BGB-43395 más Letrozol frente a CDK4/6i más Letrozol para pacientes con cáncer de mama avanzado o metastásico HR+/HER2- que no han recibido tratamiento previo para la enfermedad avanzada o metastásica (KANDELA-302)
23 de octubre de 2026 actualizado por: BeOne Medicines
Un estudio abierto, aleatorizado y multicéntrico de fase 3 que investiga la eficacia y la seguridad de BGB-43395 más letrozol frente a inhibidores de CDK4/6 (abemaciclib, palbociclib, ribociclib) más letrozol en pacientes con cáncer de mama HR+/HER2- avanzado o metastásico que no han recibido tratamiento sistémico previo contra el cáncer para la enfermedad avanzada o metastásica
The purpose of this study is to investigate the efficacy and safety of BGB-43395 in combination with letrozole compared with investigator's choice of cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) in combination with letrozole in patients with advanced or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) who have not received prior systemic treatment for advanced or metastatic disease.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
1056
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Study Director
- Número de teléfono: 877-828-5568
- Correo electrónico: clinicaltrials@beonemed.com
Ubicaciones de estudio
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Berlin, Alemania, 13125
- Reclutamiento
- Helios Klinikum Berlin Buch Brustzentrum
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Esslingen am Neckar, Alemania, 73730
- Reclutamiento
- Klinikum Esslingen Gmbh Klinik Fuer Frauenheilkunde Und Geburtshilfe
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Frankfurt am Main, Alemania, 60389
- Reclutamiento
- Centrum Fur Haematologie Und Onkologie Bethanien
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Koblenz, Alemania, 56068
- Reclutamiento
- Invo Institut Fur Versorgungsforschung in Der Onkologie
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New South Wales
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Blacktown, New South Wales, Australia, NSW 2148
- Reclutamiento
- Blacktown Cancer and Haematology Centre
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Liverpool, New South Wales, Australia, NSW 2170
- Reclutamiento
- Liverpool Hospital
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Wollongong, New South Wales, Australia, NSW 2500
- Reclutamiento
- Wollongong Hospital
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Queensland
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Birtinya, Queensland, Australia, QLD 4575
- Reclutamiento
- Sunshine Coast University Private Hospital
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Douglas, Queensland, Australia, QLD 4814
- Reclutamiento
- Townsville University Hospital
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Victoria
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Melbourne, Victoria, Australia, VIC 3000
- Reclutamiento
- Peter Maccallum Cancer Centre
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Western Australia
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Murdoch, Western Australia, Australia, WA 6150
- Reclutamiento
- Fiona Stanley Hospital
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Nedlands, Western Australia, Australia, WA 6009
- Reclutamiento
- One Clinical Research
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Barretos, Brasil, 14.784-400
- Reclutamiento
- Fundacao Pio Xii Hospital de Amor de Barretos
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Brasília, Brasil, 71681-603
- Reclutamiento
- Hospital Brasilia
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Caxias do Sul, Brasil, 95070-560
- Reclutamiento
- Fundacao Universidade de Caxias Do Sul
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Curitiba, Brasil, 80510-130
- Reclutamiento
- Ictr Instituto Do Cancer E Transplante de Curitiba
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Fortaleza, Brasil, 60336-232
- Reclutamiento
- Centro Regional Integrado de Oncologia Crio
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Ijuí, Brasil, 98700-000
- Reclutamiento
- Oncosite Centro de Pesquisa Clinica Em Oncologia
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Natal, Brasil, 59062-000
- Reclutamiento
- Liga Norte Riograndene Contra O Cancer
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Porto Alegre, Brasil, 90610-000
- Reclutamiento
- Hospital Sao Lucas Da Pucrs
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Pouso Alegre, Brasil, 37554-238
- Reclutamiento
- Instituto Sul Mineiro de Oncologia Ltda
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Recife, Brasil, 50040-000
- Reclutamiento
- Hospital Do Cancer de Pernambuco
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Rio de Janeiro, Brasil, 20560-120
- Reclutamiento
- Instituto Nacional de Cancer
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São Paulo, Brasil, 01246-000
- Reclutamiento
- Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
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Vitória, Brasil, 29043-260
- Reclutamiento
- Hospital Santa Rita de Cassia Afecc
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Suwon, Corea del Sur, 16499
- Reclutamiento
- Ajou University Hospital
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Busan Gwang'yeogsi
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HaeundaeGu, Busan Gwang'yeogsi, Corea del Sur, 48108
- Reclutamiento
- Inje University Haeundae Paik Hospital
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Seogu, Busan Gwang'yeogsi, Corea del Sur, 49201
- Reclutamiento
- Dong A University Hospital
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Chungcheongbukdo
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Cheongju-si, Chungcheongbukdo, Corea del Sur, 28644
