Can a new pill slow advanced breast cancer better than standard hormone therapy?
NCT ID NCT04975308
First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time
Summary
This phase 3 trial is testing an experimental oral drug called imlunestrant, alone or combined with abemaciclib, against standard hormone therapies for people with ER+/HER2- advanced or metastatic breast cancer that has worsened after prior hormone treatment. The study aims to see if imlunestrant can delay cancer growth better than current options. Participants are randomly assigned to receive imlunestrant, standard hormone therapy, or imlunestrant plus abemaciclib.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- imlunestrant, exemestane, fulvestrant, and abemaciclib
- What this could lead to
- If successful, imlunestrant could offer a new oral hormone therapy option for advanced breast cancer, potentially delaying disease progression.
- What could go wrong
- This is an early-phase 3 trial; results may not confirm benefit over existing therapies. Side effects from the drug combination could be significant.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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AZ Groeninge Campus Kennedylaan
Kortrijk, West-Vlaanderen, 8500, Belgium
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AZ Nikolaas
Sint-Niklaas, Oost-Vlaanderen, B-9100, Belgium
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Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital
Ankara, 06200, Turkey (Türkiye)
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Acibadem Altunizade Hospital
Üsküdar / Stanbul, Istanbul, Turkey (Türkiye)
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Acıbadem Maslak Hastanesi
Istanbul, 34457, Turkey (Türkiye)
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Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524001, China
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Afflilated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004, China
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Agaplesion Markus Krankenhaus
Frankfurt am Main, Hesse, 60431, Germany
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Agios Savvas Regional Cancer Hospital
Athens, Attikí, 115 22, Greece
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Ajou University Hospital
Suwon, Kyǒnggi-do, 16499, South Korea
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Akdeniz Universitesi Hastanesi
Antalya, 07059, Turkey (Türkiye)
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Alexandra Hospital
Athens, Attikí, 115 28, Greece
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Ankara Bilkent Şehir Hastanesi
Ankara, 06800, Turkey (Türkiye)
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Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea
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Ashford Cancer Centre Research
Kurralta Park, South Australia, 5037, Australia
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Aultman Hospital
Canton, Ohio, 44710, United States
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Avera Cancer Institute Sioux Falls
Sioux Falls, South Dakota, 57105, United States
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Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, 50134, Italy
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Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
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Banner MD Anderson Cancer Center at McKee Medical Center
Loveland, Colorado, 80538, United States
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Baskent University Dr. Turgut Noyan Research and Training Center
Adana, 01250, Turkey (Türkiye)
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Beijing Hospital
Beijing, Beijing Municipality, 100005, China
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Blue Ridge Cancer Care
The Woodlands, Texas, 77380, United States
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Box Hill Hospital
Box Hill, Victoria, 3128, Australia
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Broome Oncology
The Woodlands, Texas, 77380, United States
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CHU Besançon
Besançon, Doubs, 25000, France
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CHU UCL Namur/Site Sainte Elisabeth
Namur, 5000, Belgium
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CIPREC
Buenos Aires, Buenos Aires F.D., C1061AAS, Argentina
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CNPE "Regional Center of Oncology"
Kharkiv, Kharkiv Oblast, 61070, Ukraine
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COI Centro Oncologico Internacional S.A.P.I. de C.V.
Álvaro Obregón, Mexico City, 01330, Mexico
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Care Access - Clifton
Clifton, New Jersey, 07013, United States
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Centre Hospitalier de la Côte Basque
Bayonne, Pyrénées-Atlantiques, 64109, France
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Centre de Cancérologie du Grand Montpellier
Montpellier, Languedoc-Roussillon, 34070, France
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Centro Medico Privado CEMAIC
Capital, Córdoba Province, X5008HHW, Argentina
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Centro Medico Zambrano Hellion
San Pedro Garza García, Nuevo León, 66278, Mexico
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Centro de Investigación Clínica de Alta Especialidad
Torreón, Coahuila, 27010, Mexico
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Chi Mei Hospital - Liouying Branch
Tainan, Tainan, 73657, Taiwan
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Chiba cancer center
Chiba, Chiba, 260-8717, Japan
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Clermont Oncology Center
Clermont, Florida, 34711, United States
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Clinica Viedma
Viedma, Río Negro Province, 8500, Argentina
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Clinique Victor Hugo Le Mans
Le Mans, Pays de la Loire Region, 72000, France
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Clínica de Pesquisa e Centro de Estudos em Ginecologia Oncológica e Mamária LTDA
São Paulo, 01317-001, Brazil
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Columbia University Medical Center
New York, New York, 10032, United States
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Communal Enterprise 'Kryvyi Rih Oncology Dispensary' of the Dnipropetrovsk Regional Council
Kryvyi Rih, Dnipropetrovsk Oblast, 50048, Ukraine
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Cro-Irccs
Aviano, Friuli Venezia Giulia, 33081, Italy
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Deenanath Mangeshkar Hospital & Research Centre
Pune, Maharashtra, 411004, India
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Dicle Üniversitesi
Diyarbakır, 21200, Turkey (Türkiye)
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Dong-A University Hospital
Busan, Pusan-Kwangyǒkshi, 49201, South Korea
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Ege Universitesi Hastanesi
Izmir, 35100, Turkey (Türkiye)
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Euromedica General Clinic of Thessaloniki
Thessaloniki, Thessaloníki, 546 45, Greece
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European Interbalkan Medical Center
Thessaloniki, Thessaloníki, 570 01, Greece
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Evangelisches Krankenhaus Bethesda Mönchengladbach
Mönchengladbach, North Rhine-Westphalia, 41061, Germany
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Faculdade de Medicina do ABC
Santo André, São Paulo, 09060-650, Brazil
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Fakultni Thomayerova nemocnice
Prague, Praha 4, 14059, Czechia
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Fakultni nemocnice Kralovske Vinohrady
Prague, Praha 10, 10034, Czechia
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Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, 100039, China
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Filios Alta Medicina
Monterrey, Nuevo León, 64460, Mexico
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Florida Cancer Specialists
Sarasota, Florida, 34232, United States
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Florida Cancer Specialists
St. Petersburg, Florida, 33705, United States
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Florida Cancer Specialists
Nashville, Tennessee, 37203, United States
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Fondazione Policlinico Universitario Agostino Gemelli
Rome, Lazio, 00168, Italy
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Fujian Provincial Cancer Hospital
Fuzhou, Fujian, 350014, China
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Fundación Cenit Para La Investigación En Neurociencias
CABA, Buenos Aires F.D., 1125, Argentina
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Gachon University Gil Medical Center
Namdong-gu, Incheon-gwangyeoksi [Incheon], 21565, South Korea
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Gangnam Severance Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 06273, South Korea
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General Oncology Hospital of Kifissia "Agioi Anargiroi"
Nea Kifissia, Attikí, 14564, Greece
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Government Medical College And Hospital - Nagpur
Nagpur, Maharashtra, 440003, India
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Grupo Medico Camino Sc
Mexico City, Mexico City, 03310, Mexico
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Gunma Prefectural Cancer Center
Otashi, Gunma, 373-8550, Japan
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Gynäkologisch-Onkologische Praxis am Pelikanplatz
Hanover, Lower Saxony, 30177, Germany
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HCG Cancer Centre
Mumbai, Maharashtra, 400092, India
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HCG Manavata Cancer Centre
Nashik, Maharashtra, 422002, India
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Hacettepe Universitesi
Ankara, 06230, Turkey (Türkiye)
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Haga Ziekenhuis locatie Leyweg
The Hague, South Holland, 2545 AA, Netherlands
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Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
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Hiroshima City Hospital
Hiroshima, 730-8518, Japan
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Hospital Clinico San Carlos
Madrid, 28040, Spain
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Hospital Clinico de Valencia
Valencia, Valenciana, Comunitat, 46010, Spain
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Hospital Quirónsalud Valencia
Valencia, València, 46010, Spain
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Hospital San Pedro de Alcántara
Cáceres, Extremadura, 10003, Spain
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Hospital Universitari Dexeusa
Barcelona, Catalunya [Cataluña], 08028, Spain
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Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], 08035, Spain
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Hospital Universitario Arnau de Vilanova de Lleida
Lleida, Lleida [Lérida], 25198, Spain
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Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, 28034, Spain
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Hospital Universitario San Cecilio
Granada, 18016, Spain
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Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
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Hospital Universitario Virgen Macarena
Seville, 41009, Spain
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Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain
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Hospital de Cancer de Londrina
Londrina, Paraná, 86015-520, Brazil
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Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya [Cataluña], 08041, Spain
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Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
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Hunan Cancer Hospital
Changsha, Hunan, 421000, China
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Hwa Mei Hospital University of Chinese Academy of Sciences
Ningbo, Zhejiang, 315010, China
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Hyogo Cancer Center
Akashi, Hyōgo, 673-8558, Japan
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Hôpital René Huguenin
Saint-Cloud, Hauts-de-Seine, 92210, France
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IU Health Ball Memorial Hospital, Inc.
Muncie, Indiana, 47303, United States
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Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, 01246-000, Brazil
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Imelda General Hospital
Bonheiden, Antwerpen, 2820, Belgium
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Institut Curie
Paris, 75248, France
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Institut Jules Bordet
Brussels, Bruxelles-Capitale, Région de, 1000, Belgium
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Institut de Cancérologie de Lorraine Alexis Vautrin
Vandœuvre-lès-Nancy, 54519, France
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Institut de cancérologie Strasbourg Europe (ICANS)
Strasbourg, Alsace, 67033, France
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Instituto Argentino de Diagnóstico y Tratamiento (IADT)
Buenos Aires, 1122, Argentina
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Instituto San Marcos
San Juan, 5400, Argentina
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Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata, Buenos Aires, B7600FZO, Argentina
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Ironwood Cancer & Research Centers
Chandler, Arizona, 85224, United States
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Istituto Nazionale Tumori IRCCS Fondazione Pascale
Naples, Campania, 80131, Italy
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Istituto Oncologico Veneto IRCCS
Padova, 35128, Italy
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Jackson Oncology Associates, PLLC
Jackson, Mississippi, 39202, United States
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Jiangmen Center Hospital
Jiangmen, Guangdong, China
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Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
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Jinan Central Hospital
Jinan, Shandong, 250013, China
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Juntendo University Hospital
Tokyo, 113-8431, Japan
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Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819, United States
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Kaluga Regional Clinical Oncology Center
Kaluga, Kalužskaja Oblast', 248007, Russia
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Kanagawa cancer center
Yokohama, Kanagawa, 2418515, Japan
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Kangbuk Samsung Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 03181, South Korea
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Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung
Essen, North Rhine-Westphalia, 45136, Germany
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Klinikum Ludwigsburg
Ludwigsburg, Baden-Wurttemberg, 71640, Germany
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Klinikum der Ludwig-Maximilians-Universitaet Muenchen
München, Bavaria, 80336, Germany
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Koo Foundation Sun Yat-Sen Cancer Center
Taipei, 112, Taiwan
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Kumamoto Shinto General Hospital
Kumamoto, 862-8655, Japan
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Kurume General Hospital
Kurume, Fukuoka, 830-0013, Japan
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Kyungpook National University Chilgok Hospital
Daegu, Taegu-Kwangyǒkshi, 41404, South Korea
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Lifepoint Multispeciality Hospital
Pune, Maharashtra, 411057, India
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Maastricht UMC+
Maastricht, Limburg, 6229 HX, Netherlands
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Marin Cancer Care
Greenbrae, California, 94904, United States
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Maroondah Hospital
Melbourne, Victoria, 3135, Australia
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Medipol University Medical Faculty
Stanbul, Istanbul, 34214, Turkey (Türkiye)
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Medische Centrum Leeuwarden
Leeuwarden, Provincie Friesland, 8934 AD, Netherlands
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Medizinische Universität Graz
Graz, Styria, 8036, Austria
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Medstar Speciality Hospital
Bangalore, Karnataka, 560092, India
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Memorial Ankara Hastanesi
Ankara, 06520, Turkey (Türkiye)
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Memorial Sloan Kettering - Bergen
Montvale, New Jersey, 07645, United States
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Mercy Health - St. Vincent Medical Center
Toledo, Ohio, 43608, United States
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Mersin University
Mersin, 33343, Turkey (Türkiye)
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Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763, United States
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Minnesota Oncology/Hematology PA
The Woodlands, Texas, 77380, United States
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Municipal Enterprise "Volyn Regional Medical Oncology Centre" of the Volyn Regional Council
Lutsk, Volyn Oblast, 43018, Ukraine
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Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council
Odesa, Odesa Oblast, 65025, Ukraine
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N.N.Petrov Research Institute of Oncology
Saint Petersburg, 197758, Russia
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Nagano Municipal Hospital
Tomitake, Nagano, 381-8551, Japan
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Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560, Japan
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Nanyang Second General Hospital
Nanyang, Henan, 473000, China
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National Cheng Kung University Hospital
Tainan, 704, Taiwan
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National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804, Japan
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National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395, Japan
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National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280, Japan
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National Taiwan University Hospital
Taipei, 10002, Taiwan
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Nemocnice Horovice
Hořovice, Beroun, 268 31, Czechia
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Nemocnice Na Bulovce
Prague, Praha 8, 180 81, Czechia
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Niigata Cancer Center Hospital
Niigata, Niigata, 951-8566, Japan
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Ningbo Medical Center
Ningbo, Zhejiang, 315048, China
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NorthShore University HealthSystem - Evanston Hospital
Evanston, Illinois, 60201, United States
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Núcleo de Pesquisa Clínica da Rede São Camilo
São Paulo, 04014-002, Brazil
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Oaxaca Site Management Organization
Oaxaca City, 68000, Mexico
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Oblastni nemocnice Pribram
Příbram, Příbram, 261 01, Czechia
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Onkologiezentrum Donauwörth
Donauwörth, Bavaria, 86609, Germany
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Osaka International Cancer Institute
Osaka, 541-8567, Japan
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Ospedale San Martino
Genoa, Liguria, 16132, Italy
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Papageorgiou General Hospital of Thessaloniki
Thessaloniki, Thessaloníki, 564 29, Greece
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Polyclinique De Blois
La Chaussée-Saint-Victor, Centre-Val de Loire, 41260, France
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Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
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Private Practice - Dr. Joaquin Reinoso
Monterrey, Nuevo León, 64320, Mexico
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Rashtrasant Tukdoji Regional Cancer Hospital
Nagpur, Maharashtra, 440027, India
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Regional Cancer Centre - Thiruvananthapuram
Thiruvananthapuram, Kerala, 695011, India
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Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
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Sagara Hospital
Kagoshima, 892-0833, Japan
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Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea
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Sanatorio Norte
Santiago del Estero, 4200, Argentina
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Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea
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Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [Seoul], 03722, South Korea
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Sharp Memorial Hospital
San Diego, California, 92123, United States
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Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518035, China
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Shinko Hospital
Kobe, Hyōgo, 651-0072, Japan
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Shizuoka General Hospital
Shizuoka, 420-8527, Japan
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Showa University Hospital
Shinagawa, Tokyo, 142-8555, Japan
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Sichuan Cancer hospital
Chengdu, Sichuan, 610042, China
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Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310016, China
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Soon Chun Hyang University Cheonan Hospital
Cheonan-si, Chungcheongnam-do [Chungnam], 31151, South Korea
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St Vincent's Hospital
Darlinghurst, New South Wales, 2010, Australia
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St. Marianna University School of Medicine Hospital
Kawasaki, Kanagawa, 216-8511, Japan
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Sun Yat-Sen University Cancer Centre
Guangzhou, Guangdong, 511400, China
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TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul, 34722, Turkey (Türkiye)
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Taichung Veterans General Hospital
Taichung, 407, Taiwan
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Texas Oncology - Austin Central
The Woodlands, Texas, 78731, United States
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Texas Oncology - Carrollton
Lewisville, Texas, 75056, United States
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Texas Oncology - Carrollton
The Woodlands, Texas, 77380, United States
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Texas Oncology - Dallas Presbyterian Hospital
Dallas, Texas, 75231, United States
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Texas Oncology - Denison
The Woodlands, Texas, 75020, United States
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Texas Oncology - McKinney
The Woodlands, Texas, 77380, United States
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Texas Oncology - Medical City Dallas
The Woodlands, Texas, 77380, United States
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Texas Oncology - Methodist Charlton Cancer Center
The Woodlands, Texas, 77380, United States
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Texas Oncology - Paris
The Woodlands, Texas, 75460, United States
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Texas Oncology - San Antonio Medical Center
The Woodlands, Texas, 77380, United States
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Texas Oncology - The Woodlands
The Woodlands, Texas, 77380, United States
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Texas Oncology - Willowbrook
The Woodlands, Texas, 77380, United States
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Texas Oncology Fort Worth
The Woodlands, Texas, 77380, United States
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Texas Oncology-Baylor Charles A. Sammons Cancer Center
The Woodlands, Texas, 77380, United States
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The Fifth Affiliated Hospital of Sun Yat-Sen University
Zhuhai, Guangdong, 519000, China
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The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, Henan, 471003, China
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The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
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The First People's Hospital of Changde City
Changde, Hunan, 415003, China
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The Mark H Zangmeister Cancer Center
Nashville, Tennessee, 37203, United States
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The Second Hospital of Jilin University
Changchun, Jilin, China
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The Second People's Hospital of Neijiang
Neijiang, Sichuan, 641000, China
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The Third Hospital of Nanchang
Nanchang, Jiangxi, 330009, China
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The University of Louisville, James Graham Brown Cancer Center
Louisville, Kentucky, 40202, United States
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The University of Vermont Medical Center Inc.
Burlington, Vermont, 05401, United States
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Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
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Tongji Hospital Tongji Medical,Science & Technology
Wuhan, Hubei, 430030, China
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Trakya University
Edirne, 22030, Turkey (Türkiye)
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Tsuchiura Kyodo General Hospital
Tsuchiura, Ibaraki, 300-0028, Japan
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Tsukuba University Hospital
Tsukuba, Ibaraki, 305-8576, Japan
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USO - Texas Oncology - Allen
Allen, Texas, 75013, United States
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USO-Rocky Mountain Cancer Center
The Woodlands, Texas, 77380, United States
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UZ Brussel
Brussels, Bruxelles-Capitale, Région de, 1090, Belgium
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UZ Gent
Ghent, Oost-Vlaanderen, 9000, Belgium
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UZ Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
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Unidad Médica Onco-hematológica
Puebla City, 72424, Mexico
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Unidad de Investigación en Salud
Chihuahua City, 31203, Mexico
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Uniklinikum Salzburg
Salzburg, 5020, Austria
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Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, State of Vienna, 1090, Austria
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Universitaetsklinikum Erlangen
Erlangen, Bavaria, 91054, Germany
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Universitaetsklinikum Schleswig-Holstein Campus Kiel
Kiel, Schleswig-Holstein, 24105, Germany
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University General Hospital of Heraklion
Heraklion, Irakleío, 711 10, Greece
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University General Hospital of Larissa
Larissa, Thessalía, 41110, Greece
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University of California Davis (UC Davis) Comprehensive Cancer Center
Sacramento, California, 95817, United States
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University of Chicago Medical Center
Chicago, Illinois, 60637, United States
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University of Florida College of Medicine
Gainesville, Florida, 32610, United States
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University of Health Sciences,Gulhane School of Medicine
Ankara, 06010, Turkey (Türkiye)
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University of Naples Federico II
Naples, Campania, 80100, Italy
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University of North Carolina Medical Center
Chapel Hill, North Carolina, 27599, United States
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Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
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Uzhgorod Central City Clinical Hospital
Uzhhorod, Zakarpattia Oblast, 88000, Ukraine
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Volgograd Regional Clinical Cancer Clinic No.1
Volgograd, Volgograd Oblast, 400138, Russia
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Willamette Valley Cancer Institute & Research Ctr.
Houston, Texas, 77070, United States
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Xiangya Hospital Central South University
Changsha, Hunan, 410008, China
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Yashoda Hospitals
Hyderabad, Telangana, 500082, India
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Yeungnam Univeristy Medical Center
Daegu, Kyǒngsangbuk-do, 42415, South Korea
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
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Zhongshan Peoples Hospital
Zhongshan, Guangdong, 528403, China
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İnönü Üniversitesi Turgut Özal Tıp Merkezi
Malatya, 44280, Turkey (Türkiye)
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