BGB-43395 Plus Letrozol Versus CDK4/6i Plus Letrozol voor Patiënten met Geavanceerde of Uitgezaaide HR+/HER2- Borstkanker Die Nog Geen Eerdere Behandeling voor Geavanceerde of Uitgezaaide Ziekte Hebben Ontvangen (KANDELA-302)
23 oktober 2026 bijgewerkt door: BeOne Medicines
Een open-label, gerandomiseerd, multicenter fase 3-onderzoek naar de werkzaamheid en veiligheid van BGB-43395 plus letrozol versus CDK4/6-remmers (abemaciclib, palbociclib, ribociclib) plus letrozol bij patiënten met gevorderde of gemetastaseerde HR+/HER2- borstkanker die nog geen eerdere systemische antikankerbehandeling hebben ontvangen voor de gevorderde of gemetastaseerde ziekte
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.
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
1056
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Study Director
- Telefoonnummer: 877-828-5568
- E-mail: clinicaltrials@beonemed.com
Studie Locaties
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New South Wales
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Blacktown, New South Wales, Australië, NSW 2148
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- Blacktown Cancer and Haematology Centre
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Liverpool, New South Wales, Australië, NSW 2170
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- Liverpool Hospital
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Wollongong, New South Wales, Australië, NSW 2500
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- Wollongong Hospital
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Queensland
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Birtinya, Queensland, Australië, QLD 4575
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- Sunshine Coast University Private Hospital
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Douglas, Queensland, Australië, QLD 4814
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- Townsville University Hospital
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Victoria
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Melbourne, Victoria, Australië, VIC 3000
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- Peter Maccallum Cancer Centre
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Western Australia
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Murdoch, Western Australia, Australië, WA 6150
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- Fiona Stanley Hospital
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Nedlands, Western Australia, Australië, WA 6009
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- One Clinical Research
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Barretos, Brazilië, 14.784-400
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- Fundacao Pio Xii Hospital de Amor de Barretos
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Brasília, Brazilië, 71681-603
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- Hospital Brasilia
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Caxias do Sul, Brazilië, 95070-560
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- Fundacao Universidade de Caxias Do Sul
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Curitiba, Brazilië, 80510-130
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- Ictr Instituto Do Cancer E Transplante de Curitiba
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Fortaleza, Brazilië, 60336-232
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- Centro Regional Integrado de Oncologia Crio
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Ijuí, Brazilië, 98700-000
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- Oncosite Centro de Pesquisa Clinica Em Oncologia
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Natal, Brazilië, 59062-000
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- Liga Norte Riograndene Contra O Cancer
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Porto Alegre, Brazilië, 90610-000
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- Hospital Sao Lucas Da Pucrs
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Pouso Alegre, Brazilië, 37554-238
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- Instituto Sul Mineiro de Oncologia Ltda
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Recife, Brazilië, 50040-000
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- Hospital Do Cancer de Pernambuco
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Rio de Janeiro, Brazilië, 20560-120
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- Instituto Nacional de Cancer
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São Paulo, Brazilië, 01246-000
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- Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
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Vitória, Brazilië, 29043-260
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- Hospital Santa Rita de Cassia Afecc
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Anhui
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Bengbu, Anhui, China, 233004
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- The First Affiliated Hospital of Bengbu Medical University
