AzTrials
AzTrials

HER2-positive Breast CancerPhase 3NCT03975647

A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer

A Phase 3 study testing tucatinib and T-DM1 in people with HER2-positive Breast Cancer, run by Seagen, a wholly owned subsidiary of Pfizer at 490 sites in 20 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HER2-positive Breast Cancer
What is being tested?
tucatinib and T-DM1
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
466 participants
Where
490 sitesin 20 countries
Study dates
2 Oct 2019to 10 Mar 2029
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 14Show fewer
  • No evidence of brain metastases
  • Untreated brain metastases not needing immediate local therapy
  • 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:
  • 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.
  • 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

Who cannot join

  • Prior treatment with tucatinib, afatinib, trastuzumab deruxtecan (DS-8201a), or any other investigational anti-HER2, anti-EGFR, or HER2 TKI agent. Prior treatment with lapatinib or neratinib within 12 months of starting study treatment (except in cases where they were given for ≤21 days and was discontinued for reasons other than disease progression or severe toxicity). Prior treatment with pyrotinib for recurrent of mBC (except in cases where pyrotinib was given for ≤21 days and was discontinued for reasons other than disease progression or severe toxicity).
  • CNS Exclusion - Based on screening contrast brain magnetic resonance imaging (MRI), participants must not have any of the following:
  • Any untreated brain lesions >2 cm in size
  • Ongoing use of corticosteroids for control of symptoms of brain metastases at a total daily dose of >2 mg of dexamethasone (or equivalent).
  • Any brain lesion thought to require immediate local therapy
  • Known or concurrent leptomeningeal disease as documented by the investigator
  • Poorly controlled generalized or complex partial seizures

Trial locations and contacts

490 sites in 20 countries.

469 sites in 20 countries

United States300 sites

  • New York Oncology Hematology, P.C.

    Albany, New York, 12206

  • Virginia Cancer Specialists, PC

    Alexandria, Virginia, 22304

  • UCLA Hematology/Oncology - Alhambra

    Alhambra, California, 91801

  • Florida Cancer Specialists

    Altamonte Springs, Florida, 32701

  • Texas Oncology - West Texas

    Amarillo, Texas, 79124

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Kaiser Permanente Medical Center Lab Drawing Station

    Antioch, California, 94509

  • Kaiser Permanente Medical Center Lab Drawing Station

    Antioch, California, 94531

  • The Center for Cancer and Blood Disorders

    Arlington, Texas, 76014

  • Virginia Cancer Specialists, PC

    Arlington, Virginia, 22201

  • Northside Hospital, Inc. - GCS/ Athens

    Athens, Georgia, 30606

  • Winship Cancer Institute, Emory University.

    Atlanta, Georgia, 30322

  • Atlanta Cancer Care - Atlanta

    Atlanta, Georgia, 30342

  • Northside Hospital, Inc. - Central Research Department

    Atlanta, Georgia, 30342

  • Northside Hospital, Inc. - GCS/Northside

    Atlanta, Georgia, 30342

  • Georgia Cancer Center at Augusta University

    Augusta, Georgia, 30912

  • Rocky Mountain Cancer Centers, LLP

    Aurora, Colorado, 80012

  • Clinical and Translational Research Center (CTRC)

    Aurora, Colorado, 80045

  • University of Colorado Hospital - Anschutz Cancer Pavilion(ACP)

    Aurora, Colorado, 80045

  • University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)

    Aurora, Colorado, 80045

  • University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)

    Aurora, Colorado, 80045

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Texas Oncology - Austin

    Austin, Texas, 78731

  • Texas Oncology - Austin

    Austin, Texas, 78745

  • University of Maryland, Greenebaum Comprehensive Cancer Center.

    Baltimore, Maryland, 21201

  • Mercy Medical Center -Weinberg Center

    Baltimore, Maryland, 21202

  • Mercy Medical Center.

    Baltimore, Maryland, 21202

  • OHSU Knight Cancer Institute, Beaverton

    Beaverton, Oregon, 97006

  • Texas Oncology - DFWW

    Bedford, Texas, 76022

  • Texas Oncology - DFW

    Bedford, Texas, 76022

  • Summit Medical Group

    Berkeley Heights, New Jersey, 07922

  • Maryland Oncology Hematology, P.A

    Bethesda, Maryland, 20817

  • UCLA Hematology/Oncology- Beverly Hills

    Beverly Hills, California, 90212

  • St. Vincent Healthcare

    Billings, Montana, 59101

  • St. Vincent - Frontier Cancer Center

    Billings, Montana, 59102

  • Oncology & Hematology Associates of Southwest Virginia,Inc.DBA Blue Ridge Cancer Care

    Blacksburg, Virginia, 24060

  • Northside Hospital, Inc. - GCS/Blairsville

    Blairsville, Georgia, 30512

  • Illinois CancerCare- Bloomington

    Bloomington, Illinois, 61704

  • Florida Cancer Specialists

    Bonita Springs, Florida, 34135

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Rocky Mountain Cancer Centers, LLP

    Boulder, Colorado, 80303

  • Florida Cancer Specialists

    Brandon, Florida, 33511

  • Maryland Oncology Hematology, P.A

    Brandywine, Maryland, 20613

  • Brighton Center for Specialty Care

    Brighton, Michigan, 48116

  • The Center for Cancer and Blood Disorders

    Burleson, Texas, 76028

  • Northside Hospital, Inc. - GCS/Canton

    Canton, Georgia, 30115

  • Florida Cancer Specialists

    Cape Coral, Florida, 33909

  • Rocky Mountain Cancer Centers, LLP

    Centennial, Colorado, 80112

  • Carolinas Medical Center (biopsy only)

    Charlotte, North Carolina, 28203

  • Charlotte Radiology Medical Center Plaza Breast Center (biopsy only)

    Charlotte, North Carolina, 28203

  • Carolinas Medical Center Investigational Drug Services

    Charlotte, North Carolina, 28204

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Carolinas Medical Center - Mercy (biopsy only)

    Charlotte, North Carolina, 28207

  • Atrium Health Pineville (biopsy only)

    Charlotte, North Carolina, 28210

  • Levine Cancer Institute-Pineville

    Charlotte, North Carolina, 28210

  • Atrium Health University City (biopsy only)

    Charlotte, North Carolina, 28262

  • Rush University Medical Center, Professional Office Building Infusion Pharmacy

    Chicago, Illinois, 60612

  • Rush University Medical Center.

    Chicago, Illinois, 60612

  • University of Chicago Medical Center, CCD- Investigational Drug Service Pharmacy

    Chicago, Illinois, 60637

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Siteman Cancer Center - St Peters

    City of Saint Peters, Missouri, 63376

  • Providence Cancer Institute Clackamas Clinic

    Clackamas, Oregon, 97015

  • Florida Cancer Specialists

    Clearwater, Florida, 33761

  • Rocky Mountain Cancer Centers, LLP

    Colorado Springs, Colorado, 80907

  • UCH-MHS Memorial Hospital Central

    Colorado Springs, Colorado, 80909

  • Printers Park Medical Plaza

    Colorado Springs, Colorado, 80910

  • Briargate Medical Campus

    Colorado Springs, Colorado, 80920

  • UCH-MHS Memorial Hospital North

    Colorado Springs, Colorado, 80920

  • Maryland Oncology Hematology, P.A

    Columbia, Maryland, 21044

  • Atrium Health Cabarrus (biopsy only)

    Concord, North Carolina, 28025

  • Levine Cancer Institute Concord

    Concord, North Carolina, 28025

  • Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center

    Coral Gables, Florida, 33146

  • UC Irvine Health Cancer Center - Newport

    Costa Mesa, California, 92627

  • Siteman Cancer Center - West County

    Creve Coeur, Missouri, 63141

  • Atlanta Cancer Care - Cumming

    Cumming, Georgia, 30041

  • Texas Oncology - DFWW

    Dallas, Texas, 75203

  • Texas Oncology - DFW

    Dallas, Texas, 75203

  • Parkland Health and Hospital System

    Dallas, Texas, 75235

  • Texas Oncology - DFWW

    Dallas, Texas, 75246

  • Texas Oncology - DFW

    Dallas, Texas, 75246

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • UT Southwestern Medical Center - Simmons Cancer Center Pharmacy

    Dallas, Texas, 75390

  • UT Southwestern Medical Center - Simmons Cancer Center

    Dallas, Texas, 75390

  • UT Southwestern University Hospital - William P. Clements, Jr

    Dallas, Texas, 75390

  • UT Southwestern University Hospital - Zale Lipshy

    Dallas, Texas, 75390

  • Florida Cancer Specialists.

    Daytona Beach, Florida, 32117

  • Sylvester Comprehensive Cancer Center- Deerfield Beach

    Deerfield Beach, Florida, 33442

  • UCHealth Cherry Creek Medical Center

    Denver, Colorado, 80206

  • UCHealth IDS Research Pharmacy - Cherry Creek

    Denver, Colorado, 80206

  • Cancer Centers of Colorado at Saint Joseph Hospital

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers, LLP

    Denver, Colorado, 80218

  • SCL Health Saint Joseph Hospital

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers, LLP

    Denver, Colorado, 80220

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Tennessee Oncology PLLC

    Dickson, Tennessee, 37055

  • City of Hope Investigational Drug Services (IDS)

    Duarte, California, 91010

  • City of Hope(City of Hope National Medical Center,City of Hope Medical Center)

    Duarte, California, 91010

  • Kaiser Permanente Medical Center (Radiology)

    Dublin, California, 94568

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Minnesota Oncology Hematology, P.A.

    Edina, Minnesota, 55435

  • UCLA Hematology/Oncology - Encino

    Encino, California, 91436

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Kaiser Permanente Medical Center Lab Drawing Station

    Fairfield, California, 94533

  • University of Utah, Farmington Health Center

    Farmington, Utah, 84025

  • Summit Medical Group

    Florham Park, New Jersey, 07932

  • Siteman Cancer Center - North County

    Florissant, Missouri, 63031

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Cancer Care & Hematology - Fort Collins

    Fort Collins, Colorado, 80528

  • Florida Cancer Specialists - South Region

    Fort Myers, Florida, 33901

  • Florida Cancer Specialists

    Fort Myers, Florida, 33905

  • Florida Cancer Specialists

    Fort Myers, Florida, 33908

  • Ft Wayne Medical Oncology and Hematology, Inc TRIO

    Fort Wayne, Indiana, 46804

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • UT Southwestern Medical Center - d/b/a Moncrief Cancer Institute - Ft. Worth - Pharmacy

    Fort Worth, Texas, 76104

  • UT Southwestern Medical Center d/b/a Moncrief Cancer Institute - Ft. Worth

    Fort Worth, Texas, 76104

  • Tennessee Oncology PLLC

    Franklin, Tennessee, 37067

  • Maryland Oncology Hematology, P.A

    Frederick, Maryland, 21702

  • Florida Cancer Specialists

    Gainesville, Florida, 32605

  • Virginia Cancer Specialists, PC

    Gainesville, Virginia, 20155

  • Illinois CancerCare - Galesburg

    Galesburg, Illinois, 61401

  • Tennessee Oncology PLLC

    Gallatin, Tennessee, 37066

  • Banner Gateway Medical Center

    Gilbert, Arizona, 85234

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • Kaiser Permanente Medical Center Lab Drawing Station

    Gilroy, California, 95020

  • Western Regional Medical Center, LLC

    Goodyear, Arizona, 85338

  • Cancer Care & Hematology - Greeley

    Greeley, Colorado, 80634

  • OHSU Knight Cancer Institute, Gresham

    Gresham, Oregon, 97030

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89074

  • Comprehensive Cancer Centers of Nevada Research Department

    Henderson, Nevada, 89119

  • Tennessee Oncology PLLC

    Hendersonville, Tennessee, 37075

  • Tennessee Oncology PLLC

    Hermitage, Tennessee, 37076

  • Hawai'i Pacific Health Research Institute - Administrative Site

    Honolulu, Hawaii, 96813

  • Kaiser Permanente Hawaii.

    Honolulu, Hawaii, 96819

  • Kaiser Permanente Hawaii

    Honolulu, Hawaii, 96819

  • Kapi'olani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Kapi'olani Women's Center

    Honolulu, Hawaii, 96826

  • Oncology Consultants, P.A.

    Houston, Texas, 77024

  • Texas Oncology - Gulf Coast

    Houston, Texas, 77024

  • Baylor College of Medicine Medical center

    Houston, Texas, 77030

  • Baylor St. Luke's Medical Center

    Houston, Texas, 77030

  • Harris Health System - Ben Taub General Hospital

    Houston, Texas, 77030

  • Oncology Consultants, P.A.

    Houston, Texas, 77030

  • Harris Health System - Smith Clinic

    Houston, Texas, 77054

  • MidAmerica Division, Inc. c/o Centerpoint Medical Center

    Independence, Missouri, 64057

  • UCLA Hematology/Oncology- Irvine

    Irvine, California, 92604

  • Swedish Cancer Institute - Issaquah Campus

    Issaquah, Washington, 98029

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • Saint Luke's Hospital Investigational Pharmacy

    Kansas City, Kansas, 64111

  • The University of Kansas Cancer Center - West

    Kansas City, Kansas, 66112

  • Saint Luke's Cancer institute

    Kansas City, Missouri, 64111

  • The University of Kansas Cancer Center

    Kansas City, Missouri, 64116

  • MidAmerica Division, Inc., c/o Research Medical Center

    Kansas City, Missouri, 64132

  • The University of Kansas Cancer Center -North

    Kansas City, Missouri, 64154

  • Brig Center for Cancer Care and Survivorship

    Knoxville, Tennessee, 37909

  • SCL Health Good Samaritan Medical Center Cancer Centers of Colorado

    Lafayette, Colorado, 80026

  • SCL Health Good Samaritan Medical Center

    Lafayette, Colorado, 80026

  • Rocky Mountain Cancer Centers, LLP

    Lakewood, Colorado, 80228

  • Florida Cancer Specialists

    Largo, Florida, 33770

  • Maryland Oncology Hematology, P.A

    Largo, Maryland, 20774

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89128

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89144

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89148

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Tennessee Oncology PLLC

    Lebanon, Tennessee, 37090

  • Florida Cancer Specialists

    Lecanto, Florida, 34461

  • The University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064

  • Virginia Cancer Specialists, PC

    Leesburg, Virginia, 20176

  • CHI Saint Joseph Cancer Care

    Lexington, Kentucky, 40509

  • Saint Joseph Health Infusion Services

    Lexington, Kentucky, 40509

  • Rocky Mountain Cancer Centers, LLP

    Littleton, Colorado, 80120

  • Cooperman Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Rocky Mountain Cancer Centre, LLP

    Lone Tree, Colorado, 80124

  • Drug Management Only: UCLA West Medical Pharmacy, Attn: Steven L Wong, Pharm.D.

    Los Angeles, California, 90095

  • Regulatory Management only: TRIO-US Central Administration

    Los Angeles, California, 90095

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

  • UCLA Hematology/Oncology

    Los Angeles, California, 90095

  • UCLA West Medical Pharmacy

    Los Angeles, California, 90095

  • Cancer Care & Hematology - Loveland

    Loveland, Colorado, 80538

  • Oncology and Hematology Associates of Southwest Virginia Inc

    Low Moor, Virginia, 24457

  • Northside Hospital, Inc. - GCS/Macon

    Macon, Georgia, 31217

  • Northside Hospital, Inc. - GCS/Kennestone

    Marietta, Georgia, 30060

  • Kaiser Permanente Medical Center Lab Drawing Station

    Martinez, California, 94553

  • Bascom Palmer Eye Institute

    Miami, Florida, 33136

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Miami Cancer Institute at Baptist Health, Inc.

    Miami, Florida, 33176

  • Sylvester Comprehensive Cancer Center Kendall

    Miami, Florida, 33176

  • Kaiser Permanente Medical Center Lab Drawing Station

    Milpitas, California, 95035

  • University of South Alabama Health Children's and Women's Hospital

    Mobile, Alabama, 36604

  • University of South Alabama Mitchell Cancer Institute

    Mobile, Alabama, 36604

  • University of South Alabama Health University Hospital

    Mobile, Alabama, 36617

  • Kaiser Permanente Medical Center Lab Drawing Station

    Modesto, California, 95356

  • Atrium Health Union (biopsy only)

    Monroe, North Carolina, 28112

  • Kaiser Permanente Medical Center Lab Drawing Station

    Mountain View, California, 94041

  • Tennessee Oncology PLLC

    Murfreesboro, Tennessee, 37129

  • Kaiser Permanente Medical Center Lab Drawing Station

    Napa, California, 94558

  • Florida Cancer Specialists

    Naples, Florida, 34102

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37203

  • The Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37205

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37207

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37211

  • Texas Oncology - San Antonio

    New Braunfels, Texas, 78130

  • University of Chicago Comprehensive Cancer Center at Silver Cross Hospital

    New Lenox, Illinois, 60451

  • Dana Farber Cancer Institute- Chestnut Hill

    Newton, Massachusetts, 02459

  • Kaiser Permanente Medical Center (clinic+DSL)

    Oakland, California, 94611

  • Kaiser Permanente Medical Center (Radiology)

    Oakland, California, 94611

  • Florida Cancer Specialists

    Ocala, Florida, 34474

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists

    Omaha, Nebraska, 68114

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists

    Omaha, Nebraska, 68124

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • West Omaha Imaging

    Omaha, Nebraska, 68130

  • Chao Family Comprehensive Cancer Center University of California Irvine

    Orange, California, 92868

  • UC Irvine Medical Center Attn: Trisha Maris

    Orange, California, 92868

  • UCI Medical Center - Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Orland Park - University of Chicago Center for Advanced Care

    Orland Park, Illinois, 60462

  • AdventHealth Orlando

    Orlando, Florida, 32803

  • AdventHealth Hematology and Oncology

    Orlando, Florida, 32804

  • AdventHealth Medical Group Orlando

    Orlando, Florida, 32804

  • AdventHealth Orlando Infusion Center

    Orlando, Florida, 32804

  • AdventHealth Orlando, Investigational Drug Services

    Orlando, Florida, 32804

  • Florida Cancer Specialists

    Orlando, Florida, 32806

  • Orlando Health, Inc. TRIO

    Orlando, Florida, 32806

  • MidAmerica Division, Inc. c/o Menorah Medical Center

    Overland Park, Kansas, 66209

  • The University of Kansas Cancer Center - Overland Park

    Overland Park, Kansas, 66210

  • The University of Kansas Cancer Center - Indian Creek Campus

    Overland Park, Kansas, 66211

  • The University of Kansas Cancer Center Breast Surgery Center - Indian Creek Campus

    Overland Park, Kansas, 66211

  • Illinois CancerCare- Pekin

    Pekin, Illinois, 61554

  • Illinois CancerCare, P.C.

    Peoria, Illinois, 61615

  • Illinois CancerCare- Peru

    Peru, Illinois, 61354

  • Hospital of the University of Pennsylvania, Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104

  • Sylvester Comprehensive Cancer Center Plantation

    Plantation, Florida, 33324

  • Kaiser Permanente Medical Center Lab Drawing Station

    Pleasanton, California, 94588

  • Florida Cancer Specialists

    Port Charlotte, Florida, 33980

  • UCLA Hematology/Oncology - Porter Ranch

    Porter Ranch, California, 91326

  • OHSU Knight Cancer Institute, Northwest Portland

    Portland, Oregon, 97210

  • Northwest Cancer Specialists P.C.

    Portland, Oregon, 97213

  • Providence Cancer Institute Franz Clinic

    Portland, Oregon, 97213

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • OHSU Knight Cancer Institute, East Portland

    Portland, Oregon, 97216

  • Northwest Cancer Specialists P.C.

    Portland, Oregon, 97227

  • OHSU Center for Health and Healing 2

    Portland, Oregon, 97239

  • OHSU Center for Health and Healing

    Portland, Oregon, 97239

  • OHSU Research Pharmacy Services

    Portland, Oregon, 97239

  • Oregon Health And Science University

    Portland, Oregon, 97239

  • Kaiser Permanente Medical Center Lab Drawing Station

    Redwood City, California, 94063

  • UT Southwestern Medical Center - Clinical Center Richardson/Plano - Pharmacy

    Richardson, Texas, 75080

  • UT Southwestern Medical Center - Clinical Center Richardson/Plano

    Richardson, Texas, 75080

  • Oncology & Hematology Associates of Southwest Virginia,Inc.DBA Blue Ridge Cancer Care

    Roanoke, Virginia, 24014

  • Maryland Oncology Hematology, P.A

    Rockville, Maryland, 20850

  • Kaiser Permanente Medical Center (clinic+DSL)

    Roseville, California, 95661

  • Kaiser Permanente Sacramento J Street Medical Center (clinic+DSL+Lab Drawing Station)

    Sacramento, California, 95814

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • University of California Davis

    Sacramento, California, 95817

  • Kaiser Permanente Medical Center (Radiology)

    Sacramento, California, 95825

  • Oncology & Hematology Associates of Southwest Virginia,Inc.DBA Blue Ridge Cancer Care

    Salem, Virginia, 24153

  • University of Utah, Sugar House Health Center

    Salt Lake City, Utah, 84106

  • University of Utah, Huntsman Cancer Hospital

    Salt Lake City, Utah, 84112

  • University of Utah, Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Texas Oncology-San Antonio

    San Antonio, Texas, 78217

  • Texas Oncology-San Antonio

    San Antonio, Texas, 78240

  • Texas Oncology-San Antonio

    San Antonio, Texas, 78258

  • Zuckerberg San Francisco General Hospital

    San Francisco, California, 94110

  • Kaiser Permanente Medical Center (clinic+DSL)

    San Francisco, California, 94115

  • University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center.

    San Francisco, California, 94158

  • Kaiser Permanente Mission Bay Medical Center Lab Drawing Station

    San Francisco, California, 94518

  • Kaiser Permanente Medical Center Lab Drawing Station

    San Jose, California, 95110

  • Kaiser Permanente Medical Center (clinic+DSL)

    San Jose, California, 95119

  • Kaiser Permanente Medical Center (clinic+DSL)

    San Leandro, California, 94577

  • UCLA Hematology/Oncology - San Luis Obispo

    San Luis Obispo, California, 93401

  • Kaiser Permanente Medical Center (clinic+DSL)

    Santa Clara, California, 95051

  • UCLA Hematology/Oncology - Santa Monica

    Santa Monica, California, 90404

  • UCLA Hematology/Oncology Parkside

    Santa Monica, California, 90404

  • Florida Cancer Specialists

    Sarasota, Florida, 34236

  • Tennessee Oncology PLLC

    Shelbyville, Tennessee, 37160

  • Maryland Oncology Hematology, P.A

    Silver Spring, Maryland, 20904

  • Tennessee Oncology PLLC

    Smyrna, Tennessee, 37167

  • University of Utah, South Jordan Health Center

    South Jordan, Utah, 84009

  • Kaiser Permanente Medical Center (clinic+DSL)

    South San Francisco, California, 94080

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Washington University School of Medicine - Siteman Cancer Center.

    St Louis, Missouri, 63110

  • Washington University School of Medicine - St. Louis

    St Louis, Missouri, 63110

  • Siteman Cancer Center - South County

    St Louis, Missouri, 63129

  • Florida Cancer Specialists - North Region

    St. Petersburg, Florida, 33705

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33705

  • Stony Brook Advanced Imaging

    Stony Brook, New York, 11794

  • Stony Brook Cancer Center

    Stony Brook, New York, 11794

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Florida Cancer Specialists.

    Stuart, Florida, 34994

  • Florida Cancer Specialists

    Tampa, Florida, 33607

  • Moffitt Cancer Center, Richard M, Schulze Family Foundation Outpatient Center at McKinley Campus

    Tampa, Florida, 33612

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Moffitt McKinley Hospital

    Tampa, Florida, 33612

  • Florida Cancer Specialists

    Tavares, Florida, 32778

  • Florida Cancer Specialists

    The Villages, Florida, 32159

  • Rocky Mountain Cancer Centers, LLP

    Thornton, Colorado, 80260

  • Northwest Cancer Specialists, P.C.

    Tigard, Oregon, 97223

  • Torrance Memorial Physician Network - Cancer Care

    Torrance, California, 90505

Other trials in United States

France30 sites

  • University Hospital of Besancon

    Besançon, Other, 25030

  • CHRU Besancon Service Radiologie

    Besançon, 25000

  • CHRU Besancon

    Besançon, 25000

  • Dimeo lmagerie Medicale Polyclinique - Besancon

    Besançon, 25000

  • CHRU Morvan Pharmacie des essais cliniques

    Brest, 29200

  • CHRU Morvan Unité de recherche clinique en cancérologie

    Brest, 29200

  • Service de radiologie Centre Francois Baclesse

    Caen, Other, 14076 Cedex 5

  • Centre Francois Baclesse

    Caen, 14076

  • Department de Radiodiagnostic Centre GF Leclerc

    Dijon, Other, 21079 Cedex

  • Centre GF Leclerc

    Dijon, 21079

  • Clinique du mail

    Grenoble, 38100

  • Departement de radiologie Clinique Victor Hugo

    Le Mans, Sarthe, 72000

  • Clinique Victor Hugo Centre de Cancerologie de la Sarthe

    Le Mans, 72000

  • Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes

    Lyon, Other, 69008

  • Centre Leon Berard Departement de Medecine

    Lyon, 69008

  • Departement de radiologie Centre Leon Berard

    Lyon, 69373 CEDEX 08

  • Pharmacie des essais cliniques -lnstitut Paoli calmettes

    Marseille, 13009

  • lnstitut Paoli Calmettes, Departement ONCOLOGIE MEDICALE

    Marseille, 13273

  • Groupement hospitalier Portes de Provence Quartier Beausseret

    Montélimar, 26216 cedex

  • Departement d'imagerie medicale Institut Curie - Site Paris

    Paris, 75248 Cedex 05

  • Essais Cliniques- Pharmacie - Institut Curie- Site Paris

    Paris, 75248 Cedex 05

  • lnstitut Curie- Site Paris

    Paris, 75248

  • Centre Paul Strauss - pharmacie

    Strasbourg, 67065

  • lnstitut de cancerologie Strasbourg Europe

    Strasbourg, 67200

  • IUCT-O

    Toulouse, 31059 Cedex 9

  • lnstitut Claudius Regaud - IUCT-O

    Toulouse, 31059

  • Departement de radiologie Hopital Bretonneau - CHRU de Tours

    Tours, Other, 37044 Cedex 9

  • Hopital Bretonneau CHRU de Tours

    Tours, Other, 37044 Cedex 9

  • Pharmacie Hopital Bretonneau - CHRU de Tours

    Tours, Other, 37044 Cedex 9

  • Hopital Nord Franche-Comte Pole imagerie radiologie

    Trévenans, 90400

Other trials in France

China24 sites

  • Beijing Hospital

    Beijing, 100010

  • Cancer Hospital Chinese Academy of medical sciences

    Beijing, 100021

  • Peking University People's Hospital

    Beijing, 100044

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012

  • Hunan Cancer Hospital.

    Changsha, Hu'nan, 410013

  • Maternal and child Health Hospital of Guangdong Province

    Guangzhou, Guangdong, 511442

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong

  • The First Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310002

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

  • Nanchang Third Hospital

    Nanchang, Jiangxi

  • Nanjing Drum Tower Hospital , The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, 530201

  • Shengjing Hospital Of China Medical University

    Shenyang, Liaoning, 110004

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality, 300060

  • Tianjin Cancer Hospital

    Tianjin

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710061

  • Xi'an International Medical Center Hospital

    Xi’an, Shanxi, 710100

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221009

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong, 524000

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

  • Zigong First People's Hospital

    Zigong, Sichuan, 643000

Other trials in China

Japan22 sites

  • Chiba Cancer Center

    Chiba, 260-8717

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

  • National Hospital Organization Kyushu Cancer Center.

    Fukuoka, Fukuoka, 811-1395

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, Chūgoku, 730-8518

  • Advanced Imaging Center

    Ibaraki, 305-8576

  • Hakuaikai Medical Corporation Sagara Hospital

    Kagoshima, Kagoshima-ken, 892-0833

  • Hakuaikai Medical Corporation Sagara Perth Street Clinic

    Kagoshima, Kagoshima-ken, 892-0838

  • National Cancer Center Hospital East.

    Kashiwa, Chiba, 277-8577

  • Saitama Cancer Center, Breast Oncology

    Kitaadachi-gun, Saitama, 362-0806

  • Kumamoto Shinto General Hospital

    Kumamoto, 862-8655

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

  • Shizuoka Cancer Center

    Nagaizumi-cho, Shizuoka, 411-8777

  • Nagoya Radiological Diagnosis Foundation, East Nagoya Imaging Diagnosis Center

    Nagoya, Aichi-ken, 464-0044

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, 464-8681

  • Hyogo college of medicine hospital

    Nishinomiya, Hyōgo, 663-8501

  • National Hospital Organization Osaka National Hospital

    Osaka, 540-0006

  • Osaka Prefectural Hospital Organization Osaka International Cancer Institute

    Osaka, 541-8567

  • National Hospital Organization Hokkaido Cancer Center.

    Sapporo, Hokkaido, 003-0804

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

  • University of Tsukuba Hospital

    Tsukuba, Ibaraki, 305-8576

  • Koyasu Neurosurgical Clinic

    Yokohama, Kanagawa, 241-0821

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

Spain14 sites

  • Hospital Quiron Barcelona

    Barcelona, Other, 08023

  • Vall d'Hebron University Hospital

    Barcelona, 08035

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Clinica Nuestra Senora del Rosario

    Madrid, 28006

  • Hospital Ruber Internacional

    Madrid, 28034

  • Hospital Universitario Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07120

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Santa CRUZ DE Tenerife, 38320

  • Hospital Moises Broggi- ICO

    Sant Joan Despí, 08970

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Quirón Zaragoza

    Zaragoza, 50006

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Italy10 sites

  • Azienda Ospedaliero Universitaria di Bologna - IRCCS

    Bologna, Emilia-Romagna, 40138

  • Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi

    Bologna, Emilia-Romagna, 40138

  • AUSL della Romagna. P.O. Ospedale Cervesi. U.O. di Oncologia.

    Cattolica, Rimini, 47841

  • AUSL della Romagna. P.O. Ospedale degli lnfermi. U.O. di Oncologia.

    Faenza, Ravenna, 48018

  • AUSL della Romagna. P.O. Ospedale di Lugo Umberto I. U.O. di Oncologia.

    Lugo, Ravenna, 48022

  • lstituto Europeo di Oncologia

    Milan, 20141

  • AUSL della Romagna. P.O. Ospedale Santa Maria delle Croci. U.O. di Oncologia.

    Ravenna, 48121

  • AUSL della Romagna P.O. Ospedale Infermi U.O. di Oncologia

    Rimini, 47923

  • Fondazione Policlinico Gemelli IRCCS

    Rome, Lazio, 00168

  • A.O.U. Ospedali Riuniti di Ancona.

    Torrette, Ancona, 60126

Other trials in Italy

Australia9 sites

  • Austin Health

    Heidelberg, Victoria, 3084

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • Epic Pharmacy Hollywood

    Nedlands, Western Australia, 6009

  • Hollywood Private Hospital

    Nedlands, Western Australia, 6009

  • Starcevich Day Clinic, Hollywood Private Hospital

    Nedlands, Western Australia, 6009

  • Breast Cancer Research Centre - WA

    Nedlands, 6009

  • Patricia Ritchie Centre for Cancer Care and Research Mater Hospital Sydney

    North Sydney, New South Wales, 2060

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • The Crown Princess Mary Cancer Centre, Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Belgium8 sites

  • Institut Jules Bordet

    Anderlecht, Bruxelles-capitale, Région de, 1070

  • Clinical Trails Conduct Unit(CTCU) Institut Jules Bordet

    Brussels, 1000

  • GHdC

    Charleroi, 6000

  • University Hospital Antwerp

    Edegem, 2650

  • AZ Groeninge

    Kortrijk, 8500

  • UZ Leuven

    Leuven, 3000

  • CHU de Liege

    Liège, 4000

  • CHU UCL Site Sainte Elisabeth

    Namur, 5000

Other trials in Belgium

Germany8 sites

  • Universitätsklinikum Schleswig-Holstein - Campus Kiel

    Kiel, Schleswig-Holstein, 24105

  • InVO-lnstitut für Versorgungsforschung in der Onkologie GbR

    Koblenz, 56068

  • Universitatsmedizin Mainz

    Mainz, Other, 55131

  • Klinikum rechts der Isar, Klinik und Poliklinik fur Frauenheikunde

    München, 81675

  • Sana Klinikum Offenbach GmbH Ambulantes Onkologisches Zentrum

    Offenbach/ Main, 63069

  • Sana Klinikum Offenbach GmbH Institut fur Pathologie

    Offenbach/ Main, 63069

  • Sana Klinikum Offenbach GmbH Klinik fur Kardiologie

    Offenbach/ Main, 63069

  • Sana Klinikum Offenbach GmbH Zentralinstitut fur Diagnostische und Interventionelle Radiologie

    Offenbach/ Main, 63069

Other trials in Germany

Denmark7 sites

  • Herlev og Gentofte Hospital

    Herlev, 2730

  • Radiology: Herlev - og Gentofte Hospital - Radiologisk afdeling

    Herlev, E2-2730

  • Blandecentralen Odense Universitetshospital

    Odense C, Other, 5000

  • Onkologisk Afdeling R, Odense Universitetshospital

    Odense C, Other, 5000

  • Pharmacy.

    Vejle, Other, 7100

  • Radiology.

    Vejle, 7100

  • Vejle Sygehus

    Vejle, 7100

Other trials in Denmark

South Korea7 sites

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • National Cancer Center

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Canada6 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • London Regional Cancer Program, London Health Sciences Centre

    London, Ontario, N6A 5W9

  • Centre Hospitalier de l'Universite de Motreal (CHUM)

    Montreal, Quebec, H2X 3E4

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6

  • CHU de Québec-Université Laval, St-Sacrement Hospital

    Québec, G1S 4L8

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

United Kingdom6 sites

  • University Hospitals Birmingham NHS Foundation Trust Queen Elizabeth Hospital

    Birmingham, B15 2TH

  • "Edinburgh Cancer Centre, Western General Hospital,"

    Edinburgh, Scotland, EH4 2XU

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • The Royal Marsden NHS Foundation Trust

    Sutton, SM2 5PT

  • The Royal Cornwall Hospital

    Truro, Cornwall, TR1 3LJ

Other trials in United Kingdom

Austria4 sites

  • Universitatsklinik Innsbruck fur Gynakologie und Geburtshilfe BrustGesundheitzentrum

    Innsbruck, 6020

  • CT/MRIfacility:Diagnosezentrum Urania

    Vienna, 1010

  • Klinik Ottakring.

    Vienna, 1160

  • Wilhelminen Krebsforschung GmbH

    Vienna, 1160

Other trials in Austria

Israel3 sites

  • Oncology Institute, Meir Medical Center

    Kfar Saba, 4428164

  • Institute of Oncology - Davidoff Center, Rabin Medical Center, Beilinson Hospital

    Petah Tikva, 4941492

  • Oncology Institute, Kaplan Medical Center

    Rehovot, 7610001

Other trials in Israel

Netherlands3 sites

  • Amphia Ziekenhuis

    Breda, 4818 CK

  • Martini Ziekenhuis

    Groningen, 9728 TN

  • Erasmus Medisch Centrum Daniel Den Hoed

    Rotterdam, 3015 GD

Other trials in Netherlands

Singapore2 sites

  • National Cancer Centre Singapore

    Singapore, Other, 168583

  • National University Hospital

    Singapore, 119074

Other trials in Singapore

Sweden2 sites

  • Sahlgrenska University Hospital

    Gothenburg, 413 45

  • Onkologkliniken, KPE, Malpunkt K,

    J0nkoping, SE-551 85

Other trials in Sweden

Switzerland2 sites

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, 1011

  • Kantonsspital Winterthur Onkologie

    Winterthur, 8401

Other trials in Switzerland

Taiwan2 sites

  • National Cheng Kung University Hospital

    Tainan, 704, R.O.C.

  • National Taiwan University Hospital

    Taipei, 100225

Other trials in Taiwan

About this study

Official title: 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)

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.

Read the detailed description

This study is designed to evaluate the efficacy and safety of tucatinib in combination with T-DM1 in participants with unresectable locally-advanced or metastatic HER2+ breast cancer who have had prior treatment with a taxane and trastuzumab in any setting. Prior pertuzumab treatment is permitted, but not required. Participants will be randomized in a 1:1 manner to receive 21-day cycles of either tucatinib or placebo in combination with T-DM1.

While on study treatment, participants will be assessed for progression every 6 weeks for the first 24 weeks, and every 9 weeks thereafter, irrespective of dose holds or interruptions. Study treatment will continue until unacceptable toxicity, disease progression, withdrawal of consent, or study closure. After completion of study treatment and after occurrence of disease progression, participants in both arms of the study will continue to be followed for survival until study closure or withdrawal of consent.

Being tested
tucatinib, placebo, T-DM1
Keywords
Seattle Genetics, Seagen

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tucatinibDrug

    Also called ONT-380

    300mg given twice per day by mouth (orally)

  • placeboDrug

    Given twice per day orally

  • T-DM1Drug

    Also called Kadcyla

    3.6 mg/kg given into the vein (IV; intravenously) every 21 days

Study groups in NCT03975647
Study groupRoleWhat they receive
Tucatinib + T-DM1ExperimentalTucatinib + T-DM1
Receives: Drug: tucatinib; Drug: T-DM1
Placebo + T-DM1Active comparatorPlacebo + T-DM1
Receives: Drug: placebo; Drug: T-DM1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 Based on Investigator Assessment

    PFS as per investigator was defined as the time from the date of randomization to the investigator assessment of disease progression (PD) as per RECIST v1.1 or death from any cause, whichever occurred first. PD: at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimiter (mm). Participants without documentation of PD, or death at the time of analysis were censored at the date of the last tumor assessment.

    Measured: From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 43 months)

Secondary outcomes (12)

  1. Overall Survival (OS)

    OS was defined as the time from randomization to death due to any cause. For a participant who was not known to have died by the end of study follow-up, observation of OS was censored on the date the participant was last known to be alive (i.e., the date of last contact).

    Measured: Up to approximately 5 years

  2. Progression-Free Survival as Per RECIST v1.1 in Participants With Brain Metastases at Baseline Based on Investigator Assessment

    PFS as per investigator was defined as the time from the date of randomization to the investigator assessment of PD as per RECIST v1.1 or death from any cause, whichever occurred first. PD: at least a 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Participants without documentation of PD, or death at the time of analysis were censored at the date of the last tumor assessment. PFS was analyzed in participants with presence or history of brain metastases.

    Measured: From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 45 months)

  3. Objective Response Rate (ORR) as Per RECIST v1.1 Based on Investigator Assessment

    ORR was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than (<)10 mm. PR: a greater than equal (>=) 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response. ORR by investigator assessment is based on investigator response assessments. Two-sided 95% exact confidence interval, computed using the Clopper-Pearson method.

    Measured: From the date of first CR or PR until the date of the first documentation of PD or death, whichever occurred first (maximum up to 43 months)

  4. Overall Survival in Participants With Brain Metastases at Baseline

    OS was defined as the time from randomization to death due to any cause. For a participant who was not known to have died by the end of study follow-up, observation of OS was censored on the date the participant was last known to be alive (i.e., the date of last contact). OS was analyzed in participants with presence or history of brain metastases.

    Measured: Up to approximately 5 years

  5. Progression-Free Survival as Per RECIST v1.1 Determined by Blinded Independent Committee Review (BICR)

    PFS as per BICR was defined as the time from the date of randomization to the centrally-reviewed documented PD as per RECIST v1.1 or death from any cause, whichever occurred first. PD: at least a 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Participants without documented progression of PD or death at the time of analysis were censored at the date of the last tumor assessment.

    Measured: From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 43 months)

  6. Progression-Free Survival in Participants With Brain Metastases at Baseline as Per RECIST v1.1 Determined by BICR

    PFS as per BICR was defined as the time from the date of randomization to the centrally-reviewed documented PD as per RECIST v1.1 or death from any cause, whichever occurred first. PD: at least a 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PFS was analyzed in participants with presence or history of brain metastases.

    Measured: From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 43 months)

  7. Objective Response Rate as Per RECIST v1.1 Determined by BICR

    ORR was defined as the percentage of participants with confirmed CR or PR according to RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A >= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR per BICR is based on BICR response assessments.

    Measured: From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 43 months)

  8. Duration of Response (DOR) as Per RECIST v1.1 Based on Investigator Assessment

    DOR was defined as the time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD as per RECIST v1.1 PD: at least a 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Participants without documentation of PD, or death at the time of analysis were censored at the date of the last tumor assessment. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. DOR per investigator was based on investigator response assessments.

    Measured: Up to approximately 5 years

  9. Duration of Response as Per RECIST v1.1 by BICR

    DOR was defined as the time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD as per RECIST v1.1 PD: at least a 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Participants without documentation of PD, or death at the time of analysis were censored at the date of the last tumor assessment. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. DOR per BICR was based on BICR response assessments.

    Measured: Up to approximately 5 years

  10. Clinical Benefit Rate (CBR) Per RECIST v1.1 Based on Investigator Assessment

    CBR was defined as the percentage of participants with stable disease (SD) or non-CR or non-PD >= 6 months or best response of CR or PR according to RECIST v1.1. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A >= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CBR was based on investigator assessment.

    Measured: Up to approximately 5 years

  11. Clinical Benefit Rate as Per RECIST v1.1 by BICR

    CBR was defined as the percentage of participants with SD or non-CR or non-PD >= 6 months or best response of CR or PR according to RECIST v1.1. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A >= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CBR per BICR is based on BICR response assessments.

    Measured: Up to approximately 5 years

  12. Number of Participants With Treatment Emergent Adverse Events (AEs)

    An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE was defined as AE that is newly occurred or worsened after the start of study treatment.

    Measured: From start of treatment up to 30 days after the last study treatment (approximately 43 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2019
  2. Study start2 Oct 2019
  3. Primary completion29 Jun 2023
  4. Study completion10 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
466 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03975647
Sponsor's protocol ID
SGNTUC-016
Other IDs
C4251001, 2024-514733-38-00
Status last verified
Jul 2026
First submitted
4 Jun 2019
Last updated
23 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Hurvitz SA, Loi S, O'Shaughnessy J, Okines AFC, Tolaney SM, Sohn J, Saura C, Zhu X, Cameron D, Bachelot T, Hamilton E, Curigliano G, Wolff AC, Harbeck N, Masuda N, Vahdat L, Zaman K, Valdes-Albini F, Block M, Pluard T, Tan TJ, Gawryletz C, Chan A, Bedard PL, Yerushalmi R, Xu B, Schmitt M, Xie D, Borges VF; HER2CLIMB-02 study investigators. Tucatinib and trastuzumab emtansine for patients with previously treated HER2-positive locally advanced and metastatic breast cancer: primary analysis of the randomized phase III trial HER2CLIMB-02. Ann Oncol. 2026 Mar;37(3):341-352. doi: 10.1016/j.annonc.2025.11.005. Epub 2025 Nov 17.

    PubMed 41260264

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing tucatinib and T-DM1 in people with HER2-positive Breast Cancer, run by Seagen, a wholly owned subsidiary of Pfizer at 490 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 490 sites in United States, France, China, Japan, Spain and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 Based on Investigator Assessment (time frame: From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 43 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03975647, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.

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