, United States, 10032
        • Active, not recruiting
        • Columbia University Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina Medical Center
        • Principal Investigator:
          • Lisa Carey
    • Ohio
      • Canton, Ohio, United States, 44710
        • Recruiting
        • Aultman Hospital
        • Principal Investigator:
          • Sunitha Vemulapalli
      • Toledo, Ohio, United States, 43608
        • Recruiting
        • Mercy Health - St. Vincent Medical Center
        • Contact:
          • Phone Number: 419-251-4919
        • Principal Investigator:
          • Adnan R Alkhalili
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Active, not recruiting
        • Avera Cancer Institute Sioux Falls
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute SCRI
        • Principal Investigator:
          • SMO Sarah Cannon Research Inst.
    • Texas
      • Dallas, Texas, United States, 75231
        • Completed
        • Texas Oncology - Dallas Presbyterian Hospital
      • Denton, Texas, United States, 76201
        • Active, not recruiting
        • Texas Oncology Denton
      • Houston, Texas, United States, 77070
        • Completed
        • Willamette Valley Cancer Institute & Research Ctr.
      • Houston, Texas, United States, 77380
        • Recruiting
        • Texas Oncology - Willowbrook
        • Contact:
          • Phone Number: 281-863-1000
        • Principal Investigator:
          • Henna Malik
      • The Woodlands, Texas, United States, 77380
        • Recruiting
        • US Oncology
        • Principal Investigator:
          • SMO US Oncology
      • The Woodlands, Texas, United States, 77380
        • Completed
        • Texas Oncology - The Woodlands
      • The Woodlands, Texas, United States, 77380
        • Completed
        • Broome Oncology
      • The Woodlands, Texas, United States, 77380
        • Completed
        • Texas Oncology - Denison
      • The Woodlands, Texas, United States, 77380
        • Recruiting
        • Texas Oncology - McKinney
        • Principal Investigator:
          • Monte Jones
        • Contact:
          • Phone Number: 281-863-1000
      • The Woodlands, Texas, United States, 77380
        • Active, not recruiting
        • Texas Oncology - San Antonio Medical Center
      • The Woodlands, Texas, United States, 77380
        • Active, not recruiting
        • Texas Oncology Denton
      • The Woodlands, Texas, United States, 77380
        • Completed
        • Texas Oncology Fort Worth
      • The Woodlands, Texas, United States, 77380
        • Active, not recruiting
        • Texas Oncology-Baylor Charles A. Sammons Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Completed
        • Utah Cancer Specialists
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Active, not recruiting
        • The University of Vermont Medical Center Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have a diagnosis of ER+, HER2- locally advanced or metastatic breast cancer

  • Have disease that has demonstrated progression on or after an aromatase inhibitor alone or in combination with a cyclin-dependent kinase (CDK)4/6 inhibitor

    -- Participants are expected to have received prior treatment with a CDK4/6 inhibitor, if this treatment is approved and can be reimbursed

  • Must be deemed appropriate for treatment with endocrine therapy
  • If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
  • Have RECIST evaluable disease (measurable disease and/or nonmeasurable bone-only disease)
  • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)
  • Have adequate renal, hematologic, and hepatic organ function
  • Must be able to swallow capsules/tablets

Exclusion Criteria:

  • Have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, or any investigational-ER-directed therapy (including SERDs and non-SERDs), any PI3K-, mTOR- or AKT- inhibitor
  • Have visceral crisis, lymphangitic spread within the lung, or any evidence of leptomeningeal disease.
  • Have symptomatic or untreated brain metastasis.
  • Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study
  • Known allergic reaction against any of the components of the study treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Imlunestrant
Imlunestrant administered orally.
Drug: Imlunestrant
Administered orally.
Other Names:
  • LY3484356
Active Comparator: Investigator's Choice of Endocrine Therapy
Investigator's choice of exemestane administered orally or fulvestrant administered intramuscularly (IM). See local approved label for additional instructions.
Drug: Exemestane
Administered orally.
Drug: Fulvestrant
Administered IM.
Experimental: Imlunestrant plus Abemaciclib
Imlunestrant plus abemaciclib administered orally.
Drug: Abemaciclib
Administered orally.
Other Names:
  • LY2835219
Drug: Imlunestrant
Administered orally.
Other Names:
  • LY3484356

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS) in the Intent-to-Treat (IIT) Population
Time Frame: Randomization to the date of first documented progression of disease or death from any cause (estimated as up to 3 years)
PFS by investigator assessment in the IIT population
Randomization to the date of first documented progression of disease or death from any cause (estimated as up to 3 years)
PFS in the Estrogen Receptor 1 (ESR1)-mutation Detected Population
Time Frame: Randomization to the date of first documented progression of disease or death from any cause (estimated as up to 3 years)
PFS by investigator assessment in ESR1-mutation detected population
Randomization to the date of first documented progression of disease or death from any cause (estimated as up to 3 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) in the IIT Population
Time Frame: Randomization until death from any cause (estimated as up to 5 years)
OS in the IIT population
Randomization until death from any cause (estimated as up to 5 years)
OS in the ESR1-mutation Detected Population
Time Frame: Randomization until death from any cause (estimated as up to 5 years)
OS in the ESR1-mutation detected population
Randomization until death from any cause (estimated as up to 5 years)
Objective Response Rate (ORR): Percentage of Participants Who Achieve a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR)
Time Frame: Randomization until measured progressive disease (estimated as up to 1 year)
ORR
Randomization until measured progressive disease (estimated as up to 1 year)
Duration of Response (DoR)
Time Frame: Date of CR or PR to date of disease progression or death due to any cause (estimated up to 3 years)
DoR
Date of CR or PR to date of disease progression or death due to any cause (estimated up to 3 years)
Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve a Best Overall Response of CR, PR or Stable Disease for Greater than or Equal to (≥) 24 Weeks
Time Frame: Randomization until measured progressive disease (estimated as up to 1 year)
CBR
Randomization until measured progressive disease (estimated as up to 1 year)
Progression Free Survival (PFS)
Time Frame: Randomization to the date of first documented progression of disease or death from any cause(estimated as up to 3 years)
PFS by blinded independent review
Randomization to the date of first documented progression of disease or death from any cause(estimated as up to 3 years)
Patient Reported Outcomes (PRO): Time to Worsening of "Worst Pain"
Time Frame: Screening through follow-up (estimated as up to 3 years)
Measured by the Worst Pain Numeric Rating Scale (NRS). NRS is a single item, participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "pain as bad as you can imagine."
Screening through follow-up (estimated as up to 3 years)
Pharmacokinetics (PK): Steady State Plasma Concentrations of Imlunestrant
Time Frame: Cycle 2 to Cycle 4 (cycle = 28 days)
PK: steady state plasma concentrations of imlunestrant
Cycle 2 to Cycle 4 (cycle = 28 days)
PK: Steady State Plasma Concentrations of Imlunestrant and Abemaciclib
Time Frame: Cycle 2 to Cycle 4 (cycle = 28 days)
PK: steady state plasma concentrations of imlunestrant and abemaciclib
Cycle 2 to Cycle 4 (cycle = 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: 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), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2021

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

July 22, 2021

First Submitted That Met QC Criteria

July 22, 2021

First Posted (Actual)

July 23, 2021

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18175
  • J2J-OX-JZLC (Other Identifier: Eli Lilly and Company)
  • 2021-000079-35 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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