BGB-43395 plus Letrozol versus CDK4/6i plus Letrozol til patienter med fremskreden eller metastatisk HR+/HER2- brystkræft, som ikke tidligere har modtaget behandling for fremskreden eller metastatisk sygdom (KANDELA-302)
23. oktober 2026 opdateret af: BeOne Medicines
Et åbent, randomiseret, multicenter fase 3-studie, der undersøger effektiviteten og sikkerheden af BGB-43395 plus letrozol versus CDK4/6-hæmmere (abemaciclib, palbociclib, ribociclib) plus letrozol hos patienter med fremskreden eller metastatisk HR+/HER2- brystkræft, der ikke har modtaget tidligere systemisk antikræftbehandling for fremskreden eller metastatisk sygdom
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.
Studieoversigt
Status
Status
Rekruttering
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
Tilmelding
1056
Fase
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
Studiekontakt
- Navn: Study Director
- Telefonnummer: 877-828-5568
- E-mail: clinicaltrials@beonemed.com
Studiesteder
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New South Wales
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Blacktown, New South Wales, Australien, NSW 2148
- Rekruttering
- Blacktown Cancer and Haematology Centre
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Liverpool, New South Wales, Australien, NSW 2170
- Rekruttering
- Liverpool Hospital
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Wollongong, New South Wales, Australien, NSW 2500
- Rekruttering
- Wollongong Hospital
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Queensland
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Birtinya, Queensland, Australien, QLD 4575
- Rekruttering
- Sunshine Coast University Private Hospital
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Douglas, Queensland, Australien, QLD 4814
- Rekruttering
- Townsville University Hospital
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Victoria
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Melbourne, Victoria, Australien, VIC 3000
- Rekruttering
- Peter Maccallum Cancer Centre
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Western Australia
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Murdoch, Western Australia, Australien, WA 6150
- Rekruttering
- Fiona Stanley Hospital
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Nedlands, Western Australia, Australien, WA 6009
- Rekruttering
- One Clinical Research
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Barretos, Brasilien, 14.784-400
- Rekruttering
- Fundacao Pio Xii Hospital de Amor de Barretos
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Brasília, Brasilien, 71681-603
- Rekruttering
- Hospital Brasilia
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Caxias do Sul, Brasilien, 95070-560
- Rekruttering
- Fundacao Universidade de Caxias Do Sul
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Curitiba, Brasilien, 80510-130
- Rekruttering
- Ictr Instituto Do Cancer E Transplante de Curitiba
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Fortaleza, Brasilien, 60336-232
- Rekruttering
- Centro Regional Integrado de Oncologia Crio
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Ijuí, Brasilien, 98700-000
- Rekruttering
- Oncosite Centro de Pesquisa Clinica Em Oncologia
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Natal, Brasilien, 59062-000
- Rekruttering
- Liga Norte Riograndene Contra O Cancer
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Porto Alegre, Brasilien, 90610-000
- Rekruttering
- Hospital Sao Lucas Da Pucrs
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Pouso Alegre, Brasilien, 37554-238
- Rekruttering
- Instituto Sul Mineiro de Oncologia Ltda
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Recife, Brasilien, 50040-000
- Rekruttering
- Hospital Do Cancer de Pernambuco
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Rio de Janeiro, Brasilien, 20560-120
- Rekruttering
- Instituto Nacional de Cancer
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São Paulo, Brasilien, 01246-000
- Rekruttering
- Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
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Vitória, Brasilien, 29043-260
- Rekruttering
- Hospital Santa Rita de Cassia Afecc
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Guildford, Det Forenede Kongerige, GU27XX
- Rekruttering
- Royal Surrey County Hospital
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Maidstone, Det Forenede Kongerige, ME16 9QQ
- Rekruttering
- Maidstone and Tunbridge Wells Nhs Trust Kent Oncology Centre Maidstone Hospital
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Alabama
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Birmingham, Alabama, Forenede Stater, 35211
- Rekruttering
- Alabama Oncology Princeton
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Alaska
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Anchorage, Alaska, Forenede Stater, 99508-2974
