A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

612

Participants

Timeline

Start Date

January 28, 2016

Primary Completion Date

September 4, 2019

Study Completion Date

August 11, 2022

Conditions
HER2 Positive Breast Cancer
Interventions
DRUG

tucatinib

300 mg orally twice daily

DRUG

capecitabine

1000 mg/m2 orally twice daily on Days 1-14 of each 21-day cycle

DRUG

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.

DRUG

placebo

Oral dose twice daily

Trial Locations (176)

1200

Cliniques Universitaires Saint Luc, Brussels

2060

Mater Hospital, North Sydney

2145

Westmead Hospital, Westmead

2730

Herlev Hospital, Herlev

2930

AZ Klina, Brasschaat

3000

Peter MacCallum Cancer Centre, Melbourne

3021

Sunshine Hospital, St Albans

3084

Austin Hospital, Heidelberg

3144

Cabrini Education and Research Precinct, Malvern

4010

KH d. Barmherzigen Schwestern Linz, Linz

4101

Icon Cancer Care South Brisbane, South Brisbane

Mater Health Services, South Brisbane

5000

CHU UCL Namur-Site de Saint Elisabeth, Namur

Odense University Hospital, Odense C

5020

LKH Salzburg, Universitatsklinikum der PMU, Salzburg

6000

Grand Hopital de Charleroi, Charleroi

6009

Breast Cancer Research Centre, Nedlands

6020

Medizinische Universitat Innsbruck, Innsbruck

6500

Institute of Oncology of Southern Switzerland, Bellinzona

6800

Centre Hospitalier de l'Ardenne, Libramont

7100

Sygehus Lillebaelt - Vejle Sygehus, Vejle

8036

LKH- Universitat Klinikum Graz, Graz

9100

Aalborg Universitetshospital, Aalborg

10002

Hospital San Pedro de Alcantara, Cáceres

10003

Mount Sinai Beth Israel, New York

10016

New York University (NYU) Cancer Institute, New York

10117

Charite Universitatsmedizin Berlin, Berlin

10467

Montefiore Medical Center, The Bronx

11794

Stony Brook University Cancer Center, Stony Brook

13273

Institut Paoli Calmettes, Marseille

15706

Hospital Clinico Univ De Santiago De Compostela, Santiago de Compostela

16132

Ospedale Policlinico San Martino, Genova

19104

University of Pennsylvania / Perelman Center for Advanced Medicine, Philadelphia

19124

Cancer Treatment Centers of America / Eastern Regional Medical Center, Philadelphia

20007

Lombardi Cancer Center / Georgetown University Medical Center, Washington D.C.

20141

Istituto Europeo di Oncologia, Milan

20246

Universitaetsklinikum Hamburg-Eppendorf (UKE) - Onkologisches Zentrum - Interdisziplinaere Klinik und Poliklinik fuer Stammzelltransplantation, Hamburg

20850

Maryland Oncology Hematology, P.A., Rockville

21201

University of Maryland, Baltimore

22031

Virginia Cancer Specialists, PC, Fairfax

22601

Shenandoah Oncology P.C., Winchester

24008

Complejo Asistencial Universitario de Leon, León

24105

Universitatsklinikum Schleswig-Holstein, Kiel

25030

University Hospital of Besancon, Besançon

27100

IRCSS Policlinico San Matteo, Pavia

27599

UNC Lineberger Comprehensive Cancer Center / University of North Carolina, Chapel Hill

27710

Duke University Medical Center, Durham

27834

Leo W. Jenkins Cancer Services / Brody School of Medicine East Carolina University, Greenville

28007

Hospital General Universitario Gregorio Marañon, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

29414

Roper St. Francis Healthcare, Charleston

29425

Medical University of South Carolina/Hollings Cancer Center, Charleston

30265

Cancer Treatment Centers of America, Newnan

30322

Winship Cancer Institute / Emory University School of Medicine, Atlanta

30342

Northside Hospital, Atlanta

30625

Medizinische Hochschule Hannover, Hanover

30912

Augusta University, Augusta

31059

Institut Claudius Regaud, Toulouse

31096

Rambam Health Corp., Haifa

32207

Baptist MD Anderson Cancer Center, Jacksonville

32806

Orlando Health, Inc. TRIO, Orlando

33021

Memorial Regional Hospital TRIO, Hollywood

33136

University of Miami, Miami

33140

Mount Sinai Medical Center / Florida, Miami Beach

33401

Florida Cancer Specialists - East West Palm Beach, FL (SCRI), West Palm Beach

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

33705

Florida Cancer Specialists - North Region, St. Petersburg

33901

Florida Cancer Specialists - South Region, Fort Myers

35042

Centre Eugene Marquis, Rennes

35249

University of Alabama at Birmingham, Birmingham

36604

University of South Alabama - Mitchell Cancer Institute, Mobile

37044

CHU Tours - Hopital Bretonneau, Tours

37203

Tennessee Oncology - Nashville, Nashville

37204

Vanderbilt University Medical Center, Nashville

37660

Wellmont Cancer Institute, Kingsport

39100

Ospedale di Bolzano, Bolzano

40138

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

41012

Ospedale Ramazzini di Carpi, Carpi

43210

James Cancer Hospital / Ohio State University, Columbus

44281

Meir Medical Center, Kfar Saba

45136

Kliniken Essen-Mitte - Evang. Huyssens-Stiftung, Essen

46015

Hospital Arnau De Vilanova, Valencia

48073

William Beaumont Hospital, Royal Oak

48202

Henry Ford Health System, Detroit

49414

Rabin Medical Center, Petah Tikva

50009

Hospital Clinico Universitario Lozano Blesa de Zaragoza, Zaragoza

50937

Universitatsklinikum Koln, Cologne

51056

Institut Jean Godinot, Reims

52621

Sheba Medical Center, Tel Litwinsky

53792

Carbone Cancer Center / University of Wisconsin, Madison

55407

Virginia Piper Cancer Institute, Minneapolis

56068

InVO- Institut fUr Versorgungsforschung in der onkologie GbR, Koblenz

60126

A.O.U. - Ospedali Riuniti di Ancona, Torrette

60612

Rush University Medical Center, Chicago

60714

Illinois Cancer Specialists / Advocate Lutheran General Hospital, Niles

61801

Carle Cancer Center, Urbana

63069

Sana Klinikum Offenbach GmbH, Offenbach

64113

Saint Luke's Cancer Institute LLC, Kansas City

64239

Tel Aviv Sourasky Medical Center, Tel Aviv

66205

University of Kansas Cancer Center, Westwood

67200

Hopitaux Universitaires de Strasbourg, Strasbourg

68130

Nebraska Cancer Specialists, Omaha

69373

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

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

72000

Clinique Victor Hugo, Le Mans

72100

Presido Ospedaliero- Senatore Antonio Perrino, Brindisi

75005

Institute Curie - Centre de Lutte Contre Le Cancer CLCC de Paris, Paris

75075

Texas Oncology - Plano East, Plano

75203

Texas Oncology Methodist, Dallas

75460

Paris Regional Medical Center / US Oncology, Paris

76100

Kaplan Medical Center, Rehovot

76104

The Center for Cancer and Blood Disorders: Fortworth, Fort Worth

76210

Texas Oncology - Denton South, Denton

77024

Texas Oncology - Houston Memorial City, Houston

77030

Baylor Clinic, Houston

77380

US Oncology Central Regulatory, The Woodlands

77520

Fakultni Nemocnice Olomouc (Fnol) - Onkologicka Klinika, Olomouc

77598

Texas Oncology - Deke Slayton Cancer Center, Webster

78212

Texas Oncology - San Antonio Medical Center Northeast, San Antonio

78229

University of Texas Health Science Center at San Antonio, San Antonio

78705

Texas Oncology - Austin Midtown, Austin

79410

Joe Arrington Cancer Research and Treatment Center, Lubbock

80639

HOPE- Onkologisches Zentrum Rotkreuzklinikum, München

84112

University of Utah, Salt Lake City

85016

Arizona Oncology Associates, PC - HAL, Phoenix

85338

Cancer Treatment Centers of America - Phoenix, Goodyear

90095

TRIO - Central Regulatory Office, Los Angeles

UCLA Medical Center / David Geffen School of Medicine, Los Angeles

90277

Torrance Memorial Physician Network - TRIO, Redondo Beach

91120

Hadassah Medical Center, Jerusalem

92078

Kaiser Permanente San Marcos Medical Offices, San Marcos

93454

Central Coast Medical Oncology Corporation TRIO, Santa Maria

94134

University of California at San Francisco, San Francisco

94589

Kaiser Permanente Medical Center Northern California, Vallejo

97062

Northwest Cancer Specialists, P.C., Tualatin

97213

Providence Portland Medical Center, Portland

98104

Swedish Cancer Institute, Seattle

91010-3000

City of Hope National Medical Center, Duarte

80045-0510

University of Colorado Hospital / University of Colorado, Aurora

06520

Yale Cancer Center, New Haven

60637-1470

University of Chicago, Chicago

02215

Dana Farber Cancer Institute, Boston

03756

Dartmouth-Hitchcock Medical Center/ Norris Cotton Cancer Center, Lebanon

07601

Hackensack University Medical Center, Hackensack

97239-3098

Oregon Health and Science University, Portland

77030-4095

MD Anderson Cancer Center / University of Texas, Houston

98109-1023

Seattle Cancer Care Alliance / University of Washington, Seattle

T2N 4N2

Tom Baker Cancer Centre, Calgary

T6G 1Z2

University of Alberta / Cross Cancer Institute, Edmonton

B3H 2Y9

Queen Elizabeth II Health Sciences Centre, Halifax

H3T 1E2

Jewish General Hospital, Montreal

G1S 4L8

Hopital du Saint-Sacrement, CHU de Quebec-Universite Laval, Québec

S4T7T1

Allan Blair Cancer Centre, Regina

S7N 4H4

Saskatoon Cancer Centre, Saskatoon

A1B 3V6

H. Bliss Murphy Cancer Centre, St. John's

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

M5G 2M9

University Health Network, Princess Margaret Hospital, Toronto

V5Z 4E6

British Columbia Cancer Agency - Vancouver Centre, Vancouver

500 05

Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie, Hradec Králové

DK 2100

Rigs Hospiltalet, Copenhagen

05100

Azienda Ospedaliera S. Maria di Terni, Terni

1998-018

Hospital Cuf Descobertas R. Mario Botas Parque das Nacoes, Lisbon

4099-001

Centro Hospitalar do Porto - Hospital Santo Antonio, Porto

08035

Hospital Universitario Vall d'Hebron, Barcelona

08036

Hospital Clinic i Provincial de Barcelona, Barcelona

07010

Hospital Son Espases, Palma de Mallorca

C04 5JL

Colchester Hospital University NHS Foundation Trust, Colchester

SW3 6JJ

The Royal Marsden Hospital, London

W1G 6AD

Sarah Cannon Research Institute UK, London

M20 4BX

The Christie NHS Foundation Trust, Manchester

HA6 2RN

Mount Vernon Hospital, UK, Northwood

NG5 1PD

Nottingham University Hospitals NHS Trust, Nottingham

PE3 9GZ

Peterborough City Hospital, Peterborough

S10 2SJ

Weston Park Hospital- UK, Sheffield

SM2 5PT

The Royal Marsden Hospital (Surrey), Sutton

TR1 3LQ

Royal Cornwall Hospitals NHS Trust, Truro

All Listed Sponsors
lead

Seagen Inc.

INDUSTRY

NCT02614794 - A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer | Biotech Hunter | Biotech Hunter