BGB-43395 Plus Letrozole Contre CDK4/6i Plus Letrozole pour les Patient·e·s Atteint·e·s d'un Cancer du Sein HR+/HER2- Avancé ou Métastatique N'ayant Pas Reçu de Traitement Préalable pour une Maladie Avancée ou Métastatique (KANDELA-302)
23 octobre 2026 mis à jour par: BeOne Medicines
Étude de phase 3 ouverte, randomisée et multicentrique évaluant l'efficacité et l'innocuité du BGB-43395 associé au letrozole par rapport aux inhibiteurs de CDK4/6 (abémaciclib, palbociclib, ribociclib) associés au letrozole chez des patientes atteintes d'un cancer du sein HR+/HER2- avancé ou métastatique n'ayant pas reçu de traitement anticancéreux systémique préalable pour la maladie avancée ou métastatique
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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
1056
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Study Director
- Numéro de téléphone: 877-828-5568
- E-mail: clinicaltrials@beonemed.com
Lieux d'étude
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Berlin, Allemagne, 13125
- Recrutement
- Helios Klinikum Berlin Buch Brustzentrum
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Esslingen am Neckar, Allemagne, 73730
- Recrutement
- Klinikum Esslingen Gmbh Klinik Fuer Frauenheilkunde Und Geburtshilfe
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Frankfurt am Main, Allemagne, 60389
- Recrutement
- Centrum Fur Haematologie Und Onkologie Bethanien
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Koblenz, Allemagne, 56068
- Recrutement
- Invo Institut Fur Versorgungsforschung in Der Onkologie
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New South Wales
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Blacktown, New South Wales, Australie, NSW 2148
- Recrutement
- Blacktown Cancer and Haematology Centre
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Liverpool, New South Wales, Australie, NSW 2170
- Recrutement
- Liverpool Hospital
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Wollongong, New South Wales, Australie, NSW 2500
- Recrutement
- Wollongong Hospital
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Queensland
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Birtinya, Queensland, Australie, QLD 4575
- Recrutement
- Sunshine Coast University Private Hospital
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Douglas, Queensland, Australie, QLD 4814
- Recrutement
- Townsville University Hospital
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Victoria
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Melbourne, Victoria, Australie, VIC 3000
- Recrutement
- Peter Maccallum Cancer Centre
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Western Australia
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Murdoch, Western Australia, Australie, WA 6150
- Recrutement
- Fiona Stanley Hospital
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Nedlands, Western Australia, Australie, WA 6009
- Recrutement
- One Clinical Research
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Barretos, Brésil, 14.784-400
- Recrutement
- Fundacao Pio Xii Hospital de Amor de Barretos
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Brasília, Brésil, 71681-603
- Recrutement
- Hospital Brasilia
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Caxias do Sul, Brésil, 95070-560
- Recrutement
- Fundacao Universidade de Caxias Do Sul
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Curitiba, Brésil, 80510-130
- Recrutement
- Ictr Instituto Do Cancer E Transplante de Curitiba
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Fortaleza, Brésil, 60336-232
- Recrutement
- Centro Regional Integrado de Oncologia Crio
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Ijuí, Brésil, 98700-000
- Recrutement
- Oncosite Centro de Pesquisa Clinica Em Oncologia
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Natal, Brésil, 59062-000
- Recrutement
- Liga Norte Riograndene Contra O Cancer
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Porto Alegre, Brésil, 90610-000
- Recrutement
- Hospital Sao Lucas Da Pucrs
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Pouso Alegre, Brésil, 37554-238
- Recrutement
- Instituto Sul Mineiro de Oncologia Ltda
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Recife, Brésil, 50040-000
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- Hospital Do Cancer de Pernambuco
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Rio de Janeiro, Brésil, 20560-120
- Recrutement
- Instituto Nacional de Cancer
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São Paulo, Brésil, 01246-000
- Recrutement
- Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
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Vitória, Brésil, 29043-260
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- Hospital Santa Rita de Cassia Afecc
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Anhui
