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A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer

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研究单位: [1]Seagen Inc. [2]Merck Sharp & Dohme LLC [3]Merck Sharp & Dohme LLC [4]Mayo Clinic Arizona,Phoenix,Arizona,United States,85054 [5]CARTI Cancer Center,Little Rock,Arkansas,United States,72205 [6]UC San Diego / Moores Cancer Center,La Jolla,California,United States,92093 [7]UCLA Department of Medicine - Hematology & Oncology,Santa Monica,California,United States,90404 [8]Lundquist Institute/Harbor-UCLA,Torrance,California,United States,90502 [9]Mayo Clinic Florida,Jacksonville,Florida,United States,32224 [10]AdventHealth Cancer Institute,Orlando,Florida,United States,32804 [11]Orlando Health, Inc. TRIO,Orlando,Florida,United States,32806 [12]Winship Cancer Institute / Emory University School of Medicine,Atlanta,Georgia,United States,30322 [13]Kaiser Permanente Moanalua Medical Center,Honolulu,Hawaii,United States,96819 [14]University of Illinois at Chicago,Chicago,Illinois,United States,60612 [15]Norton Cancer Institute,Louisville,Kentucky,United States,40202 [16]Norton Cancer Institute,Louisville,Kentucky,United States,40207 [17]Norton Cancer Institute,Louisville,Kentucky,United States,40241 [18]Mercy Medical Center -Weinberg Center,Baltimore,Maryland,United States,21202 [19]Mayo Clinic Rochester,Rochester,Minnesota,United States,55905 [20]Saint Luke's Cancer Institute LLC,Kansas City,Missouri,United States,64113 [21]Nebraska Cancer Specialists,Grand Island,Nebraska,United States,68803 [22]Oncology Hematology West, P.C.,Omaha,Nebraska,United States,68130 [23]Rutgers Cancer Institute of New Jersey,Jersey City,New Jersey,United States,07302 [24]Monmouth Medical Center Southern Campus,Lakewood,New Jersey,United States,08701 [25]Saint Barnabas Medical Center Cancer Center,Livingston,New Jersey,United States,07039 [26]Monmouth Medical Center,Long Branch,New Jersey,United States,07740 [27]Rutgers Cancer Institute of New Jersey,New Brunswick,New Jersey,United States,08903-2681 [28]Newark Beth Israel Medical Center,Newark,New Jersey,United States,07112 [29]Robert Wood Johnson University Hospital Somerset,Somerville,New Jersey,United States,08876 [30]Community Medical Center,Toms River,New Jersey,United States,08755 [31]Montefiore Medical Center,Bronx,New York,United States,10461 [32]Cleveland Clinic, The,Cleveland,Ohio,United States,44195 [33]Zangmeister Cancer Center,Columbus,Ohio,United States,43219 [34]Thomas Jefferson University,Philadelphia,Pennsylvania,United States,19107 [35]Thomas Jefferson University,Philadelphia,Pennsylvania,United States,19114 [36]Thomas Jefferson University,Willow Grove,Pennsylvania,United States,19090 [37]Charleston Oncology,Charleston,South Carolina,United States,29414 [38]Tennessee Oncology-Nashville/Sarah Cannon Research Institute,Nashville,Tennessee,United States,37203 [39]Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington,Seattle,Washington,United States,98109 [40]Medical College of Wisconsin (Milwaukee),Milwaukee,Wisconsin,United States,53226 [41]Cancer Research South Australia,Adelaide,Other,Australia,5000 [42]Flinders Medical Centre,Bedford Park,Other,Australia,5042 [43]Box Hill Hospital,Box Hill,Other,Australia,3128 [44]Chris O'Brien Lifehouse,Camperdown,Other,Australia,2050 [45]Peninsula and South East Oncology,Frankston,Other,Australia,3199 [46]Austin Health,Heidelberg,Other,Australia,3084 [47]Macquarie University Hospital,Macquarie University,Other,Australia,2109 [48]St John of God Subiaco Hospital,Subiaco,Other,Australia,6008 [49]Westmead Hospital,Sydney,Other,Australia,2145 [50]LKH- Universitat Klinikum Graz,Graz,Other,Austria,8036 [51]Ordensklinikum Linz GmbH Barmherzige Schwestern,Linz,Other,Austria,A-4010 [52]Ordination Priv.-Doz. Dr. M. Hubalek,Schwaz,Other,Austria,6130 [53]AKH - Medizinische Universitat Wien,Vienna,Other,Austria,1090 [54]Institut Jules Bordet,Anderlecht,Other,Belgium,B-1070 [55]UCL Saint-Luc,Brussels,Other,Belgium,1200 [56]Universitair Ziekenhuis Brussel,Bruxelles-Capitale,Other,Belgium,1090 [57]Clinique Saint Pierre,Ottignies,Other,Belgium,1340 [58]GZA Hospital Sint-Augustinus,Wilrijk,Other,Belgium,2610 [59]Hospital de Cancer de Barretos - Fundacao Pio XII,Barretos,Other,Brazil,14784-400 [60]Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda.,Bela Vista,Other,Brazil,01317-001 [61]INCAN - Instituto do Cancer - Hospital Pompeia,Caxias do Sul,Other,Brazil,95010-005 [62]Centro Regional Integrado de Oncologia,Fortaleza,Other,Brazil,60336-045 [63]Hospital Araujo Jorge - Associacao de Combate ao Cancer em Goias,Goiania,Other,Brazil,74605-070 [64]Fundação Doutor Amaral Carvalho,Jaú,Other,Brazil,17210-120 [65]Hospital do Cancer de Londrina,Londrina,Other,Brazil,86015-520 [66]Liga Norte-Rio-Grandense Contra o Cancer,Natal,Other,Brazil,59151-600 [67]Irmandade da Santa Casa de Misericordia de Porto Alegre,Porto Alegre,Other,Brazil,90020-090 [68]Hospital de Clinicas de Porto Alegre,Porto Alegre,Other,Brazil,90035-903 [69]Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa,Porto Alegre,Other,Brazil,90110-270 [70]Hospital Nossa Senhora da Conceição,Porto Alegre,Other,Brazil,91350-200 [71]CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia,Santo Andre,Other,Brazil,09060-870 [72]Praxis Pesquisa Medica,Santo Andre,Other,Brazil,09090-790 [73]Fundação Faculdade Regional de Medicina de São José do Rio Preto,Sao Jose Rio Preto,Other,Brazil,15090-000 [74]Sao Camilo Oncologia,Sao Paulo,Other,Brazil,04014-002 [75]ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira,São Paulo,Other,Brazil,01246-000 [76]Fundação NAtonio Prudente (AC Camargo Cancer Center),Sao Paulo,Brazil,01509-010 [77]University of Alberta / Cross Cancer Institute,Edmonton,Alberta,Canada,T6G 1Z2 [78]BC Cancer Kelowna,Kelowna,British Columbia,Canada,V1Y5L3 [79]Ottawa Hospital Cancer Centre,Ottawa,Ontario,Canada,K1H 8L6 [80]Sunnybrook Health Sciences Centre,Toronto,Ontario,Canada,M4N 3M5 [81]CIUSSS du Saguenay Lac Saint Jean,Chicoutimi,Quebec,Canada,G7H 5H6 [82]Centre Hospitalier de l'Universite de Montreal,Montreal,Quebec,Canada,H2X 3E4 [83]Jewish General Hospital,Montreal,Quebec,Canada,H3T 1E2 [84]Clinica Universidad Catolica del Maule,Talca,Other,Chile,3460000 [85]Sociedad de Investigaciones Medicas Limitada,Temuco,Other,Chile,4810469 [86]Oncocentro APYS,Viña del Mar,Other,Chile,2520598 [87]Affiliated Hospital of Hebei University,Baoding,Other,China,071000 [88]Beijing Hospital,Beijing,Other,China,100730 [89]The First Bethune Hospital of Jilin University,Changchun,Other,China,130021 [90]The Second Xiangya Hospital of Central South University,Changsha,Other,China,410011 [91]Affiliated Hospital of Chengde Medical University,Chengde,Other,China,067000 [92]The First People's Hospital of Foshan,Foshan,Other,China,528000 [93]Fujian Provincial Cancer Hospital,Fuzhou,Other,China,350015 [94]900TH Hospital of Joint Logistics Support Force,Fuzhou,Other,China,350025 [95]Guangdong Provincial People's Hospital,Guangzhou,Other,China,510081 [96]The first Affiliated Hospital of Hainan Medical University,Haikou,Other,China,570102 [97]Zhejiang Cancer Hospital,Hangzhou City,Other,China,310022 [98]The Second Affiliated Hospital of Zhejiang University School of Medicine,Hangzhou,Other,China,310009 [99]Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine,Hangzhou,Other,China,310016 [100]Harbin Medical University Cancer Hospital,Harbin,Other,China,150081

关键词: HER2+ breast cancer Breast Cancer Metastatic breast cancer Seattle Genetics

研究目的:
This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). In this study, all participants will get either tucatinib or placebo. Participants will be assigned randomly to a group. This is a blinded study, so patients and their doctors will not know which group a participant is in. All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat this type of cancer.

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