BGB-43395 più Letrozolo contro CDK4/6i più Letrozolo per pazienti con carcinoma mammario HR+/HER2- avanzato o metastatico che non hanno ricevuto precedenti trattamenti per la malattia avanzata o metastatica (KANDELA-302)
23 ottobre 2026 aggiornato da: BeOne Medicines
Uno Studio di Fase 3 Aperto, Randomizzato, Multicentrico che Valuta l’Efficacia e la Sicurezza di BGB-43395 più Letrozolo Rispetto agli Inibitori CDK4/6 (Abemaciclib, Palbociclib, Ribociclib) più Letrozolo in Pazienti con Carcinoma Mammario HR+/HER2- Avanzato o Metastatico che non Hanno Ricevuto Precedenti Trattamenti Anticancerogeni Sistemici per la Malattia Avanzata o Metastatica
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.
Panoramica dello studio
Stato
Stato
Reclutamento
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Interventistico
Iscrizione (Stimato)
Iscrizione
1056
Fase
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
Contatto studio
- Nome: Study Director
- Numero di telefono: 877-828-5568
- Email: clinicaltrials@beonemed.com
Luoghi di studio
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New South Wales
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Blacktown, New South Wales, Australia, NSW 2148
- Reclutamento
- Blacktown Cancer and Haematology Centre
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Liverpool, New South Wales, Australia, NSW 2170
- Reclutamento
- Liverpool Hospital
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Wollongong, New South Wales, Australia, NSW 2500
- Reclutamento
- Wollongong Hospital
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Queensland
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Birtinya, Queensland, Australia, QLD 4575
- Reclutamento
- Sunshine Coast University Private Hospital
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Douglas, Queensland, Australia, QLD 4814
- Reclutamento
- Townsville University Hospital
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Victoria
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Melbourne, Victoria, Australia, VIC 3000
- Reclutamento
- Peter Maccallum Cancer Centre
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Western Australia
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Murdoch, Western Australia, Australia, WA 6150
- Reclutamento
- Fiona Stanley Hospital
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Nedlands, Western Australia, Australia, WA 6009
- Reclutamento
- One Clinical Research
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Barretos, Brasile, 14.784-400
- Reclutamento
- Fundacao Pio Xii Hospital de Amor de Barretos
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Brasília, Brasile, 71681-603
- Reclutamento
- Hospital Brasilia
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Caxias do Sul, Brasile, 95070-560
- Reclutamento
- Fundacao Universidade de Caxias Do Sul
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Curitiba, Brasile, 80510-130
- Reclutamento
- Ictr Instituto Do Cancer E Transplante de Curitiba
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Fortaleza, Brasile, 60336-232
- Reclutamento
- Centro Regional Integrado de Oncologia Crio
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Ijuí, Brasile, 98700-000
- Reclutamento
- Oncosite Centro de Pesquisa Clinica Em Oncologia
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Natal, Brasile, 59062-000
- Reclutamento
- Liga Norte Riograndene Contra O Cancer
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Porto Alegre, Brasile, 90610-000
- Reclutamento
- Hospital Sao Lucas Da Pucrs
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Pouso Alegre, Brasile, 37554-238
- Reclutamento
- Instituto Sul Mineiro de Oncologia Ltda
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Recife, Brasile, 50040-000
- Reclutamento
- Hospital Do Cancer de Pernambuco
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Rio de Janeiro, Brasile, 20560-120
- Reclutamento
- Instituto Nacional de Cancer
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São Paulo, Brasile, 01246-000
- Reclutamento
- Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
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Vitória, Brasile, 29043-260
- Reclutamento
- Hospital Santa Rita de Cassia Afecc
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Anhui
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Bengbu, Anhui, Cina, 233004
- Reclutamento
- The First Affiliated Hospital of Bengbu Medical University
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Hefei, Anhui, Cina, 230000
- Reclutamento
- Anhui Provincial Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, Cina, 100142
- Reclutamento
- Beijing Cancer Hospital
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Cina, 630014
- Reclutamento
- The First Affiliated Hospital of Chongqing Medical University
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Fujian
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Fuzhou, Fujian, Cina, 350001
- Reclutamento
- Fujian Medical University Union Hospital
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Fuzhou, Fujian, Cina, 350014
- Reclutamento
- Fujian Cancer Hospital
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Fuzhou, Fujian, Cina, 350009
- Reclutamento
- The Peoples Hospital Affiliated to Fujian University of Traditional Chinese Medicine
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Guangdong
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Guangzhou, Guangdong, Cina, 510060
- Reclutamento
- Sun Yat Sen University Cancer Center
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Guangzhou, Guangdong, Cina, 510245
- Reclutamento
- Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
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Shantou, Guangdong, Cina, 515031
- Reclutamento
- Cancer Hospital of Shantou University Medical College
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Guangxi
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Nanning, Guangxi, Cina, 530201
- Reclutamento
- Guangxi Medical University Cancer Hospital Wuxiang Branch
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Hainan
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Haikou, Hainan, Cina, 570206
- Reclutamento
- Hainan General Hospital
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Hebei
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Baoding, Hebei, Cina, 71000
- Reclutamento
- Affiliated Hospital of Hebei University(North Branch)
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Shijiazhuang, Hebei, Cina, 050035
- Reclutamento
- The Fourth Hospital of Hebei Medical University East Branch
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Heilongjiang
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Harbin, Heilongjiang, Cina, 150000
- Reclutamento
- Harbin Medical University Cancer Hospital
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Henan
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Zhengzhou, Henan, Cina, 450052
- Reclutamento
- The First Affiliated Hospital of Zhengzhou University
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Hubei
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Wuhan, Hubei, Cina, 430079
- Reclutamento
- Hubei Cancer Hospital
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Wuhan, Hubei, Cina, 430048
- Reclutamento
- Union Hospital Tongji Medical College Huazhong University of Science and Technologyjinyinhu Branch
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Hunan
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Changde, Hunan, Cina, 415000
- Reclutamento
- The First Peoples Hospital of Changde City
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Changsha, Hunan, Cina, 410008
- Reclutamento
- Xiangya Hospital of Central South University
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Jiangsu
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Nanjing, Jiangsu, Cina, 210036
- Reclutamento
- Jiangsu Province Hospital Longjiang Branch
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Nantong, Jiangsu, Cina, 201203
- Reclutamento
- Affiliated Hospital of Nantong University
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Jiangxi
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Nanchang, Jiangxi, Cina, 330029
- Reclutamento
- Jiangxi Cancer Hospital
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Nanchang, Jiangxi, Cina, 330025
- Reclutamento
- Nanchang Peoples Hospitalchaoyang Branch
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Shaanxi
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Xi'an, Shaanxi, Cina, 710004
- Reclutamento
- The Second Affiliated Hospital of Xian Jiaotong University
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Shandong
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Weifang, Shandong, Cina, 261000
- Reclutamento
- Weifang Peoples Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Cina, 200000
- Reclutamento
- Fudan University Shanghai Cancer Center
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Shanxi
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Yuncheng, Shanxi, Cina, 44099
- Reclutamento
- Yuncheng Central Hospital West Branch
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Sichuan
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Chengdu, Sichuan, Cina, 610071
- Reclutamento
- Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Cina, 300453
- Reclutamento
- Binhai Hospital, Tianjin Medical University Cancer Institute and Hospital
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Yunnan
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Kunming, Yunnan, Cina, 650100
- Reclutamento
- Yunnan Cancer Hospital
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Zhejiang
