BGB-43395 plus letrozol jämfört med CDK4/6i plus letrozol för patienter med avancerad eller metastaserad HR+/HER2- bröstcancer som inte tidigare har fått behandling för avancerad eller metastaserad sjukdom (KANDELA-302)
23 oktober 2026 uppdaterad av: BeOne Medicines
En öppen, randomiserad, multikenter fas 3-studie som undersöker effektiviteten och säkerheten hos BGB-43395 plus letrozol jämfört med CDK4/6-hämmare (abemaciclib, palbociclib, ribociclib) plus letrozol hos patienter med avancerad eller metastaserad HR+/HER2- bröstcancer som inte har fått tidigare systemisk antikancerbehandling för avancerad eller metastaserad sjukdom
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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
1056
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Study Director
- Telefonnummer: 877-828-5568
- E-post: clinicaltrials@beonemed.com
Studieorter
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New South Wales
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Blacktown, New South Wales, Australien, NSW 2148
- Rekrytering
- Blacktown Cancer and Haematology Centre
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Liverpool, New South Wales, Australien, NSW 2170
- Rekrytering
- Liverpool Hospital
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Wollongong, New South Wales, Australien, NSW 2500
- Rekrytering
- Wollongong Hospital
-
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Queensland
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Birtinya, Queensland, Australien, QLD 4575
- Rekrytering
- Sunshine Coast University Private Hospital
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Douglas, Queensland, Australien, QLD 4814
- Rekrytering
- Townsville University Hospital
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Victoria
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Melbourne, Victoria, Australien, VIC 3000
- Rekrytering
- Peter Maccallum Cancer Centre
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Western Australia
-
Murdoch, Western Australia, Australien, WA 6150
- Rekrytering
- Fiona Stanley Hospital
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Nedlands, Western Australia, Australien, WA 6009
- Rekrytering
- One Clinical Research
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-
-
-
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Barretos, Brasilien, 14.784-400
- Rekrytering
- Fundacao Pio Xii Hospital de Amor de Barretos
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Brasília, Brasilien, 71681-603
- Rekrytering
- Hospital Brasilia
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Caxias do Sul, Brasilien, 95070-560
- Rekrytering
- Fundacao Universidade de Caxias Do Sul
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Curitiba, Brasilien, 80510-130
- Rekrytering
- Ictr Instituto Do Cancer E Transplante de Curitiba
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Fortaleza, Brasilien, 60336-232
- Rekrytering
- Centro Regional Integrado de Oncologia Crio
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Ijuí, Brasilien, 98700-000
- Rekrytering
- Oncosite Centro de Pesquisa Clinica Em Oncologia
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Natal, Brasilien, 59062-000
- Rekrytering
- Liga Norte Riograndene Contra O Cancer
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Porto Alegre, Brasilien, 90610-000
- Rekrytering
- Hospital Sao Lucas Da Pucrs
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Pouso Alegre, Brasilien, 37554-238
- Rekrytering
- Instituto Sul Mineiro de Oncologia Ltda
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Recife, Brasilien, 50040-000
- Rekrytering
- Hospital Do Cancer de Pernambuco
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Rio de Janeiro, Brasilien, 20560-120
- Rekrytering
- Instituto Nacional de Cancer
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São Paulo, Brasilien, 01246-000
- Rekrytering
- Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
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Vitória, Brasilien, 29043-260
- Rekrytering
- Hospital Santa Rita de Cassia Afecc
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-
-
-
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Bordeaux, Frankrike, 33076
- Rekrytering
- Centre de Lutte Contre Le Cancer Institut Bergonie
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Lyon, Frankrike, 69373
- Rekrytering
- Centre Leon Berard
