654
Participants
Start Date
March 7, 2022
Primary Completion Date
September 5, 2025
Study Completion Date
September 28, 2027
Tucatinib
300mg given by mouth (orally) twice daily
Trastuzumab
6mg/kg given into the vein (IV; intravenously) or 600mg injected under the skin (SC; subcutaneous) every 21 days
Pertuzumab
420mg given by IV every 21 days
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.
Placebo
Given orally twice daily
National Taiwan University Hospital, Taipei
Koo Foundation Sun Yat-Sen Cancer Center, Taipei
Chang Gung Memorial Hospital LinKou, Taoyuan
National Cheng Kung University Hospital, Tainan City
Chi Mei Medical Center, Tainan City
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City
Jules Bordet lnstituut, Anderlecht
Universitair Ziekenhuis Brussel (UZ Brussel), Brussels
Cliniques Universitaires Saint-Luc, Brussels
Clinique St-Pierre, Ottignies
Chris O'Brien Lifehouse, Camperdown
Macquarie University Clinical Trials Unit., Macquarie University
Western Sydney Local Health District (WSLHD), Westmead Hospital, Westmead
Austin Health, Heidelberg
Box Hill Hospital, Box Hill
Cancer Research SA, Adelaide
St Andrews Medical Centre, Adelaide
Flinders Medical Centre, Bedford Park
Kantonsspital Baden., Baden
St John of God Subiaco Hospital Clinical Trials Unit Bendat Family Comprehensive Cancer Centre, Subiaco
Brust-Zentrum AG, Zurich
Kantonsspital Winterthur, Winterthur
Hospital San Pedro de Alcantara, Cáceres
Charite Universtitatsmedizin Berlin Klinik fur Gynakologie mit Brustzentrum, Berlin
National Cancer Center, Goyang-si
MacKay Medical Foundation The Presbyterian Church in Taiwan MacKay Memorial Hospital, Taipei
Montefiore Einstein Comprehensive Cancer Center, The Bronx
Taipei Veterans General Hospital, Taipei
"General Hospital of Athens Alexandra Clinical Therapeutics Department, Hematology/Oncology Unit", Athens
Charite - Universitatsmedizin Berlin, Berlin
Seoul National University Bundang Hospital, Seongnam-si
Fakultni Thomayerova nemocnice Onkologicka klinika 1. LF UK a FTN, Praha 4 - Krc
Centre de Lutte contre le Cancer - François Baclesse, Caen
Fakultni nemocnice v Motole Onkologicka klinika 2. LF UK a FN Motol, Praha 5 - Motol
IASO General Clinic Oncology Clinic, Marousi
IRCCS Ospedale Policlinico, San Martino, Genoa
The Catholic University of Korea, St. Vincent's Hospital, Suwon
Ajou University Hospital, Suwon
Institut Catala d'Oncologia Girona - ICO Girona, Girona
Hospital Universitario Virgen de las Nieves, Granada
Metaxa Anticancer Hospital of Piraeus, Pireaus
Asplundh Cancer Pavillion, Willow Grove
Istituto Clinico Humanitas, Milan
Divisione di Senologia Medica; Istituto Europeo di Oncologia, Milan
Universitatsklinikum Hamburg-Eppendorf (UKE), Hamburg
ASST Monza Ospedale San Gerardo Centro Ricerca di Fase 1, Monza (MB)
Mercy Medical Center, Baltimore
Gachon University Gil Medical Center, Incheon
"CARIO - Centre Armoricain de Radiotherapie lmagerie medicate et d'Oncologie -Hopital Prive des", Plérin
CHU Besancon, Besançon
Hospital Universitari Arnau de Vilanova, Lleida
Yonsei University Wonju Severance Christian Hospital, Wŏnju
University General Hospital of Patras, Oncology Department, Internal Medicine Clinic, Patra
Istituti Clinici Scientifici Maugeri IRCCS, Pavia
Hospital General Universitario Gregorio Maranon, Madrid
Hospital Universitario Ramon y Cajal, Madrid
Chungbuk Nationl University Hospital, Cheongju-si
Hospital El Angel Grupo Hla, S.L.U, Málaga
Hospital Universitario Virgen De La Arrixaca, EI Palmar
Emory University Hospital Midtown, Atlanta
Emory University Clinic, Atlanta
Winship Cancer Institute, Atlanta
Emory Saint Joseph's Hospital, Atlanta
Mayo Clinic Florida, Jacksonville
AdventHealth Altamonte Infusion Center, Altamonte Springs
AdventHealth Medical Group Altamonte(second location), Altamonte Springs
AdventHealth Medical Group Altamonte, Altamonte Springs
AdventHealth Medical Group Orlando, Orlando
AdventHealth Orlando Infusion Center, Orlando
Institut Bergonie, Bordeaux
Tampere University Hospital, FONK/RSYO, Tampere
Centre de Cancérologie du Grand Montpellier, Montpellier
Institut Régional du Cancer de Montpellier, Montpellier
Hospital Universitario de Salamanca (Spain Salamanca), Salamanca
Tennessee Oncology, PLLC, Gallatin
Tennessee Oncology, PLLC, Murfreesboro
Tennessee Oncology, PLLC, Shelbyville
Sarah Cannon Research Institute- Pharmacy, Nashville
Tennessee Oncology, PLLC, Nashville
Divisione Oncologia Medica, Ospedale di Trento - Presidio Ospedaliero (PO) Santa Chiara, Trento
SOC Farmacia, Ospedale di Trento - Presidio Ospedaliero (PO), Trento
Hospital Universitario de Canarias, La Laguna Tenerife
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi, Bologna
SSD Oncologia Medica Addarii - Zamagni, Policlinico Sant'Orsola - Malpighi, Bologna
Norton Cancer Institute - Downtown, Louisville
Norton Cancer Institute, Downtown, Louisville
Norton Cancer Institute, St Matthews Campus, Louisville
Norton Cancer Institute, Brownsboro Hospital Campus, Louisville
Hospital Universitario Virgen del Rocio, Seville
University General Hospital of Larissa, Oncology Clinic, Larissa
UOC di Oncologia Medica, Azienda Ospedaliero Universitaria (AOU) di Parma, Parma
Cleveland Clinic Taussig Cancer Center Investigational Pharmacy, Cleveland
Cleveland Clinic Cancer Center - Strongsville, Strongsville
Cleveland Clinic, Cleveland
Institut de Cancerologie de lOuest - Site Rene Gauducheau, Saint-Herblain
Institut de Cancerologie de lOuest-Saint Herblain, Saint-Herblain
Fundacion lnstituto Valenciano de Oncologia, Valencia
Hospital Clinico Universitario de Valencia, Valencia
Hospital Universitario de Basurto, Bilbao
University Hospital Muenster Senology, Münster
Dong-A University Hospital, Busan
Froedtert Hospital/Medical College of Wisconsin, Milwaukee
Mayo Clinic, Rochester
Oncologia Medica Azienda Usl Toscana Nord Ovest - Ospedali Riuniti di Livor, Livorno
S.O.C. Oncologia Medica - Nuovo Ospedale di Prato Santo Stefano, Prato
Azienda Ospedaliero Universitaria delle Marche SOD Clinica Oncologica, Torrette
University of Illinois Hospital and Health Systems (Investigational Drug Pharmacy), Chicago
University of Illinois Hospital and Health Systems (Outpatient Cancer Center), Chicago
University of Illinois Hospital and Health Systems, Chicago
Centre Jean Perrin, Clermont-Ferrand
Saint Luke's Cancer Institute., Kansas City
Institut de Cancerologie Strasbourg Europe, Strasbourg
Oncology Hematology West PC dba Nebraska Cancer Specialists, Papillion
Oncology Hematology West PC dba Nebraska Cancer Specialists, Omaha
Oncology Hematology West PC dba Nebraska Cancer Specialists, Omaha
Oncology Hematology West PC dba Nebraska Cancer Specialists, Omaha
Pharmacy:Fortuna Herstellung GmbH, Mannheim
Universitätsmedizin Mannheim Universitätsfrauenklinik, Manheim
Oncology Hematology West PC dba Nebraska Cancer Specialists, Grand Island
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island, Grand Island
Hospices Civils de Lyon, Pierre-Bénite
Central Arkansas Radiation Therapy Institute Inc d.b.a CARTI, Little Rock
Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer, Rouen
Azienda Ospedaliera Universitaria Federico II, Napoli
lstituto Nazionale Tumori IRCCS - Fondazione Pascale U.O.C. Oncologia Medica Senologica, Napoli
Klinikum Rechts der Isar der Technischen Universitaet Muenchen, München
Institut Sainte-Catherine., Avignon
Mayo Clinic Hospital, Phoenix
Mayo Clinic, Scottsdale
"Universitatsklinikum Augsburg Klinik fur Frauenheilkunde und Geburtshilfe", Augsburg
Universitatsklinikum Ulm Klinik fur Frauenheilkunde und Geburtshilfe, Ulm
Administrative Address: UCLA Hematology/Oncology, Los Angeles
UCLA Hematology/Oncology, Los Angeles
UCLA Hematology/Oncology - Beverly Hills, Beverly Hills
UCLA Hematology/Oncology - Santa Monica, Santa Monica
UCLA Hematology/Oncology Parkside, Santa Monica
Clinical And Translational Research Center, Torrance
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance
Harbor-UCLA Medical Center, Torrance
UCLA Hematology/Oncology - Santa Clarita, Valencia
UCLA Hematology/Oncology- Westlake, Westlake Village
UCLA Hematology/Oncology - Burbank, Burbank
UCSD Medical Center - Encinitas, Encinitas
Sulpizio Cardiovascular Center at UC San Diego Health, La Jolla
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion), La Jolla
UCSD Koman Family Outpatient Pavilion, La Jolla
UCSD Perlman Medical Offices, La Jolla
UCSD Medical Center - Vista, Vista
UC San Diego Moores Cancer Center, La Jolla
UC San Diego Medical Center - Hillcrest, San Diego
Institut Curie - site St-Cloud, Saint-Cloud
Institut Curie, Saint-Cloud
UCLA Hematology/Oncology - Laguna Hills, Laguna Hills
UCLA Hematology/Oncology- Santa Barbara, Santa Barbara
UCLA Hematology/Oncology - San Luis Obispo, San Luis Obispo
Humanitas lstituto Clinico Catanese, Catania (CT)
Universitatsklinikum Wurzburg Frauenklinik und Poliklinik, Würzburg
Universitatsklinikum Wurzburg, Comprehensive Cancer Center - Mainfranken (CCCMF), Würzburg
Fred Hutchinson Cancer Center, Seattle
University of Washington Medical Center, Seattle
Beijing Hospital, Beijing
The First Hospital of China Medical University, Shenyang
Liaoning Cancer Hospital & Insitute, Shenyang
The First Hospital of Jilin University, Changchun
Ruijin Hospital of Shanghai Jiaotong University School of Medicine, Shanghai
Fudan University Shanghai Cancer Center, Shanghai
Nanjing Medical University (NMU) - Jiangsu Province Hospital, Nanjing
The Second Hospital of Anhui Medical University, Hefei
Jinan Central Hospital, Jinan
Linyi Cancer Hospital, Linyi
Tianjin Medical University Cancer Institute & Hospital, Tianjin
Zhejiang Cancer Hospital, Hangzhou
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou
The Second Affiliated Hospital of Nanchang University, Nanchang
The Second Xiangya Hospital of Central South University, Changsha
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan
Hubei Cancer Hospital, Wuhan
Henan Cancer Hospital, Zhengzhou
Guangdong Provincial People's Hospital, Guangzhou
Meizhou People's Hospital, Meizhou
Guangxi Medical University Affiliated Tumor Hospital, Nanning
The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning
Liuzhou People's Hospital, Liuzhou
The first Affiliated Hospital of Hainan Medical University, Haikou
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an
UCSD Medical Center - Bankers Hill, San Diego
Clinica Universidad Catolica del Maule, Talca
James Lind Centro De Investigacion Del Cancer, Temuco
RWJBarnabas Health- Jersey City Medical Center, Jersey City
RWJBarnabas Health- Monmouth Medical Center-Southern Campus, Lakewood
RWJBarnabas Health- Cooperman Barnabas Medical Center, Livingston
RWJBarnabas Health- Monmouth Medical Center, Long Branch
Rutgers Cancer Institute of New Jersey, New Brunswick
Newark Beth Israel Medical Center, Newark
RWJBarnabas Health-Robert Wood Johnson University Hospital, Somerset, Somerville
Steeplechase Cancer Center, Somerville
RWJBarnabas Health - Community Medical Center, Toms River
Satellite Infusion Center-Monmouth Medical Center Vantage Point Infusion Center, West Long Branch
Ordination Priv.-Doz. Dr. Michael Hubalek, Schwaz
Medizinische Universitat Graz, Graz
Ordensklinikum Linz GmbH Barmherzige Schwestern, Linz
Medizinische Universitat Wien Universitatsklinik Fur Frauenheilkunde, Vienna
CRIO - Centro Regional lntegrado de Oncologia, Fortaleza
Hospital Araujo Jorge, Goiânia
Hospital Do Cancer De Londrina, Londrina
Liga Norte-Rio Grandense Contra o Cancer, Natal
Hospital de Clinicas de Porto Alegre, Porto Alegre
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital do Cancer Mae de Deu, Porto Alegre
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital do Cancer Mae de Deu, Porto Alegre
Fundacao Pio XII, Hospital do Amor de Barretos, Barretos
Fundacao Dr Amaral Carvalho, Jaú
CEPHO- Centro de Estudos e Pesquisas de Hematologia e Oncologia, Santo André
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia, Santo André
Irmandade da Santa Casa de Misericordia de Porto Alegre centro Multidisciplinar de pesquisa clinica, Porto Alegre/RS
Faculdade Regional de Medicina de Sao Jose do Rio Preto, São José do Rio Preto
ICESP- Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira, São Paulo
Sao Camilo Oncologia, São Paulo
Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecologica e Mamária Ltda., São Paulo
A.C. Camargo Câncer Center, São Paulo/SP
Cross Cancer Institute, Edmonton
BC Cancer Agency, Kelowna
The Ottawa Hospital Cancer Centre, Ottawa
Sunnybrook Research Institute, Toronto
Mount Sinai Hospital, Toronto
Centre integre universitaire de sante et de services sociaux du Saguenay-Lac-Saint-Jean, Chicoutimi
Centre Hospitalier de l'Universite de Motreal (CHUM), Montreal
Jewish General Hospital, Montreal
Oncocentro Apys, Viña del Mar
Centro de Investigacion Clínica Bradford Hill, Recoleta
Shaanxi Provincial People's Hospital, Xi'an
Affiliated Hospital of Hebei University, Baoding
Masarykuv Onkologicky Ustav, Brno
Ustavni lekarna Masarykuv onkologicky ustav, Brno
Vseobecna fakultni nemocnice v Praze, Prague
Hopital Avicenne, Bobigny
CENTRE FRANCOIS BACLESSE - Service lmagerie medicale, Caen
Center Georges-Francois Leclerc, Dijon
Centre Oscar Lambret, Lille
Center Leon Berard, Lyon
Institut Regional du Cancer de Montpellier Service lmagerie medicale, Montpellier
Centre Antoine Lacassagne, Nice
Centre Eugene Marquis, Rennes
Centre Henri Becquerel, Rouen
Tesshokai Kameda General Hospital, Kamogawa
National Cancer Center Hospital East, Kashiwa-Shi
NHO Shikoku Cancer Center, Matsuyama
National Hospital Organization Kyushu Cancer Center, Fukuoka
Fukushima Medical University Hospital, Fukushima
National Hospital Organization Hokkaido Cancer Center, Sapporo
Ishikawa Prefectural Central Hospital, Kanazawa
Kanagawa Cancer Center, Yokohama
University of Tsukuba Hospital, Tsukuba
Naha Nishi Clinic, Naha
Kindai University Hospital, Osakasayama-shi
National Cancer Center Hospital, Chuo-ku
St. Luke's International Hospital., Chuo-ku
Toranomon Hospital, Minato-ku
Showa University Hospital, Shinagawa-ku
Albert Schweitzer Hospital, Doedrecht
Albert Schweitzer Ziekenhuis, Dordrecht
St. Antonius Hospital, Utrecht
VieCuri Medsich Centrum, Venlo
Narodowy lnstytut Onkologii im. Marii Sklodowskiej-Curie-Panstwowy lnstytut Badawczy, Gliwice
Uniwersyteckie Centrum Kliniczne, Gdansk
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Lodz
SP ZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego w Opolu, Opole
Centro Clinico Academico Braga Hospital de Braga, Braga
Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE (IPO, Coimbra), Coimbra
Fundacao Champalimaud, Lisbon
Hospital CUF Descobertas, Lisbon
Korea University Anam Hospital, Seoul
Seoul National University Hospital, Seoul
Severance Hospital Yonsei University Health System, Seoul
Asan Medical Center, Seoul
Gangnam Severance Hospital, Yonsei University Health System, Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul
Ewha Womans University Mokdong Hospital, Seoul
Hospital Universitario Son Espases, Palma de Mallorca
Fundación Privada Instituto de Investigación Oncológica de Vall Hebron, Barcelona
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca, Barcelona
Hospital Universitari Vall d'Hebron, Barcelona
Hospital General Universitario Alicante, Alicante
Hospital de la Santa Creu i Sant Pau, Barcelona
Changhua Christian Medical Foundation Changhua Christian Hospital, Changhua
Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare, New Taipei City
China Medical University Hospital, Taichung
Tri-Service General Hospital, Taipei
Academic Oncology, London
The Royal Marsden NHS Foundation Trust (Surrey), London
The Royal Marsden, Sutton
Finchley Memorial Hospital, London
University College London Hospital (UCLH) NHS Foundation Trust, London
The Royal Marsden, London
Christie Hospital NHS Foundation Trust, Manchester
Seagen, a wholly owned subsidiary of Pfizer
INDUSTRY