- Rekruttering
- Alaska Oncology and Hematology, Llc
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Fairbanks, Alaska, Forenede Stater, 99701
- Rekruttering
- Fairbanks Cancer Care Physicians Pc
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Arizona
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Bullhead City, Arizona, Forenede Stater, 86442
- Rekruttering
- Pioneer Research Center
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Chandler, Arizona, Forenede Stater, 85224-5665
- Rekruttering
- Ironwood Cancer and Research Centers Chandler Ii
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Goodyear, Arizona, Forenede Stater, 85338
- Rekruttering
- City of Hope Phoenix Cancer Center
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Arkansas
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Hot Springs, Arkansas, Forenede Stater, 71913
- Rekruttering
- Genesis Cancer and Blood Institute Hot Springs (Harmony Park)
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California
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Duarte, California, Forenede Stater, 91010-3012
- Rekruttering
- City of Hope National Medical Center
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Fountain Valley, California, Forenede Stater, 92708
- Rekruttering
- Helios Clinical Research the Oncology Institute Fountain Valley
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Los Angeles, California, Forenede Stater, 90027
- Rekruttering
- California Research Institute
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Oxnard, California, Forenede Stater, 93030
- Rekruttering
- Ventura County Hematology Oncology Specialists
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San Marcos, California, Forenede Stater, 92078
- Rekruttering
- Kaiser Permanente San Marcos Medical Offices
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Santa Monica, California, Forenede Stater, 90404-2303
- Rekruttering
- Providence Saint Johns Health Center
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West Hills, California, Forenede Stater, 91307
- Rekruttering
- Wellness Oncology and Hematology
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Colorado
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Lone Tree, Colorado, Forenede Stater, 80124-5641
- Rekruttering
- Rocky Mountain Cancer Centers, Llp(Us Oncology Research)
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Connecticut
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Danbury, Connecticut, Forenede Stater, 06810
- Rekruttering
- Danbury Hospital
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Florida
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Coral Springs, Florida, Forenede Stater, 33065
- Rekruttering
- Brcr Coral Springs
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Orange City, Florida, Forenede Stater, 32763-8316
- Rekruttering
- Mid Florida Hematology and Oncology Center
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Palm Bay, Florida, Forenede Stater, 32901
- Rekruttering
- Cancer Care Centers of Brevard Palm Bay
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Plantation, Florida, Forenede Stater, 33322
- Rekruttering
- Florida Clinical Trials Group Plantation
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Port Saint Lucie, Florida, Forenede Stater, 34952-7596
- Rekruttering
- Hematology Oncology Associates of the Treasure Coast
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South Miami, Florida, Forenede Stater, 33143
- Rekruttering
- The Oncology Institute of Hope and Innovation South Miami
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Tamarac, Florida, Forenede Stater, 33321
- Rekruttering
- Florida Clinical Trials Group Tamarac
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Tampa, Florida, Forenede Stater, 33612
- Rekruttering
- Moffitt Cancer Center McKinley Campus Richard M Shulze Family Foundation Outpatient Center
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Georgia
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Athens, Georgia, Forenede Stater, 30607
- Rekruttering
- University Cancer and Blood Center Athens Comprehensive Cancer Center
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Macon, Georgia, Forenede Stater, 31210
- Rekruttering
- Central Georgia Cancer Care Macon Office
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96813
- Rekruttering
- Hawaii Cancer Care
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Illinois
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Hinsdale, Illinois, Forenede Stater, 60521-0509
- Rekruttering
- Hope and Healing Cancer Services
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O'Fallon, Illinois, Forenede Stater, 62269
- Rekruttering
- Cancer Care Specialists For Illinois
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Zion, Illinois, Forenede Stater, 60099