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Hefei, Anhui, China, 230000
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- Anhui Provincial Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100142
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- Beijing Cancer Hospital
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Chongqing Municipality
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Chongqing, Chongqing Municipality, China, 630014
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- The First Affiliated Hospital of Chongqing Medical University
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Fujian
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Fuzhou, Fujian, China, 350001
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- Fujian Medical University Union Hospital
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Fuzhou, Fujian, China, 350014
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- Fujian Cancer Hospital
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Fuzhou, Fujian, China, 350009
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- The Peoples Hospital Affiliated to Fujian University of Traditional Chinese Medicine
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Guangdong
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Guangzhou, Guangdong, China, 510060
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- Sun Yat Sen University Cancer Center
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Guangzhou, Guangdong, China, 510245
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- Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
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Shantou, Guangdong, China, 515031
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- Cancer Hospital of Shantou University Medical College
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Guangxi
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Nanning, Guangxi, China, 530201
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- Guangxi Medical University Cancer Hospital Wuxiang Branch
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Hainan
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Haikou, Hainan, China, 570206
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- Hainan General Hospital
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Hebei
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Baoding, Hebei, China, 71000
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- Affiliated Hospital of Hebei University(North Branch)
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Shijiazhuang, Hebei, China, 050035
- Werving
- The Fourth Hospital of Hebei Medical University East Branch
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Heilongjiang
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Harbin, Heilongjiang, China, 150000
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- Harbin Medical University Cancer Hospital
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Henan
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Zhengzhou, Henan, China, 450052
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- The First Affiliated Hospital of Zhengzhou University
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Hubei
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Wuhan, Hubei, China, 430079
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- Hubei Cancer Hospital
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Wuhan, Hubei, China, 430048
- Werving
- Union Hospital Tongji Medical College Huazhong University of Science and Technologyjinyinhu Branch
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Hunan
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Changde, Hunan, China, 415000
- Werving
- The First Peoples Hospital of Changde City
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Changsha, Hunan, China, 410008
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- Xiangya Hospital of Central South University
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Jiangsu
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Nanjing, Jiangsu, China, 210036
- Werving
- Jiangsu Province Hospital Longjiang Branch
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Nantong, Jiangsu, China, 201203
- Werving
- Affiliated Hospital of Nantong University
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Jiangxi
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Nanchang, Jiangxi, China, 330029
- Werving
- Jiangxi Cancer Hospital
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Nanchang, Jiangxi, China, 330025
- Werving
- Nanchang Peoples Hospitalchaoyang Branch
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Shaanxi
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Xi'an, Shaanxi, China, 710004
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- The Second Affiliated Hospital of Xian Jiaotong University
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Shandong
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Weifang, Shandong, China, 261000
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- Weifang Peoples Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200000