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Marseille, Frankrike, 13009
- Rekrytering
- Institut Paoli Calmettes
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Montpellier, Frankrike, 34090
- Rekrytering
- Icm Val Daurelle
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Rennes, Frankrike, 35043
- Rekrytering
- Centre Eugene Marquis
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SaintHerblain, Frankrike, 44805
- Rekrytering
- Ico Site Rene Gauducheau
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Villejuif, Frankrike, 94800
- Rekrytering
- Institut Gustave Roussy
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-
-
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Alabama
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Birmingham, Alabama, Förenta staterna, 35211
- Rekrytering
- Alabama Oncology Princeton
-
-
Alaska
-
Anchorage, Alaska, Förenta staterna, 99508-2974
- Rekrytering
- Alaska Oncology and Hematology, Llc
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Fairbanks, Alaska, Förenta staterna, 99701
- Rekrytering
- Fairbanks Cancer Care Physicians Pc
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-
Arizona
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Bullhead City, Arizona, Förenta staterna, 86442
- Rekrytering
- Pioneer Research Center
-
Chandler, Arizona, Förenta staterna, 85224-5665
- Rekrytering
- Ironwood Cancer and Research Centers Chandler Ii
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Goodyear, Arizona, Förenta staterna, 85338
- Rekrytering
- City of Hope Phoenix Cancer Center
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Arkansas
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Hot Springs, Arkansas, Förenta staterna, 71913
- Rekrytering
- Genesis Cancer and Blood Institute Hot Springs (Harmony Park)
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California
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Duarte, California, Förenta staterna, 91010-3012
- Rekrytering
- City of Hope National Medical Center
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Fountain Valley, California, Förenta staterna, 92708
- Rekrytering
- Helios Clinical Research the Oncology Institute Fountain Valley
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Los Angeles, California, Förenta staterna, 90027
- Rekrytering
- California Research Institute
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Oxnard, California, Förenta staterna, 93030
- Rekrytering
- Ventura County Hematology Oncology Specialists
-
San Marcos, California, Förenta staterna, 92078
- Rekrytering
- Kaiser Permanente San Marcos Medical Offices
-
Santa Monica, California, Förenta staterna, 90404-2303
- Rekrytering
- Providence Saint Johns Health Center
-
West Hills, California, Förenta staterna, 91307
- Rekrytering
- Wellness Oncology and Hematology
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-
Colorado
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Lone Tree, Colorado, Förenta staterna, 80124-5641
- Rekrytering
- Rocky Mountain Cancer Centers, Llp(Us Oncology Research)
-
-
Connecticut
-
Danbury, Connecticut, Förenta staterna, 06810
- Rekrytering
- Danbury Hospital
-
-
Florida
-
Coral Springs, Florida, Förenta staterna, 33065
- Rekrytering
- Brcr Coral Springs
-
Orange City, Florida, Förenta staterna, 32763-8316
- Rekrytering
- Mid Florida Hematology and Oncology Center
-
Palm Bay, Florida, Förenta staterna, 32901
- Rekrytering
- Cancer Care Centers of Brevard Palm Bay
-
Plantation, Florida, Förenta staterna, 33322
- Rekrytering
- Florida Clinical Trials Group Plantation
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Port Saint Lucie, Florida, Förenta staterna, 34952-7596
- Rekrytering
- Hematology Oncology Associates of the Treasure Coast
-
South Miami, Florida, Förenta staterna, 33143
- Rekrytering
- The Oncology Institute of Hope and Innovation South Miami
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Tamarac, Florida, Förenta staterna, 33321
- Rekrytering
- Florida Clinical Trials Group Tamarac
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Tampa, Florida, Förenta staterna, 33612
- Rekrytering
- Moffitt Cancer Center McKinley Campus Richard M Shulze Family Foundation Outpatient Center
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Georgia
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Athens, Georgia, Förenta staterna, 30607
- Rekrytering
- University Cancer and Blood Center Athens Comprehensive Cancer Center
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Macon, Georgia, Förenta staterna, 31210
- Rekrytering
- Central Georgia Cancer Care Macon Office
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Hawaii
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Honolulu, Hawaii, Förenta staterna, 96813
- Rekrytering
- Hawaii Cancer Care
-
-
Illinois
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Hinsdale, Illinois, Förenta staterna, 60521-0509
- Rekrytering
- Hope and Healing Cancer Services
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O'Fallon, Illinois, Förenta staterna, 62269
- Rekrytering
- Cancer Care Specialists For Illinois
-
Zion, Illinois, Förenta staterna, 60099
- Rekrytering
- City of Hope Chicago Cancer Center
-
-
Indiana
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Fort Wayne, Indiana, Förenta staterna, 46804
- Rekrytering
- Fort Wayne Medical Oncology and Hematology
-
Indianapolis, Indiana, Förenta staterna, 46260
- Rekrytering
- Hematology Oncology of Indiana
-
-
Iowa
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Cedar Rapids, Iowa, Förenta staterna, 52403
- Rekrytering
- Mercy Medical Center
-
-
Kentucky
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Owensboro, Kentucky, Förenta staterna, 42303
- Rekrytering
- Owensboro Health Mitchell Memorial Cancer Center
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Michigan
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Detroit, Michigan, Förenta staterna, 48201-2013
- Rekrytering
- Karmanos Cancer Institute
-
-
Minnesota
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Duluth, Minnesota, Förenta staterna, 55805
- Rekrytering
- Aspirus St Lukes Hospital
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Minneapolis, Minnesota, Förenta staterna, 55407
- Rekrytering
- Allina Health Cancer Institute Minneapolis
-
Saint Paul, Minnesota, Förenta staterna, 55101-2502
- Rekrytering
- Metro Minnesota Community Oncology Research Consortium (Mmcorc)
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Mississippi
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Hattiesburg, Mississippi, Förenta staterna, 39401-7233
- Rekrytering
- Hattiesburg Hematology and Oncology Clinic
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-
Missouri
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Columbia, Missouri, Förenta staterna, 65201
- Rekrytering
- Missouri Cancer Associates Columbia, Mo
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Springfield, Missouri, Förenta staterna, 65807-5288
- Rekrytering
- Oncology Hematology Associates
-
-
Nebraska
-
Grand Island, Nebraska, Förenta staterna, 68803
- Rekrytering
- Nebraska Cancer Specialists St Francis Grand Island
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Lincoln, Nebraska, Förenta staterna, 68506-7548
- Rekrytering
- Nebraska Hematology Oncology
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Lincoln, Nebraska, Förenta staterna, 68516
- Rekrytering
- Cancer Partners of Nebraska April Sampson Cancer Center
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Omaha, Nebraska, Förenta staterna, 68130-2042
- Rekrytering
- Nebraska Cancer Specialists
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Nevada
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Las Vegas, Nevada, Förenta staterna, 89169-3321
- Rekrytering
- Comprehensive Cancer Centers of Nevada
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Reno, Nevada, Förenta staterna, 89502
- Rekrytering
- Renown Regional Medical Center
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New Jersey
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East Brunswick, New Jersey, Förenta staterna, 08816-4096
- Rekrytering
- Astera Cancer Care East Brunswick
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Florham Park, New Jersey, Förenta staterna, 07932-1049
- Rekrytering
- Summit Medical Group
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New Brunswick, New Jersey, Förenta staterna, 08901-1914
- Rekrytering
- Rutgers Cancer Institute of New Jersey
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New York
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Brooklyn, New York, Förenta staterna, 11220
- Rekrytering
- Nyu Langone Health Perlmutter Cancer Center Sunset Park
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Mineola, New York, Förenta staterna, 11501
- Rekrytering
- Nyu Langone Health Perlmutter Cancer Center At Nyu Langone Hospital Long Island
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New York, New York, Förenta staterna, 10016
- Rekrytering
- Nyu Langone Health Perlmutter Cancer Center 34Th Street
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Rochester, New York, Förenta staterna, 14642-0001
- Rekrytering
- University of Rochester
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Shirley, New York, Förenta staterna, 11967
- Rekrytering
- New York Cancer and Blood Specialists
-
Stony Brook, New York, Förenta staterna, 11794
- Rekrytering
- Stony Brook Cancer Center
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-
North Carolina
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Chapel Hill, North Carolina, Förenta staterna, 27514-4220
- Rekrytering
- University of North Carolina At Chapel Hill
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Hendersonville, North Carolina, Förenta staterna, 28739
- Rekrytering
- Pardee Cancer Center
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Wilson, North Carolina, Förenta staterna, 27896
- Rekrytering
- Carolina Cancer Research Center
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Ohio
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Canton, Ohio, Förenta staterna, 44718-2566
- Rekrytering
- Gabrail Cancer Center Research
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Dayton, Ohio, Förenta staterna, 45409
- Rekrytering
- Dayton Physicians Network
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Oregon
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Eugene, Oregon, Förenta staterna, 97401
- Rekrytering
- Oncology Associates of Oregon Willamette Valley Cancer Center
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Salem, Oregon, Förenta staterna, 97301
- Rekrytering
- Oregon Oncology Specialists
-
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Pennsylvania
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Broomall, Pennsylvania, Förenta staterna, 19008
- Rekrytering
- Consultants in Medical Oncology and Hematology Cancer Center At Broomall
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West Reading, Pennsylvania, Förenta staterna, 19611-2143
- Rekrytering
- McGlinn Cancer Institute
-
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South Dakota
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Sioux Falls, South Dakota, Förenta staterna, 57105-2108
- Rekrytering
- Avera Cancer Institute
-
-
Tennessee
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Kingsport, Tennessee, Förenta staterna, 37660
- Rekrytering
- Ballad Health Cancer Center Kingsport
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Nashville, Tennessee, Förenta staterna, 37204
- Rekrytering
- Vanderbilt Ingram Cancer Center Nashville Vanderbilt Breast Center
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Texas
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Austin, Texas, Förenta staterna, 78731-4214
- Rekrytering
- Texas Oncology Austin Central
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Dallas, Texas, Förenta staterna, 75246-2003
- Rekrytering
- Texas Oncology Baylor Charles A Sammons Cancer Center
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Round Rock, Texas, Förenta staterna, 78665
- Rekrytering
- Baylor Scott and White Medical Center Round Rock
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Utah
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Salt Lake City, Utah, Förenta staterna, 84107
- Rekrytering
- Utah Cancer Specialists Cancer Center
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Virginia
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Blacksburg, Virginia, Förenta staterna, 24060-6325
- Rekrytering
- Oncology and Hematology Associates of Southwest Virginia, Inc (Us Oncology Research)
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Charlottesville, Virginia, Förenta staterna, 22908-0817
- Rekrytering
- University of Virginia
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Fairfax, Virginia, Förenta staterna, 22031-2171
- Rekrytering
- Virginia Cancer Specialists
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Norfolk, Virginia, Förenta staterna, 23502-2800
- Rekrytering
- Virginia Oncology Associates
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Richmond, Virginia, Förenta staterna, 23229-8605
- Rekrytering
- Virginia Cancer Institute
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Washington
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Olympia, Washington, Förenta staterna, 98506
- Rekrytering
- Vista Oncology East Olympia
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Spokane, Washington, Förenta staterna, 99204
- Rekrytering
- Multicare Cancer Institute Deaconess Medical Office Building 1
-
Tacoma, Washington, Förenta staterna, 98405
- Rekrytering
- Northwest Medical Specialties
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Tacoma, Washington, Förenta staterna, 98405
- Rekrytering
- Multicare Cancer Institute Tacoma General Hospital
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Yakima, Washington, Förenta staterna, 98902
- Rekrytering
- Multicare Cancer Institute North Star Lodge
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Wisconsin
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La Crosse, Wisconsin, Förenta staterna, 54601-5467
- Rekrytering
- Gundersen Health System
-
Milwaukee, Wisconsin, Förenta staterna, 53226-3522
- Rekrytering
- Medical College of Wisconsin
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-
-
-
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Bergamo, Italien, 24127
- Rekrytering
- Asst Papa Giovanni Xxiii
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Milan, Italien, 20141
- Rekrytering
- Istituto Europeo Di Oncologia
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Monza, Italien, 20900
- Rekrytering
- Azienda Socio Sanitaria Territoriale Di Monza (Presidio San Gerardo)
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Roma, Italien, 00168
- Rekrytering
- Fondazione Policlinico Universitario Agostino Gemelli
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-
-
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Fukuoka
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Kurumeshi, Fukuoka, Japan, 830-0013
- Rekrytering
- Japan Community Healthcare Organization Kurume General Hospital
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-
Gunma
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Otashi, Gunma, Japan, 373-8550
- Rekrytering
- Gunma Prefectural Cancer Center
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-
Hiroshima
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Hiroshima, Hiroshima, Japan, 730-8518
- Rekrytering
- Hiroshima City Hiroshima Citizens Hospital
-
-
Hokkaido
-
Sapporo, Hokkaido, Japan, 003-0804
- Rekrytering
- National Hospital Organization Hokkaido Cancer Center
-
-
Hyōgo
-
Nishinomiyashi, Hyōgo, Japan, 663-8501
- Rekrytering
- Hyogo Medical University Hospital
-
-
Kagoshima-ken
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Kagoshima, Kagoshima-ken, Japan, 892-0833
- Rekrytering
- Social Medical Corporation Hakuaikai Sagara Hospital
-
-
Kanagawa
-
Iseharashi, Kanagawa, Japan, 259-1193
- Rekrytering
- Tokai University Hospital
-
Kawasakishi, Kanagawa, Japan, 211-8533
- Rekrytering
- Nippon Medical School Musashi Kosugi Hospital
-
Yokohama, Kanagawa, Japan, 232-0024
- Rekrytering
- Yokohama City University Medical Center
-
Yokohama, Kanagawa, Japan, 241-8515
- Rekrytering
- Kanagawa Cancer Center
-
-
Mie-ken
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Tsu, Mie-ken, Japan, 514-8507
- Rekrytering
- Mie University Hospital
-
-
Osaka
-
OsakaShi, Osaka, Japan, 541-8567
- Rekrytering
- Osaka International Cancer Institute
-
Osakashi, Osaka, Japan, 540-0006
- Rekrytering
- National Hospital Organization Osaka National Hospital
-
Suitashi, Osaka, Japan, 565-0871
- Rekrytering
- The University of Osaka Hospital
-
-
Shizuoka
-
Suntogun, Shizuoka, Japan, 411-8777
- Rekrytering
- Shizuoka Cancer Center
-
-
Tokyo
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Bunkyoku, Tokyo, Japan, 113-8677
- Rekrytering
- Tokyo Metropolitan Komagome Hospital
-
Kotoku, Tokyo, Japan, 135-8550
- Rekrytering
- Cancer Institute Hospital of Jfcr
-
Shinagawaku, Tokyo, Japan, 142-8666
- Rekrytering
- Showa Medical University Hospital
-
Shinjukuku, Tokyo, Japan, 162-8666
- Rekrytering
- Tokyo Womens Medical University Hospital
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-
-
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Anhui
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Bengbu, Anhui, Kina, 233004
- Rekrytering
- The First Affiliated Hospital of Bengbu Medical University
-
Hefei, Anhui, Kina, 230000
- Rekrytering
- Anhui Provincial Hospital
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Kina, 100142
- Rekrytering
- Beijing Cancer Hospital
-
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Chongqing Municipality
-
Chongqing, Chongqing Municipality, Kina, 630014
- Rekrytering
- The First Affiliated Hospital of Chongqing Medical University
-
-
Fujian
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Fuzhou, Fujian, Kina, 350001
- Rekrytering
- Fujian Medical University Union Hospital
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Fuzhou, Fujian, Kina, 350014
- Rekrytering
- Fujian Cancer Hospital
-
Fuzhou, Fujian, Kina, 350009
- Rekrytering
- The Peoples Hospital Affiliated to Fujian University of Traditional Chinese Medicine
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-
Guangdong
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Guangzhou, Guangdong, Kina, 510060
- Rekrytering
- Sun Yat Sen University Cancer Center
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Guangzhou, Guangdong, Kina, 510245
- Rekrytering
- Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
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Shantou, Guangdong, Kina, 515031
- Rekrytering
- Cancer Hospital of Shantou University Medical College
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Guangxi
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Nanning, Guangxi, Kina, 530201
- Rekrytering
- Guangxi Medical University Cancer Hospital Wuxiang Branch
-
-
Hainan
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Haikou, Hainan, Kina, 570206
- Rekrytering
- Hainan General Hospital
-
-
Hebei
-
Baoding, Hebei, Kina, 71000
- Rekrytering
- Affiliated Hospital of Hebei University(North Branch)
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Shijiazhuang, Hebei, Kina, 050035
- Rekrytering
- The Fourth Hospital of Hebei Medical University East Branch
-
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Heilongjiang
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Harbin, Heilongjiang, Kina, 150000
- Rekrytering
- Harbin Medical University Cancer Hospital
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-
Henan
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Zhengzhou, Henan, Kina, 450052
- Rekrytering
- The First Affiliated Hospital of Zhengzhou University
-
-
Hubei
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Wuhan, Hubei, Kina, 430079
- Rekrytering
- Hubei Cancer Hospital
-
Wuhan, Hubei, Kina, 430048
- Rekrytering
- 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
- Rekrytering
- The First Peoples Hospital of Changde City
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Changsha, Hunan, Kina, 410008
- Rekrytering
- Xiangya Hospital of Central South University
-
-
Jiangsu
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Nanjing, Jiangsu, Kina, 210036
- Rekrytering
- Jiangsu Province Hospital Longjiang Branch
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Nantong, Jiangsu, Kina, 201203
- Rekrytering
- Affiliated Hospital of Nantong University
-
-
Jiangxi
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Nanchang, Jiangxi, Kina, 330029
- Rekrytering
- Jiangxi Cancer Hospital
-
Nanchang, Jiangxi, Kina, 330025
- Rekrytering
- Nanchang Peoples Hospitalchaoyang Branch
-
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Shaanxi
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Xi'an, Shaanxi, Kina, 710004
- Rekrytering
- The Second Affiliated Hospital of Xian Jiaotong University
-
-
Shandong
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Weifang, Shandong, Kina, 261000
- Rekrytering
- Weifang Peoples Hospital
-
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Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina, 200000
- Rekrytering
- Fudan University Shanghai Cancer Center
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Shanxi
-
Yuncheng, Shanxi, Kina, 44099
- Rekrytering
- Yuncheng Central Hospital West Branch
-
-
Sichuan
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Chengdu, Sichuan, Kina, 610071
- Rekrytering
- Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
-
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Tianjin Municipality
-
Tianjin, Tianjin Municipality, Kina, 300453
- Rekrytering
- Binhai Hospital, Tianjin Medical University Cancer Institute and Hospital
-
-
Yunnan
-
Kunming, Yunnan, Kina, 650100
- Rekrytering
- Yunnan Cancer Hospital
-
-
Zhejiang
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Hangzhou, Zhejiang, Kina, 310016
- Rekrytering
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
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Wenzhou, Zhejiang, Kina, 325000
- Rekrytering
- The First Affiliated Hospital of Wenzhou Medical University
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-
-
-
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George Town, Malaysia, 10450
- Rekrytering
- Pulau Pinang Hospital
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Ipoh, Malaysia, 30450
- Rekrytering
- Hospital Raja Permaisuri Bainun
-
Johor Bahru, Malaysia, 15586
- Rekrytering
- Hospital Raja Perempuan Zainab Ii
-
Kota Kinabalu Sabah, Malaysia, 88996
- Rekrytering
- Hospital Wanita Dan Kanak Kanak Sabah (Hospital Likas)
-
Kuala Lumpur, Malaysia, 59100
- Rekrytering
- University Malaya Medical Centre
-
Kuala Lumpur, Malaysia, 50586
- Rekrytering
- Hospital Kuala Lumpur
-
Kuching, Malaysia, 93586
- Rekrytering
- Sarawak General Hospital
-
Petaling Jaya, Malaysia, 46300
- Rekrytering
- Hospital Picaso
-
Putrajaya, Malaysia, 62250
- Rekrytering
- National Cancer Institute (Institut Kanser Negara)
-
-
-
-
-
Bialystok, Polen, 15-027
- Rekrytering
- Bialostockie Centrum Onkologii Im M Sklodowskiej Curie W Bialymstoku
-
Gdynia, Polen, 81-519
- Rekrytering
- Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia
-
Kielce, Polen, 25-734
- Rekrytering
- Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
-
Krakow, Polen, 31-826
- Rekrytering
- Szpital Specjalistyczny Im Ludwika Rydygiera W Krakowie
-
Krakow, Polen, 30-727
- Rekrytering
- Pratia McM Krakow
-
Opole, Polen, 45-061
- Rekrytering
- Opolskie Centrum Onkologii
-
Otwock, Polen, 05-400
- Rekrytering
- Europejskie Centrum Zdrowia Otwock
-
Warsaw, Polen, 02-781
- Rekrytering
- Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie W Warszawie
-
-
-
-
-
San Juan, Puerto Rico, 00917
- Rekrytering
- Brcr Global Puerto Rico Hato Rey
-
-
-
-
-
Badajoz, Spanien, 06006
- Rekrytering
- Hospital Universitario de Badajoz
-
Barcelona, Spanien, 08036
- Rekrytering
- Hospital Clinic de Barcelona
-
Barcelona, Spanien, 08035
- Rekrytering
- Vall D Hebron Institute of Oncology Vhio
-
Donostiasan Sebastian, Spanien, 20014
- Rekrytering
- Hospital Universitario Donostia
-
Elcheelx, Spanien, 03203
- Rekrytering
- Hospital General Universitario de Elche
-
Granada, Spanien, 18016
- Rekrytering
- Hospital Universitario Clinico San Cecilio
-
Madrid, Spanien, 28041
- Rekrytering
- Hospital Universitario 12 de Octubre
-
Madrid, Spanien, 28240
- Rekrytering
- Hospital Clinico San Carlos
-
Madrid, Spanien, 28007
- Rekrytering
- Hospital General Universitario Gregorio Maranon
-
Madrid, Spanien, 28007
- Rekrytering
- Iob Institute of Oncology Madrid
-
Santiago de Compostela, Spanien, 15706
- Rekrytering
- Complejo Hospitalario Univ de Santiago (Chus)
-
Seville, Spanien, 41013
- Rekrytering
- Hospital Universitario Virgen Del Rocio
-
-
-
-
-
Guildford, Storbritannien, GU27XX
- Rekrytering
- Royal Surrey County Hospital
-
Maidstone, Storbritannien, ME16 9QQ
- Rekrytering
- Maidstone and Tunbridge Wells Nhs Trust Kent Oncology Centre Maidstone Hospital
-
-
-
-
-
Suwon, Sydkorea, 16499
- Rekrytering
- Ajou University Hospital
-
-
Busan Gwang'yeogsi
-
HaeundaeGu, Busan Gwang'yeogsi, Sydkorea, 48108
- Rekrytering
- Inje University Haeundae Paik Hospital
-
Seogu, Busan Gwang'yeogsi, Sydkorea, 49201
- Rekrytering
- Dong A University Hospital
-
-
Chungcheongbukdo
-
Cheongju-si, Chungcheongbukdo, Sydkorea, 28644
- Rekrytering
- Chungbuk National University Hospital
-
-
Chungcheongnam-do
-
Cheonansi, Chungcheongnam-do, Sydkorea, 31151
- Rekrytering
- Soon Chun Hyang University Cheonan Hospital
-
-
Daegu Gwang'yeogsi
-
Dalseogu, Daegu Gwang'yeogsi, Sydkorea, 42601
- Rekrytering
- Keimyung University Dongsan Hospital
-
-
Gyeonggi-do
-
BundangGu SeongnamSi, Gyeonggi-do, Sydkorea, 13496
- Rekrytering
- Cha Bundang Medical Center, Cha University
-
DanwonGu AnsanSi, Gyeonggi-do, Sydkorea, 15355
- Rekrytering
- Korea University Ansan Hospital
-
IlsandongGu GoyangSi, Gyeonggi-do, Sydkorea, 10408
- Rekrytering
- National Cancer Center (Korea)
-
PaldalGu SuwonSi, Gyeonggi-do, Sydkorea, 16247
- Rekrytering
- The Catholic University of Korea, St Vincents Hospital
-
Seongnam-si, Gyeonggi-do, Sydkorea, 13620
- Rekrytering
- Seoul National University Bundang Hospital
-
-
Incheon Gwang'yeogsi
-
Jemulpogu, Incheon Gwang'yeogsi, Sydkorea, 22332
- Rekrytering
- Inha University Hospital
-
NamdongGu, Incheon Gwang'yeogsi, Sydkorea, 21565
- Rekrytering
- Gachon University Gil Medical Center
-
-
Jeonnam-Gwangju S.M. City
-
HwasunGun, Jeonnam-Gwangju S.M. City, Sydkorea, 58128
- Rekrytering
- Chonnam National University Hwasun Hospital
-
-
Seoul Teugbyeolsi
-
DongjakGu, Seoul Teugbyeolsi, Sydkorea, 06973
- Rekrytering
- Chung Ang University Hospital
-
GangnamGu, Seoul Teugbyeolsi, Sydkorea, 06351
- Rekrytering
- Samsung Medical Center
-
GuroGu, Seoul Teugbyeolsi, Sydkorea, 08308
- Rekrytering
- Korea University Guro Hospital
-
SeochoGu, Seoul Teugbyeolsi, Sydkorea, 06591
- Rekrytering
- The Catholic University of Korea, Seoul St Marys Hospital
-
SeodaemunGu, Seoul Teugbyeolsi, Sydkorea, 03722
- Rekrytering
- Severance Hospital Yonsei University Health System
-
SeongbukGu, Seoul Teugbyeolsi, Sydkorea, 02841
- Rekrytering
- Korea University Anam Hospital
-
Seoul, Seoul Teugbyeolsi, Sydkorea, 03080
- Rekrytering
- Seoul National University Hospital
-
Seoul, Seoul Teugbyeolsi, Sydkorea, 06273
- Rekrytering
- Gangnam Severance Hospital, Yonsei University Health System
-
Seoul, Seoul Teugbyeolsi, Sydkorea, 07985
- Rekrytering
- Ehwa Womans University Mokdong Hospital
-
SongpaGu, Seoul Teugbyeolsi, Sydkorea, 05505
- Rekrytering
- Asan Medical Center
-
-
Ulsan Gwang'yeogsi
-
Ulsan, Ulsan Gwang'yeogsi, Sydkorea, 44033
- Rekrytering
- Ulsan University Hospital
-
-
-
-
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Beitou Dist, Taiwan, 11217
- Rekrytering
- Taipei Veterans General Hospital
-
Taichung, Taiwan, 40447
- Rekrytering
- China Medical University Hospital
-
Tainan, Taiwan, 704
- Rekrytering
- National Cheng Kung University Hospital
-
Zhongzheng Dist, Taiwan, 100225
- Rekrytering
- National Taiwan University Hospital
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-
-
-
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Adana, Turkiet (Türkiye), 01060
- Rekrytering
- Adana City Education and Research Hospital
-
Ankara, Turkiet (Türkiye), 06200
- Rekrytering
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
-
Ankara, Turkiet (Türkiye), 6100
- Rekrytering
- Hacettepe University
-
Ankara City Hospital, Turkiet (Türkiye), 06800
- Rekrytering
- Ankara City Hospital
-
Istanbul, Turkiet (Türkiye), 34899
- Rekrytering
- Marmara University Pendik Research and Training Hospital
-
Izmir, Turkiet (Türkiye), 35100
- Rekrytering
- Ege University Medical Faculty
-
Kocaeli, Turkiet (Türkiye), 41380
- Rekrytering
- Kocaeli Universitesi Tip Fakultesi
-
Mersin City Hospital, Turkiet (Türkiye), 33240
- Rekrytering
- Mersin City Hospital
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-
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-
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Berlin, Tyskland, 13125
- Rekrytering
- Helios Klinikum Berlin Buch Brustzentrum
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Esslingen am Neckar, Tyskland, 73730
- Rekrytering
- Klinikum Esslingen Gmbh Klinik Fuer Frauenheilkunde Und Geburtshilfe
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Frankfurt am Main, Tyskland, 60389
- Rekrytering
- Centrum Fur Haematologie Und Onkologie Bethanien
-
Koblenz, Tyskland, 56068
- Rekrytering
- Invo Institut Fur Versorgungsforschung in Der Onkologie
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Progression-Free Survival (PFS) Determined by Blinded Independent Central Review (BICR)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall Survival (OS)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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.
Tidsram: 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)
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Study Director, BeOne Medicines
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
22 maj 2026
Primärt slutförande (Beräknad)
1 april 2029
Avslutad studie (Beräknad)
7 augusti 2037
Studieregistreringsdatum
Först inskickad
20 mars 2026
Först inskickad som uppfyllde QC-kriterierna
20 mars 2026
Första postat (Faktisk)
25 mars 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
26 oktober 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 oktober 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- BGB-43395-302
- 2025-523960-19-00 (Ctis)
- 2025 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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.
Tidsram för IPD-delning
See plan description
Kriterier för IPD Sharing Access
See plan description
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- CSR
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .