Breast NeoplasmsPhase 3EMBER-4NCT05514054
A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer
A Phase 3 study testing Imlunestrant, Tamoxifen and Anastrozole in people with Breast Neoplasms, run by Eli Lilly and Company at 672 sites in 31 countries.
Trial summary
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Imlunestrant, Tamoxifen and Anastrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,000 participants
- Where
- 672 sitesin 31 countries
- Study dates
- 4 Oct 2022to Mar 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without evidence of distant metastasis.
- Participants must have received at least 24 months but not more than 60 months of any adjuvant ET, from time of adjuvant ET initiation.
- Participants may have received (neo) adjuvant chemotherapy and/or targeted therapy with a CDK4/6- or PARP- inhibitor.
- Must have an increased risk of disease recurrence based on clinical-pathological risk features.
- Have a Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group scale.
- Have adequate organ function.
Who cannot join
- Have any evidence of metastatic disease (including contralateral ALN) or inflammatory breast cancer at primary breast cancer diagnosis.
- Participants with more than a 6-month consecutive gap in therapy during the course of prior adjuvant ET.
- Participants who have completed or discontinued prior adjuvant ET >6 months prior to screening.
- Participants with a history of previous breast cancer are excluded, with the exception of ipsilateral DCIS treated by locoregional therapy alone ≥5 years ago.
- Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after the last dose of study intervention.
- Participant has previously received ET of any duration for breast cancer prevention (tamoxifen or AIs) or raloxifene.
- Participants with a history of any other cancer.
- Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study.
Trial locations and contacts
672 sites in 31 countries.
672 sites in 31 countries
United States137 sites
New York Oncology Hematology Associate
Albany, New York, 12206
New Mexico Oncology Hematology Consultants Ltd.
Albuquerque, New Mexico, 87109
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87131
AdventHealth Altamonte Springs
Altamonte Springs, Florida, 32701
Messino Cancer Center
Asheville, North Carolina, 28806
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
Northside Hospital
Atlanta, Georgia, 30342
Anschutz Cancer Pavilion
Aurora, Colorado, 80045
USO - Texas Oncology
Austin, Texas, 78731
UCSF - John Muir Health Cancer Center Berkeley
Berkeley, California, 94702
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Maimonides Cancer Center
Brooklyn, New York, 11220
NYU Langone Health - Brooklyn
Brooklyn, New York, 11220
MD Anderson Cancer Center at Cooper
Camden, New Jersey, 08103
Aultman Hospital
Canton, Ohio, 44710
University of Virginia Health System
Charlottesville, Virginia, 22908
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of Illinois at Chicago
Chicago, Illinois, 60612
USO - Oncology Hematology Care
Cincinnati, Ohio, 45242
UCHealth Memorial Hospital
Colorado Springs, Colorado, 80909
University of Missouri Hospital
Columbia, Missouri, 65212
Good Samaritan Regional Medical Center
Corvallis, Oregon, 97330
Ochsner Clinic Foundation
Covington, Louisiana, 70433
USO - Texas Oncology
Dallas, Texas, 75231
USO - Texas Oncology
Dallas, Texas, 75246
Mass General/North Shore Cancer Center
Danvers, Massachusetts, 01923
USO - Southern Cancer Center
Daphne, Alabama, 36526
USO - Texas Oncology
Denison, Texas, 75020
Astera Cancer Care
East Brunswick, New Jersey, 08816
M Health Fairview Cancer Clinic -Edina
Edina, Minnesota, 55435
Texas Oncology - West Texas
El Paso, Texas, 79902
William Beaumont Army Medical Center
El Paso, Texas, 79918
USO - Oncology Associates of Oregon
Eugene, Oregon, 97401
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Southcoast Centers for Cancer Care
Fairhaven, Massachusetts, 02719
USO - Texas Oncology
Flower Mound, Texas, 75028
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, 22060
UCHealth Harmony
Fort Collins, Colorado, 80528
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
John Peter Smith Hospital
Fort Worth, Texas, 76104
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104
USO - Texas Oncology
Fort Worth, Texas, 76104
Dana-Farber Cancer Institute - Foxborough
Foxborough, Massachusetts, 02035
USO - Texas Oncology
Fredericksburg, Texas, 78624
Washington Health
Fremont, California, 94538
The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee, 38138
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
USO - Arizona Oncology Associates - HAL
Glendale, Arizona, 85308
Banner MD Anderson Cancer Center at North Colorado Medical Center
Greeley, Colorado, 80631
St Francis Cancer Center
Greenville, South Carolina, 29607
Pontchartrain Cancer Center
Hammond, Louisiana, 70403
Memorial Regional Hospital
Hollywood, Florida, 33021
Millennium Oncology Research Clinic
Hollywood, Florida, 33024
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
USO - Alliance Cancer Specialists, PC
Horsham, Pennsylvania, 19044
Clearview Cancer Institute
Huntsville, Alabama, 35805
Chao Family Comprehensive Cancer Center and Ambulatory Care (CIACC) - Irvine
Irvine, California, 92612
Mayo Clinic in Florida
Jacksonville, Florida, 32224
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
R.J. Zuckerberg Cancer Center
Lake Success, New York, 11042
USO - Rocky Mountain Cancer Centers
Lakewood, Colorado, 80228
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Regional Cancer Care Associates
Little Silver, New Jersey, 07739
Loma Linda University Cancer Center
Loma Linda, California, 92350-1700
Dana-Farber - New Hampshire Oncology/Hematology
Londonderry, New Hampshire, 03053
Banner MD Anderson Cancer Center at McKee Medical Center
Loveland, Colorado, 80538
USO - Texas Oncology
McAllen, Texas, 78503
Dana-Farber Cancer Institute - Merrimack Valley
Methuen, Massachusetts, 01844
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176
Bon Secours St. Francis Medical Center
Midlothian, Virginia, 23114
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center
Milford, Massachusetts, 01757
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, 11501
USO - Minnesota Oncology Hematology
Minneapolis, Minnesota, 55404
Allina Health Cancer Institute
Minneapolis, Minnesota, 55407
Infirmary Cancer Care
Mobile, Alabama, 36607
Pacific Cancer Care
Monterey, California, 93940
Northern Westchester Hospital
Mount Kisco, New York, 10549
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Yale-New Haven Hospital
New Haven, Connecticut, 06510
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Laura and Isaac Perlmutter Cancer Center
New York, New York, 10016
NYC Health + Hospitals / Bellevue
New York, New York, 10016
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Mass General Cancer Center at Newton-Wellesley
Newton, Massachusetts, 02462
USO - Virginia Oncology Associates
Norfolk, Virginia, 23502
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
St. Joseph Hospital
Orange, California, 92868
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Orange, California, 92868
USO - Cancer Care Centers of Brevard
Palm Bay, Florida, 32901
Capital Health Medical Center - Hopewell
Pennington, New Jersey, 08534
USO - Woodlands Medical Specialists
Pensacola, Florida, 32503
Illinois Cancer Care
Peoria, Illinois, 61615
Thomas Jefferson University - Clinical Research Institute
Philadelphia, Pennsylvania, 19107
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85004
Mayo Clinic in Arizona - Phoenix
Phoenix, Arizona, 85054
USO - Texas Oncology
Plano, Texas, 75075
Miami Cancer Institute - Plantation
Plantation, Florida, 33324
Oregon Health and Science University
Portland, Oregon, 97239
Lifespan Cancer Institute
Providence, Rhode Island, 02906
Queens Medical Associates
Queens, New York, 11374
USO - Virginia Cancer Specialists
Reston, Virginia, 20190
USO - Oncology & Hematology Associates of Southwest Virginia
Roanoke, Virginia, 24014
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, 55905
University of Rochester - Wilmot Cancer Institute
Rochester, New York, 14642
Scott & White Hospital - Round Rock
Round Rock, Texas, 78665
University of California Davis (UC Davis) Comprehensive Cancer Center
Sacramento, California, 95817
Mays Cancer Center
San Antonio, Texas, 78229
Kaiser Permanente San Diego Mission Road
San Diego, California, 92108
Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, 94110
UCSF Medical Center at Mission Bay
San Francisco, California, 94158
Summit Cancer Care, PC
Savannah, Georgia, 31405
Phelps Hospital
Sleepy Hollow, New York, 10591
Dana-Farber/Brigham and Women's Cancer Center - South Shore Hospital
South Weymouth, Massachusetts, 02190
Highlands Oncology Group
Springdale, Arkansas, 72762
Simmons Cancer Institute at SIU
Springfield, Illinois, 62702
Washington University School of Medicine
St Louis, Missouri, 63108
Staten Island University Hospital
Staten Island, New York, 10305
Saint Joseph's Medical Center
Stockton, California, 95204
Tampa General Hospital
Tampa, Florida, 33606
Baylor Scott & White Medical Center - Temple
Temple, Texas, 76508
US Oncology Research Network
The Woodlands, Texas, 77380
USO - Compass Oncology
Tigard, Oregon, 97223
Mercy Health - St. Vincent Medical Center
Toledo, Ohio, 43608
TMC HealthCare
Tucson, Arizona, 85711
The University of Arizona Cancer Center - North Campus
Tucson, Arizona, 85719
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
USO - Texas Oncology
Webster, Texas, 77598
Clinical Research Alliance
Westbury, New York, 11590
The University of Kansas Cancer Center - Westwood
Westwood, Kansas, 66205
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
York Hospital
York Village, Maine, 03909
China51 sites
Anyang Cancer Hospital
Anyang, 455000
Affiliated Hospital of Hebei University
Baoding, 071000
Beijing Hospital
Beijing, 100005
Cancer Hospital Chinese Academy of Medical Science
Beijing, 100021
Peking University People's Hospital
Beijing, 100034
Beijing Friendship Hospital Affiliate of Capital University
Beijing, 100050
The First Hospital of Jilin University
Changchun, 130021
The First People's Hospital of Changde City
Changde, 415003
Xiangya Hospital Central South University
Changsha, 410008
Hunan Cancer Hospital
Changsha, 421000
Sichuan Cancer hospital
Chengdu, 610042
Deyang City People's Hospital
Deyang, 618000
Dongguan People's Hospital
Dongguan, 523059
Shunde Hospital of Southern Medical Univesity
Foshan, 528399
Fujian Medical University Union Hospital-1 Bingfanglou
Fuzhou, 350001
The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army
Fuzhou, 350025
Sun Yat-sen University Cancer Center
Guangzhou, 510060
Guangdong Maternity and Child Health Care Hospital
Guangzhou, 511400
Hainan General Hospital
Haikou, 570311
The First People's Hospital of Hangzhou
Hangzhou, 310000
Zhejiang Provincial People's Hospital
Hangzhou, 310014
Zhejiang Cancer Hospital
Hangzhou, 310022
First Huai'an Hospital Affiliated to Nanjing Medical University
Huai'an, 223300
Huizhou Municipal Central Hospital
Huizhou, 516001
Jiangmen Center Hospital
Jiangmen, 529000
Jinan Central Hospital
Jinan, 250013
Jining Medical University - Affiliated Hospital
Jining, 272100
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, 471003
The Third Hospital of Nanchang
Nanchang, 330009
Jiangsu Province Hospital
Nanjing, 210029
The Second People's Hospital of Neijiang
Neijiang, 641000
Hwa Mei Hospital University of Chinese Academy of Sciences
Ningbo, 315010
Ningbo First Hospital
Ningbo, 315010
Fudan University Shanghai Cancer Center
Shanghai, 200032
Cancer Hospital of Shantou University Medical College
Shantou, 515041
ShenZhen People's Hospital
Shenzhen, 518020
Shenzhen Second People's Hospital
Shenzhen, 518035
Cancer Hospital Chinese Academy of Medical Sciences. Shenzhen Center
Shenzhen
The First Affiliated Hospital of Soochow University
Suzhou, 215006
Tianjin Medical University Cancer Institute & Hospital
Tianjing, 300060
Xinjiang Medical University Cancer Hospital - Urumqi
Ürümqi, 830000
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430022
Renmin Hospital of Wuhan University
Wuhan, 430060
Hubei Cancer Hospital
Wuhan, 430079
Wannan Medical College Yijishan Hospital
Wuhu, 241001
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710061
Xiangyang Central Hospital
Xiangyang, 441021
The Central Hospital of Yongzhou - North Campus
Yongzhou, 425000
The First People's Hospital of Yueyang
Yueyang, 414000
Yuncheng Central Hospital - Eastern Hospital
Yuncheng, 044000
Central Hospital of Guangdong Provincial Agricutural Reclamation
Zhanjiang, 524002
Japan50 sites
Juntendo University Hospital
Bunkyō City, 113-8431
Chiba University Hospital
Chiba, 260-8677
Chiba cancer center
Chiba, 260-8717
St. Luke's International Hospital
Chūōku, 104-8560
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
Fukushima Medical University
Fukushima, 960-1295
Fukuyama City Hospital
Fukuyama, 721-8511
Gifu University Hospital
Gifu, 501-1194
Tokai University Hachioji Hospital
Hachioji-shi, 192-0032
Kansai Medical University Hospital
Hirakata, 573-1191
Hiroshima City Hospital
Hiroshima, 730-8518
Hiroshima University Hospital
Hiroshima, 734-8551
Shimane University Hospital
Izumo, 693-0021
Sagara Hospital
Kagoshima, 892-0833
Kameda Clinic
Kamogawa, 296-0041
Ishikawa Prefectural Central Hospital
Kanazawa, 920-8530
St. Marianna University Hospital
Kawasaki, 216-8511
Japanese Foundation for Cancer Research
Kōtō City, 135-8550
Kumamoto Breast Surgical Hospital
Kumamoto, 860-0812
Kumamoto Shinto General Hospital
Kumamoto, 862-8655
University Hospital,Kyoto Prefectural University of Medicine
Kyoto, 602-8566
Kyoto University Hospital
Kyoto, 606-8507
Shinshu University Hospital
Matsumoto, 390-8621
National Hospital Organization Shikoku Cancer Center
Matsuyama, 791-0280
Miyazaki Prefectural Miyazaki Hospital
Miyazaki, 880-8510
Kanazawa Medical University Hospital
Mukai-awagasaki, 920-0265
Nagoya University Hospital
Nagoya, 466-8560
Nagoya City University Hospital
Nagoya, 467-8602
Naha Nishi Clinic
Naha, 901-0154
Niigata Cancer Center Hospital
Niigata, 951-8566
Hyogo Medical University Hospital
Nishinomiya, 663-8501
Okayama University Hospital
Okayama, 700-8558
Nakagami Hospital Okinawa
Okinawa, 904-2195
National Hospital Organization - Osaka National Hospital - Institute For Clinical Research
Osaka, 540-0006
Gunma Prefectural Cancer Center
Otashi, 373-8550
Kitasato University Hospital
Sagamihara, 252-0375
Saitama Red Cross Hospital
Saitama, 330-8553
National Hospital Organization Hokkaido Cancer Center
Sapporo, 003-0804
Hokkaido University Hospital
Sapporo, 060-8648
Tohoku University Hospital
Sendai, 980-8574
Showa Medical University Hospital
Shinagawa City, 142-8555
National Center for Global Health and Medicine
Shinjyuku-ku, 162-8655
Shizuoka General Hospital
Shizuoka, 420-8527
National Hospital Organization Takasaki General Medical Center
Takasaki, 370-0829
Tokushima University Hospital
Tokushima, 770-8503
Tsukuba University Hospital
Tsukuba, 305-8576
Tochigi Cancer Center
Utsunomiya, 320-0834
Iwate Medical University Hospital
Yahaba-cho, Shiwa-gun, 028-3695
Yokohama City University Medical Center
Yokohama, 232-0024
Kanagawa cancer center
Yokohama, 2418515
Spain44 sites
CHUAC-Hospital Teresa Herrera
A Coruña, 15006
Hospital General Universitario de Alicante
Alicante, 03010
Hospital Universitario Torrecárdenas
Almería, 04009
Hospital Infanta Cristina
Badajoz, 06006
Parc de Salut Mar - Hospital del Mar
Barcelona, 08003
Hospital Quiron Barcelona
Barcelona, 08023
Hospital Universitari Dexeus
Barcelona, 08028
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Clínic de Barcelona
Barcelona, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Osi Bilbao-Basurto
Bilbao, 48013
Hospital Universitario de Burgos
Burgos, 09006
Hospital San Pedro de Alcántara
Cáceres, 10003
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120
Hospital Universitario Getafe
Getafe, 28905
Hospital Universitario San Cecilio
Granada, 18016
Complejo Hospitalario de Jaén
Jaén, 23007
Hospital Universitario Arnau de Vilanova de Lleida
Lleida, 25198
Hospital San Pedro
Logroño, 26006
Hospital Lucus Augusti
Lugo, 27003
Hospital La Princesa
Madrid, 28006
Hospital Beata María Ana
Madrid, 28007
Hospital General Universitario Gregorio Marañon
Madrid, 28009
Hospital Universitario Infanta Leonor
Madrid, 28031
Hospital Ruber Internacional
Madrid, 28034
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Clinico San Carlos
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
H.R.U Málaga - Hospital Materno-infantil
Málaga, 29011
Hospital Vithas Málaga
Málaga, 29016
Hospital Universitari Son Espases
Palma, 07120
Complejo Hospitalario de Navarra
Pamplona, 31009
Hospital Universitari Sant Joan de Reus
Reus, 43204
Hospital Universitario de Canarias
San Cristóbal de La Laguna, 38320
Hospital Universitari General de Catalunya
Sant Cugat del Vallès, 08915
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, 38010
Hospital Universitario Virgen Macarena
Seville, 41009
Hospital Universitario Virgen Del Rocio
Seville, 41013
Hospital Universitario de Toledo
Toledo, 45007
Hospital Clinico de Valencia
Valencia, 46010
Hospital Quirónsalud Valencia
Valencia, 46010
Hospital Clínico Universitario de Valladolid
Valladolid, 47003
Hospital Clínico Universitario Lozano Blesa
Zaragoza, 50009
Brazil36 sites
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, 14784400
CTO - Centro de Tratamento Oncológico
Belém, 66063-495
Oncocentro de Minas Gerais
Belo Horizonte, 30180-060
Hospital Sirio Libanes
Brasília, 70200-730
Centro Integrado de Oncologia de Curitiba
Curitiba, 80810050
Centro de Pesquisa Clínica do Instituto do Câncer do Ceará
Fortaleza, 60430230
Hospital Araújo Jorge
Goiânia, 74605070
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
Ijuí, 98700-000
Hospital de Cancer de Londrina
Londrina, 86015-520
Hospital Moinhos de Vento
Porto Alegre, 90035001
Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa
Porto Alegre, 90110-270
Hospital São Lucas da PUCRS
Porto Alegre, 90610-000
Hospital de Amor Amazônia
Porto Velho, 76834-899
Multihemo
Recife, 50070-170
Hospital de Clínicas de Ribeirão Preto
Ribeirão Preto, 14051-140
Instituto Nacional de Câncer - INCA
Rio de Janeiro, 20560121
Hospital São Lucas de Copacabana
Rio de Janeiro, 22061-080
Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA
Rio de Janeiro, 22250-905
Instituto de Educação, Pesquisa e Gestão em Saúde
Rio de Janeiro, 22793080
Nucleo de Oncologia da Bahia
Salvador, 40170-110
Faculdade de Medicina do ABC
Santo André, 09060-650
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, 15090000
IPITEC
São Paulo, 01221-020
NotreDame Intermedica Saude S.A
São Paulo, 01229-010
Instituto de Ensino e Pesquisa São Lucas
São Paulo, 01236030
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, 01246-000
Hospital Sírio Libanês
São Paulo, 01308-060
Clínica de Pesquisa e Centro de Estudos em Ginecologia Oncológica e Mamária LTDA
São Paulo, 01317-001
Hospital BP
São Paulo, 01321-001
Hospital Alemao Oswaldo Cruz
São Paulo, 01327-001
A. C. Camargo Cancer Center
São Paulo, 01509-010
Núcleo de Pesquisa Clínica da Rede São Camilo
São Paulo, 04014-002
Instituto de Assistência Médica ao Servidor Público Estadual - IAMSPE/HSPE-FMO Conhecer Centro de Oncolog -T
São Paulo, 04039-901
Instituto D'Or de Pesquisa e Ensino (IDOR)
São Paulo, 04543-000
Hospital Santa Paula
São Paulo, 04556-100
CEDOES
Vitória, 29055450
France34 sites
Sainte Catherine Institut du Cancer Avignon Provence
Avignon, 84918
Centre Hospitalier de la Côte Basque
Bayonne, 64109
CHU Besançon
Besançon, 25000
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, 33076
CHRU de Brest
Brest, 29609
Pole Santé République
Clermont-Ferrand, 63050
Henri Mondor Hospital
Créteil
Polyclinique De Blois
La Chaussée-Saint-Victor, 41260
CHD Vendee
La Roche-sur-Yon, 85000
Groupe Hospitalier La Rochelle-Ré-Aunis - Hôpital Saint Louis
La Rochelle, 17019
Chu Grenoble Alpes
La Tronche, 38700
Clinique Victor Hugo Le Mans
Le Mans, 72000
Clinique Francois Chenieux
Limoges, 87039
Hopital Prive Jean Mermoz
Lyon, 69008
Centre Hospitalier Régional Metz Thionville - Hôpital de Mercy
Metz, 57085
Centre Hospitalier Intercommunal de Mont-de-Marsan et du Pays des Sources
Mont-de-Marsan, 40024
Centre de Cancérologie du Grand Montpellier
Montpellier, 34070
Polyclinique de Gentilly
Nancy, 54100
Centre Antoine-Lacassagne
Nice, 06189
Hôpital Saint-Louis
Paris, 75010
Groupe hospitalier Paris saint Joseph
Paris, 75014
Hôpital Européen Georges Pompidou
Paris, 75015
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, 75020
Institut Curie
Paris, 75248
Hôpital Tenon
Paris, 75970
Centre Hospitalier de Pau
Pau, 64000
Centre Catalan d'Oncologie
Perpignan, 66000
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021
Institut Jean Godinot
Reims, 51726
Institut Curie - site Saint-Cloud
Saint-Cloud, 92210
Centre Hospitalier Privé Saint-Grégoire
Saint-Grégoire, 35768
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44805
Centre de cancérologie des Dentellières
Valenciennes, 59300
Institut de Cancérologie de Lorraine Alexis Vautrin
Vandœuvre-lès-Nancy, 54519
Germany34 sites
Gemeinschaftspraxis hop-augsburg
Augsburg, 86150
Universitaetsklinikum Augsburg
Augsburg, 86156
Praxisklinik Krebsheilkunde fur Frauen
Berlin, 10367
Onkologische Schwerpunktpraxis Kurfuerstendamm
Berlin, 10707
Helios Klinikum Berlin-Buch
Berlin, 13125
Marienhospital Bottrop
Bottrop, 46236
Universitaetsklinikum Koeln
Cologne, 50937
Städtisches Klinikum Dessau
Dessau, 06847
Onkologiezentrum Donauwörth
Donauwörth, 86609
St.-Johannes-Hospital Dortmund
Dortmund, 44137
MVZ Medical Center Düsseldorf GmbH
Düsseldorf, 40235
Universitaetsklinikum Erlangen
Erlangen, 91054
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung
Essen, 45136
Agaplesion Markus Krankenhaus
Frankfurt, 60431
Universitaetsklinikum Freiburg
Freiburg im Breisgau, 79106
Private Practice - Dr. Helmut Oettle und Prof.Dr.med. Frank Mayer
Friedrichshafen, 88045
SRH Wald-Klinikum Gera
Gera, 07548
OSP Göttingen
Göttingen, 37073
St. Anna Hospital
Herne, 44649
Universitaetsklinikum des Saarlandes
Homburg, 66421
Klinikverbund Allgäu gGmbH
Kempten, 87439
Universitaetsklinikum Schleswig-Holstein Campus Kiel
Kiel, 24105
Zentrum fuer ambulante gynaekologische Onkologie (ZAGO)
Krefeld, 47805
Universitätsmedizin Mannheim
Mannheim, 68167
Onkologisch-hämatologisches Forschungsinstitut am Habsburgring
Mayen, 56727
Klinikum der Ludwig-Maximilians-Universitaet Muenchen
München, 80336
Klinikum Ernst von Bergmann
Potsdam, 14467
HELIOS Kliniken Schwerin
Schwerin, 19055
Robert-Bosch-Krankenhaus
Stuttgart, 70376
SRH Zentralklinikum Suhl
Suhl, 98527
Klinikum Mutterhaus der Borromäerinnen
Trier, 54290
Universitaetsklinikum Tuebingen
Tübingen, 72076
Universitaetsklinikum Ulm
Ulm, 89075
Helios HSK Wiesbaden
Wiesbaden, 65199
Turkey (Türkiye)25 sites
Adana Medical Park Seyhan Hastanesi
Adana, 01140
Adana City Hospital
Adana, 01370
Sakarya Training and Research Hospital
Adapazarı, 54290
Hacettepe Universitesi
Altindağ, 06230
Ankara Gülhane Eitim ve Aratrma Hastanesi
Ankara, 06010
Ankara Etlik City Hospital
Ankara, 06170
Memorial Ankara Hastanesi
Ankara, 06520
Ankara Bilkent Şehir Hastanesi
Ankara, 06800
Akdeniz Universitesi Hastanesi
Antalya, 07059
Antalya Egitim ve Arastırma Hastanesi
Antalya, 07100
Uludag Universitesi
Bursa, 16059
Dicle Üniversitesi
Diyarbakır, 21200
Trakya University Medical Faculty Hospital
Edirne, 22030
Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
Gaziantep, 27310
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul, 34722
Marmara Universitesi Pendik Egitim Arastirma Hastanesi
Istanbul, Pendik, 34899
Ege Universitesi Hastanesi
Izmir, 35100
zmir Katip Çelebi Üniversitesi Atatürk Eitim Ve Aratrma Hastanesi
Izmir, 35360
Izmir Medical Park Hospital
Izmir, Karsiyaka, 009035575
Kocaeli Üniversitesi
Kocaeli, 41380
İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi
Malatya, 44280
Mersin University
Mersin, 33110
Mugla Sitki Kocman Universitesi Egitim ve Arastirma Hastanesi
Muğla, 48000
Ondokuz Mayıs Universitesi
Samsun, 55270
Medipol Mega Universite Hastanesi
Stanbul, 34214
Australia22 sites
Ballarat Health Services
Ballarat Central, 3350
Box Hill Hospital
Box Hill, 3128
Monash Health
Clayton, 3168
Coffs Harbour Health Campus
Coffs Harbour, 2450
St Vincent's Hospital
Darlinghurst, 2010
Barwon Health
Geelong, 3220
Royal Hobart Hospital
Hobart, 7000
Launceston General Hospital
Launceston, 7250
Liverpool Hospital
Liverpool, 2170
Mackay Base Hospital
Mackay, 4740
St Vincent's Hospital
Melbourne, 3065
Northern Hospital
Melbourne, 3076
Maroondah Hospital
Melbourne, 3135
Breast Cancer Research Centre-WA
Nedlands, 6009
Lake Macquarie Private Hospital
Newcastle, 2290
Goulburn Valley Health
Shepparton, 3630
Gold Coast University Hospital
Southport, 4215
Mater Hospital Sydney
Sydney, 2060
Royal Darwin Hospital
Tiwi, 0810
The Townsville Hospital
Townsville, 4814
Hervey Bay Hospital
Urraween, 4655
The Queen Elizabeth Hospital
Woodville, 5011
South Korea21 sites
Dongnam Institute of Radiological and Medical Sciences
Busan, 46033
Soon Chun Hyang University Cheonan Hospital
Cheonan-si, 31151
Chungbuk National University Hospital
Cheongju-si, 28644
Kyungpook National University Chilgok Hospital
Daegu, 41404
National Cancer Center
Goyang-si, 10408
Yeungnam Univeristy Medical Center
Gyeongsan-si, 42415
Chonnam National University Hwasun Hospital
Hwasun-gun, 58128
Inha University Hospital
Incheon, 22332
Gachon University Gil Medical Center
Namdong-gu, 21565
Seoul National University Bundang Hospital
Seongnam, 13620
CHA Bundang Medical Center, CHA University
Seongnam-si, 13496
Korea University Anam Hospital
Seoul, 02841
Seoul National University Hospital
Seoul, 03080
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Gangnam Severance Hospital
Seoul, 06273
Samsung Medical Center
Seoul, 06351
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, 06591
Korea University Guro Hospital
Seoul, 08308
Ajou University Hospital
Suwon, 16499
Ulsan University Hospital
Ulsan, 44033
Argentina20 sites
Centro de Oncología e Investigación de Buenos Aires
Berazategui, B1884BBF
Centro de Investigaciones Medicas y Desarrollo LC
Buenos Aires, 1113
Investigaciones Clinicas Moleculares (ICM)
Buenos Aires, 1425
Centro Oncologico Korben
Buenos Aires, 1426
CIPREC
Buenos Aires, C1061
Mautalen Salud e Investigación
Buenos Aires, C1128AAF
Fundación Respirar
Buenos Aires, C1426ABP
Instituto Alexander Fleming
Buenos Aires, C1426ANZ
Clinica Adventista Belgrano
CABA, C1430EGF
Centro Medico Privado CEMAIC
Capital, X5008HHW
Fundación CORI para la Investigación y Prevención del Cáncer
La Rioja, F5300COE
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata, B7600FZO
Fundacion Scherbovsky
Mendoza, 5500
Instituto Médico Río Cuarto
Río Cuarto, 5800
Fundacion Estudios Clinicos
Rosario, S2000DEJ
Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan
San Juan, 5400
Instituto San Marcos
San Juan, 5400
Exelsus Oncología Clínica
San Miguel de Tucumán, 4000
Go Centro Medico San Nicolás
San Nicolás, 2900
Clinica Viedma S. A
Viedma, R8500ACE
Italy20 sites
Aou Ospedali Riuniti Umberto I
Ancona, 60126
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, 24127
IRCCS - AOU di Bologna
Bologna, 40138
Ospedale Antonio Perrino
Brindisi, 72100
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
Candiolo, 10060
Azienda Ospedaliera Universitaria Careggi
Florence, 50134
Ospedale San Martino
Genova, 16132
Istituto Europeo di Oncologia IRCCS
Milan, 20141
Humanitas Istituto Clinico Catanese
Misterbianco, 95045
Azienda Ospedaliero Universitaria
Modena, 41125
Ospedale San Gerardo-ASST Monza
Monza, 20900
University of Naples Federico II
Naples, 80100
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Naples, 80131
Istituto Oncologico Veneto IRCCS
Padova, 35128
Azienda Ospedaliero Universitaria di Parma
Parma, 43126
Ospedale Generale Provinciale Macerata
Province of Macerata, 62100
Istituto Nazionale Tumori Regina Elena
Rome, 00144
Humanitas
Rozzano, 20089
Ospedale San Giovanni Moscati
Statte, 74100
Azienda Ospedaliera Santa Maria Terni
Terni, 05100
India18 sites
Hemato Oncology Clinic
Ahmedabad, 380054
KD Hospital
Ahmedabad, 382421
Medstar Speciality Hospital
Bangalore, 560092
KLES Dr. Prabhakar Kore Hospital & M.R.C
Belagavi, 590010
All India Institute of Medical Sciences
Bhubaneswar, 751019
Postgraduate Institute of Medical Education & Research
Chandigarh, 160012
Cancer Institute (WIA)
Chennai, 600036
Nizam's Institute of Medical Sciences
Hyderabad, 500082
Regency Hospital
Kanpur, 208005
Krishna Institute of Medical Sciences - Karad
Karad, 415539
Kolhapur Cancer Centre Private Limited
Kolhāpur, 416234
Tata Memorial Hospital
Mumbai, 400012
Rashtrasant Tukdoji Regional Cancer Hospital
Nagpur, 440027
Delhi State Cancer Institute
New Delhi, 110095
Grant Medical Foundation - Ruby Hall Clinic
Pune, 411001
Lifepoint Multispeciality Hospital
Pune, 411057
Regional Cancer Centre - Thiruvananthapuram
Thiruvananthapuram, 695011
Mahatma Gandhi Cancer Hospital and Research Institute
Visakhapatnam, 530017
Mexico18 sites
Scientia Investigacion Clinica S.C.
Chihuahua City, 31207
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
Ciudad Madero, 89440
CIO - Centro de Inmuno-Oncología de Occidente
Guadalajara, 44630
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara, 44650
Preparaciones Oncologicas
León, 37178
CENEIT Oncológicos. Centro Especializado en Investigación y Tratamientos Oncológicos
Mexico City, 03100
Grupo Medico Camino Sc
Mexico City, 03310
Axis Heilsa S. de R.L. de C.V.
Monterrey, 64040
Centro Regiomontano de Investigación
Monterrey, 64060
Filios Alta Medicina
Monterrey, 64460
Oaxaca Site Management Organization
Oaxaca City, 68000
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, 68020
Unidad Médica Onco-hematológica
Puebla City, 72424
PanAmerican Clinical Research - Querétaro - Avenida Antea
Querétaro, 76100
Oncologico Potosino, S.C.
San Luis Potosí City, 78209
Centro Medico Zambrano Hellion
San Pedro Garza García, 66278
Hospital Angeles
Tijuana, 22010
Centro Oncologico Estatal ISSEMyM ( COEI )
Toluca, 50180
Belgium17 sites
Institut Jules Bordet
Anderlecht, 1070
CHIREC - site delta
Auderghem, 1160
CHU Saint-Pierre
Brussels, 1000
Centre Hospitalier Universitaire Brugmann
Brussels, 1020
Cliniques universitaires Saint-Luc
Brussels, 1200
Grand Hôpital de Charleroi
Charleroi, 6000
Jessa Ziekenhuis
Hasselt, 3500
Jan Yperman Ziekenhuis
Ieper, 8900
AZ Groeninge Campus Kennedylaan
Kortrijk, 8500
Groupe Jolimont
La Louvière, 7100
UZ Leuven
Leuven, 3000
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège, 4000
CHU UCL Namur/Site Sainte Elisabeth
Namur, 5000
AZ Oostende vzw
Ostend, 8400
Clinique Saint Pierre
Ottignies, 1340
AZ Nikolaas
Sint-Niklaas, B-9100
CHR Verviers - La Tourelle
Verviers, 4800
Greece14 sites
Agios Savvas Regional Cancer Hospital
Athens, 115 22
Alexandra Hospital
Athens, 115 28
IASO Obstetrics - Gynecology Clinic
Athens, 151 23
Iaso Private General Obstetrics Gynecological & Pediatric Clinic Diagnostic Therapeutic & Research Center -T
Athens, 151 23
Attikon General University Hospital
Chaïdári, 12462
University General Hospital of Heraklion
Heraklion, 711 10
University Hospital of Ioannina
Ioannina, 455 00
University General Hospital of Larissa
Larissa, 41110
General Oncology Hospital of Kifissia "Agioi Anargiroi"
Nea Kifissia, 145 64
Olympion General Clinic
Pátrai, 26443
University Hospital of Patras
Pátrai, 26504
BioClinic Thessaloniki
Thessaloniki, 546 22
Agios Loukas Clinic
Thessaloniki, 552 36
European Interbalkan Medical Center
Thessaloniki, 570 01
United Kingdom13 sites
Colchester General Hospital
Colchester, CO4 5JL
Hairmyres Hospital
East Kilbride, Glasgow, G75 8RG
Western General Hospital
Edinburgh, EH4 2XU
Clatterbridge Cancer Centre - Liverpool
Liverpool, L7 8YA
St Bartholomew's Hospital
London, EC1A 7BE
The Christie NHS Foundation Trust
Manchester, M20 4BX
Mount Vernon Hospital
Northwood, HA6 2RN
Derriford Hospital
Plymouth, Pl6 8DH
Panthera Biopartners - Preston
Preston, PR2 9QB
Royal Berkshire Hospital
Reading, RG1 5AN
Panthera Biopartners - Manchester
Rochdale, OL11 4AU
Lister Hospital
Stevenage, SG1 4AB
Oncology Research
Wigan, WN1 2NN
Netherlands11 sites
Wilhelmina Ziekenhuis Assen
Assen, 9401 RK
Amphia Ziekenhuis, locatie Breda Molengracht
Breda, 4818 CK
Reinier de Graaf Ziekenhuis, locatie Delft
Delft, 2625 AD
Deventer Ziekenhuis
Deventer, 7416 SE
Albert Schweitzer Ziekenhuis, locatie Dordwijk
Dordrecht, 3318 AT
Ziekenhuisgroep Twente, locatie Almelo
Hengelo, 7555 DL Hengelo
Spaarne Gasthuis - Hoofddorp
Hoofddorp, 2134 TM
Maastricht UMC+
Maastricht, 6229 HX
Haga Ziekenhuis locatie Leyweg
The Hague, 2545 AA
VieCuri Medisch Centrum, locatie Venlo
Venlo, 5912 BL
Zaans Medisch Centrum
Zaandam, 1502 DV
Romania11 sites
C.M.D.T.A. Neomed
Brasov, 500283
Onco Medint Srl
Bucharest, 010644
Lotus-Med
Bucharest, 012292
SC Memorial Healthcare International SRL
Bucharest, 013812
Spitalul Clinic Colțea
Bucharest, 030171
Gral Medical Diagnostic Center
Bucharest, 031422
Institutul Oncologic Cluj
Cluj-Napoca, 400015
Centrul de Oncologie "Sfântul Nectarie"
Craiova, 200542
Radiology Therapeutic Center
Otopeni, 075100
Ovidius Clinical Hospital OCH
Ovidiu, 905900
S C Oncocenter Oncologie Clinica S R L
Timișoara, 300166
Taiwan11 sites
Changhua Christian Hospital
Changhua County, 50006
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Taipei Tzu Chi General Hospital
New Taipei City, 231
Taichung Veterans General Hospital
Taichung, 407219
National Cheng Kung University Hospital
Tainan, 704
Chi Mei Hospital - Liouying Branch
Tainan, 73657
National Taiwan University Hospital
Taipei, 10002
Mackay Memorial Hospital
Taipei, 10449
Taipei Veterans General Hospital
Taipei, 11217
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, 112
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
Canada9 sites
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, T2N 5G2
Victoria Hospital & Children's Hospital - London Health Sciences Centre
London, N6A 5W9
Centre Hospitalier de l'Université de Montréal
Montreal, H2X 3E4
Jewish General Hospital
Montreal, H3T 1E2
Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSSS NÎM) - H -T
Montreal, H4J 1C5
CHU de Québec-Université Laval, Hôpital du Saint-Sacrement
Québec, G1S 4L8
BC Cancer Surrey
Surrey, V3V 1Z2
Humber River Hospital
Toronto, M3M 0B2
Sunnybrook Research Institute
Toronto, M4N 3M5
Ireland9 sites
Bon Secours Cork Hospital
Cork, T12 DV56
Cork University Hospital
Cork, T12 E8YV
St. Vincent's University Hospital
Dublin, D04 N2E0
St. James's Hospital
Dublin, D08 E9P6
UCD School of Medicine Beacon Hospital
Dublin, D18 AK68
Beaumont Hospital, Dublin
Dublin, D9
Galway University Hospital
Galway, H91 YR71
Sligo General Hospital
Sligo, F91 H684
Waterford Regional Hospital
Waterford, X91 ER8E
Poland9 sites
Szpitale Pomorskie Sp. z o. o.
Gdynia, 81-519
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie
Koszalin, 75-581
Salve Medica
Lodz, 91-211
Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego
Opole, 45-061
FORMED2
Oświęcim, 32-600
Mazowiecki Szpital Wojewódzki w Siedlcach
Siedlce, 08-110
MICS Centrum Medyczne Torun
Torun, 87-100
Luxmed Onkologia sp. z o. o.
Warsaw, 01-748
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
Warsaw, 02-781
Czechia8 sites
Masarykuv onkologicky ustav
Brno, 656 53
Nemocnice Horovice
Hořovice, 268 31
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05
Fakultni nemocnice Ostrava
Ostrava, 708 52
Multiscan
Pardubice, 53203
Fakultni Thomayerova nemocnice
Prague, 14059
Fakultni nemocnice Motol
Prague, 150 06
Fakultni nemocnice Bulovka
Prague, 180 81
Israel8 sites
Carmel Hospital
Haifa, 3436212
Shaare Zedek Medical Center
Jerusalem, 9013102
Hadassah Medical Center
Jerusalem, 9112001
Meir Medical Center
Kfar Saba, 4428164
Rabin Medical Center
Petah Tikva, 4941492
Sheba Medical Center
Ramat Gan, 5265601
Sourasky Medical Center
Tel Aviv, 6423906
Yitzhak Shamir Medical Center
Tsrifin, 70300
Austria6 sites
Medizinische Universität Graz
Graz, 8036
Uniklinikum Salzburg
Salzburg, 5020
Private Practice - Dr. Hubalek
Schwaz, 6130
Medizinische Universität Wien
Vienna, 1090
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, 1090
Klinik Hietzing
Vienna, 1130
Portugal6 sites
Hopital Garcia de Orta
Almada, 2805-267
Champalimaud Foundation
Lisbon, 1400-038
Hospital da Luz Lisboa
Lisbon, 1500-650
Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon, 1649-035
Hospital Beatriz Ângelo
Lisbon, 2674-514
Centro Hospitalar de Vila Nova de Gaia/Espinho - Unidade I
Vila Nova de Gaia, 4434-502
Hungary5 sites
Országos Onkológiai Intézet
Budapest, 1122
Uzsoki Utcai Kórház
Budapest, 1145
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
Bacs-Kiskun Megyei Korhaz
Kecskemét, 6000
Szabolcs Szatmár Bereg Vármegyei Oktatókórház
Nyíregyháza, 4400
Singapore2 sites
National Cancer Centre Singapore
Singapore, 168583
Raffles Hospital
Singapore, 188770
Slovakia2 sites
Onkologicky Ustav sv. Alzbety
Bratislava, 812 50
Narodny onkologicky ustav
Bratislava, 833 10
About this study
Official title: EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients Who Have Previously Received 2 to 5 Years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer With an Increased Risk of Recurrence
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years.
- Conditions
- Breast Neoplasms
- Being tested
- Imlunestrant, Tamoxifen, Anastrozole, Letrozole, Exemestane
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImlunestrantDrug
Also called LY3484356
Administered orally.
TamoxifenDrug
Administered per local approved label.
AnastrozoleDrug
Administered per local approved label.
LetrozoleDrug
Administered per local approved label.
ExemestaneDrug
Administered per local approved label.
| Study group | Role | What they receive |
|---|---|---|
| Imlunestrant | Experimental | Imlunestrant administered orally. Receives: Drug: Imlunestrant |
| Investigator's Choice of Endocrine Therapy | Active comparator | Investigator's choice of tamoxifen, anastrozole, letrozole, or exemestane administered per local approved label. Receives: Drug: Tamoxifen; Drug: Anastrozole; Drug: Letrozole; Drug: Exemestane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive Disease-Free Survival (IDFS)
IDFS excluding second non-breast primary invasive cancers
Measured: Randomization to recurrence or death from any cause (up to 10 years)
Secondary outcomes (7)
Distant Recurrence-Free Survival (DRFS)
DRFS
Measured: Randomization to Distant Recurrence or Death from Any Cause (up to 10 Years)
Overall Survival (OS)
OS
Measured: Randomization to Death from Any Cause (up to 10 Years)
Pharmacokinetics (PK): Steady State Plasma Concentrations of Imlunestrant
PK: steady state plasma concentrations of imlunestrant
Measured: Year 1, Month 2 to Month 4
Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) Physical Functioning
The EORTC QLQ-C30 is a 30-question patient reported instrument used to assess multidimensional quality of life (QOL) in cancer patients. It consists of 15 domains: 1 global QOL scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). Physical functioning was measured by items 1 to 5. The sum score was linearly transformed to the range 0 - 100 as recommended by the EORTC (higher score is better).
Measured: Visit 1 Day 1 up to end of Year 5
Change from Baseline in the EORTC QLQ-C30 Role Functioning
The EORTC QLQ-C30 is a 30-question patient reported instrument used to assess the multidimensional QOL in cancer patients. It consists of 15 domains: 1 global QOL scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). Role functioning was measured by items 6 and 7. The sum score was linearly transformed to the range 0 - 100 as recommended by the EORTC (higher score is better).
Measured: Visit 1 Day 1 up to end of Year 5
Change from Baseline in the EORTC QLQ-C30 Global QOL
The EORTC QLQ-C30 is a 30-question patient reported instrument used to assess the multidimensional QOL in cancer patients. It consists of 15 domains: 1 global QOL scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). Global QOL was measured by items 29 and 30. The sum score was linearly transformed to the range 0 - 100 as recommended by the EORTC (higher score is better).
Measured: Visit 1 Day 1 up to end of Year 5
Proportion of Time on Study Treatment with High Overall Adverse Event Burden
FACT GP5 = Functional Assessment of Cancer Therapy - General Physical Well-being Item 5 (FACT GP5). High overall adverse event burden is defined as a score of 3 or 4 on a 5-point Likert scale. Higher scores represent higher symptom burden.
Measured: Visit 1 Day 1 up to end of Year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start4 Oct 2022
- Primary completionOct 2027 (estimated)
- Study completionMar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05514054
- Sponsor's protocol ID
- 18459
- Other IDs
- J2J-MC-JZLH, 2022-501007-28
- Acronym
- EMBER-4
- Status last verified
- Apr 2026
- First submitted
- 23 Aug 2022
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients Who Have Previously Received 2 to 5 Years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer With an Increased Risk of Recurrence
- ClinicalTrials.gov ID
- NCT05514054
- Acronym / sponsor ID
- EMBER-4 / 18459
- Conditions
- Breast Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Mar 2032 (estimated)
- First posted
- 24 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imlunestrant | Experimental | Drug: ImlunestrantImlunestrant administered orally. |
| Investigator's Choice of Endocrine Therapy | Active comparator | Drug: Tamoxifen, Drug: Anastrozole, Drug: Letrozole, Drug: ExemestaneInvestigator's choice of tamoxifen, anastrozole, letrozole, or exemestane administered per local approved label. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have a diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without evidence of distant metastasis.
- Participants must have received at least 24 months but not more than 60 months of any adjuvant ET, from time of adjuvant ET initiation.
- Participants may have received (neo) adjuvant chemotherapy and/or targeted therapy with a CDK4/6- or PARP- inhibitor.
- Must have an increased risk of disease recurrence based on clinical-pathological risk features.
- Have a Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group scale.
Key exclusion criteria (8 listed)
- Have any evidence of metastatic disease (including contralateral ALN) or inflammatory breast cancer at primary breast cancer diagnosis.
- Participants with more than a 6-month consecutive gap in therapy during the course of prior adjuvant ET.
- Participants who have completed or discontinued prior adjuvant ET >6 months prior to screening.
- Participants with a history of previous breast cancer are excluded, with the exception of ipsilateral DCIS treated by locoregional therapy alone ≥5 years ago.
- Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after the last dose of study intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImlunestrantAlso: LY3484356Administered orally. | Drug | Imlunestrant |
| TamoxifenAdministered per local approved label. | Drug | Investigator's Choice of Endocrine Therapy |
| AnastrozoleAdministered per local approved label. | Drug | Investigator's Choice of Endocrine Therapy |
| LetrozoleAdministered per local approved label. | Drug | Investigator's Choice of Endocrine Therapy |
| ExemestaneAdministered per local approved label. | Drug | Investigator's Choice of Endocrine Therapy |
Primary outcome
Invasive Disease-Free Survival (IDFS)
Time frame: Randomization to recurrence or death from any cause (up to 10 years)
IDFS excluding second non-breast primary invasive cancers
7 secondary outcomes
Distant Recurrence-Free Survival (DRFS)
Time frame: Randomization to Distant Recurrence or Death from Any Cause (up to 10 Years)
Overall Survival (OS)
Time frame: Randomization to Death from Any Cause (up to 10 Years)
Pharmacokinetics (PK): Steady State Plasma Concentrations of Imlunestrant
Time frame: Year 1, Month 2 to Month 4
Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) Physical Functioning
Time frame: Visit 1 Day 1 up to end of Year 5
Change from Baseline in the EORTC QLQ-C30 Role Functioning
Time frame: Visit 1 Day 1 up to end of Year 5
Change from Baseline in the EORTC QLQ-C30 Global QOL
Time frame: Visit 1 Day 1 up to end of Year 5
Proportion of Time on Study Treatment with High Overall Adverse Event Burden
Time frame: Visit 1 Day 1 up to end of Year 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer (EMBER-4)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
672 sites in 31 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Imlunestrant, Tamoxifen and Anastrozole in people with Breast Neoplasms, run by Eli Lilly and Company at 672 sites in 31 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 672 sites in United States, China, Japan, Spain, Brazil and 26 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive Disease-Free Survival (IDFS) (time frame: Randomization to recurrence or death from any cause (up to 10 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.