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Hangzhou, Zhejiang, Cina, 310016
- Reclutamento
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
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Wenzhou, Zhejiang, Cina, 325000
- Reclutamento
- The First Affiliated Hospital of Wenzhou Medical University
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-
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Suwon, Corea del Sud, 16499
- Reclutamento
- Ajou University Hospital
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Busan Gwang'yeogsi
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HaeundaeGu, Busan Gwang'yeogsi, Corea del Sud, 48108
- Reclutamento
- Inje University Haeundae Paik Hospital
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Seogu, Busan Gwang'yeogsi, Corea del Sud, 49201
- Reclutamento
- Dong A University Hospital
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Chungcheongbukdo
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Cheongju-si, Chungcheongbukdo, Corea del Sud, 28644
- Reclutamento
- Chungbuk National University Hospital
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Chungcheongnam-do
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Cheonansi, Chungcheongnam-do, Corea del Sud, 31151
- Reclutamento
- Soon Chun Hyang University Cheonan Hospital
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Daegu Gwang'yeogsi
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Dalseogu, Daegu Gwang'yeogsi, Corea del Sud, 42601
- Reclutamento
- Keimyung University Dongsan Hospital
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Gyeonggi-do
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BundangGu SeongnamSi, Gyeonggi-do, Corea del Sud, 13496
- Reclutamento
- Cha Bundang Medical Center, Cha University
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DanwonGu AnsanSi, Gyeonggi-do, Corea del Sud, 15355
- Reclutamento
- Korea University Ansan Hospital
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IlsandongGu GoyangSi, Gyeonggi-do, Corea del Sud, 10408
- Reclutamento
- National Cancer Center (Korea)
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PaldalGu SuwonSi, Gyeonggi-do, Corea del Sud, 16247
- Reclutamento
- The Catholic University of Korea, St Vincents Hospital
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Seongnam-si, Gyeonggi-do, Corea del Sud, 13620
- Reclutamento
- Seoul National University Bundang Hospital
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Incheon Gwang'yeogsi
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Jemulpogu, Incheon Gwang'yeogsi, Corea del Sud, 22332
- Reclutamento
- Inha University Hospital
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NamdongGu, Incheon Gwang'yeogsi, Corea del Sud, 21565
- Reclutamento
- Gachon University Gil Medical Center
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Jeonnam-Gwangju S.M. City
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HwasunGun, Jeonnam-Gwangju S.M. City, Corea del Sud, 58128
- Reclutamento
- Chonnam National University Hwasun Hospital
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Seoul Teugbyeolsi
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DongjakGu, Seoul Teugbyeolsi, Corea del Sud, 06973
- Reclutamento
- Chung Ang University Hospital
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GangnamGu, Seoul Teugbyeolsi, Corea del Sud, 06351
- Reclutamento
- Samsung Medical Center
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GuroGu, Seoul Teugbyeolsi, Corea del Sud, 08308
- Reclutamento
- Korea University Guro Hospital
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SeochoGu, Seoul Teugbyeolsi, Corea del Sud, 06591
- Reclutamento
- The Catholic University of Korea, Seoul St Marys Hospital
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SeodaemunGu, Seoul Teugbyeolsi, Corea del Sud, 03722
- Reclutamento
- Severance Hospital Yonsei University Health System
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SeongbukGu, Seoul Teugbyeolsi, Corea del Sud, 02841
- Reclutamento
- Korea University Anam Hospital
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Seoul, Seoul Teugbyeolsi, Corea del Sud, 03080
- Reclutamento
- Seoul National University Hospital
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Seoul, Seoul Teugbyeolsi, Corea del Sud, 06273
- Reclutamento
- Gangnam Severance Hospital, Yonsei University Health System
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Seoul, Seoul Teugbyeolsi, Corea del Sud, 07985
- Reclutamento
- Ehwa Womans University Mokdong Hospital
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SongpaGu, Seoul Teugbyeolsi, Corea del Sud, 05505
- Reclutamento
- Asan Medical Center
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Ulsan Gwang'yeogsi
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Ulsan, Ulsan Gwang'yeogsi, Corea del Sud, 44033