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Bengbu, Anhui, Chine, 233004
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- The First Affiliated Hospital of Bengbu Medical University
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Hefei, Anhui, Chine, 230000
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- Anhui Provincial Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, Chine, 100142
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- Beijing Cancer Hospital
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Chine, 630014
- Recrutement
- The First Affiliated Hospital of Chongqing Medical University
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Fujian
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Fuzhou, Fujian, Chine, 350001
- Recrutement
- Fujian Medical University Union Hospital
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Fuzhou, Fujian, Chine, 350014
- Recrutement
- Fujian Cancer Hospital
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Fuzhou, Fujian, Chine, 350009
- Recrutement
- The Peoples Hospital Affiliated to Fujian University of Traditional Chinese Medicine
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Guangdong
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Guangzhou, Guangdong, Chine, 510060
- Recrutement
- Sun Yat Sen University Cancer Center
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Guangzhou, Guangdong, Chine, 510245
- Recrutement
- Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
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Shantou, Guangdong, Chine, 515031
- Recrutement
- Cancer Hospital of Shantou University Medical College
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Guangxi
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Nanning, Guangxi, Chine, 530201
- Recrutement
- Guangxi Medical University Cancer Hospital Wuxiang Branch
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Hainan
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Haikou, Hainan, Chine, 570206
- Recrutement
- Hainan General Hospital
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Hebei
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Baoding, Hebei, Chine, 71000
- Recrutement
- Affiliated Hospital of Hebei University(North Branch)
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Shijiazhuang, Hebei, Chine, 050035
- Recrutement
- The Fourth Hospital of Hebei Medical University East Branch
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Heilongjiang
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Harbin, Heilongjiang, Chine, 150000
- Recrutement
- Harbin Medical University Cancer Hospital
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Henan
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Zhengzhou, Henan, Chine, 450052
- Recrutement
- The First Affiliated Hospital of Zhengzhou University
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Hubei
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Wuhan, Hubei, Chine, 430079
- Recrutement
- Hubei Cancer Hospital
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Wuhan, Hubei, Chine, 430048
- Recrutement
- Union Hospital Tongji Medical College Huazhong University of Science and Technologyjinyinhu Branch
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Hunan
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Changde, Hunan, Chine, 415000
- Recrutement
- The First Peoples Hospital of Changde City
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Changsha, Hunan, Chine, 410008
- Recrutement
- Xiangya Hospital of Central South University
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Jiangsu
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Nanjing, Jiangsu, Chine, 210036
- Recrutement
- Jiangsu Province Hospital Longjiang Branch
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Nantong, Jiangsu, Chine, 201203
- Recrutement
- Affiliated Hospital of Nantong University
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Jiangxi
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Nanchang, Jiangxi, Chine, 330029
- Recrutement
- Jiangxi Cancer Hospital
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Nanchang, Jiangxi, Chine, 330025
- Recrutement
- Nanchang Peoples Hospitalchaoyang Branch
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Shaanxi
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Xi'an, Shaanxi, Chine, 710004
- Recrutement
- The Second Affiliated Hospital of Xian Jiaotong University
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Shandong
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Weifang, Shandong, Chine, 261000
- Recrutement
- Weifang Peoples Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Chine, 200000
- Recrutement
- Fudan University Shanghai Cancer Center
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Shanxi
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Yuncheng, Shanxi, Chine, 44099