- Reclutamiento
- Chungbuk National University Hospital
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Chungcheongnam-do
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Cheonansi, Chungcheongnam-do, Corea del Sur, 31151
- Reclutamiento
- Soon Chun Hyang University Cheonan Hospital
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Daegu Gwang'yeogsi
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Dalseogu, Daegu Gwang'yeogsi, Corea del Sur, 42601
- Reclutamiento
- Keimyung University Dongsan Hospital
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Gyeonggi-do
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BundangGu SeongnamSi, Gyeonggi-do, Corea del Sur, 13496
- Reclutamiento
- Cha Bundang Medical Center, Cha University
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DanwonGu AnsanSi, Gyeonggi-do, Corea del Sur, 15355
- Reclutamiento
- Korea University Ansan Hospital
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IlsandongGu GoyangSi, Gyeonggi-do, Corea del Sur, 10408
- Reclutamiento
- National Cancer Center (Korea)
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PaldalGu SuwonSi, Gyeonggi-do, Corea del Sur, 16247
- Reclutamiento
- The Catholic University of Korea, St Vincents Hospital
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Seongnam-si, Gyeonggi-do, Corea del Sur, 13620
- Reclutamiento
- Seoul National University Bundang Hospital
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Incheon Gwang'yeogsi
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Jemulpogu, Incheon Gwang'yeogsi, Corea del Sur, 22332
- Reclutamiento
- Inha University Hospital
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NamdongGu, Incheon Gwang'yeogsi, Corea del Sur, 21565
- Reclutamiento
- Gachon University Gil Medical Center
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Jeonnam-Gwangju S.M. City
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HwasunGun, Jeonnam-Gwangju S.M. City, Corea del Sur, 58128
- Reclutamiento
- Chonnam National University Hwasun Hospital
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Seoul Teugbyeolsi
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DongjakGu, Seoul Teugbyeolsi, Corea del Sur, 06973
- Reclutamiento
- Chung Ang University Hospital
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GangnamGu, Seoul Teugbyeolsi, Corea del Sur, 06351
- Reclutamiento
- Samsung Medical Center
-
GuroGu, Seoul Teugbyeolsi, Corea del Sur, 08308
- Reclutamiento
- Korea University Guro Hospital
-
SeochoGu, Seoul Teugbyeolsi, Corea del Sur, 06591
- Reclutamiento
- The Catholic University of Korea, Seoul St Marys Hospital
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SeodaemunGu, Seoul Teugbyeolsi, Corea del Sur, 03722
- Reclutamiento
- Severance Hospital Yonsei University Health System
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SeongbukGu, Seoul Teugbyeolsi, Corea del Sur, 02841
- Reclutamiento
- Korea University Anam Hospital
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Seoul, Seoul Teugbyeolsi, Corea del Sur, 03080
- Reclutamiento
- Seoul National University Hospital
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Seoul, Seoul Teugbyeolsi, Corea del Sur, 06273
- Reclutamiento
- Gangnam Severance Hospital, Yonsei University Health System
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Seoul, Seoul Teugbyeolsi, Corea del Sur, 07985
- Reclutamiento
- Ehwa Womans University Mokdong Hospital
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SongpaGu, Seoul Teugbyeolsi, Corea del Sur, 05505
- Reclutamiento
- Asan Medical Center
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Ulsan Gwang'yeogsi
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Ulsan, Ulsan Gwang'yeogsi, Corea del Sur, 44033
- Reclutamiento
- Ulsan University Hospital
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Badajoz, España, 06006
- Reclutamiento
- Hospital Universitario de Badajoz
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Barcelona, España, 08036
- Reclutamiento
- Hospital Clinic de Barcelona
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Barcelona, España, 08035
- Reclutamiento
- Vall D Hebron Institute of Oncology Vhio
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Donostiasan Sebastian, España, 20014
- Reclutamiento
- Hospital Universitario Donostia
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Elcheelx, España, 03203
- Reclutamiento
- Hospital General Universitario de Elche
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Granada, España, 18016
- Reclutamiento
- Hospital Universitario Clinico San Cecilio
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Madrid, España, 28041
- Reclutamiento
- Hospital Universitario 12 de Octubre
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Madrid, España, 28240
- Reclutamiento
- Hospital Clinico San Carlos
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Madrid, España, 28007
- Reclutamiento
- Hospital General Universitario Gregorio Maranon
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Madrid, España, 28007
- Reclutamiento
- Iob Institute of Oncology Madrid
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Santiago de Compostela, España, 15706
- Reclutamiento
- Complejo Hospitalario Univ de Santiago (Chus)
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Seville, España, 41013
- Reclutamiento
- Hospital Universitario Virgen Del Rocio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35211
- Reclutamiento
- Alabama Oncology Princeton
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Alaska
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Anchorage, Alaska, Estados Unidos, 99508-2974
- Reclutamiento