- Rekruttering
- City of Hope Chicago Cancer Center
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Indiana
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Fort Wayne, Indiana, Forenede Stater, 46804
- Rekruttering
- Fort Wayne Medical Oncology and Hematology
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Indianapolis, Indiana, Forenede Stater, 46260
- Rekruttering
- Hematology Oncology of Indiana
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Iowa
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Cedar Rapids, Iowa, Forenede Stater, 52403
- Rekruttering
- Mercy Medical Center
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Kentucky
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Owensboro, Kentucky, Forenede Stater, 42303
- Rekruttering
- Owensboro Health Mitchell Memorial Cancer Center
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Michigan
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Detroit, Michigan, Forenede Stater, 48201-2013
- Rekruttering
- Karmanos Cancer Institute
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Minnesota
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Duluth, Minnesota, Forenede Stater, 55805
- Rekruttering
- Aspirus St Lukes Hospital
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Minneapolis, Minnesota, Forenede Stater, 55407
- Rekruttering
- Allina Health Cancer Institute Minneapolis
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Saint Paul, Minnesota, Forenede Stater, 55101-2502
- Rekruttering
- Metro Minnesota Community Oncology Research Consortium (Mmcorc)
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Mississippi
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Hattiesburg, Mississippi, Forenede Stater, 39401-7233
- Rekruttering
- Hattiesburg Hematology and Oncology Clinic
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Missouri
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Columbia, Missouri, Forenede Stater, 65201
- Rekruttering
- Missouri Cancer Associates Columbia, Mo
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Springfield, Missouri, Forenede Stater, 65807-5288
- Rekruttering
- Oncology Hematology Associates
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Nebraska
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Grand Island, Nebraska, Forenede Stater, 68803
- Rekruttering
- Nebraska Cancer Specialists St Francis Grand Island
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Lincoln, Nebraska, Forenede Stater, 68506-7548
- Rekruttering
- Nebraska Hematology Oncology
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Lincoln, Nebraska, Forenede Stater, 68516
- Rekruttering
- Cancer Partners of Nebraska April Sampson Cancer Center
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Omaha, Nebraska, Forenede Stater, 68130-2042
- Rekruttering
- Nebraska Cancer Specialists
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89169-3321
- Rekruttering
- Comprehensive Cancer Centers of Nevada
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Reno, Nevada, Forenede Stater, 89502
- Rekruttering
- Renown Regional Medical Center
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New Jersey
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East Brunswick, New Jersey, Forenede Stater, 08816-4096
- Rekruttering
- Astera Cancer Care East Brunswick
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Florham Park, New Jersey, Forenede Stater, 07932-1049
- Rekruttering
- Summit Medical Group
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New Brunswick, New Jersey, Forenede Stater, 08901-1914
- Rekruttering
- Rutgers Cancer Institute of New Jersey
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New York
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Brooklyn, New York, Forenede Stater, 11220
- Rekruttering
- Nyu Langone Health Perlmutter Cancer Center Sunset Park
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Mineola, New York, Forenede Stater, 11501
- Rekruttering
- Nyu Langone Health Perlmutter Cancer Center At Nyu Langone Hospital Long Island
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New York, New York, Forenede Stater, 10016
- Rekruttering
- Nyu Langone Health Perlmutter Cancer Center 34Th Street
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Rochester, New York, Forenede Stater, 14642-0001
- Rekruttering
- University of Rochester
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Shirley, New York, Forenede Stater, 11967
- Rekruttering
- New York Cancer and Blood Specialists
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Stony Brook, New York, Forenede Stater, 11794
- Rekruttering
- Stony Brook Cancer Center
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27514-4220
- Rekruttering
- University of North Carolina At Chapel Hill
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Hendersonville, North Carolina, Forenede Stater, 28739