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- Fudan University Shanghai Cancer Center
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Shanxi
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Yuncheng, Shanxi, China, 44099
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- Yuncheng Central Hospital West Branch
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Sichuan
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Chengdu, Sichuan, China, 610071
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- Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
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Tianjin Municipality
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Tianjin, Tianjin Municipality, China, 300453
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- Binhai Hospital, Tianjin Medical University Cancer Institute and Hospital
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Yunnan
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Kunming, Yunnan, China, 650100
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- Yunnan Cancer Hospital
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Zhejiang
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Hangzhou, Zhejiang, China, 310016
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- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
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Wenzhou, Zhejiang, China, 325000
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- The First Affiliated Hospital of Wenzhou Medical University
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Berlin, Duitsland, 13125
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- Helios Klinikum Berlin Buch Brustzentrum
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Esslingen am Neckar, Duitsland, 73730
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- Klinikum Esslingen Gmbh Klinik Fuer Frauenheilkunde Und Geburtshilfe
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Frankfurt am Main, Duitsland, 60389
- Werving
- Centrum Fur Haematologie Und Onkologie Bethanien
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Koblenz, Duitsland, 56068
- Werving
- Invo Institut Fur Versorgungsforschung in Der Onkologie
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Bordeaux, Frankrijk, 33076
- Werving
- Centre de Lutte Contre Le Cancer Institut Bergonie
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Lyon, Frankrijk, 69373
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- Centre Leon Berard
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Marseille, Frankrijk, 13009
- Werving
- Institut Paoli Calmettes
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Montpellier, Frankrijk, 34090
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- Icm Val Daurelle
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Rennes, Frankrijk, 35043
- Werving
- Centre Eugene Marquis
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SaintHerblain, Frankrijk, 44805
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- Ico Site Rene Gauducheau
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Villejuif, Frankrijk, 94800
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- Institut Gustave Roussy
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Bergamo, Italië, 24127
- Werving
- Asst Papa Giovanni Xxiii
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Milan, Italië, 20141
- Werving
- Istituto Europeo Di Oncologia
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Monza, Italië, 20900
- Werving
- Azienda Socio Sanitaria Territoriale Di Monza (Presidio San Gerardo)
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Roma, Italië, 00168
- Werving
- Fondazione Policlinico Universitario Agostino Gemelli
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Fukuoka
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Kurumeshi, Fukuoka, Japan, 830-0013
- Werving
- Japan Community Healthcare Organization Kurume General Hospital
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Gunma
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Otashi, Gunma, Japan, 373-8550
- Werving
- Gunma Prefectural Cancer Center
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Hiroshima
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Hiroshima, Hiroshima, Japan, 730-8518
- Werving
- Hiroshima City Hiroshima Citizens Hospital
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Hokkaido
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Sapporo, Hokkaido, Japan, 003-0804
- Werving
- National Hospital Organization Hokkaido Cancer Center
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Hyōgo
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Nishinomiyashi, Hyōgo, Japan, 663-8501
- Werving
- Hyogo Medical University Hospital
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Kagoshima-ken
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Kagoshima, Kagoshima-ken, Japan, 892-0833
- Werving
- Social Medical Corporation Hakuaikai Sagara Hospital
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Kanagawa
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Iseharashi, Kanagawa, Japan, 259-1193
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- Tokai University Hospital
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Kawasakishi, Kanagawa, Japan, 211-8533
- Werving
- Nippon Medical School Musashi Kosugi Hospital
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Yokohama, Kanagawa, Japan, 232-0024
- Werving
- Yokohama City University Medical Center
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Yokohama, Kanagawa, Japan, 241-8515
- Werving
- Kanagawa Cancer Center
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Mie-ken
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Tsu, Mie-ken, Japan, 514-8507
- Werving
- Mie University Hospital
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Osaka
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OsakaShi, Osaka, Japan, 541-8567
- Werving
- Osaka International Cancer Institute
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Osakashi, Osaka, Japan, 540-0006
- Werving
- National Hospital Organization Osaka National Hospital
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Suitashi, Osaka, Japan, 565-0871
- Werving
- The University of Osaka Hospital
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Shizuoka
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Suntogun, Shizuoka, Japan, 411-8777
- Werving
- Shizuoka Cancer Center
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Tokyo
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Bunkyoku, Tokyo, Japan, 113-8677
- Werving
- Tokyo Metropolitan Komagome Hospital
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Kotoku, Tokyo, Japan, 135-8550
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- Cancer Institute Hospital of Jfcr
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Shinagawaku, Tokyo, Japan, 142-8666
- Werving
- Showa Medical University Hospital
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Shinjukuku, Tokyo, Japan, 162-8666
- Werving
- Tokyo Womens Medical University Hospital
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George Town, Maleisië, 10450
- Werving
- Pulau Pinang Hospital
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Ipoh, Maleisië, 30450
- Werving
- Hospital Raja Permaisuri Bainun
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Johor Bahru, Maleisië, 15586
- Werving
- Hospital Raja Perempuan Zainab Ii
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Kota Kinabalu Sabah, Maleisië, 88996
- Werving
- Hospital Wanita Dan Kanak Kanak Sabah (Hospital Likas)
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Kuala Lumpur, Maleisië, 59100
- Werving
- University Malaya Medical Centre
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Kuala Lumpur, Maleisië, 50586
- Werving
- Hospital Kuala Lumpur
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Kuching, Maleisië, 93586
- Werving
- Sarawak General Hospital
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Petaling Jaya, Maleisië, 46300
- Werving
- Hospital Picaso
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Putrajaya, Maleisië, 62250
- Werving
- National Cancer Institute (Institut Kanser Negara)
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Bialystok, Polen, 15-027
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- Bialostockie Centrum Onkologii Im M Sklodowskiej Curie W Bialymstoku
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Gdynia, Polen, 81-519
- Werving
- Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia
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Kielce, Polen, 25-734
- Werving
- Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
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Krakow, Polen, 31-826
- Werving
- Szpital Specjalistyczny Im Ludwika Rydygiera W Krakowie
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Krakow, Polen, 30-727
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- Pratia McM Krakow
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Opole, Polen, 45-061
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- Opolskie Centrum Onkologii
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Otwock, Polen, 05-400
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- Europejskie Centrum Zdrowia Otwock
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Warsaw, Polen, 02-781
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- Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie W Warszawie
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San Juan, Puerto Rico, 00917
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- Brcr Global Puerto Rico Hato Rey
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Badajoz, Spanje, 06006
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- Hospital Universitario de Badajoz
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Barcelona, Spanje, 08036
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- Hospital Clinic de Barcelona
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Barcelona, Spanje, 08035
- Werving
- Vall D Hebron Institute of Oncology Vhio
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Donostiasan Sebastian, Spanje, 20014
- Werving
- Hospital Universitario Donostia
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Elcheelx, Spanje, 03203
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- Hospital General Universitario de Elche
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Granada, Spanje, 18016
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- Hospital Universitario Clinico San Cecilio
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Madrid, Spanje, 28041
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- Hospital Universitario 12 de Octubre
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Madrid, Spanje, 28240
- Werving
- Hospital Clinico San Carlos
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Madrid, Spanje, 28007
- Werving
- Hospital General Universitario Gregorio Maranon
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Madrid, Spanje, 28007
- Werving
- Iob Institute of Oncology Madrid
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Santiago de Compostela, Spanje, 15706
- Werving
- Complejo Hospitalario Univ de Santiago (Chus)
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Seville, Spanje, 41013
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- Hospital Universitario Virgen Del Rocio
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Beitou Dist, Taiwan, 11217
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- Taipei Veterans General Hospital
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Taichung, Taiwan, 40447
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- China Medical University Hospital
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Tainan, Taiwan, 704
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- National Cheng Kung University Hospital
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Zhongzheng Dist, Taiwan, 100225
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- National Taiwan University Hospital
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Adana, Turkije (Türkiye), 01060
- Werving
- Adana City Education and Research Hospital
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Ankara, Turkije (Türkiye), 06200
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- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
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Ankara, Turkije (Türkiye), 6100
- Werving
- Hacettepe University
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Ankara City Hospital, Turkije (Türkiye), 06800
- Werving
- Ankara City Hospital
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Istanbul, Turkije (Türkiye), 34899
- Werving
- Marmara University Pendik Research and Training Hospital
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Izmir, Turkije (Türkiye), 35100
- Werving
- Ege University Medical Faculty
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Kocaeli, Turkije (Türkiye), 41380
- Werving
- Kocaeli Universitesi Tip Fakultesi
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Mersin City Hospital, Turkije (Türkiye), 33240
- Werving
- Mersin City Hospital
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Guildford, Verenigd Koninkrijk, GU27XX
- Werving
- Royal Surrey County Hospital
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Maidstone, Verenigd Koninkrijk, ME16 9QQ
- Werving
- Maidstone and Tunbridge Wells Nhs Trust Kent Oncology Centre Maidstone Hospital
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Alabama
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Birmingham, Alabama, Verenigde Staten, 35211
- Werving
- Alabama Oncology Princeton
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Alaska
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Anchorage, Alaska, Verenigde Staten, 99508-2974
- Werving
- Alaska Oncology and Hematology, Llc
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Fairbanks, Alaska, Verenigde Staten, 99701
- Werving
- Fairbanks Cancer Care Physicians Pc
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Arizona
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Bullhead City, Arizona, Verenigde Staten, 86442
- Werving
- Pioneer Research Center
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Chandler, Arizona, Verenigde Staten, 85224-5665
- Werving
- Ironwood Cancer and Research Centers Chandler Ii
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Goodyear, Arizona, Verenigde Staten, 85338
- Werving
- City of Hope Phoenix Cancer Center
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Arkansas
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Hot Springs, Arkansas, Verenigde Staten, 71913
- Werving
- Genesis Cancer and Blood Institute Hot Springs (Harmony Park)
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California
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Duarte, California, Verenigde Staten, 91010-3012
- Werving
- City of Hope National Medical Center
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Fountain Valley, California, Verenigde Staten, 92708
- Werving
- Helios Clinical Research the Oncology Institute Fountain Valley
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Los Angeles, California, Verenigde Staten, 90027
- Werving
- California Research Institute
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Oxnard, California, Verenigde Staten, 93030
- Werving
- Ventura County Hematology Oncology Specialists
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San Marcos, California, Verenigde Staten, 92078
- Werving
- Kaiser Permanente San Marcos Medical Offices
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Santa Monica, California, Verenigde Staten, 90404-2303
- Werving
- Providence Saint Johns Health Center
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West Hills, California, Verenigde Staten, 91307
- Werving
- Wellness Oncology and Hematology
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Colorado
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Lone Tree, Colorado, Verenigde Staten, 80124-5641
- Werving
- Rocky Mountain Cancer Centers, Llp(Us Oncology Research)
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Connecticut
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Danbury, Connecticut, Verenigde Staten, 06810
- Werving
- Danbury Hospital
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Florida
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Coral Springs, Florida, Verenigde Staten, 33065
- Werving
- Brcr Coral Springs
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Orange City, Florida, Verenigde Staten, 32763-8316
- Werving
- Mid Florida Hematology and Oncology Center
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Palm Bay, Florida, Verenigde Staten, 32901
- Werving
- Cancer Care Centers of Brevard Palm Bay
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Plantation, Florida, Verenigde Staten, 33322
- Werving
- Florida Clinical Trials Group Plantation
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Port Saint Lucie, Florida, Verenigde Staten, 34952-7596
- Werving
- Hematology Oncology Associates of the Treasure Coast
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South Miami, Florida, Verenigde Staten, 33143
- Werving
- The Oncology Institute of Hope and Innovation South Miami
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Tamarac, Florida, Verenigde Staten, 33321
- Werving
- Florida Clinical Trials Group Tamarac
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Tampa, Florida, Verenigde Staten, 33612
- Werving
- Moffitt Cancer Center McKinley Campus Richard M Shulze Family Foundation Outpatient Center
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Georgia
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Athens, Georgia, Verenigde Staten, 30607
- Werving
- University Cancer and Blood Center Athens Comprehensive Cancer Center
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Macon, Georgia, Verenigde Staten, 31210
- Werving
- Central Georgia Cancer Care Macon Office
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Hawaii
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Honolulu, Hawaii, Verenigde Staten, 96813
- Werving
- Hawaii Cancer Care
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Illinois
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Hinsdale, Illinois, Verenigde Staten, 60521-0509
- Werving
- Hope and Healing Cancer Services
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O'Fallon, Illinois, Verenigde Staten, 62269
- Werving
- Cancer Care Specialists For Illinois
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Zion, Illinois, Verenigde Staten, 60099
- Werving
- City of Hope Chicago Cancer Center
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Indiana
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Fort Wayne, Indiana, Verenigde Staten, 46804
- Werving
- Fort Wayne Medical Oncology and Hematology
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Indianapolis, Indiana, Verenigde Staten, 46260
- Werving
- Hematology Oncology of Indiana
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Iowa
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Cedar Rapids, Iowa, Verenigde Staten, 52403
- Werving
- Mercy Medical Center
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Kentucky
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Owensboro, Kentucky, Verenigde Staten, 42303
- Werving
- Owensboro Health Mitchell Memorial Cancer Center
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Michigan
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Detroit, Michigan, Verenigde Staten, 48201-2013
- Werving
- Karmanos Cancer Institute
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Minnesota
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Duluth, Minnesota, Verenigde Staten, 55805
- Werving
- Aspirus St Lukes Hospital
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Minneapolis, Minnesota, Verenigde Staten, 55407
- Werving
- Allina Health Cancer Institute Minneapolis
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Saint Paul, Minnesota, Verenigde Staten, 55101-2502
- Werving
- Metro Minnesota Community Oncology Research Consortium (Mmcorc)
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Mississippi
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Hattiesburg, Mississippi, Verenigde Staten, 39401-7233
- Werving
- Hattiesburg Hematology and Oncology Clinic
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Missouri
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Columbia, Missouri, Verenigde Staten, 65201
- Werving
- Missouri Cancer Associates Columbia, Mo
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Springfield, Missouri, Verenigde Staten, 65807-5288
- Werving
- Oncology Hematology Associates
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Nebraska
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Grand Island, Nebraska, Verenigde Staten, 68803
- Werving
- Nebraska Cancer Specialists St Francis Grand Island
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Lincoln, Nebraska, Verenigde Staten, 68506-7548
- Werving
- Nebraska Hematology Oncology
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Lincoln, Nebraska, Verenigde Staten, 68516
- Werving
- Cancer Partners of Nebraska April Sampson Cancer Center
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Omaha, Nebraska, Verenigde Staten, 68130-2042
- Werving
- Nebraska Cancer Specialists
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Nevada
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Las Vegas, Nevada, Verenigde Staten, 89169-3321
- Werving
- Comprehensive Cancer Centers of Nevada
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Reno, Nevada, Verenigde Staten, 89502
- Werving
- Renown Regional Medical Center
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New Jersey
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East Brunswick, New Jersey, Verenigde Staten, 08816-4096
- Werving
- Astera Cancer Care East Brunswick
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Florham Park, New Jersey, Verenigde Staten, 07932-1049
- Werving
- Summit Medical Group
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New Brunswick, New Jersey, Verenigde Staten, 08901-1914
- Werving
- Rutgers Cancer Institute of New Jersey
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New York
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Brooklyn, New York, Verenigde Staten, 11220
- Werving
- Nyu Langone Health Perlmutter Cancer Center Sunset Park
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Mineola, New York, Verenigde Staten, 11501
- Werving
- Nyu Langone Health Perlmutter Cancer Center At Nyu Langone Hospital Long Island
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New York, New York, Verenigde Staten, 10016
- Werving
- Nyu Langone Health Perlmutter Cancer Center 34Th Street
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Rochester, New York, Verenigde Staten, 14642-0001
- Werving
- University of Rochester
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Shirley, New York, Verenigde Staten, 11967
- Werving
- New York Cancer and Blood Specialists
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Stony Brook, New York, Verenigde Staten, 11794
- Werving
- Stony Brook Cancer Center
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North Carolina
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Chapel Hill, North Carolina, Verenigde Staten, 27514-4220
- Werving
- University of North Carolina At Chapel Hill
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Hendersonville, North Carolina, Verenigde Staten, 28739
- Werving
- Pardee Cancer Center
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Wilson, North Carolina, Verenigde Staten, 27896
- Werving
- Carolina Cancer Research Center
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Ohio
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Canton, Ohio, Verenigde Staten, 44718-2566
- Werving
- Gabrail Cancer Center Research
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Dayton, Ohio, Verenigde Staten, 45409
- Werving
- Dayton Physicians Network
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Oregon
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Eugene, Oregon, Verenigde Staten, 97401
- Werving
- Oncology Associates of Oregon Willamette Valley Cancer Center
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Salem, Oregon, Verenigde Staten, 97301
- Werving
- Oregon Oncology Specialists
-
-
Pennsylvania
-
Broomall, Pennsylvania, Verenigde Staten, 19008
- Werving
- Consultants in Medical Oncology and Hematology Cancer Center At Broomall
-
West Reading, Pennsylvania, Verenigde Staten, 19611-2143
- Werving
- McGlinn Cancer Institute
-
-
South Dakota
-
Sioux Falls, South Dakota, Verenigde Staten, 57105-2108
- Werving
- Avera Cancer Institute
-
-
Tennessee
-
Kingsport, Tennessee, Verenigde Staten, 37660
- Werving
- Ballad Health Cancer Center Kingsport
-
Nashville, Tennessee, Verenigde Staten, 37204
- Werving
- Vanderbilt Ingram Cancer Center Nashville Vanderbilt Breast Center
-
-
Texas
-
Austin, Texas, Verenigde Staten, 78731-4214
- Werving
- Texas Oncology Austin Central
-
Dallas, Texas, Verenigde Staten, 75246-2003
- Werving
- Texas Oncology Baylor Charles A Sammons Cancer Center
-
Round Rock, Texas, Verenigde Staten, 78665
- Werving
- Baylor Scott and White Medical Center Round Rock
-
-
Utah
-
Salt Lake City, Utah, Verenigde Staten, 84107
- Werving
- Utah Cancer Specialists Cancer Center
-
-
Virginia
-
Blacksburg, Virginia, Verenigde Staten, 24060-6325
- Werving
- Oncology and Hematology Associates of Southwest Virginia, Inc (Us Oncology Research)
-
Charlottesville, Virginia, Verenigde Staten, 22908-0817
- Werving
- University of Virginia
-
Fairfax, Virginia, Verenigde Staten, 22031-2171
- Werving
- Virginia Cancer Specialists
-
Norfolk, Virginia, Verenigde Staten, 23502-2800
- Werving
- Virginia Oncology Associates
-
Richmond, Virginia, Verenigde Staten, 23229-8605
- Werving
- Virginia Cancer Institute
-
-
Washington
-
Olympia, Washington, Verenigde Staten, 98506
- Werving
- Vista Oncology East Olympia
-
Spokane, Washington, Verenigde Staten, 99204
- Werving
- Multicare Cancer Institute Deaconess Medical Office Building 1
-
Tacoma, Washington, Verenigde Staten, 98405
- Werving
- Northwest Medical Specialties
-
Tacoma, Washington, Verenigde Staten, 98405
- Werving
- Multicare Cancer Institute Tacoma General Hospital
-
Yakima, Washington, Verenigde Staten, 98902
- Werving
- Multicare Cancer Institute North Star Lodge
-
-
Wisconsin
-
La Crosse, Wisconsin, Verenigde Staten, 54601-5467
- Werving
- Gundersen Health System
-
Milwaukee, Wisconsin, Verenigde Staten, 53226-3522
- Werving
- Medical College of Wisconsin
-
-
-
-
-
Suwon, Zuid -Korea, 16499
- Werving
- Ajou University Hospital
-
-
Busan Gwang'yeogsi
-
HaeundaeGu, Busan Gwang'yeogsi, Zuid -Korea, 48108
- Werving
- Inje University Haeundae Paik Hospital
-
Seogu, Busan Gwang'yeogsi, Zuid -Korea, 49201
- Werving
- Dong A University Hospital
-
-
Chungcheongbukdo
-
Cheongju-si, Chungcheongbukdo, Zuid -Korea, 28644
- Werving
- Chungbuk National University Hospital
-
-
Chungcheongnam-do
-
Cheonansi, Chungcheongnam-do, Zuid -Korea, 31151
- Werving
- Soon Chun Hyang University Cheonan Hospital
-
-
Daegu Gwang'yeogsi
-
Dalseogu, Daegu Gwang'yeogsi, Zuid -Korea, 42601
- Werving
- Keimyung University Dongsan Hospital
-
-
Gyeonggi-do
-
BundangGu SeongnamSi, Gyeonggi-do, Zuid -Korea, 13496
- Werving
- Cha Bundang Medical Center, Cha University
-
DanwonGu AnsanSi, Gyeonggi-do, Zuid -Korea, 15355
- Werving
- Korea University Ansan Hospital
-
IlsandongGu GoyangSi, Gyeonggi-do, Zuid -Korea, 10408
- Werving
- National Cancer Center (Korea)
-
PaldalGu SuwonSi, Gyeonggi-do, Zuid -Korea, 16247
- Werving
- The Catholic University of Korea, St Vincents Hospital
-
Seongnam-si, Gyeonggi-do, Zuid -Korea, 13620
- Werving
- Seoul National University Bundang Hospital
-
-
Incheon Gwang'yeogsi
-
Jemulpogu, Incheon Gwang'yeogsi, Zuid -Korea, 22332
- Werving
- Inha University Hospital
-
NamdongGu, Incheon Gwang'yeogsi, Zuid -Korea, 21565
- Werving
- Gachon University Gil Medical Center
-
-
Jeonnam-Gwangju S.M. City
-
HwasunGun, Jeonnam-Gwangju S.M. City, Zuid -Korea, 58128
- Werving
- Chonnam National University Hwasun Hospital
-
-
Seoul Teugbyeolsi
-
DongjakGu, Seoul Teugbyeolsi, Zuid -Korea, 06973
- Werving
- Chung Ang University Hospital
-
GangnamGu, Seoul Teugbyeolsi, Zuid -Korea, 06351
- Werving
- Samsung Medical Center
-
GuroGu, Seoul Teugbyeolsi, Zuid -Korea, 08308
- Werving
- Korea University Guro Hospital
-
SeochoGu, Seoul Teugbyeolsi, Zuid -Korea, 06591
- Werving
- The Catholic University of Korea, Seoul St Marys Hospital
-
SeodaemunGu, Seoul Teugbyeolsi, Zuid -Korea, 03722
- Werving
- Severance Hospital Yonsei University Health System
-
SeongbukGu, Seoul Teugbyeolsi, Zuid -Korea, 02841
- Werving
- Korea University Anam Hospital
-
Seoul, Seoul Teugbyeolsi, Zuid -Korea, 03080
- Werving
- Seoul National University Hospital
-
Seoul, Seoul Teugbyeolsi, Zuid -Korea, 06273
- Werving
- Gangnam Severance Hospital, Yonsei University Health System
-
Seoul, Seoul Teugbyeolsi, Zuid -Korea, 07985
- Werving
- Ehwa Womans University Mokdong Hospital
-
SongpaGu, Seoul Teugbyeolsi, Zuid -Korea, 05505
- Werving
- Asan Medical Center
-
-
Ulsan Gwang'yeogsi
-
Ulsan, Ulsan Gwang'yeogsi, Zuid -Korea, 44033
- Werving
- Ulsan University Hospital
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Arm A: BGB-43395 + Letrozole
Participants will receive BGB-43395 in combination with letrozole. |
Administered orally. Administered orally. |
|
Actieve vergelijker: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Progression-Free Survival (PFS) Determined by Blinded Independent Central Review (BICR)
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Overall Survival (OS)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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.
Tijdsspanne: 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)
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Study Director, BeOne Medicines
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
22 mei 2026
Primaire voltooiing (Geschat)
1 april 2029
Studie voltooiing (Geschat)
7 augustus 2037
Studieregistratiedata
Eerst ingediend
20 maart 2026
Eerst ingediend dat voldeed aan de QC-criteria
20 maart 2026
Eerst geplaatst (Werkelijk)
25 maart 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
26 oktober 2026
Laatste update ingediend die voldeed aan QC-criteria
23 oktober 2026
Laatst geverifieerd
1 september 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- BGB-43395-302
- 2025-523960-19-00 (Ctis)
- 2025 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
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-tijdsbestek voor delen
See plan description
IPD-toegangscriteria voor delen
See plan description
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- MVO
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .