A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer

Breast Neoplasms Clinical Trial

— EMBER-4  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05514054
• Other study ID #: 18459
• Secondary ID: J2J-MC-JZLH2022-
• Status: Recruiting
• Phase: Phase 3
• Start date: October 4, 2022
• Est. completion date: March 15, 2032

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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-). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: March 15, 2032
• Est. primary completion date: October 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Imlunestrant
Administered orally.
• Tamoxifen
Administered per local approved label.
• Anastrozole
Administered per local approved label.
• Letrozole
Administered per local approved label.
• Exemestane
Administered per local approved label.

Locations

Country	Name	City	State
Argentina	Centro de Oncología e Investigación de Buenos Aires	Berazategui	Buenos Aires
Argentina	Centro Oncologico Korben	Buenos Aires
Argentina	CIPREC	Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	Fundación Respirar	Buenos Aires
Argentina	Investigaciones Clinicas Moleculares (ICM)	Buenos Aires
Argentina	Mautalen Salud e Investigación	Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	Clinica Adventista Belgrano	Caba	Ciudad Autónoma De Buenos Aires
Argentina	Fundación Cenit Para La Investigación En Neurociencias	Caba	Ciudad Autónoma De Buenos Aire
Argentina	Centro Medico Privado CEMAIC	Capital	Córdoba
Argentina	Alexander Fleming	Ciudad Autónoma de Buenos Aire	Buenos Aires
Argentina	Fundación CORI para la Investigación y Prevención del Cáncer	La Rioja
Argentina	Instituto de Investigaciones Clínicas Mar del Plata	Mar del Plata	Buenos Aires
Argentina	Fundacion Scherbovsky	Mendoza
Argentina	Instituto Médico Río Cuarto	Río Cuarto	Córdoba
Argentina	Fundacion Estudios Clinicos	Rosario	Santa Fe
Argentina	CER San Juan	San Juan
Argentina	Instituto San Marcos	San Juan
Argentina	Centro Medico San Roque	San Miguel de Tucumán	Tucumán
Argentina	Go Centro Medico San Nicolás	San Nicolas	Buenos Aires
Argentina	Clinica Viedma	Viedma	Río Negro
Australia	Ballarat Health Services	Ballarat Central	Victoria
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Monash Health	Clayton	Victoria
Australia	Coffs Harbour Health Campus	Coffs Harbour	New South Wales
Australia	St Vincent's Hospital	Darlinghurst	New South Wales
Australia	Barwon Health	Geelong	Victoria
Australia	Gosford Hospital	Gosford	New South Wales
Australia	Royal Hobart Hospital	Hobart	Tasmania
Australia	Launceston General Hospital	Launceston	Tasmania
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Mackay Base Hospital	Mackay	Queensland
Australia	Maroondah Hospital	Melbourne	Victoria
Australia	Northern Hospital	Melbourne	Victoria
Australia	St Vincent's Hospital	Melbourne	Victoria
Australia	Breast Cancer Research Centre-WA	Nedlands	Western Australia
Australia	Lake Macquarie Private Hospital	Newcastle	New South Wales
Australia	Goulburn Valley Health	Shepparton	Victoria
Australia	Gold Coast University Hospital	Southport	Queensland
Australia	Mater Hospital Sydney	Sydney	New South Wales
Australia	Royal Darwin Hospital	Tiwi	Northern Territory
Australia	The Townsville Hospital	Townsville	Queensland
Australia	Hervey Bay Hospital	Urraween	Queensland
Australia	The Queen Elizabeth Hospital	Woodville	South Australia
Austria	Medizinische Universität Graz	Graz	Steiermark
Austria	Uniklinikum Salzburg	Salzburg
Austria	Private Practice - Dr. Hubalek	Schwaz	Tirol
Austria	Franziskus Spital GmbH	Vienna	Wien
Austria	Klinik Hietzing	Vienna	Wien
Austria	Medizinische Universität Wien	Vienna	Wien
Austria	Medizinische Universität Wien	Wien	WienWien
Belgium	Institut Jules Bordet	Anderlecht	Bruxelles-Capitale, Région De
Belgium	CHIREC - site delta	Auderghem	Bruxelles-Capitale, Région De
Belgium	CHU Saint-Pierre	Brussels	Bruxelles-Capitale, Région De
Belgium	Cliniques universitaires Saint-Luc	Brussels	Bruxelles-Capitale, Région De
Belgium	Grand Hôpital de Charleroi	Charleroi	Hainaut
Belgium	Jessa Ziekenhuis	Hasselt	Limburg
Belgium	Jan Yperman ziekenhuis	Ieper
Belgium	AZ Groeninge Campus Kennedylaan	Kortrijk	West-Vlaanderen
Belgium	Groupe Jolimont	La Louvière	Hainaut
Belgium	UZ Leuven	Leuven	Vlaams-Brabant
Belgium	Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman	Liège
Belgium	CHU UCL Namur/Site Sainte Elisabeth	Namur
Belgium	Clinique Saint Pierre	Ottignies
Belgium	AZ Nikolaas	Sint-Niklaas	Oost-Vlaanderen
Belgium	CHR Verviers - La Tourelle	Verviers
Brazil	Fundação Pio XII - Hospital de Câncer de Barretos	Barretos	São Paulo
Brazil	CTO - Centro de Tratamento Oncológico	Belem	Pará
Brazil	Oncocentro de Minas Gerais	Belo Horizonte	Minas Gera
Brazil	Hospital Sirio Libanes	Brasilia
Brazil	Centro Integrado de Oncologia de Curitiba	Curitiba	Paraná
Brazil	Centro de Pesquisa Clínica do Instituto do Câncer do Ceará	Fortaleza	Ceará
Brazil	Hospital Araújo Jorge	Goiânia	Goiás
Brazil	ONCOSITE - Centro de Pesquisa Clinica em Oncologia	Ijui	Rio Grande Do Sul
Brazil	Hospital de Cancer de Londrina	Londrina	Paraná
Brazil	Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital Moinhos de Vento	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital São Lucas da PUCRS	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital de Amor Amazônia	Porto Velho	Rondônia
Brazil	Multihemo	Recife	Pernambuco
Brazil	Hospital de Clínicas de Ribeirão Preto	Ribeirão Preto	São Paulo
Brazil	Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA	Rio de Janeiro
Brazil	Grupo COI - Clínicas Oncológicas Integradas	Rio de Janeiro
Brazil	Hospital São Lucas de Copacabana	Rio de Janeiro
Brazil	Instituto Nacional de Câncer - INCA	Rio de Janeiro
Brazil	Nucleo de Oncologia da Bahia	Salvador	Bahia
Brazil	Faculdade de Medicina do ABC	Santo André	São Paulo
Brazil	Hospital de Base de São José do Rio Preto	São José do Rio Preto	São Paulo
Brazil	A. C. Camargo Cancer Center	Sao Paulo	São Paulo
Brazil	Hospital BP	Sao Paulo	São Paulo
Brazil	Hospital Santa Paula	Sao Paulo	São Paulo
Brazil	Hospital Sírio Libanês	Sao Paulo	São Paulo
Brazil	Instituto D'Or de Pesquisa e Ensino (IDOR)	Sao Paulo	São Paulo
Brazil	Clínica de Pesquisa e Centro de Estudos em Ginecologia Oncológica e Mamária LTDA	São Paulo
Brazil	Hospital Alemao Oswaldo Cruz	São Paulo
Brazil	Icesp - Instituto Do Câncer Do Estado de São Paulo	São Paulo
Brazil	Instituto de Assistência Médica ao Servidor Público Estadual - IAMSPE/HSPE-FMO Conhecer Centro de Oncolog -T	São Paulo
Brazil	Instituto de Ensino e Pesquisa São Lucas	São Paulo
Brazil	IPITEC	São Paulo
Brazil	NotreDame Intermedica Saude S.A	São Paulo
Brazil	Núcleo de Pesquisa Clínica da Rede São Camilo	São Paulo
Brazil	CEDOES	Vitória	Espírito Santo
Canada	Tom Baker Cancer Center	Calgary	Alberta
Canada	London Regional Cancer Program	London	Ontario
Canada	Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSSS NÎM) - H -T	Montreal	Quebec
Canada	Jewish General Hospital	Montreal	Quebec
Canada	Centre Hospitalier de l'Université de Montréal	Montréal	Quebec
Canada	Hopital Du Saint-Sacrement	Quebec City	Quebec
Canada	BC Cancer Surrey	Surrey	British Columbia
Canada	Humber River Hospital	Toronto	Ontario
Canada	Sunnybrook Research Institute - Odette Cancer Centre	Toronto	Ontario
China	Affiliated Hospital of Hebei University	Baoding	Hebei
China	Beijing Friendship Hospital	Beijing	Beijing
China	Beijing Hospital	Beijing	Beijing
China	Cancer Hospital Chinese Academy of Medical Science	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	The Second Hospital of Jilin University	Changchun	Jilin
China	The First People's Hospital of Changde City	Changde	Hunan
China	Hunan Cancer Hospital	Changsha	Hunan
China	Xiangya Hospital Central South University	Changsha	Hunan
China	Sichuan Cancer hospital	Chengdu	Sichuan
China	Deyang City People's Hospital	Deyang	Sichuan
China	Dongguan People's Hospital	Dongguan	Guangdong
China	Shunde Hospital of Southern Medical Univesity	Foshan	Guangdong
China	Fujian Medical University Union Hospital-1 Bingfanglou	Fuzhou	Fujian
China	Fuzhou General hospital of Nanjing Military Command	Fuzhou	Fujian
China	Guangdong Maternity and Child Health Care Hospital	Guangzhou	Guangdong
China	Sun Yat-Sen University Cancer Centre	Guangzhou	Guangdong
China	Hainan General Hospital	Haikou	Hainan
China	The First People's Hospital of Hangzhou	Hangzhou	Zhejiang
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	Huizhou Municipal Central Hospital	Huizhou	Guangdong
China	Jiangmen Center Hospital	Jiangmen	Guangdong
China	Jinan Central Hospital	Jinan	Shandong
China	Jining Medical University - Affiliated Hospital	Jining	Shandong
China	The First Affiliated Hospital of Henan University of Science &Technology	Luoyang	Henan
China	The Third Hospital of Nanchang	Nanchang	Jiangxi
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	The Second People's Hospital of Neijiang	Neijiang	Sichuan
China	Hwa Mei Hospital University of Chinese Academy of Sciences	Ningbo	Zhejiang
China	Ningbo First Hospital	Ningbo	Zhejiang
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Cancer Hospital Chinese Academy of Medical Sciences. Shenzhen Center	Shenzhen	Guangdong
China	ShenZhen People's Hospital	Shenzhen	Guangdong
China	Shenzhen Second People's Hospital	Shenzhen	Guangdong
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	Tianjin Medical University Cancer Institute and Hospital	Tianjing	Tianjin
China	Xinjiang Medical University Cancer Hospital - Urumqi	Urumqi	Xinjiang
China	Hubei Cancer Hospital	Wuhan	Hubei
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
China	Wuhan Union Hospital	Wuhan	Hubei
China	Wannan Medical College Yijishan Hospital	Wuhu Shi	Anhui
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	Xiangyang Central Hospital	Xiangyang	Hubei
China	The Central Hospital of Yongzhou - North Campus	Yongzhou	Hunan
China	The First People's Hospital of Yueyang	Yueyang	Hunan
China	Yuncheng Central Hospital - Eastern Hospital	Yuncheng Shi	Shanxi
China	Central Hospital of Guangdong Provincial Agricutural Reclamation	Zhanjiang	Guangdong
Czechia	Masarykuv onkologicky ustav	Brno	Brno-mesto
Czechia	Nemocnice Horovice	Horovice	Beroun
Czechia	Fakultni nemocnice Hradec Kralove	Hradec Kralove
Czechia	Fakultni nemocnice Ostrava	Ostrava	Moravskoslezský Kraj
Czechia	Multiscan	Pardubice	Pardubický Kraj
Czechia	Fakultni nemocnice Bulovka	Prague	Praha 8
Czechia	Fakultni Thomayerova nemocnice	Prague	Praha 4
Czechia	Fakultni nemocnice Motol	Praha	Praha 5
Finland	Docrates Syöpäsairaala	Helsinki	Uusimaa
Finland	Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)	Helsinki	Uusimaa
Finland	Keski-Suomen Keskussairaala	Jyväskylä
Finland	Oulun yliopistollinen sairaala	Oulu	Pohjois-Pohjanmaa
Finland	Tampereen yliopistollinen sairaala	Tampere	Pirkanmaa
Finland	Vaasan Keskussairaala	Vaasa	Pohjanmaa
France	Sainte Catherine Institut du Cancer Avignon Provence	Avignon	Vaucluse
France	Centre Hospitalier de la Côte Basque	Bayonne	Pyrénées-Atlantiques
France	CHU Besançon	Besançon	Doubs
France	Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest	Bordeaux	Aquitaine
France	Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan	Brest	Bretagne
France	Pole Santé République	Clermont-Ferrand
France	Centre Hospitalier Sud Francilien	Corbeil-Essonnes	Île-de-France
France	Henri Mondor Hospital	Créteil	Île-de-France
France	Polyclinique De Blois	La Chaussée-Saint-Victor	Centre
France	CHD Vendee	La Roche-sur-Yon	Vendée
France	Groupe Hospitalier La Rochelle-Ré-Aunis - Hôpital Saint Louis	La Rochelle	Charente-Maritime
France	Chu Grenoble Alpes	La Tronche	Isère
France	Clinique Victor Hugo Le Mans	Le Mans	Pays-de-la
France	Clinique Francois Chenieux	Limoges	Haute-Vienne
France	Hopital Prive Jean Mermoz	Lyon	Rhône-Alpes
France	Centre Hospitalier Régional Metz Thionville - Hôpital de Mercy	Metz	Moselle
France	Centre Hospitalier Général de Mont de Marsan - Hôpital Layné	Mont-de-Marsan	Landes
France	Centre de Cancérologie du Grand Montpellier	Montpellier	Languedoc-Roussillon
France	Polyclinique de Gentilly	Nancy	Meurthe-et-Moselle
France	Centre Antoine-Lacassagne	Nice
France	Groupe Hospitalier Diaconesses Croix Saint Simon	Paris
France	Groupe hospitalier Paris saint Joseph	Paris	Île-de-France
France	Hôpital Européen Georges Pompidou	Paris
France	Hôpital Saint-Louis	Paris
France	Hôpital Tenon	Paris
France	Institut Curie	Paris
France	Centre Hospitalier de Pau	Pau	Pyrénées-Atlantiques
France	Centre Catalan d'Oncologie	Perpignan	Pyrénées-Orientales
France	Centre Hospitalier Universitaire de Poitiers	Poitiers	Vienne
France	Institut Jean Godinot	Reims	Marne
France	Institut de Cancérologie de l'Ouest	Saint Herblain	Loire-Atlantique
France	Institut Curie - site Saint-Cloud	Saint-Cloud	Hauts-de-Seine
France	Centre Hospitalier Privé Saint-Grégoire	Saint-Grégoire
France	Centre de cancérologie des Dentellières	Valenciennes
France	Institut de Cancérologie de Lorraine Alexis Vautrin	Vandoeuvre-lès-Nancy	Lorraine
Germany	Gemeinschaftspraxis hop-augsburg	Augsburg	Bayern
Germany	Universitaetsklinikum Augsburg	Augsburg	Bayern
Germany	Helios Klinikum Berlin-Buch	Berlin
Germany	Onkologische Schwerpunktpraxis Kurfuerstendamm	Berlin
Germany	Praxisklinik Krebsheilkunde fur Frauen	Berlin
Germany	Marienhospital Bottrop	Bottrop	Nordrhein-Westfalen
Germany	Städtisches Klinikum Dessau	Dessau	Sachsen-Anhalt
Germany	Onkologiezentrum Donauwörth	Donauwörth	Bayern
Germany	Kath. St.-Johannes-Gesellschaft Dortmund	Dortmund	Nordrhein-Westfalen
Germany	MVZ Medical Center Düsseldorf GmbH	Düsseldorf	Nordrhein-Westfalen
Germany	Universitaetsklinikum Erlangen	Erlangen	Bayern
Germany	Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung	Essen	Nordrhein-Westfalen
Germany	Agaplesion Markus Krankenhaus	Frankfurt	Hessen
Germany	Universitaetsklinikum Freiburg	Freiburg im Breisgau	Baden-Württemberg
Germany	Private Practice - Dr. Helmut Oettle und Prof.Dr.med. Frank Mayer	Friedrichshafen	Baden-Württemberg
Germany	SRH Wald-Klinikum Gera	Gera	Thüringen
Germany	OSP Göttingen	Göttingen
Germany	Onkologische Schwerpunktpraxis Heidelberg, Dr. med. Andreas Karcher, Dr. med. Daniel Debatin, Dr. med. Ste -T	Heidelberg	Baden-Württemberg
Germany	St. Anna Hospital	Herne	Nordrhein-Westfalen
Germany	Universitaetsklinikum des Saarlandes	Homburg	Saarland
Germany	Klinikverbund Allgäu gGmbH	Kempten	Bayern
Germany	Universitaetsklinikum Schleswig-Holstein Campus Kiel	Kiel	Schleswig-Holstein
Germany	University Hospital of Cologne	Köln	Nordrhein-Westfalen
Germany	Zentrum fuer ambulante gynaekologische Onkologie (ZAGO)	Krefeld	Nordrhein-Westfalen
Germany	Otto-von-Guericke-Universität Magdeburg	Magdeburg	Sachsen-Anhalt
Germany	Universitätsmedizin Mannheim	Mannheim	Baden-Württemberg
Germany	Institut für Versorgungsforschung Dr. Michael Maasberg, Dr. med. Maria Theresia Keller, Marion Schmitz	Mayen
Germany	Klinikum der Ludwig-Maximilians-Universitaet Muenchen	München	Bayern
Germany	Klinikum Ernst von Bergmann	Potsdam	Brandenburg
Germany	Oncologianova	Recklinghausen	Nordrhein-Westfalen
Germany	HELIOS Kliniken Schwerin	Schwerin	Mecklenburg-Vorpommern
Germany	Diakonissen-Stiftungs-Krankenhaus Speyer	Speyer	Rheinland-Pfalz
Germany	Robert-Bosch-Krankenhaus	Stuttgart	Baden-Württemberg
Germany	SRH Zentralklinikum Suhl	Suhl	Thüringen
Germany	Klinikum Mutterhaus der Borromäerinnen	Trier	Rheinland-Pfalz
Germany	Universitaetsklinikum Tuebingen	Tübingen	Baden-Württemberg
Germany	Universitaetsklinikum Ulm	Ulm	Baden-Württemberg
Germany	Helios Dr. Horst Schmidt Kliniken	Wiesbaden	Hessen
Greece	Agios Savvas Regional Cancer Hospital	Athens	Attikí
Greece	Alexandra Hospital	Athens	Attikí
Greece	Iaso Private General Obstetrics Gynecological & Pediatric Clinic Diagnostic Therapeutic & Research Center -T	Athens	Attikí
Greece	Iaso Private General Obstetrics Gynecological & Pediatric Clinic Diagnostic Therapeutic & Research Center -T	Athens	Attikí (Region)
Greece	Attikon General University Hospital	Chaidari	Attikí
Greece	University General Hospital of Heraklion	Heraklion	Irakleío
Greece	University Hospital of Ioannina	Ioannina	Ioánnina
Greece	University General Hospital of Larissa	Larissa	Thessalía
Greece	General Oncology Hospital of Kifissia "Agioi Anargiroi"	Néa Kifisiá	Attikí
Greece	Olympion General Clinic	Patras	Acha?a
Greece	University Hospital of Patras	Patras	Acha?a
Greece	Agios Loukas Clinic	Thessaloniki	Kentrikí Makedonía
Greece	BioClinic Thessaloniki	Thessaloniki	Kentrikí Makedonía
Greece	Euromedica General Clinic of Thessaloniki	Thessaloniki	Thessaloníki
Greece	European Interbalkan Medical Center	Thessaloniki	Thessaloníki
Hong Kong	Queen Mary Hospital	Hksar
Hong Kong	Hong Kong United Oncology Centre	Hong Kong
Hungary	Országos Onkológiai Intézet	Budapest
Hungary	Uzsoki Utcai Kórház	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Bacs-Kiskun Varmegyei Oktatokorhaz	Kecskemét	Bács-Kiskun
Hungary	Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház	Nyiregyhaza	Szabolcs-Szatmár-Bereg
India	KD Hospital	Ahmedabad	Gujarat
India	Medstar Speciality Hospital	Bangalore	Karnataka
India	KLES Dr. Prabhakar Kore Hospital & M.R.C	Belagave	Karnataka
India	All India Institute of Medical Sciences	Bhubaneswar	Odisha
India	Postgraduate Institute of Medical Education & Research	Chandigarh
India	Cancer Institute (WIA)	Chennai	Tamil Nadu
India	Nizam's Institute of Medical Sciences	Hyderabad	Telangana
India	Regency Hospital	Kanpur	Uttar Prad
India	Krishna Institute of Medical Sciences - Karad	Karad	Maharashtra
India	Kolhapur Cancer Centre Private Limited	Kolhapur	Maharashtra
India	Tata Memorial Hospital	Mumbai	Maharashtra
India	Rashtrasant Tukdoji Regional Cancer Hospital	Nagpur	Maharashtra
India	HCG Manavata Cancer Centre	Nashik	Maharashtra
India	Delhi State Cancer Institute	New Delhi	Delhi
India	Grant Medical Foundation - Ruby Hall Clinic	Pune	Maharashtra
India	Lifepoint Multispeciality Hospital	Pune	Maharashtr
India	Regional Cancer Centre - Thiruvananthapuram	Thiruvananthapuram	Kerala
India	Mahatma Gandhi Cancer Hospital and Research Institute	Visakhapatnam	Andhra Pradesh
Ireland	Bon Secours Cork Hospital	Cork
Ireland	Cork University Hospital	Cork
Ireland	Beaumont Hospital, Dublin	Dublin
Ireland	St. James's Hospital	Dublin
Ireland	St. Vincent's University Hospital	Dublin
Ireland	UCD School of Medicine Beacon Hospital	Dublin
Ireland	University College Hospital - Galway	Galway	Connaught
Ireland	Sligo General Hospital	Sligo
Ireland	Waterford Regional Hospital	Waterford
Israel	Soroka Medical Center	Be'er Sheva	HaDarom
Israel	Carmel Hospital	Haifa	?eifa
Israel	Shaare Zedek Medical Center	Jerusalem	Yerushalayim
Israel	Meir Medical Center	Kfar Saba	HaMerkaz
Israel	Rabin Medical Center	Petah Tikva	HaMerkaz
Israel	Sheba Medical Center	Ramat Gan	HaMerkaz
Israel	Sourasky Medical Center	Tel Aviv	Tell Abib
Israel	Yitzhak Shamir Medical Center	Zerifin	HaMerkaz
Italy	Aou Ospedali Riuniti Umberto I	Ancona
Italy	Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII	Bergamo
Italy	IRCCS - AOU di Bologna	Bologna	Emilia-Romagna
Italy	Ospedale Antonio Perrino	Brindisi
Italy	Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia	Candiolo	Torino
Italy	Azienda Ospedaliera Universitaria Careggi	Firenze	Toscana
Italy	Ospedale San Martino	Genova	Liguria
Italy	Ospedale Generale Provinciale Macerata	Macerata
Italy	Istituto Europeo di Oncologia IRCCS	Milano
Italy	Humanitas Istituto Clinico Catanese	Misterbianco	Catania
Italy	Azienda Ospedaliero Universitaria	Modena
Italy	Ospedale San Gerardo-ASST Monza	Monza	Lombardia
Italy	University of Naples Federico II	Naples	Campania
Italy	Istituto Nazionale Tumori IRCCS Fondazione Pascale	Napoli	Campania
Italy	Istituto Oncologico Veneto IRCCS	Padova
Italy	Azienda Ospedaliero Universitaria di Parma	Parma
Italy	Istituto Nazionale Tumori Regina Elena	Rome	Roma
Italy	Humanitas	Rozzano	Milano
Italy	Ospedale San Giovanni Moscati	Statte	Taranto
Italy	Azienda Ospedaliera Santa Maria Terni	Terni
Japan	Juntendo University Hospital	Bunkyo-ku	Tokyo
Japan	Chiba University Hospital	Chiba
Japan	Chiba cancer center	Chiba-shi	Chiba
Japan	St. Luke's International Hospital	Chuo-ku	Tokyo
Japan	National Hospital Organization Kyushu Cancer Center	Fukuoka
Japan	Fukushima Medical University	Fukushima
Japan	Fukuyama City Hospital	Fukuyama	Hiroshima
Japan	Gifu University Hospital	Gifu
Japan	Tokai University Hachioji Hospital	Hachioji-shi	Tokyo
Japan	Kansai Medical University Hospital	Hirakata	Osaka
Japan	Hiroshima City Hospital	Hiroshima
Japan	Hiroshima University Hospital	Hiroshima
Japan	Shimane University Hospital	Izumo	Shimane
Japan	Sagara Hospital	Kagoshima
Japan	Kameda Clinic	Kamogawa	Chiba
Japan	Ishikawa Prefectural Central Hospital	Kanazawa	Ishikawa
Japan	St. Marianna University School of Medicine Hospital	Kawasaki	Kanagawa
Japan	Japanese Foundation for Cancer Research	Koto	Tokyo
Japan	Chemotopia - Kumamoto Breast & Gastrointestinal Surgical Hospital	Kumamoto
Japan	Kumamoto Shinto General Hospital	Kumamoto
Japan	University Hospital,Kyoto Prefectural University of Medicine	Kyoto
Japan	Shinshu University Hospital	Matsumoto	Nagano
Japan	National Hospital Organization Shikoku Cancer Center	Matsuyama	Ehime
Japan	Miyazaki Prefectural Miyazaki Hospital	Miyazaki
Japan	Nagoya City University Hospital	Nagoya	Aichi
Japan	Nagoya University Hospital	Nagoya	Aichi
Japan	Naha Nishi Clinic	Naha	Okinawa
Japan	Niigata Cancer Center Hospital	Niigata-shi	Hokkaido
Japan	Hyogo College of Medicine	Nishinomiya	Hyogo
Japan	Okayama University Hospital	Okayama
Japan	Nakagami Hospital Okinawa	Okinawa
Japan	National Hospital Organization - Osaka National Hospital - Institute For Clinical Research	Osaka
Japan	Gunma Prefectural Cancer Center	Otashi	Gunma
Japan	Kitasato University Hospital	Sagamihara	Kanagawa
Japan	Saitama Red Cross Hospital	Saitama
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
Japan	National Hospital Organization Hokkaido Cancer Center	Sapporo	Hokkaido
Japan	Tohoku University Hospital	Sendai-shi	Miyagi
Japan	Showa University Hospital	Shinagawa	Tokyo
Japan	Center Hospital of the National Center for Global Health and Medicine	Shinjyuku-ku	Tokyo
Japan	Shizuoka General Hospital	Shizuoka
Japan	National Hospital Organization Takasaki General Medical Centar	Takasaki	Gunma
Japan	Tokushima University Hospital	Tokushima
Japan	Tsukuba University Hospital	Tsukuba	Ibaraki
Japan	Kanazawa Medical University Hospital	Uchinada	Ishikawa
Japan	Tochigi Cancer Center	Utsunomiya	Tochigi
Japan	Iwate Medical University Hospital	Yahaba-cho, Shiwa-gun	Iwate
Japan	Kanagawa cancer center	Yokohama	Kanagawa
Japan	Yokohama City University Medical Center	Yokohama	Kanagawa
Korea, Republic of	Dongnam Institute of Radiological and Medical Sciences	Busan	Pusan-Kwangyokshi
Korea, Republic of	Soon Chun Hyang University Cheonan Hospital	Cheonan-si	Chungcheongnam-do [Chungnam]
Korea, Republic of	Chungbuk National University Hospital	Cheongju-si	Chungcheongbuk-do [Chungbuk]
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu	Taegu-Kwangyokshi
Korea, Republic of	National Cancer Center	Goyang-si	Kyonggi-do
Korea, Republic of	Yeungnam Univeristy Medical Center	Gyeongsan-si	Kyongsangbuk-do
Korea, Republic of	Inha University Hospital	Incheon	Incheon-gwangyeoksi [Incheon]
Korea, Republic of	Gachon University Gil Medical Center	Namdong	Incheon-gwangyeoksi [Incheon]
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Kyonggi-do
Korea, Republic of	CHA Bundang Medical Center, CHA University	Seongnam-si	Kyonggi-do
Korea, Republic of	Asan Medical Center	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Gangnam Severance Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Korea University Anam Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Korea University Guro Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Samsung Medical Center	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Seoul National University Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	The Catholic Univ. of Korea Seoul St. Mary's Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Ajou University Hospital	Suwon-si	Kyonggi-do
Korea, Republic of	Ulsan University Hospital	Ulsan	Ulsan-Kwangyokshi
Mexico	Scientia Investigacion Clinica S.C.	Chihuahua
Mexico	Centro de Estudios de Investigacion Metabolicos y Cardiovasculares	Ciudad Madero	Tamaulipas
Mexico	CIO - Centro de Inmuno-Oncología de Occidente	Guadalajara	Jalisco
Mexico	Clinica de Investigacion en Reumatologia y Obesidad S. C.	Guadalajara	Jalisco
Mexico	Preparaciones Oncológicas S.C.	León	Guanajuato
Mexico	CENEIT Oncológicos. Centro Especializado en Investigación y Tratamientos Oncológicos	Mexico City	Distrito Federal
Mexico	COI Centro Oncologico Internacional S.A.P.I. de C.V.	Mexico City	Distrito Federal
Mexico	Grupo Medico Camino Sc	Mexico City	Distrito Federal
Mexico	Althian Clinical Research	Monterrey	Nuevo León
Mexico	Centro Regiomontano de Investigación	Monterrey	Nuevo León
Mexico	Filios Alta Medicina	Monterrey	Nuevo León
Mexico	Centro de Investigacion Clinica de Oaxaca	Oaxaca
Mexico	Oaxaca Site Management Organization	Oaxaca
Mexico	Unidad Médica Onco-hematológica	Puebla
Mexico	PanAmerican Clinical Research - Querétaro - Avenida Antea	Querétaro
Mexico	Oncologico Potosino, S.C.	San Luis Potosi	San Luis Potosí
Mexico	Centro Medico Zambrano Hellion	San Pedro Garza Garcia	Nuevo León
Mexico	Hospital Angeles	Tijuana	Baja California
Mexico	Centro Oncologico Estatal ISSEMyM ( COEI )	Toluca
Mexico	Centro de Estudios Y Prevencion Del Cancer	Tuxtla Gutierrez	Chiapas
Netherlands	Wilhelmina Ziekenhuis Assen	Assen	Drenthe
Netherlands	Amphia Ziekenhuis, locatie Breda Molengracht	Breda	Noord-Brabant
Netherlands	Reinier de Graaf Ziekenhuis, locatie Delft	Delft	Zuid-Holland
Netherlands	Haga Ziekenhuis locatie Leyweg	Den Haag	Zuid-Holland
Netherlands	Deventer Ziekenhuis	Deventer	Overijssel
Netherlands	Albert Schweitzer Ziekenhuis, locatie Dordwijk	Dordrecht	Zuid-Holland
Netherlands	Ziekenhuisgroep Twente, locatie Almelo	Hengelo	Overijssel
Netherlands	Spaarne Gasthuis - Hoofddorp	Hoofddorp	Noord-Holland
Netherlands	Maastricht UMC+	Maastricht	Limburg
Netherlands	VieCuri Medisch Centrum, locatie Venlo	Venlo	Limburg
Netherlands	Zaans Medisch Centrum	Zaandam	Noord-Holland
Poland	Szpitale Pomorskie Sp. z o. o.	Gdynia	Pomorskie
Poland	Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie	Koszalin	Zachodniopomorskie
Poland	Salve Medica	Lodz	Lódzkie
Poland	Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego	Opole	Opolskie
Poland	FORMED2	Oswiecim	Malopolskie
Poland	Mazowiecki Szpital Wojewódzki w Siedlcach	Siedlce	Mazowieckie
Poland	MICS Centrum Medyczne Torun	Torun	Kujawsko-pomorskie
Poland	Luxmed Onkologia sp. z o. o.	Warszawa	Mazowieckie
Poland	Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie	Warszawa	Mazowieckie
Portugal	Hopital Garcia de Orta	Almada	Setúbal
Portugal	Hospital Beatriz Ângelo	Lisboa
Portugal	Hospital da Luz Lisboa	Lisboa
Portugal	Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria	Lisbon	Lisboa
Portugal	Champalimaud Foundation	Lisbon	Lisboa
Portugal	Centro Hospitalar de Vila Nova de Gaia/Espinho - Unidade I	Vila Nova de Gaia	Porto
Romania	C.M.D.T.A. Neomed	Brasov	Bra?ov
Romania	Centrul medical Focus	Bucure?ti
Romania	Gral Medical Diagnostic Center	Bucure?ti
Romania	Institutul Oncologic	Cluj-Napoca	Cluj
Romania	Centrul de Oncologie "Sfântul Nectarie"	Craiova	Dolj
Romania	Radiology Therapeutic Center	Otopeni	Ilfov
Romania	Ovidius Clinical Hospital OCH	Ovidiu	Constan?a
Romania	S C Oncocenter Oncologie Clinica S R L	Timi?oara	Timi?
Singapore	National Cancer Centre Singapore	Singapore	Central Singapore
Singapore	Raffles Hospital	Singapore	Central Singapore
Slovakia	Narodny onkologicky ustav	Bratislava	Bratislavský Kraj
Slovakia	Onkologicky Ustav sv. Alzbety	Bratislava	Bratislavský Kraj
Spain	CHUAC-Hospital Teresa Herrera	A Coruña	A Coruña [La Coruña]
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Universitario Torrecárdenas	Almeria	Andalucía
Spain	Hospital Infanta Cristina	Badajoz
Spain	Hospital Clínic de Barcelona	Barcelona	Catalunya [Cataluña]
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona	Catalunya [Cataluña]
Spain	Hospital Quiron Barcelona	Barcelona	Barcelona [Barcelona]
Spain	Hospital Universitari Dexeusa	Barcelona	Catalunya [Cataluña]
Spain	Hospital Universitari Vall d'Hebron	Barcelona	Barcelona [Barcelona]
Spain	Parc de Salut Mar - Hospital del Mar	Barcelona	Barcelona [Barcelona]
Spain	Osi Bilbao-Basurto	Bilbao	País Vasco
Spain	Hospital Universitario de Burgos	Burgos
Spain	Hospital San Pedro de Alcántara	Cáceres	Extremadura
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	El Palmar	Murcia, Región De
Spain	Hospital Universitario Getafe	Getafe	Madrid, Comunidad De
Spain	Hospital Universitario San Cecilio	Granada
Spain	Complejo Hospitalario de Jaén	Jaen	Jaén
Spain	Hospital Universitario de Canarias	La Laguna	Santa Cruz De Tenerife
Spain	Hospital Universitario Arnau de Vilanova de Lleida	Lleida	Lleida [Lérida]
Spain	Hospital San Pedro	Logroño	La Rioja
Spain	Hospital Lucus Augusti	Lugo	Lugo [Lugo]
Spain	Hospital Beata María Ana	Madrid
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital General Universitario Gregorio Marañon	Madrid	Madrid, Comunidad De
Spain	Hospital La Princesa	Madrid
Spain	Hospital Ruber Internacional	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid	Madrid, Comunidad De
Spain	Hospital Universitario Infanta Leonor	Madrid	Madrid, Comunidad De
Spain	Hospital Universitario La Paz	Madrid	Madrid, Comunidad De
Spain	Hospital Universitario Ramón y Cajal	Madrid	Madrid, Comunidad De
Spain	Hospital Mateu Orfila	Mahon	Balears [Baleares]
Spain	H.R.U Málaga - Hospital Materno-infantil	Malaga	Málaga
Spain	Hospital Vithas Málaga	Málaga
Spain	Hospital Universitari Son Espases	Palma	Balears [Baleares]
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra
Spain	Hospital Universitari Sant Joan de Reus	Reus	Tarragona
Spain	Hospital Universitari General de Catalunya	Sant Cugat del Vallès	Barcelona [Barcelona]
Spain	Hospital Universitario Nuestra Señora de Candelaria	Santa Cruz de Tenerife
Spain	Hospital General de Segovia	Segovia
Spain	Hospital Universitario Virgen Del Rocio	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Universitario de Toledo	Toledo
Spain	Hospital Clinico de Valencia	Valencia	Valenciana, Comunitat
Spain	Hospital Quirónsalud Valencia	Valencia	València
Spain	Hospital Clínico Universitario de Valladolid	Valladolid
Spain	Hospital Clínico Universitario Lozano Blesa	Zaragoza
Taiwan	Changhua Christian Hospital	Changhua
Taiwan	Taipei Tzu Chi General Hospital	New Taipei City
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Chi Mei Hospital - Liouying Branch	Tainan City	Tainan
Taiwan	Koo Foundation Sun Yat-Sen Cancer Center	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei City	Taipei
Taiwan	Chang Gung Medical Foundation-Linkou Branch	Taoyuan
Turkey	Adana City Hospital	Adana
Turkey	Adana Medical Park Seyhan Hastanesi	Adana
Turkey	Hacettepe Universitesi	Altindag	Ankara
Turkey	Ankara Bilkent Sehir Hastanesi	Ankara
Turkey	Ankara Etlik City Hospital	Ankara
Turkey	Gulhane Egitim Arastirma Hastanesi	Ankara
Turkey	Memorial Ankara Hastanesi	Ankara
Turkey	Akdeniz Universitesi Hastanesi	Antalya
Turkey	Antalya Egitim ve Arastirma Hastanesi	Antalya
Turkey	Uludag Universitesi	Bursa
Turkey	Dicle Üniversitesi	Diyarbakir
Turkey	Trakya University	Edirne
Turkey	Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi	Gaziantep
Turkey	Marmara Universitesi Pendik Egitim Arastirma Hastanesi	Istanbul
Turkey	TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi	Istanbul
Turkey	Ege Universitesi Hastanesi	Izmir
Turkey	zmir Katip Çelebi Üniversitesi Atatürk Eitim Ve Aratrma Hastanesi	Izmir
Turkey	Izmir Medical Park Hospital	Izmir, Karsiyaka	Izmir
Turkey	Kocaeli Üniversitesi	Kocaeli
Turkey	Inönü Üniversitesi Turgut Özal Tip Merkezi Egitim ve Arastirma Hastanesi	Malatya
Turkey	Mersin University	Mersin
Turkey	Mugla Sitki Kocman Universitesi Egitim ve Arastirma Hastanesi	Mugla	Mugla
Turkey	Sakarya Training and Research Hospital	Sakarya
Turkey	Ondokuz Mayis Universitesi	Samsun
Turkey	Medipol Mega Universite Hastanesi	Stanbul	Istanbul
United Kingdom	Colchester General Hospital	Colchester	Essex
United Kingdom	Hairmyres Hospital	East Kilbride, Glasgow	Great Brit
United Kingdom	Western General Hospital	Edinburgh	Midlothian
United Kingdom	Clatterbridge Cancer Centre - Liverpool	Liverpool
United Kingdom	St Bartholomew's Hospital	London	London, City Of
United Kingdom	The Christie NHS Foundation Trust	Manchester	Greater Manchester
United Kingdom	Mount Vernon Hospital	Northwood	Hertfordshire
United Kingdom	Derriford Hospital	Plymouth	Devon
United Kingdom	Royal Berkshire Hospital	Reading
United Kingdom	Lister Hospital	Stevenage	Hertfordshire
United States	USO - New York Oncology Hematology	Albany	New York
United States	New Mexico Oncology Hematology Consultants Ltd.	Albuquerque	New Mexico
United States	University of New Mexico Comprehensive Cancer Center	Albuquerque	New Mexico
United States	AdventHealth Altamonte Springs	Altamonte Springs	Florida
United States	Messino Cancer Center	Asheville	North Carolina
United States	Northside Hospital	Atlanta	Georgia
United States	Winship Cancer Institute, Emory University	Atlanta	Georgia
United States	Augusta University	Augusta	Georgia
United States	Anschutz Cancer Pavilion	Aurora	Colorado
United States	USO - Texas Oncology	Austin	Texas
United States	Sarah Cannon Research Institute	Baton Rouge	Louisiana
United States	UCSF - John Muir Health Cancer Center Berkeley	Berkeley	California
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	St. Luke's University Health Network	Bethlehem	Pennsylvania
United States	Saint Alphonsus Regional Medical Center	Boise	Idaho
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Maimonides Cancer Center	Brooklyn	New York
United States	MD Anderson Cancer Center at Cooper	Camden	New Jersey
United States	Aultman Hospital	Canton	Ohio
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	The Christ Hospital Cancer Center	Cincinnati	Ohio
United States	USO - Oncology Hematology Care	Cincinnati	Ohio
United States	UCHealth Memorial Hospital	Colorado Springs	Colorado
United States	University of Missouri Hospital	Columbia	Missouri
United States	The Mark H Zangmeister Center	Columbus	Ohio
United States	Good Samaritan Regional Medical Center	Corvallis	Oregon
United States	Ochsner Medical Center - Jefferson Highway	Covington	Louisiana
United States	USO - Texas Oncology	Dallas	Texas
United States	USO - Texas Oncology	Dallas	Texas
United States	Mass General/North Shore Cancer Center	Danvers	Massachusetts
United States	USO - Southern Cancer Center	Daphne	Alabama
United States	USO - Texas Oncology	Denison	Texas
United States	USO - Texas Oncology	Denton	Texas
United States	Astera Cancer Care	East Brunswick	New Jersey
United States	M Health Fairview Cancer Clinic -Edina	Edina	Minnesota
United States	William Beaumont Army Medical Center	El Paso	Texas
United States	USO - Oncology Associates of Oregon	Eugene	Oregon
United States	Inova Schar Cancer Institute	Fairfax	Virginia
United States	Southcoast Centers for Cancer Care	Fairhaven	Massachusetts
United States	USO - Texas Oncology	Flower Mound	Texas
United States	New York-Presbyterian Queens	Flushing	New York
United States	Fort Belvoir Community Hospital	Fort Belvoir	Virginia
United States	UCHealth Harmony	Fort Collins	Colorado
United States	Holy Cross Hospital	Fort Lauderdale	Florida
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	John Peter Smith Hospital	Fort Worth	Texas
United States	The Center for Cancer and Blood Disorders	Fort Worth	Texas
United States	USO - Texas Oncology	Fort Worth	Texas
United States	Dana-Farber Cancer Institute - Foxborough	Foxboro	Massachusetts
United States	USO - Texas Oncology	Fredericksburg	Texas
United States	Washington Hospital Healthcare System	Fremont	California
United States	The West Clinic, PLLC dba West Cancer Center	Germantown	Tennessee
United States	Banner MD Anderson Cancer Center	Gilbert	Arizona
United States	USO - Arizona Oncology Associates - HAL	Glendale	Arizona
United States	Banner MD Anderson Cancer Center at North Colorado Medical Center	Greeley	Colorado
United States	St Francis Cancer Center	Greenville	South Carolina
United States	John Theurer Cancer Center at Hackensack University Medical Center	Hackensack	New Jersey
United States	Pontchartrain Cancer Center	Hammond	Louisiana
United States	Memorial Regional Hospital	Hollywood	Florida
United States	Millennium Oncology - Hollywood	Hollywood	Florida
United States	Kaiser Permanente Moanalua Medical Center	Honolulu	Hawaii
United States	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii
United States	USO - Alliance Cancer Specialists, PC	Horsham	Pennsylvania
United States	Clearview Cancer Institute	Huntsville	Alabama
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	University of Tennessee Medical Center	Knoxville	Tennessee
United States	R.J. Zuckerberg Cancer Center	Lake Success	New York
United States	USO - Rocky Mountain Cancer Centers	Lakewood	Colorado
United States	Memorial Medical Center	Las Cruces	New Mexico
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Central Maine Medical Center	Lewiston	Maine
United States	Regional Cancer Care Associates	Little Silver	New Jersey
United States	Loma Linda University Cancer Center	Loma Linda	California
United States	Dana-Farber - New Hampshire Oncology/Hematology	Londonderry	New Hampshire
United States	Banner MD Anderson Cancer Center at McKee Medical Center	Loveland	Colorado
United States	Care Access - Marrero	Marrero	Louisiana
United States	USO - Texas Oncology	McAllen	Texas
United States	USO - Texas Oncology	McKinney	Texas
United States	Mercy UC Davis Cancer Center	Merced	California
United States	Alliance for Multispecialty Research, LLC	Merriam	Kansas
United States	Dana-Farber Cancer Institute - Merrimack Valley	Methuen	Massachusetts
United States	Miami Cancer Institute at Baptist Health, Inc.	Miami	Florida
United States	Bon Secours St. Francis Medical Center	Midlothian	Virginia
United States	Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center	Milford	Massachusetts
United States	Perlmutter Cancer Center at NYU Langone Hospital - Long Island	Mineola	New York
United States	Allina Health Cancer Institute	Minneapolis	Minnesota
United States	USO - Minnesota Oncology Hematology	Minneapolis	Minnesota
United States	Infirmary Cancer Care	Mobile	Alabama
United States	Pacific Cancer Care	Monterey	California
United States	Northern Westchester Hospital	Mount Kisco	New York
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Yale-New Haven Hospital	New Haven	Connecticut
United States	Ochsner Medical Center - Jefferson Highway	New Orleans	Louisiana
United States	Laura and Isaac Perlmutter Cancer Center	New York	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	NYC Health + Hospitals / Bellevue	New York	New York
United States	Mass General Cancer Center at Newton-Wellesley	Newton	Massachusetts
United States	USO - Virginia Oncology Associates	Norfolk	Virginia
United States	Nebraska Methodist Hospital	Omaha	Nebraska
United States	St. Joseph Hospital	Orange	California
United States	University of California, Irvine (UCI) Health - UC Irvine Medical Center	Orange	California
United States	USO - Cancer Care Centers of Brevard	Palm Bay	Florida
United States	Capital Health Medical Center - Hopewell	Pennington	New Jersey
United States	USO - Woodlands Medical Specialists	Pensacola	Florida
United States	Illinois Cancer Care	Peoria	Illinois
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Thomas Jefferson University, Aria Jefferson Health	Philadelphia	Pennsylvania
United States	Mayo Clinic in Arizona - Phoenix	Phoenix	Arizona
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	USO - Texas Oncology	Plano	Texas
United States	Miami Cancer Institute - Plantation	Plantation	Florida
United States	Oregon Health and Science University	Portland	Oregon
United States	Lifespan Cancer Institute	Providence	Rhode Island
United States	Queens Medical Associates	Queens	New York
United States	USO - Virginia Cancer Specialists	Reston	Virginia
United States	USO - Oncology & Hematology Associates of Southwest Virginia	Roanoke	Virginia
United States	Mayo Clinic in Rochester, Minnesota	Rochester	Minnesota
United States	University of Rochester - Wilmot Cancer Institute	Rochester	New York
United States	Scott & White Hospital - Round Rock	Round Rock	Texas
United States	University of California Davis (UC Davis) Comprehensive Cancer Center	Sacramento	California
United States	Washington University	Saint Louis	Missouri
United States	Mays Cancer Center	San Antonio	Texas
United States	Kaiser Permanente San Diego Mission Road	San Diego	California
United States	UCSF Medical Center at Mission Bay	San Francisco	California
United States	Zuckerberg San Francisco General Hospital and Trauma Center	San Francisco	California
United States	Candler OncologyMedical Practice	Savannah	Georgia
United States	Phelps Hospital	Sleepy Hollow	New York
United States	Dana-Farber/Brigham and Women's Cancer Center - South Shore Hospital	South Weymouth	Massachusetts
United States	Highlands Oncology Group	Springdale	Arkansas
United States	Simmons Cancer Institute at SIU	Springfield	Illinois
United States	Saint Joseph's Medical Center	Stockton	California
United States	SUNY Upstate Medical University	Syracuse	New York
United States	Tampa General Hospital	Tampa	Florida
United States	Baylor Scott & White Medical Center - Temple	Temple	Texas
United States	US Oncology Research Network	The Woodlands	Texas
United States	USO - Compass Oncology	Tigard	Oregon
United States	Mercy Health - St. Vincent Medical Center	Toledo	Ohio
United States	The University of Arizona Cancer Center - North Campus	Tucson	Arizona
United States	USO - Arizona Oncology Associates - HOPE	Tucson	Arizona
United States	USO - Texas Oncology	Tyler	Texas
United States	Georgetown University Medical Center	Washington	District of Columbia
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	USO - Texas Oncology	Webster	Texas
United States	Clinical Research Alliance	Westbury	New York
United States	The University of Kansas Cancer Center - Westwood	Westwood	Kansas
United States	Asplundh Cancer Pavilion	Willow Grove	Pennsylvania
United States	University of Massachusetts Medical School	Worcester	Massachusetts
United States	York Hospital	York	Maine
United States	St. Elizabeth Youngstown Hospital	Youngstown	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  Czechia,  Finland,  France,  Germany,  Greece,  Hong Kong,  Hungary,  India,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Portugal,  Romania,  Singapore,  Slovakia,  Spain,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Invasive Disease-Free Survival (IDFS)	IDFS excluding second non-breast primary invasive cancers	Randomization to recurrence or death from any cause (up to 10 years)
Secondary	Distant Recurrence-Free Survival (DRFS)	DRFS	Randomization to Distant Recurrence or Death from Any Cause (up to 10 Years)
Secondary	Overall Survival (OS)	OS	Randomization to Death from Any Cause (up to 10 Years)
Secondary	Pharmacokinetics (PK): Steady State Plasma Concentrations of Imlunestrant	PK: steady state plasma concentrations of imlunestrant	Year 1, Month 2 to Month 4
Secondary	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).	Visit 1 Day 1 up to end of Year 5
Secondary	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).	Visit 1 Day 1 up to end of Year 5
Secondary	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).	Visit 1 Day 1 up to end of Year 5
Secondary	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.	Visit 1 Day 1 up to end of Year 5

External Links

•   A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer (EMBER-4)