- Reclutamento
- Ulsan University Hospital
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-
-
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Bordeaux, Francia, 33076
- Reclutamento
- Centre de Lutte Contre Le Cancer Institut Bergonie
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Lyon, Francia, 69373
- Reclutamento
- Centre Leon Berard
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Marseille, Francia, 13009
- Reclutamento
- Institut Paoli Calmettes
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Montpellier, Francia, 34090
- Reclutamento
- Icm Val Daurelle
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Rennes, Francia, 35043
- Reclutamento
- Centre Eugene Marquis
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SaintHerblain, Francia, 44805
- Reclutamento
- Ico Site Rene Gauducheau
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Villejuif, Francia, 94800
- Reclutamento
- Institut Gustave Roussy
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-
-
-
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Berlin, Germania, 13125
- Reclutamento
- Helios Klinikum Berlin Buch Brustzentrum
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Esslingen am Neckar, Germania, 73730
- Reclutamento
- Klinikum Esslingen Gmbh Klinik Fuer Frauenheilkunde Und Geburtshilfe
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Frankfurt am Main, Germania, 60389
- Reclutamento
- Centrum Fur Haematologie Und Onkologie Bethanien
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Koblenz, Germania, 56068
- Reclutamento
- Invo Institut Fur Versorgungsforschung in Der Onkologie
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-
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Fukuoka
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Kurumeshi, Fukuoka, Giappone, 830-0013
- Reclutamento
- Japan Community Healthcare Organization Kurume General Hospital
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Gunma
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Otashi, Gunma, Giappone, 373-8550
- Reclutamento
- Gunma Prefectural Cancer Center
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Hiroshima
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Hiroshima, Hiroshima, Giappone, 730-8518
- Reclutamento
- Hiroshima City Hiroshima Citizens Hospital
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Hokkaido
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Sapporo, Hokkaido, Giappone, 003-0804
- Reclutamento
- National Hospital Organization Hokkaido Cancer Center
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Hyōgo
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Nishinomiyashi, Hyōgo, Giappone, 663-8501
- Reclutamento
- Hyogo Medical University Hospital
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Kagoshima-ken
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Kagoshima, Kagoshima-ken, Giappone, 892-0833
- Reclutamento
- Social Medical Corporation Hakuaikai Sagara Hospital
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Kanagawa
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Iseharashi, Kanagawa, Giappone, 259-1193
- Reclutamento
- Tokai University Hospital
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Kawasakishi, Kanagawa, Giappone, 211-8533
- Reclutamento
- Nippon Medical School Musashi Kosugi Hospital
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Yokohama, Kanagawa, Giappone, 232-0024
- Reclutamento
- Yokohama City University Medical Center
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Yokohama, Kanagawa, Giappone, 241-8515
- Reclutamento
- Kanagawa Cancer Center
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Mie-ken
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Tsu, Mie-ken, Giappone, 514-8507
- Reclutamento
- Mie University Hospital
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Osaka
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OsakaShi, Osaka, Giappone, 541-8567
- Reclutamento
- Osaka International Cancer Institute
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Osakashi, Osaka, Giappone, 540-0006
- Reclutamento
- National Hospital Organization Osaka National Hospital
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Suitashi, Osaka, Giappone, 565-0871
- Reclutamento
- The University of Osaka Hospital
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Shizuoka
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Suntogun, Shizuoka, Giappone, 411-8777
- Reclutamento
- Shizuoka Cancer Center
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Tokyo
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Bunkyoku, Tokyo, Giappone, 113-8677
- Reclutamento
- Tokyo Metropolitan Komagome Hospital
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Kotoku, Tokyo, Giappone, 135-8550
- Reclutamento
- Cancer Institute Hospital of Jfcr
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Shinagawaku, Tokyo, Giappone, 142-8666
- Reclutamento
- Showa Medical University Hospital
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Shinjukuku, Tokyo, Giappone, 162-8666
- Reclutamento
- Tokyo Womens Medical University Hospital
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-
-
-
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Bergamo, Italia, 24127
- Reclutamento
- Asst Papa Giovanni Xxiii
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Milan, Italia, 20141
- Reclutamento
- Istituto Europeo Di Oncologia
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Monza, Italia, 20900
- Reclutamento
- Azienda Socio Sanitaria Territoriale Di Monza (Presidio San Gerardo)
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Roma, Italia, 00168
- Reclutamento
- Fondazione Policlinico Universitario Agostino Gemelli
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-
-
-
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George Town, Malaysia, 10450
- Reclutamento
- Pulau Pinang Hospital
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Ipoh, Malaysia, 30450
- Reclutamento
- Hospital Raja Permaisuri Bainun
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Johor Bahru, Malaysia, 15586
- Reclutamento
- Hospital Raja Perempuan Zainab Ii
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Kota Kinabalu Sabah, Malaysia, 88996
- Reclutamento
- Hospital Wanita Dan Kanak Kanak Sabah (Hospital Likas)
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Kuala Lumpur, Malaysia, 59100
- Reclutamento
- University Malaya Medical Centre
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Kuala Lumpur, Malaysia, 50586
- Reclutamento
- Hospital Kuala Lumpur
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Kuching, Malaysia, 93586
- Reclutamento
- Sarawak General Hospital
-
Petaling Jaya, Malaysia, 46300
- Reclutamento
- Hospital Picaso
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Putrajaya, Malaysia, 62250
- Reclutamento
- National Cancer Institute (Institut Kanser Negara)
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-
-
-
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Bialystok, Polonia, 15-027
- Reclutamento
- Bialostockie Centrum Onkologii Im M Sklodowskiej Curie W Bialymstoku
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Gdynia, Polonia, 81-519
- Reclutamento
- Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia
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Kielce, Polonia, 25-734
- Reclutamento
- Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
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Krakow, Polonia, 31-826
- Reclutamento
- Szpital Specjalistyczny Im Ludwika Rydygiera W Krakowie
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Krakow, Polonia, 30-727
- Reclutamento
- Pratia McM Krakow
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Opole, Polonia, 45-061
- Reclutamento
- Opolskie Centrum Onkologii
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Otwock, Polonia, 05-400
- Reclutamento
- Europejskie Centrum Zdrowia Otwock
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Warsaw, Polonia, 02-781
- Reclutamento
- Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie W Warszawie
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-
-
-
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San Juan, Porto Rico, 00917
- Reclutamento
- Brcr Global Puerto Rico Hato Rey
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-
-
-
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Guildford, Regno Unito, GU27XX
- Reclutamento
- Royal Surrey County Hospital
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Maidstone, Regno Unito, ME16 9QQ
- Reclutamento
- Maidstone and Tunbridge Wells Nhs Trust Kent Oncology Centre Maidstone Hospital
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-
-
-
-
Badajoz, Spagna, 06006
- Reclutamento
- Hospital Universitario de Badajoz
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Barcelona, Spagna, 08036
- Reclutamento
- Hospital Clinic de Barcelona
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Barcelona, Spagna, 08035
- Reclutamento
- Vall D Hebron Institute of Oncology Vhio
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Donostiasan Sebastian, Spagna, 20014
- Reclutamento
- Hospital Universitario Donostia
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Elcheelx, Spagna, 03203
- Reclutamento
- Hospital General Universitario de Elche
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Granada, Spagna, 18016
- Reclutamento
- Hospital Universitario Clinico San Cecilio
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Madrid, Spagna, 28041
- Reclutamento
- Hospital Universitario 12 de Octubre
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Madrid, Spagna, 28240
- Reclutamento
- Hospital Clinico San Carlos
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Madrid, Spagna, 28007
- Reclutamento
- Hospital General Universitario Gregorio Maranon
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Madrid, Spagna, 28007
- Reclutamento
- Iob Institute of Oncology Madrid
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Santiago de Compostela, Spagna, 15706
- Reclutamento
- Complejo Hospitalario Univ de Santiago (Chus)
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Seville, Spagna, 41013
- Reclutamento
- Hospital Universitario Virgen Del Rocio
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-
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Alabama
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Birmingham, Alabama, Stati Uniti, 35211
- Reclutamento
- Alabama Oncology Princeton
-
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Alaska
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Anchorage, Alaska, Stati Uniti, 99508-2974
- Reclutamento
- Alaska Oncology and Hematology, Llc
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Fairbanks, Alaska, Stati Uniti, 99701
- Reclutamento
- Fairbanks Cancer Care Physicians Pc
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Arizona
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Bullhead City, Arizona, Stati Uniti, 86442
- Reclutamento
- Pioneer Research Center
-
Chandler, Arizona, Stati Uniti, 85224-5665
- Reclutamento
- Ironwood Cancer and Research Centers Chandler Ii
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Goodyear, Arizona, Stati Uniti, 85338
- Reclutamento
- City of Hope Phoenix Cancer Center
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Arkansas
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Hot Springs, Arkansas, Stati Uniti, 71913
- Reclutamento
- Genesis Cancer and Blood Institute Hot Springs (Harmony Park)
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California
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Duarte, California, Stati Uniti, 91010-3012
- Reclutamento
- City of Hope National Medical Center
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Fountain Valley, California, Stati Uniti, 92708
- Reclutamento
- Helios Clinical Research the Oncology Institute Fountain Valley
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Los Angeles, California, Stati Uniti, 90027
- Reclutamento
- California Research Institute
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Oxnard, California, Stati Uniti, 93030
- Reclutamento
- Ventura County Hematology Oncology Specialists
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San Marcos, California, Stati Uniti, 92078
- Reclutamento
- Kaiser Permanente San Marcos Medical Offices
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Santa Monica, California, Stati Uniti, 90404-2303
- Reclutamento
- Providence Saint Johns Health Center
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West Hills, California, Stati Uniti, 91307
- Reclutamento
- Wellness Oncology and Hematology
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Colorado
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Lone Tree, Colorado, Stati Uniti, 80124-5641
- Reclutamento
- Rocky Mountain Cancer Centers, Llp(Us Oncology Research)
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-
Connecticut
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Danbury, Connecticut, Stati Uniti, 06810
- Reclutamento
- Danbury Hospital
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Florida
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Coral Springs, Florida, Stati Uniti, 33065
- Reclutamento
- Brcr Coral Springs
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Orange City, Florida, Stati Uniti, 32763-8316
- Reclutamento
- Mid Florida Hematology and Oncology Center
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Palm Bay, Florida, Stati Uniti, 32901
- Reclutamento
- Cancer Care Centers of Brevard Palm Bay
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Plantation, Florida, Stati Uniti, 33322
- Reclutamento
- Florida Clinical Trials Group Plantation
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Port Saint Lucie, Florida, Stati Uniti, 34952-7596
- Reclutamento
- Hematology Oncology Associates of the Treasure Coast
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South Miami, Florida, Stati Uniti, 33143
- Reclutamento
- The Oncology Institute of Hope and Innovation South Miami
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Tamarac, Florida, Stati Uniti, 33321
- Reclutamento
- Florida Clinical Trials Group Tamarac
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Tampa, Florida, Stati Uniti, 33612
- Reclutamento
- Moffitt Cancer Center McKinley Campus Richard M Shulze Family Foundation Outpatient Center
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Georgia
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Athens, Georgia, Stati Uniti, 30607
- Reclutamento
- University Cancer and Blood Center Athens Comprehensive Cancer Center
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Macon, Georgia, Stati Uniti, 31210
- Reclutamento
- Central Georgia Cancer Care Macon Office
-
-
Hawaii
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Honolulu, Hawaii, Stati Uniti, 96813
- Reclutamento
- Hawaii Cancer Care
-
-
Illinois
-
Hinsdale, Illinois, Stati Uniti, 60521-0509
- Reclutamento
- Hope and Healing Cancer Services
-
O'Fallon, Illinois, Stati Uniti, 62269
- Reclutamento
- Cancer Care Specialists For Illinois
-
Zion, Illinois, Stati Uniti, 60099
- Reclutamento
- City of Hope Chicago Cancer Center
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-
Indiana
-
Fort Wayne, Indiana, Stati Uniti, 46804
- Reclutamento
- Fort Wayne Medical Oncology and Hematology
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Indianapolis, Indiana, Stati Uniti, 46260
- Reclutamento
- Hematology Oncology of Indiana
-
-
Iowa
-
Cedar Rapids, Iowa, Stati Uniti, 52403
- Reclutamento
- Mercy Medical Center
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Kentucky
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Owensboro, Kentucky, Stati Uniti, 42303
- Reclutamento
- Owensboro Health Mitchell Memorial Cancer Center
-
-
Michigan
-
Detroit, Michigan, Stati Uniti, 48201-2013
- Reclutamento
- Karmanos Cancer Institute
-
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Minnesota
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Duluth, Minnesota, Stati Uniti, 55805
- Reclutamento
- Aspirus St Lukes Hospital
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Minneapolis, Minnesota, Stati Uniti, 55407
- Reclutamento
- Allina Health Cancer Institute Minneapolis
-
Saint Paul, Minnesota, Stati Uniti, 55101-2502
- Reclutamento
- Metro Minnesota Community Oncology Research Consortium (Mmcorc)
-
-
Mississippi
-
Hattiesburg, Mississippi, Stati Uniti, 39401-7233
- Reclutamento
- Hattiesburg Hematology and Oncology Clinic
-
-
Missouri
-
Columbia, Missouri, Stati Uniti, 65201
- Reclutamento
- Missouri Cancer Associates Columbia, Mo
-
Springfield, Missouri, Stati Uniti, 65807-5288
- Reclutamento
- Oncology Hematology Associates
-
-
Nebraska
-
Grand Island, Nebraska, Stati Uniti, 68803
- Reclutamento
- Nebraska Cancer Specialists St Francis Grand Island
-
Lincoln, Nebraska, Stati Uniti, 68506-7548
- Reclutamento
- Nebraska Hematology Oncology
-
Lincoln, Nebraska, Stati Uniti, 68516
- Reclutamento
- Cancer Partners of Nebraska April Sampson Cancer Center
-
Omaha, Nebraska, Stati Uniti, 68130-2042
- Reclutamento
- Nebraska Cancer Specialists
-
-
Nevada
-
Las Vegas, Nevada, Stati Uniti, 89169-3321
- Reclutamento
- Comprehensive Cancer Centers of Nevada
-
Reno, Nevada, Stati Uniti, 89502
- Reclutamento
- Renown Regional Medical Center
-
-
New Jersey
-
East Brunswick, New Jersey, Stati Uniti, 08816-4096
- Reclutamento
- Astera Cancer Care East Brunswick
-
Florham Park, New Jersey, Stati Uniti, 07932-1049
- Reclutamento
- Summit Medical Group
-
New Brunswick, New Jersey, Stati Uniti, 08901-1914
- Reclutamento
- Rutgers Cancer Institute of New Jersey
-
-
New York
-
Brooklyn, New York, Stati Uniti, 11220
- Reclutamento
- Nyu Langone Health Perlmutter Cancer Center Sunset Park
-
Mineola, New York, Stati Uniti, 11501
- Reclutamento
- Nyu Langone Health Perlmutter Cancer Center At Nyu Langone Hospital Long Island
-
New York, New York, Stati Uniti, 10016
- Reclutamento
- Nyu Langone Health Perlmutter Cancer Center 34Th Street
-
Rochester, New York, Stati Uniti, 14642-0001
- Reclutamento
- University of Rochester
-
Shirley, New York, Stati Uniti, 11967
- Reclutamento
- New York Cancer and Blood Specialists
-
Stony Brook, New York, Stati Uniti, 11794
- Reclutamento
- Stony Brook Cancer Center
-
-
North Carolina
-
Chapel Hill, North Carolina, Stati Uniti, 27514-4220
- Reclutamento
- University of North Carolina At Chapel Hill
-
Hendersonville, North Carolina, Stati Uniti, 28739
- Reclutamento
- Pardee Cancer Center
-
Wilson, North Carolina, Stati Uniti, 27896
- Reclutamento
- Carolina Cancer Research Center
-
-
Ohio
-
Canton, Ohio, Stati Uniti, 44718-2566
- Reclutamento
- Gabrail Cancer Center Research
-
Dayton, Ohio, Stati Uniti, 45409
- Reclutamento
- Dayton Physicians Network
-
-
Oregon
-
Eugene, Oregon, Stati Uniti, 97401
- Reclutamento
- Oncology Associates of Oregon Willamette Valley Cancer Center
-
Salem, Oregon, Stati Uniti, 97301
- Reclutamento
- Oregon Oncology Specialists
-
-
Pennsylvania
-
Broomall, Pennsylvania, Stati Uniti, 19008
- Reclutamento
- Consultants in Medical Oncology and Hematology Cancer Center At Broomall
-
West Reading, Pennsylvania, Stati Uniti, 19611-2143
- Reclutamento
- McGlinn Cancer Institute
-
-
South Dakota
-
Sioux Falls, South Dakota, Stati Uniti, 57105-2108
- Reclutamento
- Avera Cancer Institute
-
-
Tennessee
-
Kingsport, Tennessee, Stati Uniti, 37660
- Reclutamento
- Ballad Health Cancer Center Kingsport
-
Nashville, Tennessee, Stati Uniti, 37204
- Reclutamento
- Vanderbilt Ingram Cancer Center Nashville Vanderbilt Breast Center
-
-
Texas
-
Austin, Texas, Stati Uniti, 78731-4214
- Reclutamento
- Texas Oncology Austin Central
-
Dallas, Texas, Stati Uniti, 75246-2003
- Reclutamento
- Texas Oncology Baylor Charles A Sammons Cancer Center
-
Round Rock, Texas, Stati Uniti, 78665
- Reclutamento
- Baylor Scott and White Medical Center Round Rock
-
-
Utah
-
Salt Lake City, Utah, Stati Uniti, 84107
- Reclutamento
- Utah Cancer Specialists Cancer Center
-
-
Virginia
-
Blacksburg, Virginia, Stati Uniti, 24060-6325
- Reclutamento
- Oncology and Hematology Associates of Southwest Virginia, Inc (Us Oncology Research)
-
Charlottesville, Virginia, Stati Uniti, 22908-0817
- Reclutamento
- University of Virginia
-
Fairfax, Virginia, Stati Uniti, 22031-2171
- Reclutamento
- Virginia Cancer Specialists
-
Norfolk, Virginia, Stati Uniti, 23502-2800
- Reclutamento
- Virginia Oncology Associates
-
Richmond, Virginia, Stati Uniti, 23229-8605
- Reclutamento
- Virginia Cancer Institute
-
-
Washington
-
Olympia, Washington, Stati Uniti, 98506
- Reclutamento
- Vista Oncology East Olympia
-
Spokane, Washington, Stati Uniti, 99204
- Reclutamento
- Multicare Cancer Institute Deaconess Medical Office Building 1
-
Tacoma, Washington, Stati Uniti, 98405
- Reclutamento
- Northwest Medical Specialties
-
Tacoma, Washington, Stati Uniti, 98405
- Reclutamento
- Multicare Cancer Institute Tacoma General Hospital
-
Yakima, Washington, Stati Uniti, 98902
- Reclutamento
- Multicare Cancer Institute North Star Lodge
-
-
Wisconsin
-
La Crosse, Wisconsin, Stati Uniti, 54601-5467
- Reclutamento
- Gundersen Health System
-
Milwaukee, Wisconsin, Stati Uniti, 53226-3522
- Reclutamento
- Medical College of Wisconsin
-
-
-
-
-
Beitou Dist, Taiwan, 11217
- Reclutamento
- Taipei Veterans General Hospital
-
Taichung, Taiwan, 40447
- Reclutamento
- China Medical University Hospital
-
Tainan, Taiwan, 704
- Reclutamento
- National Cheng Kung University Hospital
-
Zhongzheng Dist, Taiwan, 100225
- Reclutamento
- National Taiwan University Hospital
-
-
-
-
-
Adana, Turchia (Türkiye), 01060
- Reclutamento
- Adana City Education and Research Hospital
-
Ankara, Turchia (Türkiye), 06200
- Reclutamento
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
-
Ankara, Turchia (Türkiye), 6100
- Reclutamento
- Hacettepe University
-
Ankara City Hospital, Turchia (Türkiye), 06800
- Reclutamento
- Ankara City Hospital
-
Istanbul, Turchia (Türkiye), 34899
- Reclutamento
- Marmara University Pendik Research and Training Hospital
-
Izmir, Turchia (Türkiye), 35100
- Reclutamento
- Ege University Medical Faculty
-
Kocaeli, Turchia (Türkiye), 41380
- Reclutamento
- Kocaeli Universitesi Tip Fakultesi
-
Mersin City Hospital, Turchia (Türkiye), 33240
- Reclutamento
- Mersin City Hospital
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Numero di armi
2
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
Sperimentale: Arm A: BGB-43395 + Letrozole
Participants will receive BGB-43395 in combination with letrozole. |
Administered orally. Administered orally. |
|
Comparatore attivo: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Progression-Free Survival (PFS) Determined by Blinded Independent Central Review (BICR)
Lasso di tempo: 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
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Overall Survival (OS)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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.
Lasso di tempo: 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)
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Sponsor
Investigatori
Investigatori
- Direttore dello studio: Study Director, BeOne Medicines
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
22 maggio 2026
Completamento primario (Stimato)
Completamento primario
1 aprile 2029
Completamento dello studio (Stimato)
Completamento dello studio
7 agosto 2037
Date di iscrizione allo studio
Primo inviato
Primo inviato
20 marzo 2026
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
20 marzo 2026
Primo Inserito (Effettivo)
Primo Inserito
25 marzo 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
26 ottobre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
23 ottobre 2026
Ultimo verificato
Ultimo verificato
1 settembre 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- BGB-43395-302
- 2025-523960-19-00 (Ctis)
- 2025 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano 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.
Periodo di condivisione IPD
See plan description
Criteri di accesso alla condivisione IPD
See plan description
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .