Um estudo de tucatinibe ou placebo com trastuzumabe e pertuzumabe para câncer de mama metastático HER2+ (HER2CLIMB-05)
Um estudo randomizado, duplo-cego, de fase 3 de tucatinibe ou placebo em combinação com trastuzumabe e pertuzumabe como terapia de manutenção para câncer de mama HER2+ metastático (HER2CLIMB-05)
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.
Visão geral do estudo
Status
Condições
Descrição detalhada
Control arm: Placebo given orally twice daily plus trastuzumab and pertuzumab every 21 days
Experimental arm: Tucatinib 300 mg given orally twice daily plus trastuzumab and pertuzumab every 21 days
Trastuzumab and pertuzumab will be administered as follows:
• Trastuzumab will be given intravenously (IV) at a dose of 6 mg/kg or subcutaneously (SC) at a fixed dose of 600 mg, once every 21 days.
AND
- Pertuzumab will be given IV at 420 mg every 21 days. OR
- Fixed dose combination of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase will be given SC, once every 21 days, in lieu of trastuzumab and pertuzumab individually.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
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Augsburg, Alemanha, 86156
- "Universitatsklinikum Augsburg Klinik fur Frauenheilkunde und Geburtshilfe"
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Berlin, Alemanha, 10117
- Charite Universtitatsmedizin Berlin Klinik fur Gynakologie mit Brustzentrum
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Berlin, Alemanha, 13353
- Charite - Universitatsmedizin Berlin
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Hamburg, Alemanha, 20246
- Universitatsklinikum Hamburg-Eppendorf (UKE)
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München, Alemanha, 81675
- Klinik und Poliklinik fur Frauenheilkunde der Technischen Universitat Munchen
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Ulm, Alemanha, 89075
- Universitatsklinikum Ulm Klinik fur Frauenheilkunde und Geburtshilfe
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Würzburg, Alemanha, 97080
- Universitatsklinikum Wurzburg Frauenklinik und Poliklinik
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Würzburg, Alemanha, 97080
- Universitatsklinikum Wurzburg, Comprehensive Cancer Center - Mainfranken (CCCMF)
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North Rhine-Westphalia
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Münster, North Rhine-Westphalia, Alemanha, 48149
- University Hospital Muenster Senology
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Other
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Manheim, Other, Alemanha, 68167
- Universitätsmedizin Mannheim Universitätsfrauenklinik
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Mannheim, Other, Alemanha, 68167
- Pharmacy:Fortuna Herstellung GmbH
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New South Wales
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Camperdown, New South Wales, Austrália, 2050
- Chris O'Brien Lifehouse
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Macquarie University, New South Wales, Austrália, 2109
- Macquarie University Clinical Trials Unit.
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Westmead, New South Wales, Austrália, 2145
- Western Sydney Local Health District (WSLHD), Westmead Hospital
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South Australia
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Adelaide, South Australia, Austrália, 5000
- Cancer Research SA
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Adelaide, South Australia, Austrália, 5000
- St Andrews Medical Centre
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Bedford Park, South Australia, Austrália, 5042
- Flinders Medical Centre
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Victoria
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Box Hill, Victoria, Austrália, 3128
- Box Hill Hospital
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Heidelberg, Victoria, Austrália, 3084
- Austin Health
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Washington
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Subiaco, Washington, Austrália, 6008
- St John of God Subiaco Hospital Clinical Trials Unit Bendat Family Comprehensive Cancer Centre
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Porto Alegre/RS, Brasil, 90050-170
- Irmandade da Santa Casa de Misericordia de Porto Alegre centro Multidisciplinar de pesquisa clinica
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São José do Rio Preto, Brasil, 15090-000
- Faculdade Regional de Medicina de Sao Jose do Rio Preto
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São Paulo, Brasil, 01246-000
- ICESP- Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira
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São Paulo, Brasil, 04014-002
- Sao Camilo Oncologia
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São Paulo, Brasil, CEP: 01317-000
- Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecologica e Mamária Ltda.