- Rekruttering
- Pardee Cancer Center
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Wilson, North Carolina, Forenede Stater, 27896
- Rekruttering
- Carolina Cancer Research Center
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Ohio
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Canton, Ohio, Forenede Stater, 44718-2566
- Rekruttering
- Gabrail Cancer Center Research
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Dayton, Ohio, Forenede Stater, 45409
- Rekruttering
- Dayton Physicians Network
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Oregon
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Eugene, Oregon, Forenede Stater, 97401
- Rekruttering
- Oncology Associates of Oregon Willamette Valley Cancer Center
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Salem, Oregon, Forenede Stater, 97301
- Rekruttering
- Oregon Oncology Specialists
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Pennsylvania
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Broomall, Pennsylvania, Forenede Stater, 19008
- Rekruttering
- Consultants in Medical Oncology and Hematology Cancer Center At Broomall
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West Reading, Pennsylvania, Forenede Stater, 19611-2143
- Rekruttering
- McGlinn Cancer Institute
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South Dakota
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Sioux Falls, South Dakota, Forenede Stater, 57105-2108
- Rekruttering
- Avera Cancer Institute
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Tennessee
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Kingsport, Tennessee, Forenede Stater, 37660
- Rekruttering
- Ballad Health Cancer Center Kingsport
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Nashville, Tennessee, Forenede Stater, 37204
- Rekruttering
- Vanderbilt Ingram Cancer Center Nashville Vanderbilt Breast Center
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Texas
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Austin, Texas, Forenede Stater, 78731-4214
- Rekruttering
- Texas Oncology Austin Central
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Dallas, Texas, Forenede Stater, 75246-2003
- Rekruttering
- Texas Oncology Baylor Charles A Sammons Cancer Center
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Round Rock, Texas, Forenede Stater, 78665
- Rekruttering
- Baylor Scott and White Medical Center Round Rock
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Utah
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Salt Lake City, Utah, Forenede Stater, 84107
- Rekruttering
- Utah Cancer Specialists Cancer Center
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Virginia
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Blacksburg, Virginia, Forenede Stater, 24060-6325
- Rekruttering
- Oncology and Hematology Associates of Southwest Virginia, Inc (Us Oncology Research)
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Charlottesville, Virginia, Forenede Stater, 22908-0817
- Rekruttering
- University of Virginia
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Fairfax, Virginia, Forenede Stater, 22031-2171
- Rekruttering
- Virginia Cancer Specialists
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Norfolk, Virginia, Forenede Stater, 23502-2800
- Rekruttering
- Virginia Oncology Associates
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Richmond, Virginia, Forenede Stater, 23229-8605
- Rekruttering
- Virginia Cancer Institute
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Washington
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Olympia, Washington, Forenede Stater, 98506
- Rekruttering
- Vista Oncology East Olympia
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Spokane, Washington, Forenede Stater, 99204
- Rekruttering
- Multicare Cancer Institute Deaconess Medical Office Building 1
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Tacoma, Washington, Forenede Stater, 98405
- Rekruttering
- Northwest Medical Specialties
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Tacoma, Washington, Forenede Stater, 98405
- Rekruttering
- Multicare Cancer Institute Tacoma General Hospital
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Yakima, Washington, Forenede Stater, 98902
- Rekruttering
- Multicare Cancer Institute North Star Lodge
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Wisconsin
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La Crosse, Wisconsin, Forenede Stater, 54601-5467
- Rekruttering
- Gundersen Health System
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Milwaukee, Wisconsin, Forenede Stater, 53226-3522
- Rekruttering
- Medical College of Wisconsin
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Bordeaux, Frankrig, 33076
- Rekruttering
- Centre de Lutte Contre Le Cancer Institut Bergonie