- Alaska Oncology and Hematology, Llc
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Fairbanks, Alaska, Estados Unidos, 99701
- Reclutamiento
- Fairbanks Cancer Care Physicians Pc
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Arizona
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Bullhead City, Arizona, Estados Unidos, 86442
- Reclutamiento
- Pioneer Research Center
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Chandler, Arizona, Estados Unidos, 85224-5665
- Reclutamiento
- Ironwood Cancer and Research Centers Chandler Ii
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Goodyear, Arizona, Estados Unidos, 85338
- Reclutamiento
- City of Hope Phoenix Cancer Center
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Arkansas
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Hot Springs, Arkansas, Estados Unidos, 71913
- Reclutamiento
- Genesis Cancer and Blood Institute Hot Springs (Harmony Park)
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California
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Duarte, California, Estados Unidos, 91010-3012
- Reclutamiento
- City of Hope National Medical Center
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Fountain Valley, California, Estados Unidos, 92708
- Reclutamiento
- Helios Clinical Research the Oncology Institute Fountain Valley
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Los Angeles, California, Estados Unidos, 90027
- Reclutamiento
- California Research Institute
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Oxnard, California, Estados Unidos, 93030
- Reclutamiento
- Ventura County Hematology Oncology Specialists
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San Marcos, California, Estados Unidos, 92078
- Reclutamiento
- Kaiser Permanente San Marcos Medical Offices
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Santa Monica, California, Estados Unidos, 90404-2303
- Reclutamiento
- Providence Saint Johns Health Center
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West Hills, California, Estados Unidos, 91307
- Reclutamiento
- Wellness Oncology and Hematology
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Colorado
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Lone Tree, Colorado, Estados Unidos, 80124-5641
- Reclutamiento
- Rocky Mountain Cancer Centers, Llp(Us Oncology Research)
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Connecticut
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Danbury, Connecticut, Estados Unidos, 06810
- Reclutamiento
- Danbury Hospital
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Florida
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Coral Springs, Florida, Estados Unidos, 33065
- Reclutamiento
- Brcr Coral Springs
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Orange City, Florida, Estados Unidos, 32763-8316
- Reclutamiento
- Mid Florida Hematology and Oncology Center
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Palm Bay, Florida, Estados Unidos, 32901
- Reclutamiento
- Cancer Care Centers of Brevard Palm Bay
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Plantation, Florida, Estados Unidos, 33322
- Reclutamiento
- Florida Clinical Trials Group Plantation
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Port Saint Lucie, Florida, Estados Unidos, 34952-7596
- Reclutamiento
- Hematology Oncology Associates of the Treasure Coast
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South Miami, Florida, Estados Unidos, 33143
- Reclutamiento
- The Oncology Institute of Hope and Innovation South Miami
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Tamarac, Florida, Estados Unidos, 33321
- Reclutamiento
- Florida Clinical Trials Group Tamarac
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Tampa, Florida, Estados Unidos, 33612
- Reclutamiento
- Moffitt Cancer Center McKinley Campus Richard M Shulze Family Foundation Outpatient Center
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Georgia
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Athens, Georgia, Estados Unidos, 30607
- Reclutamiento
- University Cancer and Blood Center Athens Comprehensive Cancer Center
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Macon, Georgia, Estados Unidos, 31210
- Reclutamiento
- Central Georgia Cancer Care Macon Office
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Hawaii
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Honolulu, Hawaii, Estados Unidos, 96813
- Reclutamiento
- Hawaii Cancer Care
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Illinois
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Hinsdale, Illinois, Estados Unidos, 60521-0509
- Reclutamiento
- Hope and Healing Cancer Services
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O'Fallon, Illinois, Estados Unidos, 62269
- Reclutamiento
- Cancer Care Specialists For Illinois
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Zion, Illinois, Estados Unidos, 60099
- Reclutamiento
- City of Hope Chicago Cancer Center
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Indiana
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Fort Wayne, Indiana, Estados Unidos, 46804
- Reclutamiento
- Fort Wayne Medical Oncology and Hematology
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Indianapolis, Indiana, Estados Unidos, 46260
- Reclutamiento
- Hematology Oncology of Indiana
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-
Iowa
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Cedar Rapids, Iowa, Estados Unidos, 52403
- Reclutamiento
- Mercy Medical Center
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Kentucky
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Owensboro, Kentucky, Estados Unidos, 42303
- Reclutamiento
- Owensboro Health Mitchell Memorial Cancer Center
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Michigan
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Detroit, Michigan, Estados Unidos, 48201-2013
- Reclutamiento
- Karmanos Cancer Institute
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Minnesota
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Duluth, Minnesota, Estados Unidos, 55805
- Reclutamiento
- Aspirus St Lukes Hospital
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Minneapolis, Minnesota, Estados Unidos, 55407
- Reclutamiento
- Allina Health Cancer Institute Minneapolis
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Saint Paul, Minnesota, Estados Unidos, 55101-2502
- Reclutamiento
- Metro Minnesota Community Oncology Research Consortium (Mmcorc)
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Mississippi
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Hattiesburg, Mississippi, Estados Unidos, 39401-7233
- Reclutamiento
- Hattiesburg Hematology and Oncology Clinic
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Missouri
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Columbia, Missouri, Estados Unidos, 65201
- Reclutamiento
- Missouri Cancer Associates Columbia, Mo
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Springfield, Missouri, Estados Unidos, 65807-5288
- Reclutamiento
- Oncology Hematology Associates
-
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Nebraska
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Grand Island, Nebraska, Estados Unidos, 68803
- Reclutamiento
- Nebraska Cancer Specialists St Francis Grand Island
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Lincoln, Nebraska, Estados Unidos, 68506-7548
- Reclutamiento
- Nebraska Hematology Oncology
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Lincoln, Nebraska, Estados Unidos, 68516
- Reclutamiento
- Cancer Partners of Nebraska April Sampson Cancer Center
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Omaha, Nebraska, Estados Unidos, 68130-2042
- Reclutamiento
- Nebraska Cancer Specialists
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89169-3321
- Reclutamiento
- Comprehensive Cancer Centers of Nevada
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Reno, Nevada, Estados Unidos, 89502
- Reclutamiento
- Renown Regional Medical Center
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New Jersey
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East Brunswick, New Jersey, Estados Unidos, 08816-4096
- Reclutamiento
- Astera Cancer Care East Brunswick
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Florham Park, New Jersey, Estados Unidos, 07932-1049
- Reclutamiento
- Summit Medical Group
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New Brunswick, New Jersey, Estados Unidos, 08901-1914
- Reclutamiento
- Rutgers Cancer Institute of New Jersey
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New York
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Brooklyn, New York, Estados Unidos, 11220
- Reclutamiento
- Nyu Langone Health Perlmutter Cancer Center Sunset Park
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Mineola, New York, Estados Unidos, 11501
- Reclutamiento
- Nyu Langone Health Perlmutter Cancer Center At Nyu Langone Hospital Long Island
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New York, New York, Estados Unidos, 10016
- Reclutamiento
- Nyu Langone Health Perlmutter Cancer Center 34Th Street
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Rochester, New York, Estados Unidos, 14642-0001
- Reclutamiento
- University of Rochester
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Shirley, New York, Estados Unidos, 11967
- Reclutamiento
- New York Cancer and Blood Specialists
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Stony Brook, New York, Estados Unidos, 11794
- Reclutamiento
- Stony Brook Cancer Center
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27514-4220
- Reclutamiento
- University of North Carolina At Chapel Hill
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Hendersonville, North Carolina, Estados Unidos, 28739
- Reclutamiento
- Pardee Cancer Center
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Wilson, North Carolina, Estados Unidos, 27896
- Reclutamiento
- Carolina Cancer Research Center
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Ohio
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Canton, Ohio, Estados Unidos, 44718-2566
- Reclutamiento
- Gabrail Cancer Center Research
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Dayton, Ohio, Estados Unidos, 45409
- Reclutamiento
- Dayton Physicians Network
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Oregon
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Eugene, Oregon, Estados Unidos, 97401
- Reclutamiento
- Oncology Associates of Oregon Willamette Valley Cancer Center
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Salem, Oregon, Estados Unidos, 97301
- Reclutamiento
- Oregon Oncology Specialists
-
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Pennsylvania
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Broomall, Pennsylvania, Estados Unidos, 19008
- Reclutamiento
- Consultants in Medical Oncology and Hematology Cancer Center At Broomall
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West Reading, Pennsylvania, Estados Unidos, 19611-2143
- Reclutamiento
- McGlinn Cancer Institute
-
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South Dakota
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Sioux Falls, South Dakota, Estados Unidos, 57105-2108
- Reclutamiento
- Avera Cancer Institute
-
-
Tennessee
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Kingsport, Tennessee, Estados Unidos, 37660
- Reclutamiento
- Ballad Health Cancer Center Kingsport
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Nashville, Tennessee, Estados Unidos, 37204
- Reclutamiento
- Vanderbilt Ingram Cancer Center Nashville Vanderbilt Breast Center
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Texas
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Austin, Texas, Estados Unidos, 78731-4214
- Reclutamiento
- Texas Oncology Austin Central
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Dallas, Texas, Estados Unidos, 75246-2003
- Reclutamiento
- Texas Oncology Baylor Charles A Sammons Cancer Center
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Round Rock, Texas, Estados Unidos, 78665
- Reclutamiento
- Baylor Scott and White Medical Center Round Rock
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Utah
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Salt Lake City, Utah, Estados Unidos, 84107
- Reclutamiento
- Utah Cancer Specialists Cancer Center
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Virginia
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Blacksburg, Virginia, Estados Unidos, 24060-6325
- Reclutamiento
- Oncology and Hematology Associates of Southwest Virginia, Inc (Us Oncology Research)
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Charlottesville, Virginia, Estados Unidos, 22908-0817
- Reclutamiento
- University of Virginia
-
Fairfax, Virginia, Estados Unidos, 22031-2171
- Reclutamiento
- Virginia Cancer Specialists
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Norfolk, Virginia, Estados Unidos, 23502-2800
- Reclutamiento
- Virginia Oncology Associates
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Richmond, Virginia, Estados Unidos, 23229-8605
- Reclutamiento
- Virginia Cancer Institute
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Washington
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Olympia, Washington, Estados Unidos, 98506
- Reclutamiento
- Vista Oncology East Olympia
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Spokane, Washington, Estados Unidos, 99204
- Reclutamiento
- Multicare Cancer Institute Deaconess Medical Office Building 1
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Tacoma, Washington, Estados Unidos, 98405
- Reclutamiento
- Northwest Medical Specialties
-
Tacoma, Washington, Estados Unidos, 98405
- Reclutamiento
- Multicare Cancer Institute Tacoma General Hospital
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Yakima, Washington, Estados Unidos, 98902
- Reclutamiento
- Multicare Cancer Institute North Star Lodge
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Wisconsin
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La Crosse, Wisconsin, Estados Unidos, 54601-5467
- Reclutamiento
- Gundersen Health System
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Milwaukee, Wisconsin, Estados Unidos, 53226-3522
- Reclutamiento
- Medical College of Wisconsin
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-
-
-
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Bordeaux, Francia, 33076
- Reclutamiento
- Centre de Lutte Contre Le Cancer Institut Bergonie
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Lyon, Francia, 69373
- Reclutamiento
- Centre Leon Berard
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Marseille, Francia, 13009
- Reclutamiento
- Institut Paoli Calmettes
-
Montpellier, Francia, 34090
- Reclutamiento
- Icm Val Daurelle
-
Rennes, Francia, 35043
- Reclutamiento
- Centre Eugene Marquis
-
SaintHerblain, Francia, 44805
- Reclutamiento
- Ico Site Rene Gauducheau
-
Villejuif, Francia, 94800
- Reclutamiento
- Institut Gustave Roussy
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-
-
-
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Bergamo, Italia, 24127
- Reclutamiento
- Asst Papa Giovanni Xxiii
-
Milan, Italia, 20141
- Reclutamiento
- Istituto Europeo Di Oncologia
-
Monza, Italia, 20900
- Reclutamiento
- Azienda Socio Sanitaria Territoriale Di Monza (Presidio San Gerardo)
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Roma, Italia, 00168
- Reclutamiento
- Fondazione Policlinico Universitario Agostino Gemelli
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-
-
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Fukuoka
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Kurumeshi, Fukuoka, Japón, 830-0013
- Reclutamiento
- Japan Community Healthcare Organization Kurume General Hospital
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-
Gunma
-
Otashi, Gunma, Japón, 373-8550
- Reclutamiento
- Gunma Prefectural Cancer Center
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-
Hiroshima
-
Hiroshima, Hiroshima, Japón, 730-8518
- Reclutamiento
- Hiroshima City Hiroshima Citizens Hospital
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-
Hokkaido
-
Sapporo, Hokkaido, Japón, 003-0804
- Reclutamiento
- National Hospital Organization Hokkaido Cancer Center
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-
Hyōgo
-
Nishinomiyashi, Hyōgo, Japón, 663-8501
- Reclutamiento
- Hyogo Medical University Hospital
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Kagoshima-ken
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Kagoshima, Kagoshima-ken, Japón, 892-0833
- Reclutamiento
- Social Medical Corporation Hakuaikai Sagara Hospital
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Kanagawa
-
Iseharashi, Kanagawa, Japón, 259-1193
- Reclutamiento
- Tokai University Hospital
-
Kawasakishi, Kanagawa, Japón, 211-8533
- Reclutamiento
- Nippon Medical School Musashi Kosugi Hospital
-
Yokohama, Kanagawa, Japón, 232-0024
- Reclutamiento
- Yokohama City University Medical Center
-
Yokohama, Kanagawa, Japón, 241-8515
- Reclutamiento
- Kanagawa Cancer Center
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-
Mie-ken
-
Tsu, Mie-ken, Japón, 514-8507
- Reclutamiento
- Mie University Hospital
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-
Osaka
-
OsakaShi, Osaka, Japón, 541-8567
- Reclutamiento
- Osaka International Cancer Institute
-
Osakashi, Osaka, Japón, 540-0006
- Reclutamiento
- National Hospital Organization Osaka National Hospital
-
Suitashi, Osaka, Japón, 565-0871
- Reclutamiento
- The University of Osaka Hospital
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-
Shizuoka
-
Suntogun, Shizuoka, Japón, 411-8777
- Reclutamiento
- Shizuoka Cancer Center
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Tokyo
-
Bunkyoku, Tokyo, Japón, 113-8677
- Reclutamiento
- Tokyo Metropolitan Komagome Hospital
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Kotoku, Tokyo, Japón, 135-8550
- Reclutamiento
- Cancer Institute Hospital of Jfcr
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Shinagawaku, Tokyo, Japón, 142-8666
- Reclutamiento
- Showa Medical University Hospital
-
Shinjukuku, Tokyo, Japón, 162-8666
- Reclutamiento
- Tokyo Womens Medical University Hospital
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-
-
-
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George Town, Malasia, 10450
- Reclutamiento
- Pulau Pinang Hospital
-
Ipoh, Malasia, 30450
- Reclutamiento
- Hospital Raja Permaisuri Bainun
-
Johor Bahru, Malasia, 15586
- Reclutamiento
- Hospital Raja Perempuan Zainab Ii
-
Kota Kinabalu Sabah, Malasia, 88996
- Reclutamiento
- Hospital Wanita Dan Kanak Kanak Sabah (Hospital Likas)
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Kuala Lumpur, Malasia, 59100
- Reclutamiento
- University Malaya Medical Centre
-
Kuala Lumpur, Malasia, 50586
- Reclutamiento
- Hospital Kuala Lumpur
-
Kuching, Malasia, 93586
- Reclutamiento
- Sarawak General Hospital
-
Petaling Jaya, Malasia, 46300
- Reclutamiento
- Hospital Picaso
-
Putrajaya, Malasia, 62250
- Reclutamiento
- National Cancer Institute (Institut Kanser Negara)
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-
-
-
-
Bialystok, Polonia, 15-027
- Reclutamiento
- Bialostockie Centrum Onkologii Im M Sklodowskiej Curie W Bialymstoku
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Gdynia, Polonia, 81-519
- Reclutamiento
- Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia
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Kielce, Polonia, 25-734
- Reclutamiento
- Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
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Krakow, Polonia, 31-826
- Reclutamiento
- Szpital Specjalistyczny Im Ludwika Rydygiera W Krakowie
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Krakow, Polonia, 30-727
- Reclutamiento
- Pratia McM Krakow
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Opole, Polonia, 45-061
- Reclutamiento
- Opolskie Centrum Onkologii
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Otwock, Polonia, 05-400
- Reclutamiento
- Europejskie Centrum Zdrowia Otwock
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Warsaw, Polonia, 02-781
- Reclutamiento
- Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie W Warszawie
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Anhui
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Bengbu, Anhui, Porcelana, 233004
- Reclutamiento
- The First Affiliated Hospital of Bengbu Medical University
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Hefei, Anhui, Porcelana, 230000
- Reclutamiento
- Anhui Provincial Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100142
- Reclutamiento
- Beijing Cancer Hospital
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Porcelana, 630014
- Reclutamiento
- The First Affiliated Hospital of Chongqing Medical University
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Fujian
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Fuzhou, Fujian, Porcelana, 350001
- Reclutamiento
- Fujian Medical University Union Hospital
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Fuzhou, Fujian, Porcelana, 350014
- Reclutamiento
- Fujian Cancer Hospital
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Fuzhou, Fujian, Porcelana, 350009
- Reclutamiento
- The Peoples Hospital Affiliated to Fujian University of Traditional Chinese Medicine
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510060
- Reclutamiento
- Sun Yat Sen University Cancer Center
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Guangzhou, Guangdong, Porcelana, 510245
- Reclutamiento
- Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
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Shantou, Guangdong, Porcelana, 515031
- Reclutamiento
- Cancer Hospital of Shantou University Medical College
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Guangxi
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Nanning, Guangxi, Porcelana, 530201
- Reclutamiento
- Guangxi Medical University Cancer Hospital Wuxiang Branch
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Hainan
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Haikou, Hainan, Porcelana, 570206
- Reclutamiento
- Hainan General Hospital
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Hebei
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Baoding, Hebei, Porcelana, 71000
- Reclutamiento
- Affiliated Hospital of Hebei University(North Branch)
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Shijiazhuang, Hebei, Porcelana, 050035
- Reclutamiento
- The Fourth Hospital of Hebei Medical University East Branch
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Heilongjiang
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Harbin, Heilongjiang, Porcelana, 150000
- Reclutamiento
- Harbin Medical University Cancer Hospital
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Henan
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Zhengzhou, Henan, Porcelana, 450052
- Reclutamiento
- The First Affiliated Hospital of Zhengzhou University
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Hubei
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Wuhan, Hubei, Porcelana, 430079
- Reclutamiento
- Hubei Cancer Hospital
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Wuhan, Hubei, Porcelana, 430048
- Reclutamiento
- Union Hospital Tongji Medical College Huazhong University of Science and Technologyjinyinhu Branch
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Hunan
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Changde, Hunan, Porcelana, 415000
- Reclutamiento
- The First Peoples Hospital of Changde City
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Changsha, Hunan, Porcelana, 410008
- Reclutamiento
- Xiangya Hospital of Central South University
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Jiangsu
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Nanjing, Jiangsu, Porcelana, 210036
- Reclutamiento
- Jiangsu Province Hospital Longjiang Branch
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Nantong, Jiangsu, Porcelana, 201203
- Reclutamiento
- Affiliated Hospital of Nantong University
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Jiangxi
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Nanchang, Jiangxi, Porcelana, 330029
- Reclutamiento
- Jiangxi Cancer Hospital
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Nanchang, Jiangxi, Porcelana, 330025
- Reclutamiento
- Nanchang Peoples Hospitalchaoyang Branch
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Shaanxi
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Xi'an, Shaanxi, Porcelana, 710004
- Reclutamiento
- The Second Affiliated Hospital of Xian Jiaotong University
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Shandong
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Weifang, Shandong, Porcelana, 261000
- Reclutamiento
- Weifang Peoples Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200000
- Reclutamiento
- Fudan University Shanghai Cancer Center
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Shanxi
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Yuncheng, Shanxi, Porcelana, 44099
- Reclutamiento
- Yuncheng Central Hospital West Branch
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Sichuan
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Chengdu, Sichuan, Porcelana, 610071
- Reclutamiento
- Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Porcelana, 300453
- Reclutamiento
- Binhai Hospital, Tianjin Medical University Cancer Institute and Hospital
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Yunnan
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Kunming, Yunnan, Porcelana, 650100
- Reclutamiento
- Yunnan Cancer Hospital
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Zhejiang
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Hangzhou, Zhejiang, Porcelana, 310016
- Reclutamiento
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
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Wenzhou, Zhejiang, Porcelana, 325000
- Reclutamiento
- The First Affiliated Hospital of Wenzhou Medical University
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San Juan, Puerto Rico, 00917
- Reclutamiento
- Brcr Global Puerto Rico Hato Rey
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Guildford, Reino Unido, GU27XX
- Reclutamiento
- Royal Surrey County Hospital
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Maidstone, Reino Unido, ME16 9QQ
- Reclutamiento
- Maidstone and Tunbridge Wells Nhs Trust Kent Oncology Centre Maidstone Hospital
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Beitou Dist, Taiwán, 11217
- Reclutamiento
- Taipei Veterans General Hospital
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Taichung, Taiwán, 40447
- Reclutamiento
- China Medical University Hospital
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Tainan, Taiwán, 704
- Reclutamiento
- National Cheng Kung University Hospital
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Zhongzheng Dist, Taiwán, 100225
- Reclutamiento
- National Taiwan University Hospital
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Adana, Turquía (Türkiye), 01060
- Reclutamiento
- Adana City Education and Research Hospital
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Ankara, Turquía (Türkiye), 06200
- Reclutamiento
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
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Ankara, Turquía (Türkiye), 6100
- Reclutamiento
- Hacettepe University
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Ankara City Hospital, Turquía (Türkiye), 06800
- Reclutamiento
- Ankara City Hospital
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Istanbul, Turquía (Türkiye), 34899
- Reclutamiento
- Marmara University Pendik Research and Training Hospital
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Izmir, Turquía (Türkiye), 35100
- Reclutamiento
- Ege University Medical Faculty
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Kocaeli, Turquía (Türkiye), 41380
- Reclutamiento
- Kocaeli Universitesi Tip Fakultesi
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Mersin City Hospital, Turquía (Türkiye), 33240
- Reclutamiento
- Mersin City Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Participants must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the informed consent.
- Participants with histologically confirmed locally advanced or metastatic HR+ HER2- breast cancer.
- Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.
- Adequate organ function.
Exclusion Criteria:
- Participants who have received prior systemic treatment in the advanced or metastatic setting.
- Participants who have received prior treatment with any selective cyclin-dependent kinase 4 (CDK4) or cyclin-dependent kinase 2 (CDK2) targeting agent, or any other investigational anticancer drug in any disease setting, except for prior investigational or approved SERDs in the adjuvant setting, provided that disease recurrence occurred more than 12 months after the last dose of endocrine-based therapy.
- Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis.
Note: Other protocol-defined inclusion/exclusion criteria may apply.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Arm A: BGB-43395 + Letrozole
Participants will receive BGB-43395 in combination with letrozole. |
Administered orally. Administered orally. |
|
Comparador activo: Arm B: Cyclin-Dependent Kinase 4/6 Inhibitor + Letrozole
Participants will receive either abemaciclib, palbociclib, or ribociclib based on the Investigator's choice in combination with letrozole. |
Administered orally. Administered orally. Administered orally. Administered orally. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Progression-Free Survival (PFS) Determined by Blinded Independent Central Review (BICR)
Periodo de tiempo: Up to approximately 4 years
|
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. |
Up to approximately 4 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overall Survival (OS)
Periodo de tiempo: Up to approximately 11 years
|
OS is defined as the time from the date of randomization until the date of death due to any cause. |
Up to approximately 11 years
|
|
Overall Response Rate (ORR)
Periodo de tiempo: Up to approximately 4 years
|
ORR is defined as the percentage of participants who had a complete response (CR) or partial response (PR), as assessed by BICR per RECIST v1.1. |
Up to approximately 4 years
|
|
Duration of Response (DOR)
Periodo de tiempo: Up to approximately 4 years
|
DOR is defined as the time from the first occurrence of a documented objective response to the time of disease progression or death from any cause, whichever occurs first, as assessed by BICR per RECIST v1.1. |
Up to approximately 4 years
|
|
PFS Determined by Investigator
Periodo de tiempo: Up to approximately 4 years
|
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. |
Up to approximately 4 years
|
|
Clinical Benefit Rate (CBR)
Periodo de tiempo: Up to approximately 4 years
|
CBR is defined as the percentage of participants who have a CR, PR, or stable disease maintained for ≥ 24 weeks after randomization (without subsequent anticancer treatment) per RECIST v1.1 . |
Up to approximately 4 years
|
|
Time to Response (TTR)
Periodo de tiempo: Up to approximately 4 years
|
TTR is defined as the time from treatment initiation to the first response confirmed by BICR per RECIST v1.1. |
Up to approximately 4 years
|
|
Number of Participants with Adverse Events (AEs)
Periodo de tiempo: From first dose of study drug up to 30 days after last dose, up to approximately 11 years
|
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory values, vital signs, physical examination findings, and electrocardiogram results. |
From first dose of study drug up to 30 days after last dose, up to approximately 11 years
|
|
Change from Baseline in European Organisation for Research and Treatment of Cancer (EORTC)-Item Library (IL)454.
Periodo de tiempo: Baseline and up to approximately 4 years
|
The EORTC-IL454 is a questionnaire that asks participants to rate their breast cancer symptoms and the impact of breast cancer on their quality of life (QoL). The EORTC-IL454 is an EORTC Item Library-derived scale set constructed using items from the validated EORTC Quality of Life Questionnaire-Core 30 (QLQ-C30) (a core measure of health-related QoL in cancer patients) and the QLQ-BR23 (its breast cancer-specific module) The EORTC-IL454 contains 26 questions, each answered on a 4-point scale (1 = Not at all; 4 = Very much), and includes 2 functional scales (physical functioning and role functioning), 2 symptom scales (Nausea/Vomiting and Diarrhea), and 1 Global Health Status (GHS)/Quality of Life (QoL) scale, 7 systemic side effects scales, 3 arm symptom scales, and 4 breast-specific symptom scales. The recall period is the past 7 days. Higher scores in GHS and functional scales and lower scores in symptom scales indicate better QoL. |
Baseline and up to approximately 4 years
|
|
Progression-Free Survival 2 (PFS2)
Periodo de tiempo: Up to approximately 4 years
|
PFS2 is defined as the time from randomization until progression on the next line of treatment (ie, first subsequent therapy), as assessed by the investigator, or death due to any cause, whichever occurs first. |
Up to approximately 4 years
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Study Director, BeOne Medicines
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
22 de mayo de 2026
Finalización primaria (Estimado)
1 de abril de 2029
Finalización del estudio (Estimado)
7 de agosto de 2037
Fechas de registro del estudio
Enviado por primera vez
20 de marzo de 2026
Primero enviado que cumplió con los criterios de control de calidad
20 de marzo de 2026
Publicado por primera vez (Actual)
25 de marzo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de octubre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
23 de octubre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BGB-43395-302
- 2025-523960-19-00 (Ctis)
- 2025 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Marco de tiempo para compartir IPD
See plan description
Criterios de acceso compartido de IPD
See plan description
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .