612
Participants
Start Date
January 28, 2016
Primary Completion Date
September 4, 2019
Study Completion Date
August 11, 2022
tucatinib
300 mg orally twice daily
capecitabine
1000 mg/m2 orally twice daily on Days 1-14 of each 21-day cycle
trastuzumab
8 mg/kg intravenously (IV) on Day 1 of Cycle 1, followed by 6 mg/kg on Day1 of each 21-day cycle. In regions where approved, trastuzumab may be given at 600mg subcutaneously once every 3-weeks at either study initiation or crossing over from previous IV trastuzumab.
placebo
Oral dose twice daily
Cliniques Universitaires Saint Luc, Brussels
Mater Hospital, North Sydney
Westmead Hospital, Westmead
Herlev Hospital, Herlev
AZ Klina, Brasschaat
Peter MacCallum Cancer Centre, Melbourne
Sunshine Hospital, St Albans
Austin Hospital, Heidelberg
Cabrini Education and Research Precinct, Malvern
KH d. Barmherzigen Schwestern Linz, Linz
Icon Cancer Care South Brisbane, South Brisbane
Mater Health Services, South Brisbane
CHU UCL Namur-Site de Saint Elisabeth, Namur
Odense University Hospital, Odense C
LKH Salzburg, Universitatsklinikum der PMU, Salzburg
Grand Hopital de Charleroi, Charleroi
Breast Cancer Research Centre, Nedlands
Medizinische Universitat Innsbruck, Innsbruck
Institute of Oncology of Southern Switzerland, Bellinzona
Centre Hospitalier de l'Ardenne, Libramont
Sygehus Lillebaelt - Vejle Sygehus, Vejle
LKH- Universitat Klinikum Graz, Graz
Aalborg Universitetshospital, Aalborg
Hospital San Pedro de Alcantara, Cáceres
Mount Sinai Beth Israel, New York
New York University (NYU) Cancer Institute, New York
Charite Universitatsmedizin Berlin, Berlin
Montefiore Medical Center, The Bronx
Stony Brook University Cancer Center, Stony Brook
Institut Paoli Calmettes, Marseille
Hospital Clinico Univ De Santiago De Compostela, Santiago de Compostela
Ospedale Policlinico San Martino, Genova
University of Pennsylvania / Perelman Center for Advanced Medicine, Philadelphia
Cancer Treatment Centers of America / Eastern Regional Medical Center, Philadelphia
Lombardi Cancer Center / Georgetown University Medical Center, Washington D.C.
Istituto Europeo di Oncologia, Milan
Universitaetsklinikum Hamburg-Eppendorf (UKE) - Onkologisches Zentrum - Interdisziplinaere Klinik und Poliklinik fuer Stammzelltransplantation, Hamburg
Maryland Oncology Hematology, P.A., Rockville
University of Maryland, Baltimore
Virginia Cancer Specialists, PC, Fairfax
Shenandoah Oncology P.C., Winchester
Complejo Asistencial Universitario de Leon, León
Universitatsklinikum Schleswig-Holstein, Kiel
University Hospital of Besancon, Besançon
IRCSS Policlinico San Matteo, Pavia
UNC Lineberger Comprehensive Cancer Center / University of North Carolina, Chapel Hill
Duke University Medical Center, Durham
Leo W. Jenkins Cancer Services / Brody School of Medicine East Carolina University, Greenville
Hospital General Universitario Gregorio Marañon, Madrid
Hospital Universitario 12 de Octubre, Madrid
Roper St. Francis Healthcare, Charleston
Medical University of South Carolina/Hollings Cancer Center, Charleston
Cancer Treatment Centers of America, Newnan
Winship Cancer Institute / Emory University School of Medicine, Atlanta
Northside Hospital, Atlanta
Medizinische Hochschule Hannover, Hanover
Augusta University, Augusta
Institut Claudius Regaud, Toulouse
Rambam Health Corp., Haifa
Baptist MD Anderson Cancer Center, Jacksonville
Orlando Health, Inc. TRIO, Orlando
Memorial Regional Hospital TRIO, Hollywood
University of Miami, Miami
Mount Sinai Medical Center / Florida, Miami Beach
Florida Cancer Specialists - East West Palm Beach, FL (SCRI), West Palm Beach
H. Lee Moffitt Cancer Center and Research Institute, Tampa
Florida Cancer Specialists - North Region, St. Petersburg
Florida Cancer Specialists - South Region, Fort Myers
Centre Eugene Marquis, Rennes
University of Alabama at Birmingham, Birmingham
University of South Alabama - Mitchell Cancer Institute, Mobile
CHU Tours - Hopital Bretonneau, Tours
Tennessee Oncology - Nashville, Nashville
Vanderbilt University Medical Center, Nashville
Wellmont Cancer Institute, Kingsport
Ospedale di Bolzano, Bolzano
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi, Bologna
Ospedale Ramazzini di Carpi, Carpi
James Cancer Hospital / Ohio State University, Columbus
Meir Medical Center, Kfar Saba
Kliniken Essen-Mitte - Evang. Huyssens-Stiftung, Essen
Hospital Arnau De Vilanova, Valencia
William Beaumont Hospital, Royal Oak
Henry Ford Health System, Detroit
Rabin Medical Center, Petah Tikva
Hospital Clinico Universitario Lozano Blesa de Zaragoza, Zaragoza
Universitatsklinikum Koln, Cologne
Institut Jean Godinot, Reims
Sheba Medical Center, Tel Litwinsky
Carbone Cancer Center / University of Wisconsin, Madison
Virginia Piper Cancer Institute, Minneapolis
InVO- Institut fUr Versorgungsforschung in der onkologie GbR, Koblenz
A.O.U. - Ospedali Riuniti di Ancona, Torrette
Rush University Medical Center, Chicago
Illinois Cancer Specialists / Advocate Lutheran General Hospital, Niles
Carle Cancer Center, Urbana
Sana Klinikum Offenbach GmbH, Offenbach
Saint Luke's Cancer Institute LLC, Kansas City
Tel Aviv Sourasky Medical Center, Tel Aviv
University of Kansas Cancer Center, Westwood
Hopitaux Universitaires de Strasbourg, Strasbourg
Nebraska Cancer Specialists, Omaha
Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes, Lyon
Centre Hospitalier Lyon Sud, Pierre-Bénite
Clinique Victor Hugo, Le Mans
Presido Ospedaliero- Senatore Antonio Perrino, Brindisi
Institute Curie - Centre de Lutte Contre Le Cancer CLCC de Paris, Paris
Texas Oncology - Plano East, Plano
Texas Oncology Methodist, Dallas
Paris Regional Medical Center / US Oncology, Paris
Kaplan Medical Center, Rehovot
The Center for Cancer and Blood Disorders: Fortworth, Fort Worth
Texas Oncology - Denton South, Denton
Texas Oncology - Houston Memorial City, Houston
Baylor Clinic, Houston
US Oncology Central Regulatory, The Woodlands
Fakultni Nemocnice Olomouc (Fnol) - Onkologicka Klinika, Olomouc
Texas Oncology - Deke Slayton Cancer Center, Webster
Texas Oncology - San Antonio Medical Center Northeast, San Antonio
University of Texas Health Science Center at San Antonio, San Antonio
Texas Oncology - Austin Midtown, Austin
Joe Arrington Cancer Research and Treatment Center, Lubbock
HOPE- Onkologisches Zentrum Rotkreuzklinikum, München
University of Utah, Salt Lake City
Arizona Oncology Associates, PC - HAL, Phoenix
Cancer Treatment Centers of America - Phoenix, Goodyear
TRIO - Central Regulatory Office, Los Angeles
UCLA Medical Center / David Geffen School of Medicine, Los Angeles
Torrance Memorial Physician Network - TRIO, Redondo Beach
Hadassah Medical Center, Jerusalem
Kaiser Permanente San Marcos Medical Offices, San Marcos
Central Coast Medical Oncology Corporation TRIO, Santa Maria
University of California at San Francisco, San Francisco
Kaiser Permanente Medical Center Northern California, Vallejo
Northwest Cancer Specialists, P.C., Tualatin
Providence Portland Medical Center, Portland
Swedish Cancer Institute, Seattle
City of Hope National Medical Center, Duarte
University of Colorado Hospital / University of Colorado, Aurora
Yale Cancer Center, New Haven
University of Chicago, Chicago
Dana Farber Cancer Institute, Boston
Dartmouth-Hitchcock Medical Center/ Norris Cotton Cancer Center, Lebanon
Hackensack University Medical Center, Hackensack
Oregon Health and Science University, Portland
MD Anderson Cancer Center / University of Texas, Houston
Seattle Cancer Care Alliance / University of Washington, Seattle
Tom Baker Cancer Centre, Calgary
University of Alberta / Cross Cancer Institute, Edmonton
Queen Elizabeth II Health Sciences Centre, Halifax
Jewish General Hospital, Montreal
Hopital du Saint-Sacrement, CHU de Quebec-Universite Laval, Québec
Allan Blair Cancer Centre, Regina
Saskatoon Cancer Centre, Saskatoon
H. Bliss Murphy Cancer Centre, St. John's
Sunnybrook Health Sciences Centre, Toronto
University Health Network, Princess Margaret Hospital, Toronto
British Columbia Cancer Agency - Vancouver Centre, Vancouver
Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie, Hradec Králové
Rigs Hospiltalet, Copenhagen
Azienda Ospedaliera S. Maria di Terni, Terni
Hospital Cuf Descobertas R. Mario Botas Parque das Nacoes, Lisbon
Centro Hospitalar do Porto - Hospital Santo Antonio, Porto
Hospital Universitario Vall d'Hebron, Barcelona
Hospital Clinic i Provincial de Barcelona, Barcelona
Hospital Son Espases, Palma de Mallorca
Colchester Hospital University NHS Foundation Trust, Colchester
The Royal Marsden Hospital, London
Sarah Cannon Research Institute UK, London
The Christie NHS Foundation Trust, Manchester
Mount Vernon Hospital, UK, Northwood
Nottingham University Hospitals NHS Trust, Nottingham
Peterborough City Hospital, Peterborough
Weston Park Hospital- UK, Sheffield
The Royal Marsden Hospital (Surrey), Sutton
Royal Cornwall Hospitals NHS Trust, Truro
Seagen Inc.
INDUSTRY