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Lyon, Frankrig, 69373
- Rekruttering
- Centre Leon Berard
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Marseille, Frankrig, 13009
- Rekruttering
- Institut Paoli Calmettes
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Montpellier, Frankrig, 34090
- Rekruttering
- Icm Val Daurelle
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Rennes, Frankrig, 35043
- Rekruttering
- Centre Eugene Marquis
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SaintHerblain, Frankrig, 44805
- Rekruttering
- Ico Site Rene Gauducheau
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Villejuif, Frankrig, 94800
- Rekruttering
- Institut Gustave Roussy
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Bergamo, Italien, 24127
- Rekruttering
- Asst Papa Giovanni Xxiii
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Milan, Italien, 20141
- Rekruttering
- Istituto Europeo Di Oncologia
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Monza, Italien, 20900
- Rekruttering
- Azienda Socio Sanitaria Territoriale Di Monza (Presidio San Gerardo)
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Roma, Italien, 00168
- Rekruttering
- Fondazione Policlinico Universitario Agostino Gemelli
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Fukuoka
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Kurumeshi, Fukuoka, Japan, 830-0013
- Rekruttering
- Japan Community Healthcare Organization Kurume General Hospital
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Gunma
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Otashi, Gunma, Japan, 373-8550
- Rekruttering
- Gunma Prefectural Cancer Center
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Hiroshima
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Hiroshima, Hiroshima, Japan, 730-8518
- Rekruttering
- Hiroshima City Hiroshima Citizens Hospital
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Hokkaido
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Sapporo, Hokkaido, Japan, 003-0804
- Rekruttering
- National Hospital Organization Hokkaido Cancer Center
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Hyōgo
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Nishinomiyashi, Hyōgo, Japan, 663-8501
- Rekruttering
- Hyogo Medical University Hospital
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Kagoshima-ken
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Kagoshima, Kagoshima-ken, Japan, 892-0833
- Rekruttering
- Social Medical Corporation Hakuaikai Sagara Hospital
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Kanagawa
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Iseharashi, Kanagawa, Japan, 259-1193
- Rekruttering
- Tokai University Hospital
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Kawasakishi, Kanagawa, Japan, 211-8533
- Rekruttering
- Nippon Medical School Musashi Kosugi Hospital
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Yokohama, Kanagawa, Japan, 232-0024
- Rekruttering
- Yokohama City University Medical Center
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Yokohama, Kanagawa, Japan, 241-8515
- Rekruttering
- Kanagawa Cancer Center
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Mie-ken
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Tsu, Mie-ken, Japan, 514-8507
- Rekruttering
- Mie University Hospital
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Osaka
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OsakaShi, Osaka, Japan, 541-8567
- Rekruttering
- Osaka International Cancer Institute
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Osakashi, Osaka, Japan, 540-0006
- Rekruttering
- National Hospital Organization Osaka National Hospital
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Suitashi, Osaka, Japan, 565-0871
- Rekruttering
- The University of Osaka Hospital
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Shizuoka
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Suntogun, Shizuoka, Japan, 411-8777
- Rekruttering
- Shizuoka Cancer Center
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Tokyo
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Bunkyoku, Tokyo, Japan, 113-8677
- Rekruttering
- Tokyo Metropolitan Komagome Hospital
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Kotoku, Tokyo, Japan, 135-8550
- Rekruttering
- Cancer Institute Hospital of Jfcr
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Shinagawaku, Tokyo, Japan, 142-8666
- Rekruttering
- Showa Medical University Hospital
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Shinjukuku, Tokyo, Japan, 162-8666
- Rekruttering
- Tokyo Womens Medical University Hospital
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Anhui
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Bengbu, Anhui, Kina, 233004
- Rekruttering
- The First Affiliated Hospital of Bengbu Medical University
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Hefei, Anhui, Kina, 230000
- Rekruttering
- Anhui Provincial Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100142
- Rekruttering
- Beijing Cancer Hospital
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Kina, 630014
- Rekruttering
- The First Affiliated Hospital of Chongqing Medical University
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Fujian
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Fuzhou, Fujian, Kina, 350001
- Rekruttering
- Fujian Medical University Union Hospital
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Fuzhou, Fujian, Kina, 350014
- Rekruttering
- Fujian Cancer Hospital
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Fuzhou, Fujian, Kina, 350009
- Rekruttering
- The Peoples Hospital Affiliated to Fujian University of Traditional Chinese Medicine
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Guangdong
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Guangzhou, Guangdong, Kina, 510060
- Rekruttering
- Sun Yat Sen University Cancer Center
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Guangzhou, Guangdong, Kina, 510245
- Rekruttering
- Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
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Shantou, Guangdong, Kina, 515031
- Rekruttering
- Cancer Hospital of Shantou University Medical College
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Guangxi
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Nanning, Guangxi, Kina, 530201
- Rekruttering
- Guangxi Medical University Cancer Hospital Wuxiang Branch
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Hainan
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Haikou, Hainan, Kina, 570206
- Rekruttering
- Hainan General Hospital
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Hebei
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Baoding, Hebei, Kina, 71000
- Rekruttering
- Affiliated Hospital of Hebei University(North Branch)
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Shijiazhuang, Hebei, Kina, 050035
- Rekruttering
- The Fourth Hospital of Hebei Medical University East Branch
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Heilongjiang
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Harbin, Heilongjiang, Kina, 150000
- Rekruttering
- Harbin Medical University Cancer Hospital
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Henan
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Zhengzhou, Henan, Kina, 450052
- Rekruttering
- The First Affiliated Hospital of Zhengzhou University
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Hubei
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Wuhan, Hubei, Kina, 430079
- Rekruttering
- Hubei Cancer Hospital
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Wuhan, Hubei, Kina, 430048
- Rekruttering
- Union Hospital Tongji Medical College Huazhong University of Science and Technologyjinyinhu Branch
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Hunan
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Changde, Hunan, Kina, 415000
- Rekruttering
- The First Peoples Hospital of Changde City
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Changsha, Hunan, Kina, 410008
- Rekruttering
- Xiangya Hospital of Central South University
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Jiangsu
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Nanjing, Jiangsu, Kina, 210036
- Rekruttering
- Jiangsu Province Hospital Longjiang Branch
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Nantong, Jiangsu, Kina, 201203
- Rekruttering
- Affiliated Hospital of Nantong University
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Jiangxi
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Nanchang, Jiangxi, Kina, 330029
- Rekruttering
- Jiangxi Cancer Hospital
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Nanchang, Jiangxi, Kina, 330025
- Rekruttering
- Nanchang Peoples Hospitalchaoyang Branch
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Shaanxi
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Xi'an, Shaanxi, Kina, 710004
- Rekruttering
- The Second Affiliated Hospital of Xian Jiaotong University
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Shandong
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Weifang, Shandong, Kina, 261000
- Rekruttering
- Weifang Peoples Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200000
- Rekruttering
- Fudan University Shanghai Cancer Center
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Shanxi
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Yuncheng, Shanxi, Kina, 44099
- Rekruttering
- Yuncheng Central Hospital West Branch
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Sichuan
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Chengdu, Sichuan, Kina, 610071
- Rekruttering
- Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Kina, 300453
- Rekruttering
- Binhai Hospital, Tianjin Medical University Cancer Institute and Hospital
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Yunnan
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Kunming, Yunnan, Kina, 650100
- Rekruttering
- Yunnan Cancer Hospital
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310016
- Rekruttering
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
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Wenzhou, Zhejiang, Kina, 325000
- Rekruttering
- The First Affiliated Hospital of Wenzhou Medical University
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-
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George Town, Malaysia, 10450
- Rekruttering
- Pulau Pinang Hospital
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Ipoh, Malaysia, 30450
- Rekruttering
- Hospital Raja Permaisuri Bainun
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Johor Bahru, Malaysia, 15586
- Rekruttering
- Hospital Raja Perempuan Zainab Ii
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Kota Kinabalu Sabah, Malaysia, 88996
- Rekruttering
- Hospital Wanita Dan Kanak Kanak Sabah (Hospital Likas)
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Kuala Lumpur, Malaysia, 59100
- Rekruttering
- University Malaya Medical Centre
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Kuala Lumpur, Malaysia, 50586
- Rekruttering
- Hospital Kuala Lumpur
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Kuching, Malaysia, 93586
- Rekruttering
- Sarawak General Hospital
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Petaling Jaya, Malaysia, 46300
- Rekruttering
- Hospital Picaso
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Putrajaya, Malaysia, 62250
- Rekruttering
- National Cancer Institute (Institut Kanser Negara)
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-
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Bialystok, Polen, 15-027
- Rekruttering
- Bialostockie Centrum Onkologii Im M Sklodowskiej Curie W Bialymstoku
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Gdynia, Polen, 81-519
- Rekruttering
- Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia
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Kielce, Polen, 25-734
- Rekruttering
- Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
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Krakow, Polen, 31-826
- Rekruttering
- Szpital Specjalistyczny Im Ludwika Rydygiera W Krakowie
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Krakow, Polen, 30-727
- Rekruttering
- Pratia McM Krakow
-
Opole, Polen, 45-061
- Rekruttering
- Opolskie Centrum Onkologii
-
Otwock, Polen, 05-400
- Rekruttering
- Europejskie Centrum Zdrowia Otwock
-
Warsaw, Polen, 02-781
- Rekruttering
- Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie W Warszawie
-
-
-
-
-
San Juan, Puerto Rico, 00917
- Rekruttering
- Brcr Global Puerto Rico Hato Rey
-
-
-
-
-
Badajoz, Spanien, 06006
- Rekruttering
- Hospital Universitario de Badajoz
-
Barcelona, Spanien, 08036
- Rekruttering
- Hospital Clinic de Barcelona
-
Barcelona, Spanien, 08035
- Rekruttering
- Vall D Hebron Institute of Oncology Vhio
-
Donostiasan Sebastian, Spanien, 20014
- Rekruttering
- Hospital Universitario Donostia
-
Elcheelx, Spanien, 03203
- Rekruttering
- Hospital General Universitario de Elche
-
Granada, Spanien, 18016
- Rekruttering
- Hospital Universitario Clinico San Cecilio
-
Madrid, Spanien, 28041
- Rekruttering
- Hospital Universitario 12 de Octubre
-
Madrid, Spanien, 28240
- Rekruttering
- Hospital Clinico San Carlos
-
Madrid, Spanien, 28007
- Rekruttering
- Hospital General Universitario Gregorio Maranon
-
Madrid, Spanien, 28007
- Rekruttering
- Iob Institute of Oncology Madrid
-
Santiago de Compostela, Spanien, 15706
- Rekruttering
- Complejo Hospitalario Univ de Santiago (Chus)
-
Seville, Spanien, 41013
- Rekruttering
- Hospital Universitario Virgen Del Rocio
-
-
-
-
-
Suwon, Sydkorea, 16499
- Rekruttering
- Ajou University Hospital
-
-
Busan Gwang'yeogsi
-
HaeundaeGu, Busan Gwang'yeogsi, Sydkorea, 48108
- Rekruttering
- Inje University Haeundae Paik Hospital
-
Seogu, Busan Gwang'yeogsi, Sydkorea, 49201
- Rekruttering
- Dong A University Hospital
-
-
Chungcheongbukdo
-
Cheongju-si, Chungcheongbukdo, Sydkorea, 28644
- Rekruttering
- Chungbuk National University Hospital
-
-
Chungcheongnam-do
-
Cheonansi, Chungcheongnam-do, Sydkorea, 31151
- Rekruttering
- Soon Chun Hyang University Cheonan Hospital
-
-
Daegu Gwang'yeogsi
-
Dalseogu, Daegu Gwang'yeogsi, Sydkorea, 42601
- Rekruttering
- Keimyung University Dongsan Hospital
-
-
Gyeonggi-do
-
BundangGu SeongnamSi, Gyeonggi-do, Sydkorea, 13496
- Rekruttering
- Cha Bundang Medical Center, Cha University
-
DanwonGu AnsanSi, Gyeonggi-do, Sydkorea, 15355
- Rekruttering
- Korea University Ansan Hospital
-
IlsandongGu GoyangSi, Gyeonggi-do, Sydkorea, 10408
- Rekruttering
- National Cancer Center (Korea)
-
PaldalGu SuwonSi, Gyeonggi-do, Sydkorea, 16247
- Rekruttering
- The Catholic University of Korea, St Vincents Hospital
-
Seongnam-si, Gyeonggi-do, Sydkorea, 13620
- Rekruttering
- Seoul National University Bundang Hospital
-
-
Incheon Gwang'yeogsi
-
Jemulpogu, Incheon Gwang'yeogsi, Sydkorea, 22332
- Rekruttering
- Inha University Hospital
-
NamdongGu, Incheon Gwang'yeogsi, Sydkorea, 21565
- Rekruttering
- Gachon University Gil Medical Center
-
-
Jeonnam-Gwangju S.M. City
-
HwasunGun, Jeonnam-Gwangju S.M. City, Sydkorea, 58128
- Rekruttering
- Chonnam National University Hwasun Hospital
-
-
Seoul Teugbyeolsi
-
DongjakGu, Seoul Teugbyeolsi, Sydkorea, 06973
- Rekruttering
- Chung Ang University Hospital
-
GangnamGu, Seoul Teugbyeolsi, Sydkorea, 06351
- Rekruttering
- Samsung Medical Center
-
GuroGu, Seoul Teugbyeolsi, Sydkorea, 08308
- Rekruttering
- Korea University Guro Hospital
-
SeochoGu, Seoul Teugbyeolsi, Sydkorea, 06591
- Rekruttering
- The Catholic University of Korea, Seoul St Marys Hospital
-
SeodaemunGu, Seoul Teugbyeolsi, Sydkorea, 03722
- Rekruttering
- Severance Hospital Yonsei University Health System
-
SeongbukGu, Seoul Teugbyeolsi, Sydkorea, 02841
- Rekruttering
- Korea University Anam Hospital
-
Seoul, Seoul Teugbyeolsi, Sydkorea, 03080
- Rekruttering
- Seoul National University Hospital
-
Seoul, Seoul Teugbyeolsi, Sydkorea, 06273
- Rekruttering
- Gangnam Severance Hospital, Yonsei University Health System
-
Seoul, Seoul Teugbyeolsi, Sydkorea, 07985
- Rekruttering
- Ehwa Womans University Mokdong Hospital
-
SongpaGu, Seoul Teugbyeolsi, Sydkorea, 05505
- Rekruttering
- Asan Medical Center
-
-
Ulsan Gwang'yeogsi
-
Ulsan, Ulsan Gwang'yeogsi, Sydkorea, 44033
- Rekruttering
- Ulsan University Hospital
-
-
-
-
-
Beitou Dist, Taiwan, 11217
- Rekruttering
- Taipei Veterans General Hospital
-
Taichung, Taiwan, 40447
- Rekruttering
- China Medical University Hospital
-
Tainan, Taiwan, 704
- Rekruttering
- National Cheng Kung University Hospital
-
Zhongzheng Dist, Taiwan, 100225
- Rekruttering
- National Taiwan University Hospital
-
-
-
-
-
Adana, Tyrkiet (Türkiye), 01060
- Rekruttering
- Adana City Education and Research Hospital
-
Ankara, Tyrkiet (Türkiye), 06200
- Rekruttering
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
-
Ankara, Tyrkiet (Türkiye), 6100
- Rekruttering
- Hacettepe University
-
Ankara City Hospital, Tyrkiet (Türkiye), 06800
- Rekruttering
- Ankara City Hospital
-
Istanbul, Tyrkiet (Türkiye), 34899
- Rekruttering
- Marmara University Pendik Research and Training Hospital
-
Izmir, Tyrkiet (Türkiye), 35100
- Rekruttering
- Ege University Medical Faculty
-
Kocaeli, Tyrkiet (Türkiye), 41380
- Rekruttering
- Kocaeli Universitesi Tip Fakultesi
-
Mersin City Hospital, Tyrkiet (Türkiye), 33240
- Rekruttering
- Mersin City Hospital
-
-
-
-
-
Berlin, Tyskland, 13125
- Rekruttering
- Helios Klinikum Berlin Buch Brustzentrum
-
Esslingen am Neckar, Tyskland, 73730
- Rekruttering
- Klinikum Esslingen Gmbh Klinik Fuer Frauenheilkunde Und Geburtshilfe
-
Frankfurt am Main, Tyskland, 60389
- Rekruttering
- Centrum Fur Haematologie Und Onkologie Bethanien
-
Koblenz, Tyskland, 56068
- Rekruttering
- Invo Institut Fur Versorgungsforschung in Der Onkologie
-
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Antal våben
2
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Arm A: BGB-43395 + Letrozole
Participants will receive BGB-43395 in combination with letrozole. |
Administered orally. Administered orally. |
|
Aktiv komparator: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-Free Survival (PFS) Determined by Blinded Independent Central Review (BICR)
Tidsramme: 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
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival (OS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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.
Tidsramme: 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)
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studieleder: Study Director, BeOne Medicines
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
22. maj 2026
Primær færdiggørelse (Anslået)
Primær færdiggørelse
1. april 2029
Studieafslutning (Anslået)
Studieafslutning
7. august 2037
Datoer for studieregistrering
Først indsendt
Først indsendt
20. marts 2026
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
20. marts 2026
Først opslået (Faktiske)
Først opslået
25. marts 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
26. oktober 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. oktober 2026
Sidst verificeret
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- BGB-43395-302
- 2025-523960-19-00 (Ctis)
- 2025 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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.
IPD-delingstidsramme
See plan description
IPD-delingsadgangskriterier
See plan description
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .