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

July 9, 2025 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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

874

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 Locations

  • Argentina
      • Buenos Aires, Argentina, 1122
        • Instituto Argentino de Diagnóstico y Tratamiento (IADT)
      • San Juan, Argentina, 5400
        • Instituto San Marcos
      • Santiago del Estero, Argentina, 4200
        • Sanatorio Norte
    • Buenos Aires
      • Mar del Plata, Buenos Aires, Argentina, B7600FZO
        • Instituto de Investigaciones Clinicas Mar del Plata
    • Ciudad Autónoma De Buenos Aires
      • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1061AAS
        • CIPREC
      • Caba, Ciudad Autónoma De Buenos Aires, Argentina, 1125
        • Fundación Cenit para la Investigación en Neurociencias
    • Córdoba
      • Capital, Córdoba, Argentina, X5008HHW
        • Centro Medico Privado CEMAIC
    • Río Negro
      • Viedma, Río Negro, Argentina, 8500
        • Clínica Viedma
  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • St Vincent's Hospital
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • South Australia
      • Kurralta Park, South Australia, Australia, 5037
        • Ashford Cancer Centre Research
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Melbourne, Victoria, Australia, 3135
        • Maroondah Hospital
  • Austria
      • Salzburg, Austria, 5020
        • Uniklinikum Salzburg
    • Steiermark
      • Graz, Steiermark, Austria, 8036
        • Medizinische Universität Graz
    • Wien
      • Vienna, Wien, Austria, 1090
        • Universitaetsklinikum Allgemeines Krankenhaus Wien
  • Belgium
      • Namur, Belgium, 5000
        • CHU UCL Namur/Site Sainte Elisabeth
    • Antwerpen
      • Bonheiden, Antwerpen, Belgium, 2820
        • Imelda General Hospital
    • Bruxelles-Capitale, Région De
      • Brussels, Bruxelles-Capitale, Région De, Belgium, 1090
        • UZ Brussel
      • Bruxelles, Bruxelles-Capitale, Région De, Belgium, 1000
        • Institut Jules Bordet
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent
      • Sint-Niklaas, Oost-Vlaanderen, Belgium, B-9100
        • AZ Nikolaas
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • UZ Leuven
    • West-Vlaanderen
      • Kortrijk, West-Vlaanderen, Belgium, 8500
        • AZ Groeninge Campus Kennedylaan
  • Brazil
      • São Paulo, Brazil, 01246-000
        • Icesp - Instituto Do Câncer Do Estado de São Paulo
      • São Paulo, Brazil, 04014-002
        • Núcleo de Pesquisa Clínica da Rede São Camilo
      • São Paulo, Brazil, 01317-001
        • Clínica de Pesquisa e Centro de Estudos em Ginecologia Oncológica e Mamária LTDA
    • Paraná
      • Londrina, Paraná, Brazil, 86015-520
        • Hospital de Cancer de Londrina
    • São Paulo
      • Santo André, São Paulo, Brazil, 09060-650
        • Faculdade de Medicina do ABC
  • China
    • Anhui
      • Bengbu, Anhui, China, 233004
        • Afflilated Hospital of Bengbu Medical College
    • Beijing
      • Beijing, Beijing, China, 100005
        • Beijing Hospital
      • Beijing, Beijing, China, 100039
        • Fifth Medical Center of Pla General Hospital
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Fujian provincial Cancer Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 511400
        • Sun Yat-Sen University Cancer Centre
      • Jiangmen, Guangdong, China
        • Jiangmen Center Hospital
      • Shenzhen, Guangdong, China, 518035
        • Shenzhen Second People's Hospital
      • Zhanjiang, Guangdong, China, 524001
        • Affiliated Hospital of Guangdong Medical University
      • Zhongshan, Guangdong, China, 528403
        • Zhongshan Peoples Hospital
      • Zhuhai, Guangdong, China, 519000
        • The Fifth Affiliated Hospital of Sun Yat-sen University
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Harbin Medical University Cancer Hospital
    • Henan
      • Luoyang, Henan, China, 471003
        • The First Affiliated Hospital of Henan University of Science &Technology
      • Nanyang, Henan, China, 473000
        • Nanyang Second General Hospital
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Hubei Cancer Hospital
      • Wuhan, Hubei, China, 430060
        • Renmin Hospital of Wuhan University
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital Tongji Medical,Science & Technology
    • Hunan
      • Changde, Hunan, China, 415003
        • The First People's Hospital of Changde City
      • Changsha, Hunan, China, 410008
        • Xiangya Hospital Central South University
      • Changsha, Hunan, China, 421000
        • Hunan Cancer Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Jiangsu Province Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China, 330009
        • The Third Hospital of Nanchang
    • Jilin
      • Changchun, Jilin, China
        • The Second Hospital of Jilin University
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • The First Affiliated Hospital of Xi'an Jiaotong University
    • Shandong
      • Jinan, Shandong, China, 250013
        • Jinan Central Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610042
        • Sichuan Cancer Hospital
      • Neijiang, Sichuan, China, 641000
        • The Second People's Hospital of Neijiang
    • Tianjin
      • Tianjing, Tianjin, China, 300060
        • Tianjin Medical University Cancer Institute and Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital
      • Hangzhou, Zhejiang, China, 310016
        • Sir Run Run Shaw Hospital
      • Ningbo, Zhejiang, China, 315010
        • Hwa Mei Hospital University of Chinese Academy of Sciences
      • Ningbo, Zhejiang, China, 315048
        • Ningbo Medical Center
  • Czechia
    • Beroun
      • Horovice, Beroun, Czechia, 268 31
        • Nemocnice Horovice
    • Praha 10
      • PRague, Praha 10, Czechia, 10034
        • Fakultni nemocnice Kralovske Vinohrady
    • Praha 4
      • Prague, Praha 4, Czechia, 14059
        • Fakultni Thomayerova nemocnice
    • Praha 8
      • Prague, Praha 8, Czechia, 180 81
        • Nemocnice Na Bulovce
    • Příbram
      • Pribram, Příbram, Czechia, 261 01
        • Oblastni nemocnice Pribram
  • France
      • Paris, France, 75248
        • Institut Curie
      • Vandoeuvre-lès-Nancy, France, 54519
        • Institut de Cancérologie de Lorraine Alexis Vautrin
    • Alsace
      • Strasbourg, Alsace, France, 67033
        • Institut de cancérologie Strasbourg Europe (ICANS)
    • Centre
      • La Chaussée-Saint-Victor, Centre, France, 41260
        • Polyclinique de Blois
    • Doubs
      • Besançon, Doubs, France, 25000
        • CHU Besançon
    • Hauts-de-Seine
      • Saint-Cloud, Hauts-de-Seine, France, 92210
        • Hopital René Huguenin
    • Languedoc-Roussillon
      • Montpellier, Languedoc-Roussillon, France, 34070
        • Centre de Cancerologie du Grand Montpellier
    • Pays-de-la-Loire
      • Le Mans, Pays-de-la-Loire, France, 72000
        • Clinique Victor Hugo Le Mans
    • Pyrénées-Atlantiques
      • Bayonne, Pyrénées-Atlantiques, France, 64109
        • Centre Hospitalier de la Cote Basque
  • Germany
    • Baden-Württemberg
      • Ludwigsburg, Baden-Württemberg, Germany, 71640
        • Klinikum Ludwigsburg
    • Bayern
      • Donauwörth, Bayern, Germany, 86609
        • Onkologiezentrum Donauwörth
      • Erlangen, Bayern, Germany, 91054
        • Universitaetsklinikum Erlangen
      • München, Bayern, Germany, 80336
        • Klinikum der Ludwig-Maximilians-Universitaet Muenchen
    • Hessen
      • Frankfurt, Hessen, Germany, 60431
        • Agaplesion Markus Krankenhaus
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30177
        • Gynäkologisch-Onkologische Praxis am Pelikanplatz
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45136
        • Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung
      • Mönchengladbach, Nordrhein-Westfalen, Germany, 41061
        • Evangelisches Krankenhaus Bethesda Mönchengladbach
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Universitaetsklinikum Schleswig-Holstein Campus Kiel
  • Greece
    • Attikí
      • Athens, Attikí, Greece, 115 22
        • Agios Savvas Regional Cancer Hospital
      • Athens, Attikí, Greece, 115 28
        • Alexandra Hospital
      • Nea Kifissia, Attikí, Greece, 14564
        • General Oncology Hospital of Kifissia "Agioi Anargiroi"
    • Irakleío
      • Heraklion, Irakleío, Greece, 711 10
        • University General Hospital of Heraklion
    • Thessaloníki
      • Thessaloniki, Thessaloníki, Greece, 570 01
        • European Interbalkan Medical Center
      • Thessaloniki, Thessaloníki, Greece, 546 45
        • Euromedica General Clinic of Thessaloniki
      • Thessaloniki, Thessaloníki, Greece, 564 29
        • Papageorgiou General Hospital of Thessaloniki
    • Thessalía
      • Larissa, Thessalía, Greece, 41110
        • University General Hospital of Larissa
  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560092
        • Medstar Speciality Hospital
    • Kerala
      • Thiruvananthapuram, Kerala, India, 695011
        • Regional Cancer Centre - Thiruvananthapuram
    • Maharashtra
      • Mumbai, Maharashtra, India, 400092
        • HCG Cancer Centre
      • Nagpur, Maharashtra, India, 440003
        • Government Medical College And Hospital - Nagpur
      • Nagpur, Maharashtra, India, 440027
        • Rashtrasant Tukdoji Regional Cancer Hospital
      • Nashik, Maharashtra, India, 422002
        • HCG Manavata Cancer Centre
      • Pune, Maharashtra, India, 411004
        • Deenanath Mangeshkar Hospital & Research Centre
      • Pune, Maharashtra, India, 411057
        • Lifepoint Multispeciality Hospital
    • Telangana
      • Hyderabad, Telangana, India, 500082
        • Yashoda Hospitals
  • Italy
      • Padova, Italy, 35128
        • Istituto Oncologico Veneto IRCCS
    • Campania
      • Naples, Campania, Italy, 80100
        • University of Naples Federico II
      • Napoli, Campania, Italy, 80131
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale
    • Friuli-Venezia Giulia
      • Aviano, Friuli-Venezia Giulia, Italy, 33081
        • Cro-Irccs
    • Lazio
      • Roma, Lazio, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli
    • Liguria
      • Genova, Liguria, Italy, 16132
        • Ospedale San Martino
    • Toscana
      • Firenze, Toscana, Italy, 50134
        • Azienda Ospedaliera Universitaria Careggi
  • Japan
      • Fukuoka, Japan, 811-1395
        • National Hospital Organization Kyushu Cancer Center
      • Hiroshima, Japan, 730-8518
        • Hiroshima City Hospital
      • Kagoshima, Japan, 892-0833
        • Sagara Hospital
      • Kumamoto, Japan, 862-8655
        • Kumamoto Shinto General Hospital
      • Osaka, Japan, 541-8567
        • Osaka International Cancer Institute
      • Shizuoka, Japan, 420-8527
        • Shizuoka General Hospital
      • Tokyo, Japan, 113-8431
        • Juntendo University Hospital
    • Aichi
      • Nagoya, Aichi, Japan, 466-8560
        • Nagoya University Hospital
    • Chiba
      • Chiba-shi, Chiba, Japan, 260-8717
        • Chiba Cancer Center
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0280
        • National Hospital Organization Shikoku Cancer Center
    • Fukuoka
      • Kurume, Fukuoka, Japan, 830-0013
        • Kurume General Hospital
    • Gunma
      • Otashi, Gunma, Japan, 373-8550
        • Gunma Prefectural Cancer Center
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 003-0804
        • National Hospital Organization Hokkaido Cancer Center
    • Hyogo
      • Akashi, Hyogo, Japan, 673-8558
        • Hyogo Cancer Center
      • Kobe, Hyogo, Japan, 651-0072
        • Shinko Hospital
    • Ibaraki
      • Tsuchiura, Ibaraki, Japan, 300-0028
        • Tsuchiura Kyodo General Hospital
      • Tsukuba, Ibaraki, Japan, 305-8576
        • Tsukuba University Hospital
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 216-8511
        • St. Marianna University School of Medicine Hospital
      • Yokohama, Kanagawa, Japan, 2418515
        • Kanagawa Cancer Center
    • Nagano
      • Tomitake, Nagano, Japan, 381-8551
        • Nagano Municipal Hospital
    • Niigata
      • Niigata-shi, Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital
    • Tokyo
      • Shinagawa, Tokyo, Japan, 142-8555
        • Showa University Hospital
  • Korea, Republic of
    • Chungcheongnam-do [Chungnam]
      • Cheonan-si, Chungcheongnam-do [Chungnam], Korea, Republic of, 31151
        • Soon Chun Hyang University Cheonan Hospital
    • Incheon-gwangyeoksi [Incheon]
      • Namdong-gu, Incheon-gwangyeoksi [Incheon], Korea, Republic of, 21565
        • Gachon University Gil Medical Center
    • Kyǒnggi-do
      • Suwon-si, Kyǒnggi-do, Korea, Republic of, 16499
        • Ajou University Hospital
    • Kyǒngsangbuk-do
      • Daegu, Kyǒngsangbuk-do, Korea, Republic of, 42415
        • Yeungnam Univeristy Medical Center
    • Pusan-Kwangyǒkshi
      • Busan, Pusan-Kwangyǒkshi, Korea, Republic of, 49201
        • Dong-A University Hospital
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 03181
        • Kangbuk Samsung Hospital
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 06273
        • Gangnam Severance Hospital
    • Taegu-Kwangyǒkshi
      • Daegu, Taegu-Kwangyǒkshi, Korea, Republic of, 41404
        • Kyungpook National University Chilgok Hospital
  • Mexico
      • Chihuahua, Mexico, 31203
        • Unidad de Investigacion en Salud
      • Oaxaca, Mexico, 68000
        • Oaxaca Site Management Organization
      • Puebla, Mexico, 72424
        • Unidad Médica Onco-hematológica
    • Coahuila
      • Torreón, Coahuila, Mexico, 27010
        • Centro de Investigación Clínica de Alta Especialidad
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 03310
        • Grupo Medico Camino Sc
      • Álvaro Obregón, Distrito Federal, Mexico, 01330
        • COI Centro Oncologico Internacional S.A.P.I. de C.V.
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64320
        • Private Practice - Dr. Joaquin Reinoso
      • Monterrey, Nuevo León, Mexico, 64460
        • Filios Alta Medicina
      • San Pedro Garza Garcia, Nuevo León, Mexico, 66278
        • Centro Medico Zambrano Hellion
  • Netherlands
    • Fryslân
      • Leeuwarden, Fryslân, Netherlands, 8934 AD
        • Medische Centrum Leeuwarden
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
        • Maastricht UMC+
    • Zuid-Holland
      • Den Haag, Zuid-Holland, Netherlands, 2545 AA
        • Haga Ziekenhuis locatie Leyweg
  • Russian Federation
      • Saint Petersburg, Russian Federation, 197758
        • N.N.Petrov Research Institute of Oncology
    • Kalužskaja Oblast'
      • Kaluga, Kalužskaja Oblast', Russian Federation, 248007
        • Kaluga Regional Clinical Oncology Center
    • Volgogradskaya Oblast'
      • Volgograd, Volgogradskaya Oblast', Russian Federation, 400138
        • Volgograd Regional Clinical Cancer Clinic No.1
  • Spain
      • Granada, Spain, 18016
        • Hospital Universitario San Cecilio
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Hospital Universitari Vall d'Hebron
    • Catalunya [Cataluña]
      • Barcelona, Catalunya [Cataluña], Spain, 08041
        • Hospital De La Santa Creu I Sant Pau
      • Barcelona, Catalunya [Cataluña], Spain, 08028
        • Hospital Universitari Dexeusa
    • Extremadura
      • Cáceres, Extremadura, Spain, 10003
        • Hospital San Pedro de Alcantara
    • Lleida [Lérida]
      • Lleida, Lleida [Lérida], Spain, 25198
        • Hospital Universitario Arnau de Vilanova de Lleida
    • Madrid, Comunidad De
      • Madrid, Madrid, Comunidad De, Spain, 28034
        • Hospital Universitario Ramon y Cajal
    • Santa Cruz De Tenerife
      • La Laguna, Santa Cruz De Tenerife, Spain, 38320
        • Hospital Universitario de Canarias
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46010
        • Hospital Clinico de Valencia
    • València
      • Valencia, València, Spain, 46010
        • Hospital Quironsalud Valencia
  • Taiwan
      • Taichung, Taiwan, 407
        • Taichung Veterans General Hospital
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taipei, Taiwan, 112
        • Koo Foundation Sun Yat-Sen Cancer Center
    • Tainan
      • Tainan City, Tainan, Taiwan, 73657
        • Chi Mei Hospital - Liouying Branch
  • Turkey
      • Adana, Turkey, 01250
        • Baskent University Dr. Turgut Noyan Research and Training Center
      • Ankara, Turkey, 06520
        • Memorial Ankara Hastanesi
      • Ankara, Turkey, 06230
        • Hacettepe Universitesi
      • Ankara, Turkey, 06200
        • Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital
      • Ankara, Turkey, 06800
        • Ankara Bilkent Sehir Hastanesi
      • Ankara, Turkey, 06010
        • University of Health Sciences,Gulhane School of Medicine
      • Antalya, Turkey, 07059
        • Akdeniz Universitesi Hastanesi
      • Diyarbakir, Turkey, 21200
        • Dicle Üniversitesi
      • Edirne, Turkey, 22030
        • Trakya University
      • Istanbul, Turkey, 34722
        • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
      • Izmir, Turkey, 35100
        • Ege Universitesi Hastanesi
      • Malatya, Turkey, 44280
        • İnönü Üniversitesi Turgut Özal Tıp Merkezi
      • Mersin, Turkey, 33343
        • Mersin University
      • İstanbul, Turkey, 34457
        • Acıbadem Maslak Hastanesi
    • İstanbul
      • Stanbul, İstanbul, Turkey, 34214
        • Medipol University Medical Faculty
      • Üsküdar / Stanbul, İstanbul, Turkey
        • Acibadem Altunizade Hospital
  • Ukraine
    • Dnipropetrovska Oblast
      • Kryvyi Rih, Dnipropetrovska Oblast, Ukraine, 50048
        • Communal Enterprise 'Kryvyi Rih Oncology Dispensary' of the Dnipropetrovsk Regional Council
    • Kharkivska Oblast
      • Kharkiv, Kharkivska Oblast, Ukraine, 61070
        • CNPE "Regional Center of Oncology"
    • Odeska Oblast
      • Odesa, Odeska Oblast, Ukraine, 65025
        • Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council
    • Volynska Oblast
      • Lutsk, Volynska Oblast, Ukraine, 43018
        • Municipal Enterprise "Volyn Regional Medical Oncology Centre" of the Volyn Regional Council
    • Zakarpatska Oblast
      • Uzhhorod, Zakarpatska Oblast, Ukraine, 88000
        • Uzhgorod Central City Clinical Hospital
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Ironwood Cancer & Research Centers
      • Gilbert, Arizona, United States, 85234
        • Banner MD Anderson Cancer Center
    • California
      • Greenbrae, California, United States, 94904
        • Marin Cancer Care
      • Sacramento, California, United States, 95817
        • University of California Davis (UC Davis) Comprehensive Cancer Center
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital
    • Colorado
      • Loveland, Colorado, United States, 80538
        • Banner MD Anderson Cancer Center at McKee Medical Center
    • Florida
      • Clermont, Florida, United States, 34711
        • Clermont Oncology Center
      • Gainesville, Florida, United States, 32610
        • University of Florida College of Medicine
      • Orange City, Florida, United States, 32763
        • Mid Florida Hematology and Oncology Center
      • Saint Petersburg, Florida, United States, 33705
        • Florida Cancer Specialists
      • Sarasota, Florida, United States, 34232
        • Florida Cancer Specialists
    • Hawaii
      • Honolulu, Hawaii, United States, 96819
        • Kaiser Permanente Moanalua Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
      • Evanston, Illinois, United States, 60201
        • NorthShore University HealthSystem - Evanston Hospital
    • Indiana
      • Muncie, Indiana, United States, 47303
        • IU Health Ball Memorial Hospital, Inc.
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • The University of Louisville, James Graham Brown Cancer Center
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Jackson Oncology Associates, PLLC
    • New Jersey
      • Clifton, New Jersey, United States, 07013
        • Care Access - Clifton
      • Montvale, New Jersey, United States, 07645
        • Memorial Sloan Kettering - Bergen
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina Medical Center
    • Ohio
      • Canton, Ohio, United States, 44710
        • Aultman Hospital
      • Toledo, Ohio, United States, 43608
        • Mercy Health - St. Vincent Medical Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute Sioux Falls
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Florida Cancer Specialists
      • Nashville, Tennessee, United States, 37203
        • The Mark H Zangmeister Cancer Center
    • Texas
      • Allen, Texas, United States, 75013
        • USO - Texas Oncology - Allen
      • Dallas, Texas, United States, 75231
        • Texas Oncology - Dallas Presbyterian Hospital
      • Houston, Texas, United States, 77070
        • Willamette Valley Cancer Institute & Research Ctr.
      • Lewisville, Texas, United States, 75056
        • Texas Oncology - Carrollton
      • The Woodlands, Texas, United States, 77380
        • Texas Oncology - The Woodlands
      • The Woodlands, Texas, United States, 77380
        • Texas Oncology Fort Worth
      • The Woodlands, Texas, United States, 77380
        • Minnesota Oncology/Hematology PA
      • The Woodlands, Texas, United States, 77380
        • Texas Oncology - McKinney
      • The Woodlands, Texas, United States, 77380
        • Texas Oncology - Medical City Dallas
      • The Woodlands, Texas, United States, 77380
        • Texas Oncology - San Antonio Medical Center
      • The Woodlands, Texas, United States, 77380
        • Texas Oncology-Baylor Charles A. Sammons Cancer Center
      • The Woodlands, Texas, United States, 77380
        • USO-Rocky Mountain Cancer Center
      • The Woodlands, Texas, United States, 77380
        • Blue Ridge Cancer Care
      • The Woodlands, Texas, United States, 77380
        • Broome Oncology
      • The Woodlands, Texas, United States, 77380
        • Texas Oncology - Carrollton
      • The Woodlands, Texas, United States, 77380
        • Texas Oncology - Methodist Charlton Cancer Center
      • The Woodlands, Texas, United States, 77380
        • Texas Oncology - Willowbrook
      • The Woodlands, Texas, United States, 78731
        • Texas Oncology - Austin Central
      • The Woodlands, Texas, United States, 75020
        • Texas Oncology - Denison
      • The Woodlands, Texas, United States, 75460
        • Texas Oncology - Paris
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Utah Cancer Specialists
    • Vermont
      • Burlington, Vermont, United States, 05401
        • 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: Arm A: Imlunestrant
Participants received Imlunestrant 400 milligrams (mg) orally once daily on days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation were met.
Drug: Imlunestrant
Administered orally.
Other Names:
  • LY3484356
Experimental: Arm B: Investigator's Choice of Endocrine Therapy
Participants received the investigator's choice of endocrine therapy, either exemestane 25 mg administered orally once daily on days 1 to 28 of a 28-day cycle, or Fulvestrant 500 mg intramuscularly on days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond, until disease progression or a criterion for discontinuation was met.
Drug: Exemestane
Administered orally.
Drug: Fulvestrant
Administered IM.
Experimental: Arm C: Imlunestrant + Abemaciclib
Participants received Imlunestrant 400 mg orally once daily on Days 1 to 28 of a 28-day cycle, plus Abemaciclib 150 mg orally twice daily on Days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation was met.
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
Investigator-assessed Progression Free Survival (PFS) (Between Arm A and Arm B)
Time Frame: Randomization to the date of first documented progression of disease or death from any cause (up to 28 months)
PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
Randomization to the date of first documented progression of disease or death from any cause (up to 28 months)
Investigator-assessed PFS (Between Arm C and Arm A)
Time Frame: Randomization to the date of first documented progression of disease or death from any cause (up to 26 months)
PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
Randomization to the date of first documented progression of disease or death from any cause (up to 26 months)
Investigator-assessed PFS in the Estrogen Receptor 1 (ESR1)-Mutation Detected Population (Between Arm A and Arm B)
Time Frame: Randomization to the date of first documented progression of disease or death from any cause (up to 28 months)
PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
Randomization to the date of first documented progression of disease or death from any cause (up to 28 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Blinded Independent Review Committee (BIRC) Assessed PFS (Between Arm A and Arm B)
Time Frame: Randomization to the date of first documented progression of disease or death from any cause (up to 28 months)
PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
Randomization to the date of first documented progression of disease or death from any cause (up to 28 months)
Blinded Independent Review Committee (BIRC) Assessed PFS (Between Arm C and Arm A)
Time Frame: Randomization to the date of first documented progression of disease or death from any cause (up to 25 months)
PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
Randomization to the date of first documented progression of disease or death from any cause (up to 25 months)
Percentage of Participants With Investigator-assessed Objective Response Rate (ORR) (Between Arm A and Arm B)
Time Frame: Randomization until measured progressive disease (up to 28 months)
ORR was the best confirmed overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
Randomization until measured progressive disease (up to 28 months)
Investigator-assessed Duration of Response (DoR) (Between Arm A and Arm B)
Time Frame: From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 26 Months)
DoR is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 26 Months)
Percentage of Participants With Investigator-assessed Clinical Benefit Rate (CBR) (Between Arm A and Arm B)
Time Frame: Randomization until measured progressive disease (up to 28 months)
CBR was the best confirmed overall tumor response of stable disease (SD) for greater than or equal to (≥) 24 weeks, CR or PR as defined by RECIST v1.1. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Randomization until measured progressive disease (up to 28 months)
Percentage of Participants With Investigator-assessed Objective Response Rate (ORR) (Between Arm C and Arm A)
Time Frame: Randomization until measured progressive disease (up to 26 months)
ORR was the best confirmed overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
Randomization until measured progressive disease (up to 26 months)
Investigator-assessed Duration of Response (DoR) (Between Arm C and Arm A)
Time Frame: From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 19 Months)
DoR is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 19 Months)
Percentage of Participants With Investigator-assessed Clinical Benefit Rate (CBR) (Between Arm C and Arm A)
Time Frame: Randomization until measured progressive disease (up to 26 months)
CBR was the best confirmed overall tumor response of stable disease (SD) for greater than or equal to (≥) 24 weeks, CR or PR as defined by RECIST v1.1. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Randomization until measured progressive disease (up to 26 months)
Time to Sustained Worsening of the "Worst Pain" as Measured by Worst Pain NRS (Between Arm A and Arm B)
Time Frame: Randomization through follow-up (up to 24 months)
Time to sustained worsening of worst pain is defined as the time from randomization to the first increase (≥2 points) in the weekly average of the worst pain score, with confirmation in the next consecutive week. It was measured by the Worst Pain Numeric Rating Scale (NRS). NRS is a single-item, participant-administered, 11-point horizontal scale ranging from 0 to 10, with 0 representing "no pain" and 10 representing "pain as bad as you can imagine." Participants not known to have sustained worsening will be censored at the last documented assessment.
Randomization through follow-up (up to 24 months)
Time to Sustained Worsening of the "Worst Pain" as Measured by Worst Pain NRS (Between Arm C and Arm A)
Time Frame: Randomization through follow-up (up to 20 months)
Time to sustained worsening of worst pain is defined as the time from randomization to the first increase (≥2 points) in the weekly average of the worst pain score, with confirmation in the next consecutive week. It was measured by the Worst Pain Numeric Rating Scale (NRS). NRS is a single-item, participant-administered, 11-point horizontal scale ranging from 0 to 10, with 0 representing "no pain" and 10 representing "pain as bad as you can imagine." Participants not known to have sustained worsening will be censored at the last documented assessment.
Randomization through follow-up (up to 20 months)
Pharmacokinetics (PK): Plasma Concentration of Imlunestrant
Time Frame: Cycle 1 Day 1 (within 2 to 4 hours post-dose), Cycle 2 Day 1 (Predose), Cycle 3 Day 1 (3 hours post-dose, 5 hours post-dose), Cycle 4 Day 1 (Predose)
  • Sampling timepoints for PK outcome analysis were relative to Imlunestrant dosing.
  • For Cycle 1 Day 1, sampling occurred at a "single" timepoint within the 2- to 4-hour window after Imlunestrant dosing, with the timepoint varying across analyzed participants.
Cycle 1 Day 1 (within 2 to 4 hours post-dose), Cycle 2 Day 1 (Predose), Cycle 3 Day 1 (3 hours post-dose, 5 hours post-dose), Cycle 4 Day 1 (Predose)
Pharmacokinetics (PK): Plasma Concentration of Total Abemaciclib
Time Frame: Cycle 1 Day 1 (within 2 to 4 hours post-dose), Cycle 2 Day 1 (Predose), Cycle 3 Day 1 (3 hours post-dose, 5 hours post-dose), Cycle 4 Day 1 (Predose)
  • Plasma concentration of total abemaciclib is the concentration of the parent abemaciclib and its metabolites in the plasma.
  • Sampling timepoints for PK outcome analysis were relative to Imlunestrant dosing.
  • For Cycle 1 Day 1, sampling occurred at a "single" timepoint within the 2- to 4-hour window after Imlunestrant dosing, with the timepoint varying across analyzed participants.
Cycle 1 Day 1 (within 2 to 4 hours post-dose), Cycle 2 Day 1 (Predose), Cycle 3 Day 1 (3 hours post-dose, 5 hours post-dose), Cycle 4 Day 1 (Predose)
Overall Survival (OS) in the ITT Population
Time Frame: Randomization until death from any cause (estimated as up to 5 years)
OS in the ITT population
Randomization until death from any cause (estimated as up to 5 years)
Blinded Independent Review Committee (BIRC) Assessed PFS in the ESR1-Mutation Detected Population (Between Arm A and Arm B)
Time Frame: Randomization to the date of first documented progression of disease or death from any cause (up to 28 months)
PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
Randomization to the date of first documented progression of disease or death from any cause (up to 28 months)
Percentage of Participants With Investigator-assessed Objective Response Rate (ORR) in the ESR1-Mutation Detected Population (Between Arm A and Arm B)
Time Frame: Randomization until measured progressive disease (up to 28 months)
ORR was the best confirmed overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
Randomization until measured progressive disease (up to 28 months)
Investigator-assessed Duration of Response (DoR) in the ESR1-Mutation Detected Population (Between Arm A and Arm B)
Time Frame: From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 24 Months)
DoR is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 24 Months)
Percentage of Participants With Investigator-assessed Clinical Benefit Rate (CBR) in the ESR1-Mutation Detected Population (Between Arm A and Arm B)
Time Frame: Randomization until measured progressive disease (up to 28 months)
CBR was the best confirmed overall tumor response of stable disease (SD) for greater than or equal to (≥) 24 weeks, CR or PR as defined by RECIST v1.1. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Randomization until measured progressive disease (up to 28 months)

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 (Actual)

June 24, 2024

Study Completion (Estimated)

August 1, 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)

July 11, 2025

Last Update Submitted That Met QC Criteria

July 9, 2025

Last Verified

July 1, 2025

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)
  • 2023-506786-63-00 (Ctis)

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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