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Исследование тукатиниба или плацебо с трастузумабом и пертузумабом при метастатическом раке молочной железы HER2+ (HER2CLIMB-05)

4 сентября 2026 г. обновлено: Seagen, a wholly owned subsidiary of Pfizer

Рандомизированное двойное слепое исследование фазы 3 тукатиниба или плацебо в комбинации с трастузумабом и пертузумабом в качестве поддерживающей терапии метастатического рака молочной железы HER2+ (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.

Обзор исследования

Статус

Активный, не рекрутирующий

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Действительный)

654

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Австралия
    • New South Wales
      • Camperdown, New South Wales, Австралия, 2050
        • Chris O'Brien Lifehouse
      • Macquarie University, New South Wales, Австралия, 2109
        • Macquarie University Clinical Trials Unit.
      • Westmead, New South Wales, Австралия, 2145
        • Western Sydney Local Health District (WSLHD), Westmead Hospital
    • South Australia
      • Adelaide, South Australia, Австралия, 5000
        • Cancer Research SA
      • Adelaide, South Australia, Австралия, 5000
        • St Andrews Medical Centre
      • Bedford Park, South Australia, Австралия, 5042
        • Flinders Medical Centre
    • Victoria
      • Box Hill, Victoria, Австралия, 3128
        • Box Hill Hospital
      • Heidelberg, Victoria, Австралия, 3084
        • Austin Health
    • Washington
      • Subiaco, Washington, Австралия, 6008
        • St John of God Subiaco Hospital Clinical Trials Unit Bendat Family Comprehensive Cancer Centre
  • Австрия
      • Graz, Австрия, A-8010
        • Medizinische Universität Graz
      • Graz, Австрия, A-8036
        • Medizinische Universitat Graz
      • Linz, Австрия, A-4010
        • Ordensklinikum Linz GmbH Barmherzige Schwestern
      • Vienna, Австрия, A-1090
        • Medizinische Universitat Wien Universitatsklinik Fur Frauenheilkunde
    • Other
      • Schwaz, Other, Австрия, A-6130
        • Ordination Priv.-Doz. Dr. Michael Hubalek
  • Бельгия
      • Anderlecht, Бельгия, 1070
        • Jules Bordet lnstituut
      • Brussels, Бельгия, 1090
        • Universitair Ziekenhuis Brussel (UZ Brussel)
      • Brussels, Бельгия, 1200
        • Cliniques Universitaires Saint-Luc
      • Ottignies, Бельгия, 1340
        • Clinique St-Pierre
  • Бразилия
      • Porto Alegre/RS, Бразилия, 90050-170
        • Irmandade da Santa Casa de Misericordia de Porto Alegre centro Multidisciplinar de pesquisa clinica
      • São José do Rio Preto, Бразилия, 15090-000
        • Faculdade Regional de Medicina de Sao Jose do Rio Preto
      • São Paulo, Бразилия, 01246-000
        • ICESP- Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira
      • São Paulo, Бразилия, 04014-002
        • Sao Camilo Oncologia
      • São Paulo, Бразилия, CEP: 01317-000
        • Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecologica e Mamária Ltda.
    • Ceará
      • Fortaleza, Ceará, Бразилия, 60336-232
        • CRIO - Centro Regional lntegrado de Oncologia
    • Goiás
      • Goiânia, Goiás, Бразилия, 74605-070
        • Hospital Araujo Jorge
    • Other
      • Sao Paulo/SP, Other, Бразилия, 01.509-010
        • A.C. Camargo Câncer Center
    • Paraná
      • Londrina, Paraná, Бразилия, 86015-520
        • Hospital Do Cancer De Londrina
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Бразилия, 59075-740
        • Liga Norte-Rio Grandense Contra o Cancer
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Бразилия, 90035-903
        • Hospital de Clinicas de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Бразилия, CEP 90110-270
        • Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital do Cancer Mae de Deu
      • Porto Alegre, Rio Grande do Sul, Бразилия, CEP 90850-170
        • Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital do Cancer Mae de Deu
    • São Paulo
      • Barretos, São Paulo, Бразилия, CEP: 14784-400
        • Fundacao Pio XII, Hospital do Amor de Barretos
      • Jaú, São Paulo, Бразилия, CEP: 17210-080
        • Fundacao Dr Amaral Carvalho
      • Santo André, São Paulo, Бразилия, 09060-650
        • CEPHO- Centro de Estudos e Pesquisas de Hematologia e Oncologia
      • Santo André, São Paulo, Бразилия, 09060-870
        • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
  • Германия
      • Augsburg, Германия, 86156
        • "Universitatsklinikum Augsburg Klinik fur Frauenheilkunde und Geburtshilfe"
      • Berlin, Германия, 10117
        • Charite Universtitatsmedizin Berlin Klinik fur Gynakologie mit Brustzentrum
      • Berlin, Германия, 13353
        • Charite - Universitatsmedizin Berlin
      • Hamburg, Германия, 20246
        • Universitatsklinikum Hamburg-Eppendorf (UKE)
      • München, Германия, 81675
        • Klinik und Poliklinik fur Frauenheilkunde der Technischen Universitat Munchen
      • Ulm, Германия, 89075
        • Universitatsklinikum Ulm Klinik fur Frauenheilkunde und Geburtshilfe
      • Würzburg, Германия, 97080
        • Universitatsklinikum Wurzburg Frauenklinik und Poliklinik
      • Würzburg, Германия, 97080
        • Universitatsklinikum Wurzburg, Comprehensive Cancer Center - Mainfranken (CCCMF)
    • North Rhine-Westphalia
      • Münster, North Rhine-Westphalia, Германия, 48149
        • University Hospital Muenster Senology
    • Other
      • Manheim, Other, Германия, 68167
        • Universitätsmedizin Mannheim Universitätsfrauenklinik
      • Mannheim, Other, Германия, 68167
        • Pharmacy:Fortuna Herstellung GmbH
  • Греция
      • Larissa, Греция, 41110
        • University General Hospital of Larissa, Oncology Clinic
      • Marousi, Греция, 15123
        • IASO General Clinic Oncology Clinic
      • Pireaus, Греция, 18537
        • Metaxa Anticancer Hospital of Piraeus
    • Attica
      • Athens, Attica, Греция, 11528
        • General Hospital of Athens "Alexandra" Clinical Therapeutics Department, Hematology/Oncology Unit
    • Peloponnese
      • Patra, Peloponnese, Греция, 26504
        • University General Hospital of Patras, Oncology Department, Internal Medicine Clinic
  • Испания
      • Barcelona, Испания, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Испания, 08035
        • Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca
      • Barcelona, Испания, 08025
        • Fundacio de Gestio Sanitaria de I'Hospital de la Santa Creu i Sant Pau
      • Barcelona, Испания, 08041
        • Hospital de la Santa Creu i Sant Pau
      • Bilbao, Испания, 48013
        • Hospital Universitario de Basurto
      • Girona, Испания, 17007
        • Institut Catala d'Oncologia Girona - ICO Girona
      • Granada, Испания, 18014
        • Hospital Universitario Virgen de las Nieves
      • Lleida, Испания, 25198
        • Hospital Universitari Arnau de Vilanova
      • Madrid, Испания, 28007
        • Hospital General Universitario Gregorio Maranon
      • Málaga, Испания, 29010
        • Hospital Universitario Virgen de la Victoria
      • Salamanca, Испания, 37007
        • Hospital Universitario de Salamanca (Spain Salamanca)
      • Seville, Испания, 41013
        • Hospital Universitario Virgen del Rocio
      • Valencia, Испания, 46009
        • Fundacion lnstituto Valenciano de Oncologia
    • Andalusia
      • Málaga, Andalusia, Испания, 29016
        • Hospital El Angel Grupo Hla, S.L.U
    • Balearic Islands
      • Palma de Mallorca, Balearic Islands, Испания, 07120
        • Hospital Universitario Son Espases
    • Murcia
      • EI Palmar, Murcia, Испания, 30120
        • Hospital Universitario Virgen De La Arrixaca
    • Other
      • Barcelona, Other, Испания, 08035
        • Fundación Privada Instituto de Investigación Oncológica de Vall Hebron
      • Cáceres, Other, Испания, 10003
        • Hospital San Pedro de Alcantara
      • Madrid, Other, Испания, 28034
        • Hospital Universitario Ramon y Cajal
      • Valencia, Other, Испания, 46010
        • Hospital Clinico Universitario de Valencia
    • Santa CRUZ DE Tenerife
      • La Laguna Tenerife, Santa CRUZ DE Tenerife, Испания, 38320
        • Hospital Universitario de Canarias
    • Valencia
      • Alicante, Valencia, Испания, 03010
        • Hospital General Universitario Alicante
  • Италия
      • Bologna, Италия, 40138
        • Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
      • Bologna, Италия, 40138
        • SSD Oncologia Medica Addarii - Zamagni, Policlinico Sant'Orsola - Malpighi
      • Milan, Италия, 20089
        • Istituto Clinico Humanitas
      • Milan, Италия, 20141
        • Divisione di Senologia Medica; Istituto Europeo di Oncologia
      • Parma, Италия, 43126
        • UOC di Oncologia Medica, Azienda Ospedaliero Universitaria (AOU) di Parma
      • Pavia, Италия, 27100
        • Istituti Clinici Scientifici Maugeri IRCCS
    • Campania
      • Naples, Campania, Италия, 80131
        • Azienda Ospedaliera Universitaria Federico II
      • Naples, Campania, Италия, 80131
        • lstituto Nazionale Tumori IRCCS - Fondazione Pascale U.O.C. Oncologia Medica Senologica
    • Liguria
      • Genoa, Liguria, Италия, 16132
        • IRCCS Ospedale Policlinico, San Martino
    • Lombardy
      • Monza (MB), Lombardy, Италия, 20900
        • ASST Monza Ospedale San Gerardo Centro Ricerca di Fase 1
    • Sicily
      • Catania (CT), Sicily, Италия, 95045
        • Humanitas lstituto Clinico Catanese
    • The Marches
      • Torrette, The Marches, Италия, 60126
        • Azienda Ospedaliero Universitaria delle Marche SOD Clinica Oncologica
    • Trentino-Alto Adige
      • Trento, Trentino-Alto Adige, Италия, 38122
        • Divisione Oncologia Medica, Ospedale di Trento - Presidio Ospedaliero (PO) Santa Chiara
      • Trento, Trentino-Alto Adige, Италия, 38122
        • SOC Farmacia, Ospedale di Trento - Presidio Ospedaliero (PO)
    • Tuscany
      • Livorno, Tuscany, Италия, 57124
        • Oncologia Medica Azienda Usl Toscana Nord Ovest - Ospedali Riuniti di Livor
      • Prato, Tuscany, Италия, 59100
        • S.O.C. Oncologia Medica - Nuovo Ospedale di Prato Santo Stefano
  • Канада
    • Alberta
      • Edmonton, Alberta, Канада, T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Kelowna, British Columbia, Канада, V1Y 5L3
        • BC Cancer Agency
    • Ontario
      • Ottawa, Ontario, Канада, K1H 8L6
        • The Ottawa Hospital Cancer Centre
      • Toronto, Ontario, Канада, M5G 1X5
        • Mount Sinai Hospital
      • Toronto, Ontario, Канада, M4N 3M5
        • Sunnybrook Research Institute
    • Quebec
      • Chicoutimi, Quebec, Канада, G7H 5H6
        • Centre integre universitaire de sante et de services sociaux du Saguenay-Lac-Saint-Jean
      • Montreal, Quebec, Канада, H3T 1E2
        • Jewish General Hospital
      • Montreal, Quebec, Канада, H2X 3E4
        • Centre Hospitalier de l'Universite de Motreal (CHUM)
  • Китай
      • Beijing, Китай, 100730
        • Beijing Hospital
      • Beijing, Китай, 100010
        • Beijing Hospital
      • Shanghai, Китай, 200032
        • Fudan University Shanghai Cancer Center
      • Tianjin, Китай, 300181
        • Tianjin Cancer Hospital Binhai Campus
    • Anhui
      • Hefei, Anhui, Китай, 230601
        • The Second Hospital of Anhui Medical University
    • Guangdong
      • Guangzhou, Guangdong, Китай, 510080
        • Guangdong Provincial People's Hospital
      • Meizhou, Guangdong, Китай, 514031
        • Meizhou People's Hospital
    • Guangxi
      • Liuzhou, Guangxi, Китай, 545006
        • Liuzhou People's Hospital
      • Nanning, Guangxi, Китай, 530021
        • The People's Hospital of Guangxi Zhuang Autonomous Region
      • Nanning, Guangxi, Китай, 530021
        • Guangxi Medical University Affiliated Tumor Hospital
    • Hainan
      • Haikou, Hainan, Китай, 570102
        • The first Affiliated Hospital of Hainan Medical University
    • Hebei
      • Baoding, Hebei, Китай, 071000
        • Affiliated Hospital of Hebei University
    • Henan
      • Zhengzhou, Henan, Китай, 450003
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, Китай, 430079
        • Hubei Cancer Hospital
      • Wuhan, Hubei, Китай, 430030
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
    • Hunan
      • Changsha, Hunan, Китай, 410011
        • The Second Xiangya Hospital of Central South University
    • Jiangsu
      • Nanjing, Jiangsu, Китай, 210036
        • Nanjing Medical University (NMU) - Jiangsu Province Hospital
    • Jiangxi
      • Nanchang, Jiangxi, Китай, 330008
        • The Second Affiliated Hospital of Nanchang University
    • Jilin
      • Changchun, Jilin, Китай, 130021
        • The First Hospital of Jilin University
    • Liaoning
      • Shenyang, Liaoning, Китай, 110042
        • Liaoning Cancer Hospital & Insitute
      • Shenyang, Liaoning, Китай, 110167
        • The First Affiliated Hospital of China Medical University
    • Other
      • Shanghai, Other, Китай, 200025
        • Ruijin Hospital of Shanghai Jiaotong University School of Medicine
    • Shaanxi
      • Xi'an, Shaanxi, Китай, 710061
        • The First Affiliated Hospital of Xi'an Jiaotong University
      • Xi'an, Shaanxi, Китай, 710068
        • Shaanxi Provincial People's Hospital
    • Shandong
      • Jinan, Shandong, Китай, 250013
        • Jinan Central Hospital
      • Linyi, Shandong, Китай, 276034
        • Linyi Cancer Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, Китай, 310016
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, Китай, 310005
        • Zhejiang Cancer Hospital
      • Hangzhou, Zhejiang, Китай, 310052
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
  • Нидерланды
      • Dordrecht, Нидерланды, 3318 AT
        • Albert Schweitzer Ziekenhuis
      • Utrecht, Нидерланды, 3543 AZ
        • St. Antonius Hospital
      • Venlo, Нидерланды, 5912 BL
        • VieCuri Medsich Centrum
    • South Holland
      • Doedrecht, South Holland, Нидерланды, 3318AT
        • Albert Schweitzer Hospital
  • Польша
      • Gdansk, Польша, 80-214
        • Uniwersyteckie Centrum Kliniczne
      • Lodz, Польша, 91-211
        • Salve Medica
      • Lodz, Польша, 91-211
        • Salve Medica Apteka Szpitalna
      • Opole, Польша, 45-061
        • SP ZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego w Opolu
    • Other
      • Lodz, Other, Польша, 93-513
        • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
    • Silesian Voivodeship
      • Gliwice, Silesian Voivodeship, Польша, 44-102
        • Narodowy lnstytut Onkologii im. Marii Sklodowskiej-Curie-Panstwowy lnstytut Badawczy
  • Португалия
      • Coimbra, Португалия, 3000-075
        • Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE (IPO, Coimbra)
      • Lisbon, Португалия, 1400-038
        • Fundacao Champalimaud
    • Other
      • Braga, Other, Португалия, 4710-243
        • Centro Clinico Academico Braga Hospital de Braga
      • Lisbon, Other, Португалия, 1998-018
        • Hospital CUF Descobertas
  • Соединенное Королевство
      • London, Соединенное Королевство, SW3 6JJ
        • The Royal Marsden
      • London, Соединенное Королевство, N12 0JE
        • Finchley Memorial Hospital
      • London, Соединенное Королевство, NW1 2PG
        • University College London Hospital (UCLH) NHS Foundation Trust
      • Manchester, Соединенное Королевство, M20 4BX
        • Christie Hospital NHS Foundation Trust
    • England
      • London, England, Соединенное Королевство, NW3 2QG
        • Academic Oncology
    • Surrey
      • Sutton, Surrey, Соединенное Королевство, SM2 5PT
        • The Royal Marsden
  • Соединенные Штаты
    • Arizona
      • Phoenix, Arizona, Соединенные Штаты, 85054
        • Mayo Clinic Hospital
      • Scottsdale, Arizona, Соединенные Штаты, 85259
        • Mayo Clinic
    • Arkansas
      • Little Rock, Arkansas, Соединенные Штаты, 72205
        • Central Arkansas Radiation Therapy Institute Inc d.b.a CARTI
    • California
      • Beverly Hills, California, Соединенные Штаты, 90212
        • UCLA Hematology/Oncology - Beverly Hills
      • Burbank, California, Соединенные Штаты, 91505
        • UCLA Hematology/Oncology - Burbank
      • Encinitas, California, Соединенные Штаты, 92024
        • UCSD Medical Center - Encinitas
      • La Jolla, California, Соединенные Штаты, 92093
        • UC San Diego Moores Cancer Center
      • La Jolla, California, Соединенные Штаты, 92037
        • Sulpizio Cardiovascular Center at UC San Diego Health
      • La Jolla, California, Соединенные Штаты, 92037
        • UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
      • La Jolla, California, Соединенные Штаты, 92037
        • UCSD Perlman Medical Offices
      • La Jolla, California, Соединенные Штаты, 92037
        • UCSD Koman Family Outpatient Pavilion
      • Laguna Hills, California, Соединенные Штаты, 92653
        • UCLA Hematology/Oncology - Laguna Hills
      • Los Angeles, California, Соединенные Штаты, 90095
        • UCLA Hematology/Oncology
      • Los Angeles, California, Соединенные Штаты, 90095
        • Administrative Address: UCLA Hematology/Oncology
      • San Diego, California, Соединенные Штаты, 92103
        • UC San Diego Medical Center - Hillcrest
      • San Diego, California, Соединенные Штаты, 912101
        • UCSD Medical Center - Bankers Hill
      • San Luis Obispo, California, Соединенные Штаты, 93401
        • UCLA Hematology/Oncology - San Luis Obispo
      • Santa Barbara, California, Соединенные Штаты, 93101
        • UCLA Hematology/Oncology- Santa Barbara
      • Santa Monica, California, Соединенные Штаты, 90404
        • UCLA Hematology/Oncology - Santa Monica
      • Santa Monica, California, Соединенные Штаты, 90404
        • UCLA Hematology/Oncology Parkside
      • Torrance, California, Соединенные Штаты, 90509
        • Harbor-UCLA Medical Center
      • Torrance, California, Соединенные Штаты, 90502
        • The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
      • Torrance, California, Соединенные Штаты, 90502
        • Clinical And Translational Research Center
      • Valencia, California, Соединенные Штаты, 91355
        • UCLA Hematology/Oncology - Santa Clarita
      • Vista, California, Соединенные Штаты, 92081
        • UCSD Medical Center - Vista
      • Westlake Village, California, Соединенные Штаты, 91361
        • UCLA Hematology/Oncology- Westlake
    • Florida
      • Altamonte Springs, Florida, Соединенные Штаты, 32701
        • AdventHealth Altamonte Infusion Center
      • Altamonte Springs, Florida, Соединенные Штаты, 32701
        • AdventHealth Medical Group Altamonte(second location)
      • Altamonte Springs, Florida, Соединенные Штаты, 32701
        • AdventHealth Medical Group Altamonte
      • Jacksonville, Florida, Соединенные Штаты, 32224
        • Mayo Clinic Florida
      • Orlando, Florida, Соединенные Штаты, 32804
        • AdventHealth Orlando Infusion Center
      • Orlando, Florida, Соединенные Штаты, 32804
        • AdventHealth Medical Group Orlando
    • Georgia
      • Atlanta, Georgia, Соединенные Штаты, 30308
        • Emory University Hospital Midtown
      • Atlanta, Georgia, Соединенные Штаты, 30342
        • Emory Saint Joseph's Hospital
      • Atlanta, Georgia, Соединенные Штаты, 30322
        • Winship Cancer Institute
      • Atlanta, Georgia, Соединенные Штаты, 30322
        • Emory University Clinic
    • Illinois
      • Chicago, Illinois, Соединенные Штаты, 60612
        • University of Illinois Hospital and Health Systems
      • Chicago, Illinois, Соединенные Штаты, 60612
        • University of Illinois Hospital and Health Systems (Outpatient Cancer Center)
      • Chicago, Illinois, Соединенные Штаты, 60612
        • University of Illinois Hospital and Health Systems (Investigational Drug Pharmacy)
    • Kentucky
      • Louisville, Kentucky, Соединенные Штаты, 40207
        • Norton Cancer Institute, St. Matthews Campus
      • Louisville, Kentucky, Соединенные Штаты, 40207
        • Norton Cancer Institute, St Matthews Campus
      • Louisville, Kentucky, Соединенные Штаты, 40241
        • Norton Cancer Institute, Brownsboro Hospital Campus
      • Louisville, Kentucky, Соединенные Штаты, 40202
        • Norton Cancer Institute, Downtown
      • Louisville, Kentucky, Соединенные Штаты, 40202
        • Norton Cancer Institute - Downtown
    • Maryland
      • Baltimore, Maryland, Соединенные Штаты, 21202
        • Mercy Medical Center
    • Minnesota
      • Rochester, Minnesota, Соединенные Штаты, 55905
        • Mayo Clinic
    • Missouri
      • Kansas City, Missouri, Соединенные Штаты, 64111
        • Saint Luke's Cancer Institute.
    • Nebraska
      • Grand Island, Nebraska, Соединенные Штаты, 68803
        • Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island
      • Grand Island, Nebraska, Соединенные Штаты, 68803
        • Oncology Hematology West PC dba Nebraska Cancer Specialists
      • Omaha, Nebraska, Соединенные Штаты, 68130
        • Oncology Hematology West PC dba Nebraska Cancer Specialists
      • Omaha, Nebraska, Соединенные Штаты, 68124
        • Oncology Hematology West PC dba Nebraska Cancer Specialists
      • Omaha, Nebraska, Соединенные Штаты, 68114
        • Oncology Hematology West PC dba Nebraska Cancer Specialists
      • Papillion, Nebraska, Соединенные Штаты, 68046
        • Oncology Hematology West PC dba Nebraska Cancer Specialists
    • New Jersey
      • Jersey City, New Jersey, Соединенные Штаты, 07302
        • RWJBarnabas Health- Jersey City Medical Center
      • Lakewood, New Jersey, Соединенные Штаты, 08701
        • RWJBarnabas Health- Monmouth Medical Center-Southern Campus
      • Livingston, New Jersey, Соединенные Штаты, 07039
        • RWJBarnabas Health- Cooperman Barnabas Medical Center
      • Long Branch, New Jersey, Соединенные Штаты, 07740
        • RWJBarnabas Health- Monmouth Medical Center
      • New Brunswick, New Jersey, Соединенные Штаты, 08903
        • Rutgers Cancer Institute of New Jersey
      • Newark, New Jersey, Соединенные Штаты, 07112
        • Newark Beth Israel Medical Center
      • Somerville, New Jersey, Соединенные Штаты, 08876
        • Steeplechase Cancer Center
      • Somerville, New Jersey, Соединенные Штаты, 08876
        • RWJBarnabas Health-Robert Wood Johnson University Hospital, Somerset
      • Toms River, New Jersey, Соединенные Штаты, 08755
        • RWJBarnabas Health - Community Medical Center
      • West Long Branch, New Jersey, Соединенные Штаты, 07764
        • Satellite Infusion Center-Monmouth Medical Center Vantage Point Infusion Center
    • New York
      • The Bronx, New York, Соединенные Штаты, 10461
        • Montefiore Einstein Comprehensive Cancer Center
    • Ohio
      • Cleveland, Ohio, Соединенные Штаты, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, Соединенные Штаты, 44106
        • Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
      • Strongsville, Ohio, Соединенные Штаты, 44136
        • Cleveland Clinic Cancer Center - Strongsville
    • Pennsylvania
      • Willow Grove, Pennsylvania, Соединенные Штаты, 19090
        • Asplundh Cancer Pavillion
    • Tennessee
      • Gallatin, Tennessee, Соединенные Штаты, 37066
        • Tennessee Oncology, PLLC
      • Murfreesboro, Tennessee, Соединенные Штаты, 37129
        • Tennessee Oncology, PLLC
      • Nashville, Tennessee, Соединенные Штаты, 37203
        • Tennessee Oncology, PLLC
      • Nashville, Tennessee, Соединенные Штаты, 37203
        • Sarah Cannon Research Institute- Pharmacy
      • Shelbyville, Tennessee, Соединенные Штаты, 37160
        • Tennessee Oncology, PLLC
    • Washington
      • Seattle, Washington, Соединенные Штаты, 98195
        • University of Washington Medical Center
      • Seattle, Washington, Соединенные Штаты, 98109
        • Fred Hutchinson Cancer Center
    • Wisconsin
      • Milwaukee, Wisconsin, Соединенные Штаты, 53226
        • Froedtert Hospital/Medical College of Wisconsin
  • Тайвань
      • Changhua, Тайвань, 500 (R.O.C.)
        • Changhua Christian Medical Foundation Changhua Christian Hospital
      • Kaohsiung City, Тайвань, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • New Taipei City, Тайвань, 23561 (R.O.C.)
        • Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
      • New Taipei City, Тайвань, 23561 (R.O.C)
        • Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
      • Taichung, Тайвань, 40447 (R.O.C.)
        • China Medical University Hospital
      • Taipei, Тайвань, 11217
        • Taipei Veterans General Hospital
      • Taipei, Тайвань, 11490, R.O.C.
        • Tri-Service General Hospital
      • Taoyuan City, Тайвань, 333
        • Chang Gung Memorial Hospital LinKou
    • Other
      • Tainan, Other, Тайвань, 704
        • National Cheng Kung University Hospital
      • Taipei, Other, Тайвань, 10449
        • MacKay Medical Foundation The Presbyterian Church in Taiwan MacKay Memorial Hospital
      • Taipei, Other, Тайвань, 112
        • Koo Foundation Sun Yat-Sen Cancer Center
    • R.o.c
      • Taipei, R.o.c, Тайвань, 100
        • National Taiwan University Hospital
    • Tainan
      • Tainan, Tainan, Тайвань, 710
        • Chi Mei Medical Center
  • Финляндия
      • Tampere, Финляндия
        • Tampere University Hospital
      • Tampere, Финляндия, 33520
        • Tampere University Hospital, FONK/RSYO
  • Франция
      • Besançon, Франция, 25000
        • CHU Besancon
      • Bobigny, Франция, 93009 Cedex
        • Hopital Avicenne
      • Caen, Франция, 14076 Cedex 5
        • CENTRE FRANCOIS BACLESSE - Service lmagerie medicale
      • Caen, Франция, 14076
        • Centre de Lutte contre le Cancer - François Baclesse
      • Caen, Франция, 14076 Cedex 5
        • Centre Francois Baclesse
      • Clermont-Ferrand, Франция, 63000
        • Centre Jean Perrin
      • Lille, Франция, 59020 Cedex
        • Centre Oscar Lambret
      • Lyon, Франция, 69373 Cedex 08
        • Center Leon Berard
      • Montpellier, Франция, 34298 Cedex 5
        • Institut Regional du Cancer de Montpellier Service lmagerie medicale
      • Montpellier, Франция, 34298
        • Institut Régional du Cancer de Montpellier
      • Nice, Франция, 06189
        • Centre Antoine Lacassagne
      • Pierre-Bénite, Франция, 69310
        • Hospices Civils de Lyon
      • Plérin, Франция, 22190
        • "CARIO - Centre Armoricain de Radiotherapie lmagerie medicate et d'Oncologie -Hopital Prive des
      • Rennes, Франция, cedex 35042
        • Centre Eugene Marquis
      • Rouen, Франция, 76038 Cedex 1
        • Centre Henri Becquerel
      • Saint-Cloud, Франция, 92210
        • Institut Curie - site St-Cloud
      • Strasbourg, Франция, 67033
        • Institut de Cancerologie Strasbourg Europe
    • Brittany Region
      • Rouen, Brittany Region, Франция, 76038
        • Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
    • Cedex
      • Bordeaux, Cedex, Франция, 33076
        • Institut Bergonie
    • Languedoc-roussillon
      • Montpellier, Languedoc-roussillon, Франция, 34070
        • Centre de Cancérologie du Grand Montpellier
    • Loire-atlantique
      • Saint-Herblain, Loire-atlantique, Франция, 44800
        • Institut de Cancerologie de lOuest - Site Rene Gauducheau
      • Saint-Herblain, Loire-atlantique, Франция, 44805
        • Institut de Cancerologie de lOuest-Saint Herblain
    • Other
      • Avignon, Other, Франция, 84918
        • Institut Sainte-Catherine.
      • Avignon, Other, Франция, 84918
        • Sainte Catherine lnstitut du Cancer Avignon Provence
      • Dijon, Other, Франция, 21079
        • Center Georges-Francois Leclerc
  • Чехия
      • Brno, Чехия, 656 53
        • Masarykuv Onkologicky Ustav
      • Prague, Чехия, 128 08
        • Vseobecna fakultni nemocnice v Praze
      • Praha 5 - Motol, Чехия, 15006
        • Nemocnicni lekarna Fakultni nemocnice v Motole
      • Praha 5 - Motol, Чехия, 15006
        • Fakultni nemocnice v Motole Onkologicka klinika 2. LF UK a FN Motol
    • Other
      • Brno, Other, Чехия, 656 53
        • Ustavni lekarna Masarykuv onkologicky ustav
      • Praha 4 - Krc, Other, Чехия, 14059
        • Fakultni Thomayerova nemocnice Onkologicka klinika 1. LF UK a FTN
  • Чили
      • Talca, Чили, 3460000
        • Clinica Universidad Catolica del Maule
      • Temuco, Чили, 4810297
        • Clinica Alemana Temuco
      • Temuco, Чили, 4810469
        • James Lind Centro De Investigacion Del Cancer
    • Santiago Metropolitan
      • Recoleta, Santiago Metropolitan, Чили, 8420323
        • Centro de Investigacion Clínica Bradford Hill
    • Valparaiso
      • Viña del Mar, Valparaiso, Чили
        • Oncocentro Apys
  • Швейцария
      • Baden, Швейцария, 5404
        • Kantonsspital Baden.
      • Zurich, Швейцария, 8008
        • Brust-Zentrum AG
    • Canton of Zurich
      • Winterthur, Canton of Zurich, Швейцария, 8401
        • Kantonsspital Winterthur
  • Южная Корея
      • Busan, Южная Корея, 49201
        • Dong-A University Hospital
      • Incheon, Южная Корея, 21565
        • Gachon University Gil Medical Center
      • Seoul, Южная Корея, 02841
        • Korea University Anam Hospital
    • Gangwon-do
      • Wŏnju, Gangwon-do, Южная Корея, 26426
        • Yonsei University Wonju Severance Christian Hospital
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Южная Корея, 10408
        • National Cancer Center
      • Seongnam-si, Gyeonggi-do, Южная Корея, 13620
        • Seoul National University Bundang Hospital
      • Suwon, Gyeonggi-do, Южная Корея, 16247
        • The Catholic University of Korea, St. Vincent's Hospital
      • Suwon, Gyeonggi-do, Южная Корея, 16499
        • Ajou University Hospital
    • North Chungcheong
      • Cheongju-si, North Chungcheong, Южная Корея, 28644
        • Chungbuk Nationl University Hospital
    • Other
      • Seoul, Other, Южная Корея, 03080
        • Seoul National University Hospital
      • Seoul, Other, Южная Корея, 05505
        • Asan Medical Center
      • Seoul, Other, Южная Корея, 06273
        • Gangnam Severance Hospital, Yonsei University Health System
      • Seoul, Other, Южная Корея, 06591
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Seoul, Other, Южная Корея, 07985
        • Ewha Womans University Mokdong Hospital
    • Seoul-teukbyeolsi [seoul]
      • Seoul, Seoul-teukbyeolsi [seoul], Южная Корея, 03722
        • Severance Hospital Yonsei University Health System
  • Япония
    • Chiba
      • Kamogawa, Chiba, Япония, 296-8602
        • Tesshokai Kameda General Hospital
      • Kashiwa-Shi, Chiba, Япония, 277-8577
        • National Cancer Center Hospital East
    • Ehime
      • Matsuyama, Ehime, Япония, 791-0280
        • NHO Shikoku Cancer Center
    • Fukuoka
      • Fukuoka, Fukuoka, Япония, 811-1395
        • National Hospital Organization Kyushu Cancer Center
    • Fukushima
      • Fukushima, Fukushima, Япония, 960-1295
        • Fukushima Medical University Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Япония, 003-0804
        • National Hospital Organization Hokkaido Cancer Center
    • Ibaraki
      • Tsukuba, Ibaraki, Япония, 305-8576
        • University of Tsukuba Hospital
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Япония, 920-8530
        • Ishikawa Prefectural Central Hospital
    • Kanagawa
      • Yokohama, Kanagawa, Япония, 241-8515
        • Kanagawa Cancer Center
    • Okinawa
      • Naha, Okinawa, Япония, 901-0154
        • Naha Nishi Clinic
    • Osaka
      • Osakasayama-shi, Osaka, Япония, 589-8511
        • Kindai University Hospital
      • Sakai, Osaka, Япония, 590-0197
        • Kindai University Hospital
    • Tokyo
      • Chuo-ku, Tokyo, Япония, 104-0045
        • National Cancer Center Hospital
      • Chuo-ku, Tokyo, Япония, 104-8560
        • St. Luke's International Hospital.
      • Minato-ku, Tokyo, Япония, 105-8470
        • Toranomon Hospital
      • Shinagawa-ku, Tokyo, Япония, 142-8666
        • Showa University Hospital

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Четырехместный

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Tucatinib + trastuzumab + pertuzumab

Tucatinib + trastuzumab + pertuzumab
Лекарство: Tucatinib

300mg given by mouth (orally) twice daily

Другие имена:
  • ТУКЫСА, ОНТ-380, АРРИ-380
Лекарство: Trastuzumab

6mg/kg given into the vein (IV; intravenously) or 600mg injected under the skin (SC; subcutaneous) every 21 days

Другие имена:
  • Герцептин, Герцептин Хилекта
Лекарство: Pertuzumab

420mg given by IV every 21 days

Другие имена:
  • Перьета
Лекарство: Combination product: Trastuzumab + Pertuzumab

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.

Другие имена:
  • Фесго
Активный компаратор: Placebo + trastuzumab + pertuzumab

Placebo + trastuzumab + pertuzumab
Лекарство: Trastuzumab

6mg/kg given into the vein (IV; intravenously) or 600mg injected under the skin (SC; subcutaneous) every 21 days

Другие имена:
  • Герцептин, Герцептин Хилекта
Лекарство: Pertuzumab

420mg given by IV every 21 days

Другие имена:
  • Перьета
Лекарство: Combination product: Trastuzumab + Pertuzumab

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.

Другие имена:
  • Фесго
Лекарство: Placebo

Given orally twice daily

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Progression-Free Survival (PFS) as Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
Временное ограничение: 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)

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Overall Survival (OS)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
Number of Participants With TEAEs: Through Study Completion
Временное ограничение: 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)

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Seagen, a wholly owned subsidiary of Pfizer

Следователи

  • Директор по исследованиям: Pfizer CT.gov Call Center, Pfizer

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

7 марта 2022 г.

Первичное завершение (Действительный)

5 сентября 2025 г.

Завершение исследования (Оцененный)

28 сентября 2027 г.

Даты регистрации исследования

Первый отправленный

12 ноября 2021 г.

Впервые представлено, что соответствует критериям контроля качества

12 ноября 2021 г.

Первый опубликованный (Действительный)

24 ноября 2021 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

29 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

4 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • SGNTUC-028
  • C4251007 (Другой идентификатор: Alias Study Number)
  • 2023-503826-37-00 (Идентификатор реестра: CTIS (EU))
  • 2023 (Грант/контракт NIH США)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана 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.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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