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Ceará
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Fortaleza, Ceará, Brasil, 60336-232
- CRIO - Centro Regional lntegrado de Oncologia
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Goiás
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Goiânia, Goiás, Brasil, 74605-070
- Hospital Araujo Jorge
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Other
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Sao Paulo/SP, Other, Brasil, 01.509-010
- A.C. Camargo Câncer Center
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Paraná
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Londrina, Paraná, Brasil, 86015-520
- Hospital Do Cancer De Londrina
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Rio Grande do Norte
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Natal, Rio Grande do Norte, Brasil, 59075-740
- Liga Norte-Rio Grandense Contra o Cancer
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasil, 90035-903
- Hospital de Clinicas de Porto Alegre
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Porto Alegre, Rio Grande do Sul, Brasil, CEP 90110-270
- Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital do Cancer Mae de Deu
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Porto Alegre, Rio Grande do Sul, Brasil, CEP 90850-170
- Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital do Cancer Mae de Deu
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São Paulo
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Barretos, São Paulo, Brasil, CEP: 14784-400
- Fundacao Pio XII, Hospital do Amor de Barretos
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Jaú, São Paulo, Brasil, CEP: 17210-080
- Fundacao Dr Amaral Carvalho
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Santo André, São Paulo, Brasil, 09060-650
- CEPHO- Centro de Estudos e Pesquisas de Hematologia e Oncologia
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Santo André, São Paulo, Brasil, 09060-870
- CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
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Anderlecht, Bélgica, 1070
- Jules Bordet lnstituut
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Brussels, Bélgica, 1090
- Universitair Ziekenhuis Brussel (UZ Brussel)
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Brussels, Bélgica, 1200
- Cliniques Universitaires Saint-Luc
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Ottignies, Bélgica, 1340
- Clinique St-Pierre
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Alberta
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Edmonton, Alberta, Canadá, T6G 1Z2
- Cross Cancer Institute
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British Columbia
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Kelowna, British Columbia, Canadá, V1Y 5L3
- BC Cancer Agency
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Ontario
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Ottawa, Ontario, Canadá, K1H 8L6
- The Ottawa Hospital Cancer Centre
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Toronto, Ontario, Canadá, M5G 1X5
- Mount Sinai Hospital
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Toronto, Ontario, Canadá, M4N 3M5
- Sunnybrook Research Institute
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Quebec
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Chicoutimi, Quebec, Canadá, G7H 5H6
- Centre integre universitaire de sante et de services sociaux du Saguenay-Lac-Saint-Jean
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Montreal, Quebec, Canadá, H3T 1E2
- Jewish General Hospital
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Montreal, Quebec, Canadá, H2X 3E4
- Centre Hospitalier de l'Universite de Motreal (CHUM)
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Talca, Chile, 3460000
- Clinica Universidad Catolica del Maule
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Temuco, Chile, 4810297
- Clinica Alemana Temuco
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Temuco, Chile, 4810469
- James Lind Centro De Investigacion Del Cancer
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Santiago Metropolitan
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Recoleta, Santiago Metropolitan, Chile, 8420323
- Centro de Investigacion Clínica Bradford Hill
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Valparaiso
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Viña del Mar, Valparaiso, Chile
- Oncocentro Apys
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Beijing, China, 100730
- Beijing Hospital
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Beijing, China, 100010
- Beijing Hospital
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Shanghai, China, 200032
- Fudan University Shanghai Cancer Center
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Tianjin, China, 300181
- Tianjin Cancer Hospital Binhai Campus
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Anhui
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Hefei, Anhui, China, 230601
- The Second Hospital of Anhui Medical University
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Guangdong
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Guangzhou, Guangdong, China, 510080
- Guangdong Provincial People's Hospital
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Meizhou, Guangdong, China, 514031
- Meizhou People's Hospital
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Guangxi
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Liuzhou, Guangxi, China, 545006
- Liuzhou People's Hospital
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Nanning, Guangxi, China, 530021
- The People's Hospital of Guangxi Zhuang Autonomous Region
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Nanning, Guangxi, China, 530021
- Guangxi Medical University Affiliated Tumor Hospital
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Hainan
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Haikou, Hainan, China, 570102
- The first Affiliated Hospital of Hainan Medical University
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Hebei
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Baoding, Hebei, China, 071000
- Affiliated Hospital of Hebei University
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Henan
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Zhengzhou, Henan, China, 450003
- Henan Cancer Hospital
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Hubei
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Wuhan, Hubei, China, 430079
- Hubei Cancer Hospital
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Wuhan, Hubei, China, 430030
- Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
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Hunan
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Changsha, Hunan, China, 410011
- The Second Xiangya Hospital of Central South University
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Jiangsu
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Nanjing, Jiangsu, China, 210036
- Nanjing Medical University (NMU) - Jiangsu Province Hospital
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Jiangxi
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Nanchang, Jiangxi, China, 330008
- The Second Affiliated Hospital of Nanchang University
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Jilin
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Changchun, Jilin, China, 130021
- The First Hospital of Jilin University
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Liaoning
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Shenyang, Liaoning, China, 110042
- Liaoning Cancer Hospital & Insitute
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Shenyang, Liaoning, China, 110167
- The First Affiliated Hospital of China Medical University
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Other
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Shanghai, Other, China, 200025
- Ruijin Hospital of Shanghai Jiaotong University School of Medicine
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Shaanxi
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Xi'an, Shaanxi, China, 710061
- The First Affiliated Hospital of Xi'an Jiaotong University
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Xi'an, Shaanxi, China, 710068
- Shaanxi Provincial People's Hospital
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Shandong
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Jinan, Shandong, China, 250013
- Jinan Central Hospital
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Linyi, Shandong, China, 276034
- Linyi Cancer Hospital
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Zhejiang
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Hangzhou, Zhejiang, China, 310016
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
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Hangzhou, Zhejiang, China, 310005
- Zhejiang Cancer Hospital
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Hangzhou, Zhejiang, China, 310052
- The Second Affiliated Hospital of Zhejiang University School of Medicine
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Busan, Coréia do Sul, 49201
- Dong-A University Hospital
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Incheon, Coréia do Sul, 21565
- Gachon University Gil Medical Center
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Seoul, Coréia do Sul, 02841
- Korea University Anam Hospital
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Gangwon-do
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Wŏnju, Gangwon-do, Coréia do Sul, 26426
- Yonsei University Wonju Severance Christian Hospital
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Gyeonggi-do
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Goyang-si, Gyeonggi-do, Coréia do Sul, 10408
- National Cancer Center
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Seongnam-si, Gyeonggi-do, Coréia do Sul, 13620
- Seoul National University Bundang Hospital
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Suwon, Gyeonggi-do, Coréia do Sul, 16247
- The Catholic University of Korea, St. Vincent's Hospital
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Suwon, Gyeonggi-do, Coréia do Sul, 16499
- Ajou University Hospital
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North Chungcheong
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Cheongju-si, North Chungcheong, Coréia do Sul, 28644
- Chungbuk Nationl University Hospital
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Other
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Seoul, Other, Coréia do Sul, 03080
- Seoul National University Hospital
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Seoul, Other, Coréia do Sul, 05505
- Asan Medical Center
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Seoul, Other, Coréia do Sul, 06273
- Gangnam Severance Hospital, Yonsei University Health System
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Seoul, Other, Coréia do Sul, 06591
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Seoul, Other, Coréia do Sul, 07985
- Ewha Womans University Mokdong Hospital
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Seoul-teukbyeolsi [seoul]
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Seoul, Seoul-teukbyeolsi [seoul], Coréia do Sul, 03722
- Severance Hospital Yonsei University Health System
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-
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Barcelona, Espanha, 08035
- Hospital Universitari Vall d'Hebron
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Barcelona, Espanha, 08035
- Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca
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Barcelona, Espanha, 08025
- Fundacio de Gestio Sanitaria de I'Hospital de la Santa Creu i Sant Pau
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Barcelona, Espanha, 08041
- Hospital de la Santa Creu i Sant Pau
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Bilbao, Espanha, 48013
- Hospital Universitario de Basurto
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Girona, Espanha, 17007
- Institut Catala d'Oncologia Girona - ICO Girona
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Granada, Espanha, 18014
- Hospital Universitario Virgen de las Nieves
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Lleida, Espanha, 25198
- Hospital Universitari Arnau de Vilanova
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Madrid, Espanha, 28007
- Hospital General Universitario Gregorio Maranon
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Málaga, Espanha, 29010
- Hospital Universitario Virgen de la Victoria
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Salamanca, Espanha, 37007
- Hospital Universitario de Salamanca (Spain Salamanca)
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Seville, Espanha, 41013
- Hospital Universitario Virgen del Rocio
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Valencia, Espanha, 46009
- Fundacion lnstituto Valenciano de Oncologia
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Andalusia
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Málaga, Andalusia, Espanha, 29016
- Hospital El Angel Grupo Hla, S.L.U
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Balearic Islands
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Palma de Mallorca, Balearic Islands, Espanha, 07120
- Hospital Universitario Son Espases
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Murcia
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EI Palmar, Murcia, Espanha, 30120
- Hospital Universitario Virgen De La Arrixaca
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Other
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Barcelona, Other, Espanha, 08035
- Fundación Privada Instituto de Investigación Oncológica de Vall Hebron
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Cáceres, Other, Espanha, 10003
- Hospital San Pedro de Alcantara
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Madrid, Other, Espanha, 28034
- Hospital Universitario Ramon y Cajal
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Valencia, Other, Espanha, 46010
- Hospital Clinico Universitario de Valencia
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Santa CRUZ DE Tenerife
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La Laguna Tenerife, Santa CRUZ DE Tenerife, Espanha, 38320
- Hospital Universitario de Canarias
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Valencia
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Alicante, Valencia, Espanha, 03010
- Hospital General Universitario Alicante
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Arizona
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Phoenix, Arizona, Estados Unidos, 85054
- Mayo Clinic Hospital
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Scottsdale, Arizona, Estados Unidos, 85259
- Mayo Clinic
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
- Central Arkansas Radiation Therapy Institute Inc d.b.a CARTI
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California
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Beverly Hills, California, Estados Unidos, 90212
- UCLA Hematology/Oncology - Beverly Hills
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Burbank, California, Estados Unidos, 91505
- UCLA Hematology/Oncology - Burbank
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Encinitas, California, Estados Unidos, 92024
- UCSD Medical Center - Encinitas
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La Jolla, California, Estados Unidos, 92093
- UC San Diego Moores Cancer Center
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La Jolla, California, Estados Unidos, 92037
- Sulpizio Cardiovascular Center at UC San Diego Health
-
La Jolla, California, Estados Unidos, 92037
- UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
-
La Jolla, California, Estados Unidos, 92037
- UCSD Perlman Medical Offices
-
La Jolla, California, Estados Unidos, 92037
- UCSD Koman Family Outpatient Pavilion
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Laguna Hills, California, Estados Unidos, 92653
- UCLA Hematology/Oncology - Laguna Hills
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Los Angeles, California, Estados Unidos, 90095
- UCLA Hematology/Oncology
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Los Angeles, California, Estados Unidos, 90095
- Administrative Address: UCLA Hematology/Oncology
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San Diego, California, Estados Unidos, 92103
- UC San Diego Medical Center - Hillcrest
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San Diego, California, Estados Unidos, 912101
- UCSD Medical Center - Bankers Hill
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San Luis Obispo, California, Estados Unidos, 93401
- UCLA Hematology/Oncology - San Luis Obispo
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Santa Barbara, California, Estados Unidos, 93101
- UCLA Hematology/Oncology- Santa Barbara
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Santa Monica, California, Estados Unidos, 90404
- UCLA Hematology/Oncology - Santa Monica
-
Santa Monica, California, Estados Unidos, 90404
- UCLA Hematology/Oncology Parkside
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Torrance, California, Estados Unidos, 90509
- Harbor-UCLA Medical Center
-
Torrance, California, Estados Unidos, 90502
- The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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Torrance, California, Estados Unidos, 90502
- Clinical And Translational Research Center
-
Valencia, California, Estados Unidos, 91355
- UCLA Hematology/Oncology - Santa Clarita
-
Vista, California, Estados Unidos, 92081
- UCSD Medical Center - Vista
-
Westlake Village, California, Estados Unidos, 91361
- UCLA Hematology/Oncology- Westlake
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Florida
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Altamonte Springs, Florida, Estados Unidos, 32701
- AdventHealth Altamonte Infusion Center
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Altamonte Springs, Florida, Estados Unidos, 32701
- AdventHealth Medical Group Altamonte(second location)
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Altamonte Springs, Florida, Estados Unidos, 32701
- AdventHealth Medical Group Altamonte
-
Jacksonville, Florida, Estados Unidos, 32224
- Mayo Clinic Florida
-
Orlando, Florida, Estados Unidos, 32804
- AdventHealth Orlando Infusion Center
-
Orlando, Florida, Estados Unidos, 32804
- AdventHealth Medical Group Orlando
-
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Georgia
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Atlanta, Georgia, Estados Unidos, 30308
- Emory University Hospital Midtown
-
Atlanta, Georgia, Estados Unidos, 30342
- Emory Saint Joseph's Hospital
-
Atlanta, Georgia, Estados Unidos, 30322
- Winship Cancer Institute
-
Atlanta, Georgia, Estados Unidos, 30322
- Emory University Clinic
-
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- University of Illinois Hospital and Health Systems
-
Chicago, Illinois, Estados Unidos, 60612
- University of Illinois Hospital and Health Systems (Outpatient Cancer Center)
-
Chicago, Illinois, Estados Unidos, 60612
- University of Illinois Hospital and Health Systems (Investigational Drug Pharmacy)
-
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40207
- Norton Cancer Institute, St. Matthews Campus
-
Louisville, Kentucky, Estados Unidos, 40207
- Norton Cancer Institute, St Matthews Campus
-
Louisville, Kentucky, Estados Unidos, 40241
- Norton Cancer Institute, Brownsboro Hospital Campus
-
Louisville, Kentucky, Estados Unidos, 40202
- Norton Cancer Institute, Downtown
-
Louisville, Kentucky, Estados Unidos, 40202
- Norton Cancer Institute - Downtown
-
-
Maryland
-
Baltimore, Maryland, Estados Unidos, 21202
- Mercy Medical Center
-
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Minnesota
-
Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic
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-
Missouri
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Kansas City, Missouri, Estados Unidos, 64111
- Saint Luke's Cancer Institute.
-
-
Nebraska
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Grand Island, Nebraska, Estados Unidos, 68803
- Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island
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Grand Island, Nebraska, Estados Unidos, 68803
- Oncology Hematology West PC dba Nebraska Cancer Specialists
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Omaha, Nebraska, Estados Unidos, 68130
- Oncology Hematology West PC dba Nebraska Cancer Specialists
-
Omaha, Nebraska, Estados Unidos, 68124
- Oncology Hematology West PC dba Nebraska Cancer Specialists
-
Omaha, Nebraska, Estados Unidos, 68114
- Oncology Hematology West PC dba Nebraska Cancer Specialists
-
Papillion, Nebraska, Estados Unidos, 68046
- Oncology Hematology West PC dba Nebraska Cancer Specialists
-
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New Jersey
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Jersey City, New Jersey, Estados Unidos, 07302
- RWJBarnabas Health- Jersey City Medical Center
-
Lakewood, New Jersey, Estados Unidos, 08701
- RWJBarnabas Health- Monmouth Medical Center-Southern Campus
-
Livingston, New Jersey, Estados Unidos, 07039
- RWJBarnabas Health- Cooperman Barnabas Medical Center
-
Long Branch, New Jersey, Estados Unidos, 07740
- RWJBarnabas Health- Monmouth Medical Center
-
New Brunswick, New Jersey, Estados Unidos, 08903
- Rutgers Cancer Institute of New Jersey
-
Newark, New Jersey, Estados Unidos, 07112
- Newark Beth Israel Medical Center
-
Somerville, New Jersey, Estados Unidos, 08876
- Steeplechase Cancer Center
-
Somerville, New Jersey, Estados Unidos, 08876
- RWJBarnabas Health-Robert Wood Johnson University Hospital, Somerset
-
Toms River, New Jersey, Estados Unidos, 08755
- RWJBarnabas Health - Community Medical Center
-
West Long Branch, New Jersey, Estados Unidos, 07764
- Satellite Infusion Center-Monmouth Medical Center Vantage Point Infusion Center
-
-
New York
-
The Bronx, New York, Estados Unidos, 10461
- Montefiore Einstein Comprehensive Cancer Center
-
-
Ohio
-
Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic
-
Cleveland, Ohio, Estados Unidos, 44106
- Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
-
Strongsville, Ohio, Estados Unidos, 44136
- Cleveland Clinic Cancer Center - Strongsville
-
-
Pennsylvania
-
Willow Grove, Pennsylvania, Estados Unidos, 19090
- Asplundh Cancer Pavillion
-
-
Tennessee
-
Gallatin, Tennessee, Estados Unidos, 37066
- Tennessee Oncology, PLLC
-
Murfreesboro, Tennessee, Estados Unidos, 37129
- Tennessee Oncology, PLLC
-
Nashville, Tennessee, Estados Unidos, 37203
- Tennessee Oncology, PLLC
-
Nashville, Tennessee, Estados Unidos, 37203
- Sarah Cannon Research Institute- Pharmacy
-
Shelbyville, Tennessee, Estados Unidos, 37160
- Tennessee Oncology, PLLC
-
-
Washington
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Seattle, Washington, Estados Unidos, 98195
- University of Washington Medical Center
-
Seattle, Washington, Estados Unidos, 98109
- Fred Hutchinson Cancer Center
-
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53226
- Froedtert Hospital/Medical College of Wisconsin
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-
-
-
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Tampere, Finlândia
- Tampere University Hospital
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Tampere, Finlândia, 33520
- Tampere University Hospital, FONK/RSYO
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-
-
-
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Besançon, França, 25000
- CHU Besancon
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Bobigny, França, 93009 Cedex
- Hopital Avicenne
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Caen, França, 14076 Cedex 5
- CENTRE FRANCOIS BACLESSE - Service lmagerie medicale
-
Caen, França, 14076
- Centre de Lutte contre le Cancer - François Baclesse
-
Caen, França, 14076 Cedex 5
- Centre Francois Baclesse
-
Clermont-Ferrand, França, 63000
- Centre Jean Perrin
-
Lille, França, 59020 Cedex
- Centre Oscar Lambret
-
Lyon, França, 69373 Cedex 08
- Center Leon Berard
-
Montpellier, França, 34298 Cedex 5
- Institut Regional du Cancer de Montpellier Service lmagerie medicale
-
Montpellier, França, 34298
- Institut Régional du Cancer de Montpellier
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Nice, França, 06189
- Centre Antoine Lacassagne
-
Pierre-Bénite, França, 69310
- Hospices Civils de Lyon
-
Plérin, França, 22190
- "CARIO - Centre Armoricain de Radiotherapie lmagerie medicate et d'Oncologie -Hopital Prive des
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Rennes, França, cedex 35042
- Centre Eugene Marquis
-
Rouen, França, 76038 Cedex 1
- Centre Henri Becquerel
-
Saint-Cloud, França, 92210
- Institut Curie - site St-Cloud
-
Strasbourg, França, 67033
- Institut de Cancerologie Strasbourg Europe
-
-
Brittany Region
-
Rouen, Brittany Region, França, 76038
- Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
-
-
Cedex
-
Bordeaux, Cedex, França, 33076
- Institut Bergonie
-
-
Languedoc-roussillon
-
Montpellier, Languedoc-roussillon, França, 34070
- Centre de Cancérologie du Grand Montpellier
-
-
Loire-atlantique
-
Saint-Herblain, Loire-atlantique, França, 44800
- Institut de Cancerologie de lOuest - Site Rene Gauducheau
-
Saint-Herblain, Loire-atlantique, França, 44805
- Institut de Cancerologie de lOuest-Saint Herblain
-
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Other
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Avignon, Other, França, 84918
- Institut Sainte-Catherine.
-
Avignon, Other, França, 84918
- Sainte Catherine lnstitut du Cancer Avignon Provence
-
Dijon, Other, França, 21079
- Center Georges-Francois Leclerc
-
-
-
-
-
Larissa, Grécia, 41110
- University General Hospital of Larissa, Oncology Clinic
-
Marousi, Grécia, 15123
- IASO General Clinic Oncology Clinic
-
Pireaus, Grécia, 18537
- Metaxa Anticancer Hospital of Piraeus
-
-
Attica
-
Athens, Attica, Grécia, 11528
- General Hospital of Athens "Alexandra" Clinical Therapeutics Department, Hematology/Oncology Unit
-
-
Peloponnese
-
Patra, Peloponnese, Grécia, 26504
- University General Hospital of Patras, Oncology Department, Internal Medicine Clinic
-
-
-
-
-
Dordrecht, Holanda, 3318 AT
- Albert Schweitzer Ziekenhuis
-
Utrecht, Holanda, 3543 AZ
- St. Antonius Hospital
-
Venlo, Holanda, 5912 BL
- VieCuri Medsich Centrum
-
-
South Holland
-
Doedrecht, South Holland, Holanda, 3318AT
- Albert Schweitzer Hospital
-
-
-
-
-
Bologna, Itália, 40138
- Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
-
Bologna, Itália, 40138
- SSD Oncologia Medica Addarii - Zamagni, Policlinico Sant'Orsola - Malpighi
-
Milan, Itália, 20089
- Istituto Clinico Humanitas
-
Milan, Itália, 20141
- Divisione di Senologia Medica; Istituto Europeo di Oncologia
-
Parma, Itália, 43126
- UOC di Oncologia Medica, Azienda Ospedaliero Universitaria (AOU) di Parma
-
Pavia, Itália, 27100
- Istituti Clinici Scientifici Maugeri IRCCS
-
-
Campania
-
Naples, Campania, Itália, 80131
- Azienda Ospedaliera Universitaria Federico II
-
Naples, Campania, Itália, 80131
- lstituto Nazionale Tumori IRCCS - Fondazione Pascale U.O.C. Oncologia Medica Senologica
-
-
Liguria
-
Genoa, Liguria, Itália, 16132
- IRCCS Ospedale Policlinico, San Martino
-
-
Lombardy
-
Monza (MB), Lombardy, Itália, 20900
- ASST Monza Ospedale San Gerardo Centro Ricerca di Fase 1
-
-
Sicily
-
Catania (CT), Sicily, Itália, 95045
- Humanitas lstituto Clinico Catanese
-
-
The Marches
-
Torrette, The Marches, Itália, 60126
- Azienda Ospedaliero Universitaria delle Marche SOD Clinica Oncologica
-
-
Trentino-Alto Adige
-
Trento, Trentino-Alto Adige, Itália, 38122
- Divisione Oncologia Medica, Ospedale di Trento - Presidio Ospedaliero (PO) Santa Chiara
-
Trento, Trentino-Alto Adige, Itália, 38122
- SOC Farmacia, Ospedale di Trento - Presidio Ospedaliero (PO)
-
-
Tuscany
-
Livorno, Tuscany, Itália, 57124
- Oncologia Medica Azienda Usl Toscana Nord Ovest - Ospedali Riuniti di Livor
-
Prato, Tuscany, Itália, 59100
- S.O.C. Oncologia Medica - Nuovo Ospedale di Prato Santo Stefano
-
-
-
-
Chiba
-
Kamogawa, Chiba, Japão, 296-8602
- Tesshokai Kameda General Hospital
-
Kashiwa-Shi, Chiba, Japão, 277-8577
- National Cancer Center Hospital East
-
-
Ehime
-
Matsuyama, Ehime, Japão, 791-0280
- NHO Shikoku Cancer Center
-
-
Fukuoka
-
Fukuoka, Fukuoka, Japão, 811-1395
- National Hospital Organization Kyushu Cancer Center
-
-
Fukushima
-
Fukushima, Fukushima, Japão, 960-1295
- Fukushima Medical University Hospital
-
-
Hokkaido
-
Sapporo, Hokkaido, Japão, 003-0804
- National Hospital Organization Hokkaido Cancer Center
-
-
Ibaraki
-
Tsukuba, Ibaraki, Japão, 305-8576
- University of Tsukuba Hospital
-
-
Ishikawa-ken
-
Kanazawa, Ishikawa-ken, Japão, 920-8530
- Ishikawa Prefectural Central Hospital
-
-
Kanagawa
-
Yokohama, Kanagawa, Japão, 241-8515
- Kanagawa Cancer Center
-
-
Okinawa
-
Naha, Okinawa, Japão, 901-0154
- Naha Nishi Clinic
-
-
Osaka
-
Osakasayama-shi, Osaka, Japão, 589-8511
- Kindai University Hospital
-
Sakai, Osaka, Japão, 590-0197
- Kindai University Hospital
-
-
Tokyo
-
Chuo-ku, Tokyo, Japão, 104-0045
- National Cancer Center Hospital
-
Chuo-ku, Tokyo, Japão, 104-8560
- St. Luke's International Hospital.
-
Minato-ku, Tokyo, Japão, 105-8470
- Toranomon Hospital
-
Shinagawa-ku, Tokyo, Japão, 142-8666
- Showa University Hospital
-
-
-
-
-
Gdansk, Polônia, 80-214
- Uniwersyteckie Centrum Kliniczne
-
Lodz, Polônia, 91-211
- Salve Medica
-
Lodz, Polônia, 91-211
- Salve Medica Apteka Szpitalna
-
Opole, Polônia, 45-061
- SP ZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego w Opolu
-
-
Other
-
Lodz, Other, Polônia, 93-513
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
-
-
Silesian Voivodeship
-
Gliwice, Silesian Voivodeship, Polônia, 44-102
- Narodowy lnstytut Onkologii im. Marii Sklodowskiej-Curie-Panstwowy lnstytut Badawczy
-
-
-
-
-
Coimbra, Portugal, 3000-075
- Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE (IPO, Coimbra)
-
Lisbon, Portugal, 1400-038
- Fundacao Champalimaud
-
-
Other
-
Braga, Other, Portugal, 4710-243
- Centro Clinico Academico Braga Hospital de Braga
-
Lisbon, Other, Portugal, 1998-018
- Hospital CUF Descobertas
-
-
-
-
-
London, Reino Unido, SW3 6JJ
- The Royal Marsden
-
London, Reino Unido, N12 0JE
- Finchley Memorial Hospital
-
London, Reino Unido, NW1 2PG
- University College London Hospital (UCLH) NHS Foundation Trust
-
Manchester, Reino Unido, M20 4BX
- Christie Hospital NHS Foundation Trust
-
-
England
-
London, England, Reino Unido, NW3 2QG
- Academic Oncology
-
-
Surrey
-
Sutton, Surrey, Reino Unido, SM2 5PT
- The Royal Marsden
-
-
-
-
-
Baden, Suíça, 5404
- Kantonsspital Baden.
-
Zurich, Suíça, 8008
- Brust-Zentrum AG
-
-
Canton of Zurich
-
Winterthur, Canton of Zurich, Suíça, 8401
- Kantonsspital Winterthur
-
-
-
-
-
Changhua, Taiwan, 500 (R.O.C.)
- Changhua Christian Medical Foundation Changhua Christian Hospital
-
Kaohsiung City, Taiwan, 807
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
New Taipei City, Taiwan, 23561 (R.O.C.)
- Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
-
New Taipei City, Taiwan, 23561 (R.O.C)
- Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
-
Taichung, Taiwan, 40447 (R.O.C.)
- China Medical University Hospital
-
Taipei, Taiwan, 11217
- Taipei Veterans General Hospital
-
Taipei, Taiwan, 11490, R.O.C.
- Tri-Service General Hospital
-
Taoyuan City, Taiwan, 333
- Chang Gung Memorial Hospital LinKou
-
-
Other
-
Tainan, Other, Taiwan, 704
- National Cheng Kung University Hospital
-
Taipei, Other, Taiwan, 10449
- MacKay Medical Foundation The Presbyterian Church in Taiwan MacKay Memorial Hospital
-
Taipei, Other, Taiwan, 112
- Koo Foundation Sun Yat-Sen Cancer Center
-
-
R.o.c
-
Taipei, R.o.c, Taiwan, 100
- National Taiwan University Hospital
-
-
Tainan
-
Tainan, Tainan, Taiwan, 710
- Chi Mei Medical Center
-
-
-
-
-
Brno, Tcheca, 656 53
- Masarykuv Onkologicky Ustav
-
Prague, Tcheca, 128 08
- Vseobecna fakultni nemocnice v Praze
-
Praha 5 - Motol, Tcheca, 15006
- Nemocnicni lekarna Fakultni nemocnice v Motole
-
Praha 5 - Motol, Tcheca, 15006
- Fakultni nemocnice v Motole Onkologicka klinika 2. LF UK a FN Motol
-
-
Other
-
Brno, Other, Tcheca, 656 53
- Ustavni lekarna Masarykuv onkologicky ustav
-
Praha 4 - Krc, Other, Tcheca, 14059
- Fakultni Thomayerova nemocnice Onkologicka klinika 1. LF UK a FTN
-
-
-
-
-
Graz, Áustria, A-8010
- Medizinische Universität Graz
-
Graz, Áustria, A-8036
- Medizinische Universitat Graz
-
Linz, Áustria, A-4010
- Ordensklinikum Linz GmbH Barmherzige Schwestern
-
Vienna, Áustria, A-1090
- Medizinische Universitat Wien Universitatsklinik Fur Frauenheilkunde
-
-
Other
-
Schwaz, Other, Áustria, A-6130
- Ordination Priv.-Doz. Dr. Michael Hubalek
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
-
Centrally confirmed HER2+ breast carcinoma according to the 2018 American Society of Clinical Oncologists (ASCO) College of American Pathologists (CAP) guidelines prior to randomization (defined as a 3+ score on immunohistochemistry (IHC) and/or 2+ IHC and concurrent positive by ISH).
-
Have unresectable locally advanced or metastatic disease.
- If recurrent (after [neo]adjuvant therapy), must be at least 6 month treatment free from any trastuzumab and pertuzumab received in the early breast cancer setting for advanced HER2+ disease.
-
Have received 4-8 cycles of pre-study induction therapy including only trastuzumab, pertuzumab, and taxane as first-line of therapy for the treatment of advanced breast cancer prior to study enrollment. Participants are eligible provided they are without evidence of disease progression following completion of induction therapy.
-
Known hormone receptor status (per local guidelines; may be hormone receptor positive [HR+] or negative [HR-])
-
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
-
CNS Inclusion - Based on screening contrast-enhanced brain magnetic resonance imaging (MRI), participants may have any of the following:
-
No evidence of brain metastases
-
Untreated brain metastases which are asymptomatic not needing immediate local treatment and, if identified on prior brain imaging, without evidence of progression since starting first-line induction therapy with trastuzumab, pertuzumab, and taxane
-
Previously treated brain metastases which are asymptomatic
- Brain metastases previously treated with local therapy must not have progressed since treatment
-
Exclusion Criteria:
-
Prior treatment with any tyrosine kinase inhibitor targeting HER2 and/or epidermal growth factor receptor (EGFR) including pyrotinib, lapatinib, tucatinib, neratinib, and afatinib (except neratinib if given in extended adjuvant setting and ≥ 12 months have elapsed since last neratinib dose prior to start of study drug)
-
Unable to undergo contrast-enhanced MRI of the brain
-
CNS Exclusion - Based on screening brain MRI and clinical assessment
- Symptomatic brain metastasis after CNS-directed local therapy
- Progression of brain metastases since starting first line trastuzumab, pertuzumab, and taxane
- Ongoing use of systemic corticosteroids at a total daily dose of >2 mg of dexamethasone (or equivalent)
- Any untreated brain lesion in an anatomic site which may pose risk to participant
- Known or suspected leptomeningeal disease (LMD)
- Poorly controlled (>1/week) seizures, or other persistent neurologic symptoms
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Tucatinib + trastuzumab + pertuzumab
Tucatinib + trastuzumab + pertuzumab |
300mg given by mouth (orally) twice daily
Outros nomes:
6mg/kg given into the vein (IV; intravenously) or 600mg injected under the skin (SC; subcutaneous) every 21 days
Outros nomes:
420mg given by IV every 21 days
Outros nomes:
600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase will be given by subcutaneous injection every 21 days. May be given in place of trastuzumab and pertuzumab individually.
Outros nomes:
|
|
Comparador Ativo: Placebo + trastuzumab + pertuzumab
Placebo + trastuzumab + pertuzumab |
6mg/kg given into the vein (IV; intravenously) or 600mg injected under the skin (SC; subcutaneous) every 21 days
Outros nomes:
420mg given by IV every 21 days
Outros nomes:
600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase will be given by subcutaneous injection every 21 days. May be given in place of trastuzumab and pertuzumab individually.
Outros nomes:
Given orally twice daily |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Progression-Free Survival (PFS) as Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
Prazo: From randomization until the first documentation of PD or death from any cause or censoring date, whichever occurred first (maximum treatment exposure was of 41.3 months)
|
PFS: time from randomization to the first documented disease progression (PD) (as assessed by investigator per RECIST 1.1) or death from any cause, whichever occurred first. PD: >=20% increase in sum of diameters of target lesions, taking as reference the smallest sum of diameter recorded since the treatment started or the appearance of 1 or more new lesions. Participants without documentation of PD/ death at the time of analysis, were censored at date of last tumor assessment with an overall response of complete response (CR), partial response (PR), stable disease (SD), non-CR/non-PD or no evidence of disease (NED). CR: disappearance of all target lesions; PR: >=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameter since the treatment started. Kaplan-Meier method was used for analysis. |
From randomization until the first documentation of PD or death from any cause or censoring date, whichever occurred first (maximum treatment exposure was of 41.3 months)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Overall Survival (OS)
Prazo: From the date of randomization until date of death or censoring date (approximately 66.7 months)
|
OS: time from randomization to death due to any cause. For a participant who would not known to have died by the end of study follow-up, observation of OS would be censored on the date the participant was last known to be alive (i.e., the date of last contact). |
From the date of randomization until date of death or censoring date (approximately 66.7 months)
|
|
PFS as Assessed by Blinded Independent Central Review (BICR) Per RECIST v1.1
Prazo: From randomization until the first documentation of PD or death from any cause or censoring date, whichever occurred first (maximum treatment exposure was of 41.3 months)
|
PFS per BICR was defined as the time from the date of randomization to the documented disease progression assessed by BICR according to RECIST v1.1 or death from any cause, whichever occurred first. As per RECIST v1.1, PD: >=20% increase in sum of diameter of target lesions, taking as reference the smallest sum of diameters recorded since treatment started or appearance of 1 or more new lesions, unequivocal progression of existing non-target lesions. Participants without documentation of PD/ death were censored at date of last tumor assessment with an overall response of CR, PR, SD, non-CR/non-PD or NED. CR: disappearance of all target lesions; PR: >=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameter since the treatment started. Kaplan-Meier method was used for analysis. |
From randomization until the first documentation of PD or death from any cause or censoring date, whichever occurred first (maximum treatment exposure was of 41.3 months)
|
|
Time to Deterioration (TTD) of Health-Related Quality of Life (HRQoL)
Prazo: Approximately 66.7 months
|
Time to deterioration of HRQoL was defined as time to 10-point decrease in the global health status/QoL scale of the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-C30). EORTC QLQ-C30 is 30 item questionnaires composed of 5 multi-item functional domains (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, nausea, and vomiting) and 6 single items for symptoms (shortness of breath, loss of appetite, sleep disturbance, constipation, diarrhea and financial impact of the disease), 2 global items (health, overall QoL). Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms. |
Approximately 66.7 months
|
|
Central Nervous System (CNS) PFS as Assessed by Investigator Per RECIST v1.1
Prazo: From randomization until the first documentation of PD or death from any cause or censoring date, whichever occurred first (maximum treatment exposure was of 41.3 months)
|
CNS-PFS was defined as the time from randomization to investigator assessed disease progression in brain according to RECIST v1.1, or death from any cause, whichever occurred first. As per RECIST v1.1, PD: >= 20% increase in sum of diameter of target lesions, taking as reference the smallest sum of diameters recorded since the treatment started or appearance of 1 or more new lesions, unequivocal progression of existing non-target lesions. Participants without documentation of PD/ death at the time of analysis were censored at date of last tumor assessment with an overall response of CR, PR, SD, non-CR/non-PD or NED. CR: disappearance of all target lesions; PR: >=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameter since the treatment started. Kaplan-Meier method was used for analysis. |
From randomization until the first documentation of PD or death from any cause or censoring date, whichever occurred first (maximum treatment exposure was of 41.3 months)
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Prazo: From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 42.3 months)
|
An adverse event (AE) was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily had a causal relationship with this treatment. TEAEs were defined as events that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. AEs included both Serious AE (SAEs) and all other AEs. An AE should be classified as a serious SAE if it meets one of the following criteria: fatal, life threatening, requires or prolongs hospitalization, disabling/ incapacitating, congenital anomaly or birth defect, medically significant. |
From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 42.3 months)
|
|
Number of Participants With Treatment Emergent Laboratory Abnormalities
Prazo: From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
|
TEAEs were defined as events that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. Treatment emergent laboratory abnormalities include: hematology (hemoglobin decreased, hemoglobin increased, leukocytes decreased, neutrophils decreased, platelets decreased); chemistry (alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, creatinine increased, potassium decreased, potassium increased, sodium decreased, sodium increased, total bilirubin increased). |
From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
|
|
Number of Participants With TEAEs Leading to Dose Discontinuations
Prazo: From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
|
TEAEs were defined as events that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. In this outcome measure, number of participants with TEAEs leading to dose discontinuations with study treatment will be reported. |
From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
|
|
Number of Participants With TEAEs Leading to Dose Hold
Prazo: From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
|
TEAEs were defined as events that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. In this outcome measure, number of participants with TEAEs leading to dose hold with study treatment will be reported. Dose hold requirements are defined per protocol. |
From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
|
|
Number of Participants With TEAEs Leading to Dose Reductions
Prazo: From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
|
TEAEs were defined as events that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. In this outcome measure, number of participants with TEAEs leading to dose reductions with tucatinib, trastuzumab and pertuzumab are reported. Dose reduction requirements are defined per protocol. |
From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
|
|
Trough Concentration (Ctrough) of Tucatinib
Prazo: Pre-dose on Day 1 of Cycles 2, 3, 4, 5 and 6
|
Concentration at Trough was defined as predose/trough concentration observed directly from data. |
Pre-dose on Day 1 of Cycles 2, 3, 4, 5 and 6
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Participants With TEAEs: Through Study Completion
Prazo: From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
|
An AE was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily had a causal relationship with this treatment. TEAEs were defined as events that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. AEs included both SAEs and all other AEs. An AE should be classified as a serious SAE if it meets one of the following criteria: fatal, life threatening, requires or prolongs hospitalization, disabling/ incapacitating, congenital anomaly or birth defect, medically significant. |
From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Pfizer CT.gov Call Center, Pfizer
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Neoplasias por local
- Neoplasias
- Doenças de pele
- Doenças da mama
- Doenças da Pele e do Tecido Conjuntivo
- Neoplasias da Mama
- Aminoácidos, peptídeos e proteínas
- Proteínas
- Anticorpos, monoclonais, humanizados
- Anticorpos, monoclonais
- Anticorpos
- Imunoglobulinas
- Imunoproteínas
- Proteínas sanguíneas
- Globulinas de soro
- Globulins
- Trastuzumabe
- Pertuzumab
- Tucatinibe
Outros números de identificação do estudo
- SGNTUC-028
- C4251007 (Outro identificador: Alias Study Number)
- 2023-503826-37-00 (Identificador de registro: CTIS (EU))
- 2023 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .