Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Subjects With Unresectable Locally-advanced or Metastatic HER2+ Breast Cancer (HER2CLIMB-02)

Who is this study for? Adult HER2-positive Breast Cancer
What treatments are being studied? Tucatinib
Status: Active_not_recruiting
Location: See all (493) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. All patients in the study will get T-DM1, a drug that is often used to treat this cancer. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Histologically confirmed HER2+ breast carcinoma as determined by a sponsor-designated central laboratory

• History of prior treatment with a taxane and trastuzumab in any setting, separately or in combination

• Have progression of unresectable locally advanced/metastatic breast cancer after last systemic therapy, or be intolerant of last systemic therapy

• Measurable or non-measurable disease assessable by RECIST v1.1

• ECOG performance status score of 0 or 1

• CNS Inclusion - Based on screening contrast brain magnetic resonance imaging (MRI), participants must have at least one of the following:

⁃ (a) No evidence of brain metastases

⁃ (b) Untreated brain metastases not needing immediate local therapy

⁃ (c) Previously treated brain metastases

‣ Brain metastases previously treated with local therapy may either be stable since treatment or may have progressed since prior local CNS therapy, provided that there is no clinical indication for immediate re-treatment with local therapy

‣ Participants treated with CNS local therapy for newly identified lesions or previously treated and progressing lesions may be eligible to enroll if all of the following criteria are met:

∙ (i) Time since SRS is at least 7 days prior to first dose of study treatment, time since WBRT is at least 14 days prior to first dose, or time since surgical resection is at least 28 days.

∙ (ii) Other sites of evaluable disease are present

‣ Relevant records of any CNS treatment must be available to allow for classification of target and non-target lesions

Locations
United States
Alabama
University of South Alabama Health Children's and Women's Hospital
Mobile
University of South Alabama Health University Hospital
Mobile
University of South Alabama Mitchell Cancer Institute
Mobile
Arizona
Banner Gateway Medical Center
Gilbert
Banner MD Anderson Cancer Center
Gilbert
Western Regional Medical Center, LLC
Goodyear
Arizona Oncology Associates, PC - HOPE
Tucson
Arizona Oncology Associates, PC - HOPE
Tucson
Arizona Oncology Associates, PC - HOPE.
Tucson
California
UCLA Hematology/Oncology - Alhambra
Alhambra
Kaiser Permanente Medical Center Lab Drawing Station
Antioch
Kaiser Permanente Medical Center Lab Drawing Station
Antioch
UCLA Hematology/Oncology- Beverly Hills
Beverly Hills
UC Irvine Health Cancer Center - Newport
Costa Mesa
City of Hope Investigational Drug Services (IDS)
Duarte
City of Hope(City of Hope National Medical Center,City of Hope Medical Center)
Duarte
Kaiser Permanente Medical Center (Radiology)
Dublin
UCLA Hematology/Oncology - Encino
Encino
Kaiser Permanente Medical Center Lab Drawing Station
Fairfield
Kaiser Permanente Medical Center Lab Drawing Station
Gilroy
UCLA Hematology/Oncology- Irvine
Irvine
Drug Management Only: UCLA West Medical Pharmacy, Attn: Steven L Wong, Pharm.D.
Los Angeles
Regulatory Management only: TRIO-US Central Administration
Los Angeles
Ronald Reagan UCLA Medical Center
Los Angeles
UCLA Hematology/Oncology
Los Angeles
UCLA West Medical Pharmacy
Los Angeles
Kaiser Permanente Medical Center Lab Drawing Station
Martinez
Kaiser Permanente Medical Center Lab Drawing Station
Milpitas
Kaiser Permanente Medical Center Lab Drawing Station
Modesto
Kaiser Permanente Medical Center Lab Drawing Station
Mountain View
Kaiser Permanente Medical Center Lab Drawing Station
Napa
Kaiser Permanente Medical Center (clinic+DSL)
Oakland
Kaiser Permanente Medical Center (Radiology)
Oakland
Chao Family Comprehensive Cancer Center University of California Irvine
Orange
UC Irvine Medical Center Attn: Trisha Maris
Orange
UCI Medical Center - Chao Family Comprehensive Cancer Center
Orange
Kaiser Permanente Medical Center Lab Drawing Station
Pleasanton
UCLA Hematology/Oncology - Porter Ranch
Porter Ranch
Kaiser Permanente Medical Center Lab Drawing Station
Redwood City
Kaiser Permanente Medical Center (clinic+DSL)
Roseville
Kaiser Permanente Medical Center (Radiology)
Sacramento
Kaiser Permanente Sacramento J Street Medical Center (clinic+DSL+Lab Drawing Station)
Sacramento
University of California Davis
Sacramento
University of California Davis Medical Center
Sacramento
Kaiser Permanente Medical Center (clinic+DSL)
San Francisco
Kaiser Permanente Mission Bay Medical Center Lab Drawing Station
San Francisco
University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center.
San Francisco
Zuckerberg San Francisco General Hospital
San Francisco
Kaiser Permanente Medical Center (clinic+DSL)
San Jose
Kaiser Permanente Medical Center Lab Drawing Station
San Jose
Kaiser Permanente Medical Center (clinic+DSL)
San Leandro
UCLA Hematology/Oncology - San Luis Obispo
San Luis Obispo
Kaiser Permanente Medical Center (clinic+DSL)
Santa Clara
UCLA Hematology/Oncology - Santa Monica
Santa Monica
UCLA Hematology/Oncology Parkside
Santa Monica
Kaiser Permanente Medical Center (clinic+DSL)
South San Francisco
Torrance Memorial Physician Network - Cancer Care
Torrance
Torrance Memorial Physician Network-Cancer Care
Torrance
UCLA Torrance Oncology
Torrance
UCLA Hematology/Oncology - Santa Clarita
Valencia
Kaiser Permanente Medical Center (clinic+DSL)
Vallejo
UCLA Hematology/Oncology - Ventura
Ventura
Kaiser Permanente Medical Center (clinic+DSL)
Walnut Creek
Colorado
Clinical and Translational Research Center (CTRC)
Aurora
Rocky Mountain Cancer Centers, LLP
Aurora
University of Colorado Hospital
Aurora
University of Colorado Hospital - Anschutz Cancer Pavilion(ACP)
Aurora
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
Aurora
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
Aurora
Rocky Mountain Cancer Centers, LLP
Boulder
Rocky Mountain Cancer Centers, LLP
Centennial
Briargate Medical Campus
Colorado Springs
Printers Park Medical Plaza
Colorado Springs
Rocky Mountain Cancer Centers, LLP
Colorado Springs
UCH-MHS Memorial Hospital Central
Colorado Springs
UCH-MHS Memorial Hospital North
Colorado Springs
Cancer Centers of Colorado at Saint Joseph Hospital
Denver
Rocky Mountain Cancer Centers, LLP
Denver
Rocky Mountain Cancer Centers, LLP
Denver
SCL Health Saint Joseph Hospital
Denver
UCHealth Cherry Creek Medical Center
Denver
UCHealth IDS Research Pharmacy - Cherry Creek
Denver
Cancer Care & Hematology - Fort Collins
Fort Collins
Poudre Valley Hospital
Fort Collins
Cancer Care & Hematology - Greeley
Greeley
SCL Health Good Samaritan Medical Center
Lafayette
SCL Health Good Samaritan Medical Center Cancer Centers of Colorado
Lafayette
Rocky Mountain Cancer Centers, LLP
Lakewood
Rocky Mountain Cancer Centers, LLP
Littleton
Rocky Mountain Cancer Centre, LLP
Lone Tree
Cancer Care & Hematology - Loveland
Loveland
Rocky Mountain Cancer Centers, LLP
Thornton
Washington, D.c.
Georgetown University Medical Center
Washington D.c.
Washington Cancer Institute at MedStar Washington Hospital Center
Washington D.c.
Florida
Florida Cancer Specialists
Altamonte Springs
Florida Cancer Specialists
Bonita Springs
Florida Cancer Specialists
Brandon
Florida Cancer Specialists
Cape Coral
Florida Cancer Specialists
Clearwater
Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center
Coral Gables
Florida Cancer Specialists.
Daytona Beach
Sylvester Comprehensive Cancer Center- Deerfield Beach
Deerfield Beach
Florida Cancer Specialists
Fort Myers
Florida Cancer Specialists
Fort Myers
Florida Cancer Specialists - South Region
Fort Myers
Florida Cancer Specialists
Gainesville
Baptist MD Anderson Cancer Center
Jacksonville
Florida Cancer Specialists
Largo
Florida Cancer Specialists
Lecanto
Bascom Palmer Eye Institute
Miami
Miami Cancer Institute at Baptist Health, Inc.
Miami
Sylvester Comprehensive Cancer Center
Miami
Sylvester Comprehensive Cancer Center Kendall
Miami
Florida Cancer Specialists
Naples
Florida Cancer Specialists
Ocala
AdventHealth Hematology and Oncology
Orlando
AdventHealth Medical Group Orlando
Orlando
AdventHealth Orlando
Orlando
AdventHealth Orlando Infusion Center
Orlando
AdventHealth Orlando, Investigational Drug Services
Orlando
Florida Cancer Specialists
Orlando
Orlando Health, Inc. TRIO
Orlando
Sylvester Comprehensive Cancer Center Plantation
Plantation
Florida Cancer Specialists
Port Charlotte
Florida Cancer Specialists
Sarasota
Florida Cancer Specialists
St. Petersburg
Florida Cancer Specialists - North Region
St. Petersburg
Florida Cancer Specialists.
Stuart
Florida Cancer Specialists
Tampa
Moffitt Cancer Center
Tampa
Moffitt Cancer Center, Richard M, Schulze Family Foundation Outpatient Center at McKinley Campus
Tampa
Moffitt McKinley Hospital
Tampa
Florida Cancer Specialists
Tavares
Florida Cancer Specialists
The Villages
Florida Cancer Specialists
Trinity
Florida Cancer Specialists.
Vero Beach
Florida Cancer Specialists.
Wellington
Florida Cancer Specialists.
West Palm Beach
Georgia
Northside Hospital, Inc. - GCS/ Athens
Athens
Atlanta Cancer Care - Atlanta
Atlanta
Northside Hospital, Inc. - Central Research Department
Atlanta
Northside Hospital, Inc. - GCS/Northside
Atlanta
Winship Cancer Institute, Emory University.
Atlanta
Georgia Cancer Center at Augusta University
Augusta
Northside Hospital, Inc. - GCS/Blairsville
Blairsville
Northside Hospital, Inc. - GCS/Canton
Canton
Atlanta Cancer Care - Cumming
Cumming
Northside Hospital, Inc. - GCS/Macon
Macon
Northside Hospital, Inc. - GCS/Kennestone
Marietta
Hawaii
Hawai'i Pacific Health Research Institute - Administrative Site
Honolulu
Kaiser Permanente Hawaii
Honolulu
Kaiser Permanente Hawaii.
Honolulu
Kapi'olani Medical Center for Women and Children
Honolulu
Kapi'olani Women's Center
Honolulu
Illinois
Illinois CancerCare- Bloomington
Bloomington
Rush University Medical Center, Professional Office Building Infusion Pharmacy
Chicago
Rush University Medical Center.
Chicago
University of Chicago Medical Center
Chicago
University of Chicago Medical Center, CCD- Investigational Drug Service Pharmacy
Chicago
Illinois CancerCare - Galesburg
Galesburg
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
New Lenox
Orland Park - University of Chicago Center for Advanced Care
Orland Park
Illinois CancerCare- Pekin
Pekin
Illinois CancerCare, P.C.
Peoria
Illinois CancerCare- Peru
Peru
Indiana
Ft Wayne Medical Oncology and Hematology, Inc TRIO
Fort Wayne
Kansas
The University of Kansas Cancer Center - West
Kansas City
MidAmerica Division, Inc. c/o Menorah Medical Center
Overland Park
The University of Kansas Cancer Center - Indian Creek Campus
Overland Park
The University of Kansas Cancer Center - Overland Park
Overland Park
The University of Kansas Cancer Center Breast Surgery Center - Indian Creek Campus
Overland Park
The University of Kansas Cancer Center
Westwood
The University of Kansas Cancer Center, Investigational Drug Services
Westwood
Kentucky
CHI Saint Joseph Cancer Care
Lexington
Saint Joseph Health Infusion Services
Lexington
Massachusetts
Brigham & Women's Hospital
Boston
Dana-Farber Cancer Institute
Boston
Dana Farber Cancer Institute- Chestnut Hill
Newton
Maryland
Mercy Medical Center -Weinberg Center
Baltimore
Mercy Medical Center.
Baltimore
University of Maryland, Greenebaum Comprehensive Cancer Center.
Baltimore
Maryland Oncology Hematology, P.A
Bethesda
Maryland Oncology Hematology, P.A
Brandywine
Maryland Oncology Hematology, P.A
Columbia
Maryland Oncology Hematology, P.A
Frederick
Maryland Oncology Hematology, P.A
Largo
Maryland Oncology Hematology, P.A
Rockville
Maryland Oncology Hematology, P.A
Silver Spring
Michigan
University of Michigan
Ann Arbor
Brighton Center for Specialty Care
Brighton
Henry Ford Hospital
Detroit
Minnesota
Minnesota Oncology Hematology, P.A.
Edina
Missouri
Siteman Cancer Center - St Peters
City Of Saint Peters
Siteman Cancer Center - West County
Creve Coeur
Siteman Cancer Center - North County
Florissant
MidAmerica Division, Inc. c/o Centerpoint Medical Center
Independence
MidAmerica Division, Inc., c/o Research Medical Center
Kansas City
Saint Luke's Cancer institute
Kansas City
The University of Kansas Cancer Center
Kansas City
The University of Kansas Cancer Center -North
Kansas City
The University of Kansas Cancer Center - Lee's Summit
Lee's Summit
Barnes-Jewish Hospital
St Louis
Siteman Cancer Center - South County
St Louis
Washington University School of Medicine - Siteman Cancer Center.
St Louis
Washington University School of Medicine - St. Louis
St Louis
Montana
St. Vincent - Frontier Cancer Center
Billings
St. Vincent Healthcare
Billings
Saint Luke's Hospital Investigational Pharmacy
Ronan
North Carolina
Atrium Health Pineville (biopsy only)
Charlotte
Atrium Health University City (biopsy only)
Charlotte
Carolinas Medical Center - Mercy (biopsy only)
Charlotte
Carolinas Medical Center (biopsy only)
Charlotte
Carolinas Medical Center Investigational Drug Services
Charlotte
Charlotte Radiology Medical Center Plaza Breast Center (biopsy only)
Charlotte
Levine Cancer Institute
Charlotte
Levine Cancer Institute-Pineville
Charlotte
Atrium Health Cabarrus (biopsy only)
Concord
Levine Cancer Institute Concord
Concord
Duke University Medical Center
Durham
Atrium Health Union (biopsy only)
Monroe
Nebraska
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
West Omaha Imaging
Omaha
New Jersey
Summit Medical Group
Berkeley Heights
Summit Medical Group
Florham Park
Cooperman Barnabas Medical Center
Livingston
Nevada
Comprehensive Cancer Centers of Nevada
Henderson
Comprehensive Cancer Centers of Nevada
Henderson
Comprehensive Cancer Centers of Nevada Research Department
Henderson
Comprehensive Cancer Centers of Nevada
Las Vegas
Comprehensive Cancer Centers of Nevada
Las Vegas
Comprehensive Cancer Centers of Nevada
Las Vegas
Comprehensive Cancer Centers of Nevada
Las Vegas
Comprehensive Cancer Centers of Nevada
Las Vegas
New York
New York Oncology Hematology, P.C.
Albany
Stony Brook Advanced Imaging
Stony Brook
Stony Brook Cancer Center
Stony Brook
Stony Brook University Medical Center
Stony Brook
Oregon
OHSU Knight Cancer Institute, Beaverton
Beaverton
Providence Cancer Institute Clackamas Clinic
Clackamas
OHSU Knight Cancer Institute, Gresham
Gresham
Northwest Cancer Specialists P.C.
Portland
Northwest Cancer Specialists P.C.
Portland
OHSU Center for Health and Healing
Portland
OHSU Center for Health and Healing 2
Portland
OHSU Knight Cancer Institute, East Portland
Portland
OHSU Knight Cancer Institute, Northwest Portland
Portland
OHSU Research Pharmacy Services
Portland
Oregon Health And Science University
Portland
Providence Cancer Institute Franz Clinic
Portland
Providence Portland Medical Center
Portland
Northwest Cancer Specialists, P.C.
Tigard
OHSU Knight Cancer Institute, Tualatin
Tualatin
Pennsylvania
Hospital of the University of Pennsylvania, Perelman Center for Advanced Medicine
Philadelphia
Tennessee
Tennessee Oncology PLLC
Dickson
Tennessee Oncology PLLC
Franklin
Tennessee Oncology PLLC
Gallatin
Tennessee Oncology PLLC
Hendersonville
Tennessee Oncology PLLC
Hermitage
Brig Center for Cancer Care and Survivorship
Knoxville
Tennessee Oncology PLLC
Lebanon
Tennessee Oncology PLLC
Murfreesboro
Tennessee Oncology PLLC
Nashville
Tennessee Oncology PLLC
Nashville
Tennessee Oncology PLLC
Nashville
Tennessee Oncology PLLC
Nashville
The Sarah Cannon Research Institute
Nashville
Tennessee Oncology PLLC
Shelbyville
Tennessee Oncology PLLC
Smyrna
Texas
Texas Oncology - West Texas
Amarillo
The Center for Cancer and Blood Disorders
Arlington
Texas Oncology - Austin
Austin
Texas Oncology - Austin
Austin
Texas Oncology - DFW
Bedford
Texas Oncology - DFWW
Bedford
The Center for Cancer and Blood Disorders
Burleson
Parkland Health and Hospital System
Dallas
Texas Oncology - DFW
Dallas
Texas Oncology - DFW
Dallas
Texas Oncology - DFWW
Dallas
University of Texas Southwestern Medical Center
Dallas
UT Southwestern Medical Center - Simmons Cancer Center
Dallas
UT Southwestern Medical Center - Simmons Cancer Center Pharmacy
Dallas
UT Southwestern University Hospital - William P. Clements, Jr
Dallas
UT Southwestern University Hospital - Zale Lipshy
Dallas
The Center for Cancer and Blood Disorders
Fort Worth
UT Southwestern Medical Center - d/b/a Moncrief Cancer Institute - Ft. Worth - Pharmacy
Fort Worth
UT Southwestern Medical Center d/b/a Moncrief Cancer Institute - Ft. Worth
Fort Worth
Baylor College of Medicine Medical center
Houston
Baylor St. Luke's Medical Center
Houston
Harris Health System - Ben Taub General Hospital
Houston
Harris Health System - Smith Clinic
Houston
Oncology Consultants, P.A.
Houston
Oncology Consultants, P.A.
Houston
Texas Oncology - Gulf Coast
Houston
Texas Oncology - San Antonio
New Braunfels
UT Southwestern Medical Center - Clinical Center Richardson/Plano
Richardson
UT Southwestern Medical Center - Clinical Center Richardson/Plano - Pharmacy
Richardson
Texas Oncology-San Antonio
San Antonio
Texas Oncology-San Antonio
San Antonio
Texas Oncology-San Antonio
San Antonio
The Center for Cancer and Blood Disorders
Weatherford
Utah
University of Utah, Farmington Health Center
Farmington
University of Utah, Huntsman Cancer Hospital
Salt Lake City
University of Utah, Huntsman Cancer Institute
Salt Lake City
University of Utah, Sugar House Health Center
Salt Lake City
University of Utah, South Jordan Health Center
South Jordan
Virginia
Virginia Cancer Specialists, PC
Alexandria
Virginia Cancer Specialists, PC
Arlington
Oncology & Hematology Associates of Southwest Virginia,Inc.DBA Blue Ridge Cancer Care
Blacksburg
Virginia Cancer Specialists, PC
Fairfax
Virginia Cancer Specialists, PC
Gainesville
Virginia Cancer Specialists, PC
Leesburg
Oncology and Hematology Associates of Southwest Virginia Inc
Low Moor
Oncology & Hematology Associates of Southwest Virginia,Inc.DBA Blue Ridge Cancer Care
Roanoke
Oncology & Hematology Associates of Southwest Virginia,Inc.DBA Blue Ridge Cancer Care
Salem
Oncology and Hematology Associates of Southwest Virginia Inc
Wytheville
Washington
Swedish Cancer Institute - Edmonds Campus
Edmonds
Swedish Cancer Institute - Issaquah Campus
Issaquah
Swedish Cancer Institute
Seattle
Swedish Medical Center
Seattle
Northwest Cancer Specialists P.C.
Vancouver
Other Locations
Australia
Austin Health
Heidelberg
Peter MacCallum Cancer Centre
Melbourne
Breast Cancer Research Centre - WA
Nedlands
Epic Pharmacy Hollywood
Nedlands
Hollywood Private Hospital
Nedlands
Starcevich Day Clinic, Hollywood Private Hospital
Nedlands
Patricia Ritchie Centre for Cancer Care and Research Mater Hospital Sydney
North Sydney
The Royal Melbourne Hospital
Parkville
The Crown Princess Mary Cancer Centre, Westmead Hospital
Westmead
Austria
Universitatsklinik Innsbruck fur Gynakologie und Geburtshilfe BrustGesundheitzentrum
Innsbruck
CT/MRIfacility:Diagnosezentrum Urania
Vienna
Klinik Ottakring.
Vienna
Wilhelminen Krebsforschung GmbH
Vienna
Belgium
Institut Jules Bordet
Anderlecht
Clinical Trails Conduct Unit(CTCU) Institut Jules Bordet
Brussels
GHdC
Charleroi
University Hospital Antwerp
Edegem
AZ Groeninge
Kortrijk
UZ Leuven
Leuven
CHU de Liege
Liège
CHU UCL Site Sainte Elisabeth
Namur
Canada
Cross Cancer Institute
Edmonton
London Regional Cancer Program, London Health Sciences Centre
London
Centre Hospitalier de l'Universite de Motreal (CHUM)
Montreal
The Ottawa Hospital Cancer Centre
Ottawa
CHU de Québec-Université Laval, St-Sacrement Hospital
Québec
Princess Margaret Cancer Centre
Toronto
China
Beijing Hospital
Beijing
Cancer Hospital Chinese Academy of medical sciences
Beijing
Peking University People's Hospital
Beijing
Jilin Cancer Hospital
Changchun
Hunan Cancer Hospital.
Changsha
Maternal and child Health Hospital of Guangdong Province
Guangzhou
Sun Yat-Sen University Cancer Center
Guangzhou
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou
Zhejiang Cancer Hospital
Hangzhou
Nanchang Third Hospital
Nanchang
Nanjing Drum Tower Hospital , The Affiliated Hospital of Nanjing University Medical School
Nanjing
Guangxi Medical University Affiliated Tumor Hospital
Nanning
Shengjing Hospital Of China Medical University
Shenyang
Tianjin Cancer Hospital
Tianjin
Tianjin Cancer Hospital
Tianjin
Hubei Cancer Hospital
Wuhan
Renmin Hospital of Wuhan University
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an
Xi'an International Medical Center Hospital
Xi’an
Xuzhou Central Hospital
Xuzhou
Affiliated Hospital of Guangdong Medical University
Zhanjiang
Henan Cancer Hospital
Zhengzhou
Zigong First People's Hospital
Zigong
Denmark
Herlev og Gentofte Hospital
Herlev
Pharmacy : Region Hovedstadens Apotek-KFS Serviceproduktion - Cytostatikaenheden
Herlev
Radiology: Herlev - og Gentofte Hospital - Radiologisk afdeling
Herlev
Blandecentralen Odense Universitetshospital
Odense C
Onkologisk Afdeling R, Odense Universitetshospital
Odense C
Pharmacy.
Vejle
Radiology.
Vejle
Vejle Sygehus
Vejle
France
CHRU Besancon
Besançon
CHRU Besancon Service Radiologie
Besançon
Dimeo lmagerie Medicale Polyclinique - Besancon
Besançon
University Hospital of Besancon
Besançon
CHRU Morvan Pharmacie des essais cliniques
Brest
CHRU Morvan Unité de recherche clinique en cancérologie
Brest
Centre Francois Baclesse
Caen
Service de Pharmacie Centre Francois Baclesse
Caen
Service de radiologie Centre Francois Baclesse
Caen
Centre GF Leclerc
Dijon
Department de Radiodiagnostic Centre GF Leclerc
Dijon
Service Pharmacie Centre GF Leclerc
Dijon
Clinique du mail
Grenoble
Clinique Victor Hugo Centre de Cancerologie de la Sarthe
Le Mans
Departement de radiologie Clinique Victor Hugo
Le Mans
Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes
Lyon
Centre Leon Berard Departement de Medecine
Lyon
Departement de radiologie Centre Leon Berard
Lyon
Pharmacie - Secteur essais Cliniques Centre Leon Berard
Lyon
lnstitut Paoli Calmettes, Departement ONCOLOGIE MEDICALE
Marseille
Pharmacie des essais cliniques -lnstitut Paoli calmettes
Marseille
Groupement hospitalier Portes de Provence Quartier Beausseret
Montélimar
Departement d'imagerie medicale Institut Curie - Site Paris
Paris
lnstitut Curie- Site Paris
Paris
Centre Paul Strauss - pharmacie
Strasbourg
lnstitut de cancerologie Strasbourg Europe
Strasbourg
IUCT-O
Toulouse
lnstitut Claudius Regaud - IUCT-O
Toulouse
Departement de radiologie Hopital Bretonneau - CHRU de Tours
Tours
Hopital Bretonneau CHRU de Tours
Tours
Pharmacie Hopital Bretonneau - CHRU de Tours
Tours
Hopital Nord Franche-Comte Pole imagerie radiologie
Trévenans
Germany
Universitaetsklinikum Schieswig-Holstein, Campus Kiel, Klinik f. Gynaekologie und Geburtshilfe
Kiel
InVO-lnstitut für Versorgungsforschung in der Onkologie GbR
Koblenz
Universitatsmedizin Mainz
Mainz
Klinikum rechts der Isar, Klinik und Poliklinik fur Frauenheikunde
München
Sana Klinikum Offenbach GmbH Zentralinstitut fur Diagnostische und Interventionelle Radiologie
Offenbach/ Main
Israel
Oncology Institute, Meir Medical Center
Kfar Saba
Institute of Oncology - Davidoff Center, Rabin Medical Center, Beilinson Hospital
Petah Tikva
Oncology Institute, Kaplan Medical Center
Rehovot
Italy
Azienda Ospedaliero Universitaria di Bologna - IRCCS
Bologna
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
Bologna
AUSL della Romagna. P.O. Ospedale Cervesi. U.O. di Oncologia.
Cattolica
AUSL della Romagna. P.O. Ospedale degli lnfermi. U.O. di Oncologia.
Faenza
AUSL della Romagna. P.O. Ospedale di Lugo Umberto I. U.O. di Oncologia.
Lugo
lstituto Europeo di Oncologia
Milan
AUSL della Romagna. P.O. Ospedale Santa Maria delle Croci. U.O. di Oncologia.
Ravenna
AUSL della Romagna P.O. Ospedale Infermi U.O. di Oncologia
Rimini
Fondazione Policlinico Gemelli IRCCS
Rome
A.O.U. Ospedali Riuniti di Ancona.
Torrette
Japan
Chiba Cancer Center
Chiba
National Cancer Center Hospital
Chuo-ku
National Hospital Organization Kyushu Cancer Center.
Fukuoka
Hiroshima City Hiroshima Citizens Hospital
Hiroshima
Advanced Imaging Center
Ibaraki
Hakuaikai Medical Corporation Sagara Hospital
Kagoshima
Hakuaikai Medical Corporation Sagara Perth Street Clinic
Kagoshima
National Cancer Center Hospital East.
Kashiwa
Saitama Cancer Center, Breast Oncology
Kitaadachi-gun
Kumamoto Shinto General Hospital
Kumamoto
National Hospital Organization Shikoku Cancer Center
Matsuyama
Shizuoka Cancer Center
Nagaizumi-cho
Aichi Cancer Center Hospital
Nagoya
Nagoya Radiological Diagnosis Foundation, East Nagoya Imaging Diagnosis Center
Nagoya
Hyogo college of medicine hospital
Nishinomiya
Morinomiya Hospital
Osaka
National Hospital Organization Osaka National Hospital
Osaka
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
Osaka
National Hospital Organization Hokkaido Cancer Center.
Sapporo
The Cancer Institute Hospital of JFCR
Tokyo
University of Tsukuba Hospital
Tsukuba
Kanagawa Cancer Center
Yokohama
Koyasu Neurosurgical Clinic
Yokohama
Netherlands
Amphia Ziekenhuis
Breda
Martini Ziekenhuis
Groningen
Erasmus Medisch Centrum Daniel Den Hoed
Rotterdam
Republic of Korea
National Cancer Center
Goyang-si
Seoul National University Bundang Hospital
Seongnam-si
Asan Medical Center
Seoul
National Cancer Center
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital Yonsei University Health System
Seoul
Singapore
National Cancer Centre Singapore
Singapore
National University Hospital
Singapore
Spain
Hospital Quiron Barcelona
Barcelona
Vall d'Hebron University Hospital
Barcelona
Hospital Universitario Reina Sofia
Córdoba
Clinica Nuestra Senora del Rosario
Madrid
Hospital Ruber Internacional
Madrid
Hospital Universitario Clinico San Carlos
Madrid
Hospital Universitario HM Sanchinarro
Madrid
Hospital Universitario Son Espases
Palma De Mallorca
Hospital Universitario de Canarias
San Cristóbal De La Laguna
Hospital Moises Broggi- ICO
Sant Joan Despí
Hospital Universitario Virgen del Rocio
Seville
Hospital Clinico Universitario de Valencia
Valencia
Hospital Quirón Zaragoza
Zaragoza
Hospital Universitario Miguel Servet
Zaragoza
Sweden
Sahlgrenska University Hospital
Gothenburg
Onkologkliniken, KPE, Malpunkt K,
J0nkoping
Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne
Kantonsspital Winterthur Onkologie
Winterthur
Taiwan
National Cheng Kung University Hospital
Tainan
National Taiwan University Hospital
Taipei
United Kingdom
University Hospitals Birmingham NHS Foundation Trust Queen Elizabeth Hospital
Birmingham
Edinburgh Cancer Centre, Western General Hospital,
Edinburgh
The Royal Marsden NHS Foundation Trust
London
The Christie NHS Foundation Trust
Manchester
The Royal Marsden NHS Foundation Trust
Sutton
The Royal Cornwall Hospital
Truro
Time Frame
Start Date: 2019-10-02
Completion Date: 2029-03-10
Participants
Target number of participants: 466
Treatments
Experimental: Tucatinib + T-DM1
Tucatinib + T-DM1
Active_comparator: Placebo + T-DM1
Placebo + T-DM1
Authors
Josefina Cruz Jurado, Christina Brzezniak, Erika Hamilton, Ritesh Parajuli, Shakeela Bahadur, Debra A Patt, Tanya Wahl, Qamar J Khan, Rachel Swart, Aki Morikawa, Steven Rousey, William E Lawler, Mridula George, Michelina Cairo, David Riseberg, Teja Poosarla, Lida Mina, William MacLaughlin, Arielle Heeke, Nischala Ammannagari, Fadi Kayali, Sara Tolaney, Sramila Aithal, Ashley Frith, Melody Cobleigh, Allan Krutchik, Manuel Ruiz Borrego, Urszula Sobol, Keerthi Gogineni, Raymond Brig, Carlos Alemany, Paula Pohlmann, Shaachi Gupta, Ralph Boccia, Chelsea Gawryletz, Jay Courtright, Jay C Andersen, Rashmi Murthy, Julie Fisher, Steven Papish, Sayeh Lavasani, Neelima Denduluri, Hatem Soliman, Alison Conlin, Kelly Westbrook, Wenqing Zhang, Nisreen A Haideri, Jennifer Crozier, Joyce O'Shaughnessy, Patrick Cobb, Amelia Zelnak, Robyn Young, Zahi Mitri, Paul Richards, Elisavet Paplomata, Ali Madani, Luis Teixeira, Fernando Bazan, Jennifer Carney, Virginia Borges, Christos Vaklavas, Sunil Babu, Stephani Christensen, Atisha Manhas, Jennifer Suga, Gail Wright, Sami Diab, Asma Dilawari, Jami Fukui, Jenny Fox, Edward F McClay, Jessica Croley, Neelam Desai, Sujith R Kalmadi, Rafael Villanueva Vazquez, Margaret Block, Amy Clark, Srini Reddy, Humdum Durrani, Sumithra Vattigunta, Mothaffar Rimawi, Lea Kathleen Krekow, Paula Rosenblatt, Volkmar Mueller, Delphine Loirat, Mark Verrill, Mark Tuthill, Agnes Jager, Johannes Ettl, Mony Ung, Isabelle Desmoulins, Maria Ekholm, Andreas Schneeweiss, Richard Baird, Rachel Wuerstlein, Eva Harder Brix, Christian Jackisch, Thomas Bachelot, Mattea Reinisch, Francesco Ricci, Hugues Bourgeois, Frederic Viret, Andrew Wardley, Rudolf Weide, George Emile, Thierry Petit, Hans Tesch, Jacques Medioni, Marcus Schmidt, Timothy Crook, Marion Van Mackelenbergh, John Cole, Haythem Ali, Alison Stopeck, Uchenna Njiaju, Mili Arora, Jamal G Misleh, Carolyn Hendricks, Stephanie Graff, Barbara Haley, Olwen Hahn, Diana Medgyesy, Sara Hurvitz, Ted Vandenberg, Jeanette Dupont Jensen, Joo Hyuk Sohn, Shozo Ohsumi, Annette van der Velden, Ana Lohmann, Iryna Kuchuk, Daniel Rea, Reiki Nishimura, Lorenzo Gianni, Nayyer Iqbal, Carolien Schroder, Lemonitsa Mammatas, Jean-Pierre Ayoub, Michael Andersson, Filippo Montemurro, Ida Paris, Duncan Wheatley, Catherine Harper-Wynne, Young-Hyuck Im, Belinda Yeo, Andrea Gombos, Junichiro Watanabe, Norikazu Masuda, Edgar Petru, Begona Bermejo, Eisuke Fukuma, Claudio Zamagni, Joan Heijns, Rinat Yerushalmi, Sabino de Placido, Antonios Valachis, Frances Boyle, Rupert Bartsch, Laura Biganzoli, Takahiro Nakayama, Xinni Song, Barbro Linderholm, Rina Hui, Kathrin Strasser-Weippl, Daniel Egle, Hiroyuki Yasojima, Tira Tan, Emilio Alba, Hiroko Bando, Ella Evron, Daniel Rayson, Kenichi Inoue, Sara Lopez-Tarruella Cobo, Fredrika Killander, Catherine Doyle, Tetsuhiko Taira, Donatienne Taylor, Seock-Ah Im, Mihaela Mates, Toshimi Takano, Xiaofu Zhu, Christian Kurzeder, Ugo De Giorgi, Eriko Tokunaga, Philippe Bedard, Chiun-Sheng Huang, Xinhong Wu, Rossana Berardi, Maaike de Boer, Alicia Okines, Richard Greil, Sung Hoon Sim, Anne Armstrong, Marco Colleoni, Rikiya Nakamura, Tatsunori Shimoi, Jean-Luc Canon, Janine Nuver, Yasuo Miyoshi, Guy Jerusalem, Masato Takahashi, Toru Mukohara, Sherene Loi, Khalil Zaman, Masaya Hattori, Joan Albanell, Cristiano Ferrario, Sergio Bracarda, Francois Duhoux, Toshinari Yamashita, Gabe S Sonke, Erik Jakobsen, Hans Wildiers
Sponsors
Leads: Seagen, a wholly owned subsidiary of Pfizer

This content was sourced from clinicaltrials.gov