- Recrutement
- Yuncheng Central Hospital West Branch
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Sichuan
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Chengdu, Sichuan, Chine, 610071
- Recrutement
- Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Chine, 300453
- Recrutement
- Binhai Hospital, Tianjin Medical University Cancer Institute and Hospital
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Yunnan
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Kunming, Yunnan, Chine, 650100
- Recrutement
- Yunnan Cancer Hospital
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Zhejiang
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Hangzhou, Zhejiang, Chine, 310016
- Recrutement
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
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Wenzhou, Zhejiang, Chine, 325000
- Recrutement
- The First Affiliated Hospital of Wenzhou Medical University
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Suwon, Corée du Sud, 16499
- Recrutement
- Ajou University Hospital
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Busan Gwang'yeogsi
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HaeundaeGu, Busan Gwang'yeogsi, Corée du Sud, 48108
- Recrutement
- Inje University Haeundae Paik Hospital
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Seogu, Busan Gwang'yeogsi, Corée du Sud, 49201
- Recrutement
- Dong A University Hospital
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Chungcheongbukdo
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Cheongju-si, Chungcheongbukdo, Corée du Sud, 28644
- Recrutement
- Chungbuk National University Hospital
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Chungcheongnam-do
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Cheonansi, Chungcheongnam-do, Corée du Sud, 31151
- Recrutement
- Soon Chun Hyang University Cheonan Hospital
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Daegu Gwang'yeogsi
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Dalseogu, Daegu Gwang'yeogsi, Corée du Sud, 42601
- Recrutement
- Keimyung University Dongsan Hospital
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Gyeonggi-do
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BundangGu SeongnamSi, Gyeonggi-do, Corée du Sud, 13496
- Recrutement
- Cha Bundang Medical Center, Cha University
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DanwonGu AnsanSi, Gyeonggi-do, Corée du Sud, 15355
- Recrutement
- Korea University Ansan Hospital
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IlsandongGu GoyangSi, Gyeonggi-do, Corée du Sud, 10408
- Recrutement
- National Cancer Center (Korea)
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PaldalGu SuwonSi, Gyeonggi-do, Corée du Sud, 16247
- Recrutement
- The Catholic University of Korea, St Vincents Hospital
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Seongnam-si, Gyeonggi-do, Corée du Sud, 13620
- Recrutement
- Seoul National University Bundang Hospital
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Incheon Gwang'yeogsi
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Jemulpogu, Incheon Gwang'yeogsi, Corée du Sud, 22332
- Recrutement
- Inha University Hospital
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NamdongGu, Incheon Gwang'yeogsi, Corée du Sud, 21565
- Recrutement
- Gachon University Gil Medical Center
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Jeonnam-Gwangju S.M. City
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HwasunGun, Jeonnam-Gwangju S.M. City, Corée du Sud, 58128
- Recrutement
- Chonnam National University Hwasun Hospital
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Seoul Teugbyeolsi
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DongjakGu, Seoul Teugbyeolsi, Corée du Sud, 06973
- Recrutement
- Chung Ang University Hospital
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GangnamGu, Seoul Teugbyeolsi, Corée du Sud, 06351
- Recrutement
- Samsung Medical Center
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GuroGu, Seoul Teugbyeolsi, Corée du Sud, 08308
- Recrutement
- Korea University Guro Hospital
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SeochoGu, Seoul Teugbyeolsi, Corée du Sud, 06591
- Recrutement
- The Catholic University of Korea, Seoul St Marys Hospital
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SeodaemunGu, Seoul Teugbyeolsi, Corée du Sud, 03722
- Recrutement
- Severance Hospital Yonsei University Health System
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SeongbukGu, Seoul Teugbyeolsi, Corée du Sud, 02841
- Recrutement
- Korea University Anam Hospital
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Seoul, Seoul Teugbyeolsi, Corée du Sud, 03080
- Recrutement
- Seoul National University Hospital
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Seoul, Seoul Teugbyeolsi, Corée du Sud, 06273
- Recrutement
- Gangnam Severance Hospital, Yonsei University Health System
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Seoul, Seoul Teugbyeolsi, Corée du Sud, 07985
- Recrutement
- Ehwa Womans University Mokdong Hospital
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SongpaGu, Seoul Teugbyeolsi, Corée du Sud, 05505
- Recrutement
- Asan Medical Center
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Ulsan Gwang'yeogsi
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Ulsan, Ulsan Gwang'yeogsi, Corée du Sud, 44033
- Recrutement
- Ulsan University Hospital
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Badajoz, Espagne, 06006
- Recrutement
- Hospital Universitario de Badajoz
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Barcelona, Espagne, 08036
- Recrutement
- Hospital Clinic de Barcelona
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Barcelona, Espagne, 08035
- Recrutement
- Vall D Hebron Institute of Oncology Vhio
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Donostiasan Sebastian, Espagne, 20014
- Recrutement
- Hospital Universitario Donostia
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Elcheelx, Espagne, 03203
- Recrutement
- Hospital General Universitario de Elche
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Granada, Espagne, 18016
- Recrutement
- Hospital Universitario Clinico San Cecilio
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Madrid, Espagne, 28041
- Recrutement
- Hospital Universitario 12 de Octubre
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Madrid, Espagne, 28240
- Recrutement
- Hospital Clinico San Carlos
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Madrid, Espagne, 28007
- Recrutement
- Hospital General Universitario Gregorio Maranon
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Madrid, Espagne, 28007
- Recrutement
- Iob Institute of Oncology Madrid
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Santiago de Compostela, Espagne, 15706
- Recrutement
- Complejo Hospitalario Univ de Santiago (Chus)
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Seville, Espagne, 41013
- Recrutement
- Hospital Universitario Virgen Del Rocio
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Bordeaux, France, 33076
- Recrutement
- Centre de Lutte Contre Le Cancer Institut Bergonie
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Lyon, France, 69373
- Recrutement
- Centre Leon Berard
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Marseille, France, 13009
- Recrutement
- Institut Paoli Calmettes
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Montpellier, France, 34090
- Recrutement
- Icm Val Daurelle
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Rennes, France, 35043
- Recrutement
- Centre Eugene Marquis
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SaintHerblain, France, 44805
- Recrutement
- Ico Site Rene Gauducheau
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Villejuif, France, 94800
- Recrutement
- Institut Gustave Roussy
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Bergamo, Italie, 24127
- Recrutement
- Asst Papa Giovanni Xxiii
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Milan, Italie, 20141
- Recrutement
- Istituto Europeo Di Oncologia
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Monza, Italie, 20900
- Recrutement
- Azienda Socio Sanitaria Territoriale Di Monza (Presidio San Gerardo)
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Roma, Italie, 00168
- Recrutement
- Fondazione Policlinico Universitario Agostino Gemelli
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Fukuoka
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Kurumeshi, Fukuoka, Japon, 830-0013
- Recrutement
- Japan Community Healthcare Organization Kurume General Hospital
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Gunma
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Otashi, Gunma, Japon, 373-8550
- Recrutement
- Gunma Prefectural Cancer Center
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Hiroshima
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Hiroshima, Hiroshima, Japon, 730-8518
- Recrutement
- Hiroshima City Hiroshima Citizens Hospital
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Hokkaido
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Sapporo, Hokkaido, Japon, 003-0804
- Recrutement
- National Hospital Organization Hokkaido Cancer Center
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Hyōgo
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Nishinomiyashi, Hyōgo, Japon, 663-8501
- Recrutement
- Hyogo Medical University Hospital
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Kagoshima-ken
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Kagoshima, Kagoshima-ken, Japon, 892-0833
- Recrutement
- Social Medical Corporation Hakuaikai Sagara Hospital
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Kanagawa
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Iseharashi, Kanagawa, Japon, 259-1193
- Recrutement
- Tokai University Hospital
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Kawasakishi, Kanagawa, Japon, 211-8533
- Recrutement
- Nippon Medical School Musashi Kosugi Hospital
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Yokohama, Kanagawa, Japon, 232-0024
- Recrutement
- Yokohama City University Medical Center
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Yokohama, Kanagawa, Japon, 241-8515
- Recrutement
- Kanagawa Cancer Center
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Mie-ken
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Tsu, Mie-ken, Japon, 514-8507
- Recrutement
- Mie University Hospital
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Osaka
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OsakaShi, Osaka, Japon, 541-8567
- Recrutement
- Osaka International Cancer Institute
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Osakashi, Osaka, Japon, 540-0006
- Recrutement
- National Hospital Organization Osaka National Hospital
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Suitashi, Osaka, Japon, 565-0871
- Recrutement
- The University of Osaka Hospital
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Shizuoka
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Suntogun, Shizuoka, Japon, 411-8777
- Recrutement
- Shizuoka Cancer Center
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Tokyo
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Bunkyoku, Tokyo, Japon, 113-8677
- Recrutement
- Tokyo Metropolitan Komagome Hospital
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Kotoku, Tokyo, Japon, 135-8550
- Recrutement
- Cancer Institute Hospital of Jfcr
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Shinagawaku, Tokyo, Japon, 142-8666
- Recrutement
- Showa Medical University Hospital
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Shinjukuku, Tokyo, Japon, 162-8666
- Recrutement
- Tokyo Womens Medical University Hospital
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George Town, Malaisie, 10450
- Recrutement
- Pulau Pinang Hospital
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Ipoh, Malaisie, 30450
- Recrutement
- Hospital Raja Permaisuri Bainun
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Johor Bahru, Malaisie, 15586
- Recrutement
- Hospital Raja Perempuan Zainab Ii
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Kota Kinabalu Sabah, Malaisie, 88996
- Recrutement
- Hospital Wanita Dan Kanak Kanak Sabah (Hospital Likas)
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Kuala Lumpur, Malaisie, 59100
- Recrutement
- University Malaya Medical Centre
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Kuala Lumpur, Malaisie, 50586
- Recrutement
- Hospital Kuala Lumpur
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Kuching, Malaisie, 93586
- Recrutement
- Sarawak General Hospital
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Petaling Jaya, Malaisie, 46300
- Recrutement
- Hospital Picaso
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Putrajaya, Malaisie, 62250
- Recrutement
- National Cancer Institute (Institut Kanser Negara)
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Bialystok, Pologne, 15-027
- Recrutement
- Bialostockie Centrum Onkologii Im M Sklodowskiej Curie W Bialymstoku
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Gdynia, Pologne, 81-519
- Recrutement
- Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia
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Kielce, Pologne, 25-734
- Recrutement
- Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
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Krakow, Pologne, 31-826
- Recrutement
- Szpital Specjalistyczny Im Ludwika Rydygiera W Krakowie
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Krakow, Pologne, 30-727
- Recrutement
- Pratia McM Krakow
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Opole, Pologne, 45-061
- Recrutement
- Opolskie Centrum Onkologii
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Otwock, Pologne, 05-400
- Recrutement
- Europejskie Centrum Zdrowia Otwock
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Warsaw, Pologne, 02-781
- Recrutement
- Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie W Warszawie
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San Juan, Porto Rico, 00917
- Recrutement
- Brcr Global Puerto Rico Hato Rey
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Guildford, Royaume-Uni, GU27XX
- Recrutement
- Royal Surrey County Hospital
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Maidstone, Royaume-Uni, ME16 9QQ
- Recrutement
- Maidstone and Tunbridge Wells Nhs Trust Kent Oncology Centre Maidstone Hospital
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Beitou Dist, Taïwan, 11217
- Recrutement
- Taipei Veterans General Hospital
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Taichung, Taïwan, 40447
- Recrutement
- China Medical University Hospital
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Tainan, Taïwan, 704
- Recrutement
- National Cheng Kung University Hospital
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Zhongzheng Dist, Taïwan, 100225
- Recrutement
- National Taiwan University Hospital
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Adana, Turquie (Türkiye), 01060
- Recrutement
- Adana City Education and Research Hospital
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Ankara, Turquie (Türkiye), 06200
- Recrutement
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
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Ankara, Turquie (Türkiye), 6100
- Recrutement
- Hacettepe University
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Ankara City Hospital, Turquie (Türkiye), 06800
- Recrutement
- Ankara City Hospital
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Istanbul, Turquie (Türkiye), 34899
- Recrutement
- Marmara University Pendik Research and Training Hospital
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Izmir, Turquie (Türkiye), 35100
- Recrutement
- Ege University Medical Faculty
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Kocaeli, Turquie (Türkiye), 41380
- Recrutement
- Kocaeli Universitesi Tip Fakultesi
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Mersin City Hospital, Turquie (Türkiye), 33240
- Recrutement
- Mersin City Hospital
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Alabama
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Birmingham, Alabama, États-Unis, 35211
- Recrutement
- Alabama Oncology Princeton
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Alaska
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Anchorage, Alaska, États-Unis, 99508-2974
- Recrutement
- Alaska Oncology and Hematology, Llc
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Fairbanks, Alaska, États-Unis, 99701
- Recrutement
- Fairbanks Cancer Care Physicians Pc
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Arizona
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Bullhead City, Arizona, États-Unis, 86442
- Recrutement
- Pioneer Research Center
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Chandler, Arizona, États-Unis, 85224-5665
- Recrutement
- Ironwood Cancer and Research Centers Chandler Ii
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Goodyear, Arizona, États-Unis, 85338
- Recrutement
- City of Hope Phoenix Cancer Center
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Arkansas
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Hot Springs, Arkansas, États-Unis, 71913
- Recrutement
- Genesis Cancer and Blood Institute Hot Springs (Harmony Park)
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California
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Duarte, California, États-Unis, 91010-3012
- Recrutement
- City of Hope National Medical Center
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Fountain Valley, California, États-Unis, 92708
- Recrutement
- Helios Clinical Research the Oncology Institute Fountain Valley
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Los Angeles, California, États-Unis, 90027
- Recrutement
- California Research Institute
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Oxnard, California, États-Unis, 93030
- Recrutement
- Ventura County Hematology Oncology Specialists
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San Marcos, California, États-Unis, 92078
- Recrutement
- Kaiser Permanente San Marcos Medical Offices
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Santa Monica, California, États-Unis, 90404-2303
- Recrutement
- Providence Saint Johns Health Center
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West Hills, California, États-Unis, 91307
- Recrutement
- Wellness Oncology and Hematology
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Colorado
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Lone Tree, Colorado, États-Unis, 80124-5641
- Recrutement
- Rocky Mountain Cancer Centers, Llp(Us Oncology Research)
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Connecticut
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Danbury, Connecticut, États-Unis, 06810
- Recrutement
- Danbury Hospital
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Florida
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Coral Springs, Florida, États-Unis, 33065
- Recrutement
- Brcr Coral Springs
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Orange City, Florida, États-Unis, 32763-8316
- Recrutement
- Mid Florida Hematology and Oncology Center
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Palm Bay, Florida, États-Unis, 32901
- Recrutement
- Cancer Care Centers of Brevard Palm Bay
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Plantation, Florida, États-Unis, 33322
- Recrutement
- Florida Clinical Trials Group Plantation
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Port Saint Lucie, Florida, États-Unis, 34952-7596
- Recrutement
- Hematology Oncology Associates of the Treasure Coast
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South Miami, Florida, États-Unis, 33143
- Recrutement
- The Oncology Institute of Hope and Innovation South Miami
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Tamarac, Florida, États-Unis, 33321
- Recrutement
- Florida Clinical Trials Group Tamarac
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Tampa, Florida, États-Unis, 33612
- Recrutement
- Moffitt Cancer Center McKinley Campus Richard M Shulze Family Foundation Outpatient Center
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Georgia
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Athens, Georgia, États-Unis, 30607
- Recrutement
- University Cancer and Blood Center Athens Comprehensive Cancer Center
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Macon, Georgia, États-Unis, 31210
- Recrutement
- Central Georgia Cancer Care Macon Office
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Hawaii
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Honolulu, Hawaii, États-Unis, 96813
- Recrutement
- Hawaii Cancer Care
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Illinois
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Hinsdale, Illinois, États-Unis, 60521-0509
- Recrutement
- Hope and Healing Cancer Services
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O'Fallon, Illinois, États-Unis, 62269
- Recrutement
- Cancer Care Specialists For Illinois
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Zion, Illinois, États-Unis, 60099
- Recrutement
- City of Hope Chicago Cancer Center
-
-
Indiana
-
Fort Wayne, Indiana, États-Unis, 46804
- Recrutement
- Fort Wayne Medical Oncology and Hematology
-
Indianapolis, Indiana, États-Unis, 46260
- Recrutement
- Hematology Oncology of Indiana
-
-
Iowa
-
Cedar Rapids, Iowa, États-Unis, 52403
- Recrutement
- Mercy Medical Center
-
-
Kentucky
-
Owensboro, Kentucky, États-Unis, 42303
- Recrutement
- Owensboro Health Mitchell Memorial Cancer Center
-
-
Michigan
-
Detroit, Michigan, États-Unis, 48201-2013
- Recrutement
- Karmanos Cancer Institute
-
-
Minnesota
-
Duluth, Minnesota, États-Unis, 55805
- Recrutement
- Aspirus St Lukes Hospital
-
Minneapolis, Minnesota, États-Unis, 55407
- Recrutement
- Allina Health Cancer Institute Minneapolis
-
Saint Paul, Minnesota, États-Unis, 55101-2502
- Recrutement
- Metro Minnesota Community Oncology Research Consortium (Mmcorc)
-
-
Mississippi
-
Hattiesburg, Mississippi, États-Unis, 39401-7233
- Recrutement
- Hattiesburg Hematology and Oncology Clinic
-
-
Missouri
-
Columbia, Missouri, États-Unis, 65201
- Recrutement
- Missouri Cancer Associates Columbia, Mo
-
Springfield, Missouri, États-Unis, 65807-5288
- Recrutement
- Oncology Hematology Associates
-
-
Nebraska
-
Grand Island, Nebraska, États-Unis, 68803
- Recrutement
- Nebraska Cancer Specialists St Francis Grand Island
-
Lincoln, Nebraska, États-Unis, 68506-7548
- Recrutement
- Nebraska Hematology Oncology
-
Lincoln, Nebraska, États-Unis, 68516
- Recrutement
- Cancer Partners of Nebraska April Sampson Cancer Center
-
Omaha, Nebraska, États-Unis, 68130-2042
- Recrutement
- Nebraska Cancer Specialists
-
-
Nevada
-
Las Vegas, Nevada, États-Unis, 89169-3321
- Recrutement
- Comprehensive Cancer Centers of Nevada
-
Reno, Nevada, États-Unis, 89502
- Recrutement
- Renown Regional Medical Center
-
-
New Jersey
-
East Brunswick, New Jersey, États-Unis, 08816-4096
- Recrutement
- Astera Cancer Care East Brunswick
-
Florham Park, New Jersey, États-Unis, 07932-1049
- Recrutement
- Summit Medical Group
-
New Brunswick, New Jersey, États-Unis, 08901-1914
- Recrutement
- Rutgers Cancer Institute of New Jersey
-
-
New York
-
Brooklyn, New York, États-Unis, 11220
- Recrutement
- Nyu Langone Health Perlmutter Cancer Center Sunset Park
-
Mineola, New York, États-Unis, 11501
- Recrutement
- Nyu Langone Health Perlmutter Cancer Center At Nyu Langone Hospital Long Island
-
New York, New York, États-Unis, 10016
- Recrutement
- Nyu Langone Health Perlmutter Cancer Center 34Th Street
-
Rochester, New York, États-Unis, 14642-0001
- Recrutement
- University of Rochester
-
Shirley, New York, États-Unis, 11967
- Recrutement
- New York Cancer and Blood Specialists
-
Stony Brook, New York, États-Unis, 11794
- Recrutement
- Stony Brook Cancer Center
-
-
North Carolina
-
Chapel Hill, North Carolina, États-Unis, 27514-4220
- Recrutement
- University of North Carolina At Chapel Hill
-
Hendersonville, North Carolina, États-Unis, 28739
- Recrutement
- Pardee Cancer Center
-
Wilson, North Carolina, États-Unis, 27896
- Recrutement
- Carolina Cancer Research Center
-
-
Ohio
-
Canton, Ohio, États-Unis, 44718-2566
- Recrutement
- Gabrail Cancer Center Research
-
Dayton, Ohio, États-Unis, 45409
- Recrutement
- Dayton Physicians Network
-
-
Oregon
-
Eugene, Oregon, États-Unis, 97401
- Recrutement
- Oncology Associates of Oregon Willamette Valley Cancer Center
-
Salem, Oregon, États-Unis, 97301
- Recrutement
- Oregon Oncology Specialists
-
-
Pennsylvania
-
Broomall, Pennsylvania, États-Unis, 19008
- Recrutement
- Consultants in Medical Oncology and Hematology Cancer Center At Broomall
-
West Reading, Pennsylvania, États-Unis, 19611-2143
- Recrutement
- McGlinn Cancer Institute
-
-
South Dakota
-
Sioux Falls, South Dakota, États-Unis, 57105-2108
- Recrutement
- Avera Cancer Institute
-
-
Tennessee
-
Kingsport, Tennessee, États-Unis, 37660
- Recrutement
- Ballad Health Cancer Center Kingsport
-
Nashville, Tennessee, États-Unis, 37204
- Recrutement
- Vanderbilt Ingram Cancer Center Nashville Vanderbilt Breast Center
-
-
Texas
-
Austin, Texas, États-Unis, 78731-4214
- Recrutement
- Texas Oncology Austin Central
-
Dallas, Texas, États-Unis, 75246-2003
- Recrutement
- Texas Oncology Baylor Charles A Sammons Cancer Center
-
Round Rock, Texas, États-Unis, 78665
- Recrutement
- Baylor Scott and White Medical Center Round Rock
-
-
Utah
-
Salt Lake City, Utah, États-Unis, 84107
- Recrutement
- Utah Cancer Specialists Cancer Center
-
-
Virginia
-
Blacksburg, Virginia, États-Unis, 24060-6325
- Recrutement
- Oncology and Hematology Associates of Southwest Virginia, Inc (Us Oncology Research)
-
Charlottesville, Virginia, États-Unis, 22908-0817
- Recrutement
- University of Virginia
-
Fairfax, Virginia, États-Unis, 22031-2171
- Recrutement
- Virginia Cancer Specialists
-
Norfolk, Virginia, États-Unis, 23502-2800
- Recrutement
- Virginia Oncology Associates
-
Richmond, Virginia, États-Unis, 23229-8605
- Recrutement
- Virginia Cancer Institute
-
-
Washington
-
Olympia, Washington, États-Unis, 98506
- Recrutement
- Vista Oncology East Olympia
-
Spokane, Washington, États-Unis, 99204
- Recrutement
- Multicare Cancer Institute Deaconess Medical Office Building 1
-
Tacoma, Washington, États-Unis, 98405
- Recrutement
- Northwest Medical Specialties
-
Tacoma, Washington, États-Unis, 98405
- Recrutement
- Multicare Cancer Institute Tacoma General Hospital
-
Yakima, Washington, États-Unis, 98902
- Recrutement
- Multicare Cancer Institute North Star Lodge
-
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Wisconsin
-
La Crosse, Wisconsin, États-Unis, 54601-5467
- Recrutement
- Gundersen Health System
-
Milwaukee, Wisconsin, États-Unis, 53226-3522
- Recrutement
- Medical College of Wisconsin
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Participants must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the informed consent.
- Participants with histologically confirmed locally advanced or metastatic HR+ HER2- breast cancer.
- Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.
- Adequate organ function.
Exclusion Criteria:
- Participants who have received prior systemic treatment in the advanced or metastatic setting.
- Participants who have received prior treatment with any selective cyclin-dependent kinase 4 (CDK4) or cyclin-dependent kinase 2 (CDK2) targeting agent, or any other investigational anticancer drug in any disease setting, except for prior investigational or approved SERDs in the adjuvant setting, provided that disease recurrence occurred more than 12 months after the last dose of endocrine-based therapy.
- Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis.
Note: Other protocol-defined inclusion/exclusion criteria may apply.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Arm A: BGB-43395 + Letrozole
Participants will receive BGB-43395 in combination with letrozole. |
Administered orally. Administered orally. |
|
Comparateur actif: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Progression-Free Survival (PFS) Determined by Blinded Independent Central Review (BICR)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall Survival (OS)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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.
Délai: 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)
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Study Director, BeOne Medicines
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
22 mai 2026
Achèvement primaire (Estimé)
1 avril 2029
Achèvement de l'étude (Estimé)
7 août 2037
Dates d'inscription aux études
Première soumission
20 mars 2026
Première soumission répondant aux critères de contrôle qualité
20 mars 2026
Première publication (Réel)
25 mars 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
26 octobre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
23 octobre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- BGB-43395-302
- 2025-523960-19-00 (Ctis)
- 2025 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Délai de partage IPD
See plan description
Critères d'accès au partage IPD
See plan description
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .