A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

654

Participants

Timeline

Start Date

March 7, 2022

Primary Completion Date

September 5, 2025

Study Completion Date

September 28, 2027

Conditions
HER2 Positive Breast Cancer
Interventions
DRUG

Tucatinib

300mg given by mouth (orally) twice daily

DRUG

Trastuzumab

6mg/kg given into the vein (IV; intravenously) or 600mg injected under the skin (SC; subcutaneous) every 21 days

DRUG

Pertuzumab

420mg given by IV every 21 days

DRUG

Combination product: Trastuzumab + Pertuzumab

600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase will be given by subcutaneous injection every 21 days. May be given in place of trastuzumab and pertuzumab individually.

DRUG

Placebo

Given orally twice daily

Trial Locations (295)

100

National Taiwan University Hospital, Taipei

112

Koo Foundation Sun Yat-Sen Cancer Center, Taipei

333

Chang Gung Memorial Hospital LinKou, Taoyuan

704

National Cheng Kung University Hospital, Tainan City

710

Chi Mei Medical Center, Tainan City

807

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

1070

Jules Bordet lnstituut, Anderlecht

1090

Universitair Ziekenhuis Brussel (UZ Brussel), Brussels

1200

Cliniques Universitaires Saint-Luc, Brussels

1340

Clinique St-Pierre, Ottignies

2050

Chris O'Brien Lifehouse, Camperdown

2109

Macquarie University Clinical Trials Unit., Macquarie University

2145

Western Sydney Local Health District (WSLHD), Westmead Hospital, Westmead

3084

Austin Health, Heidelberg

3128

Box Hill Hospital, Box Hill

5000

Cancer Research SA, Adelaide

St Andrews Medical Centre, Adelaide

5042

Flinders Medical Centre, Bedford Park

5404

Kantonsspital Baden., Baden

6008

St John of God Subiaco Hospital Clinical Trials Unit Bendat Family Comprehensive Cancer Centre, Subiaco

8008

Brust-Zentrum AG, Zurich

8401

Kantonsspital Winterthur, Winterthur

10003

Hospital San Pedro de Alcantara, Cáceres

10117

Charite Universtitatsmedizin Berlin Klinik fur Gynakologie mit Brustzentrum, Berlin

10408

National Cancer Center, Goyang-si

10449

MacKay Medical Foundation The Presbyterian Church in Taiwan MacKay Memorial Hospital, Taipei

10461

Montefiore Einstein Comprehensive Cancer Center, The Bronx

11217

Taipei Veterans General Hospital, Taipei

11528

"General Hospital of Athens Alexandra Clinical Therapeutics Department, Hematology/Oncology Unit", Athens

13353

Charite - Universitatsmedizin Berlin, Berlin

13620

Seoul National University Bundang Hospital, Seongnam-si

14059

Fakultni Thomayerova nemocnice Onkologicka klinika 1. LF UK a FTN, Praha 4 - Krc

14076

Centre de Lutte contre le Cancer - François Baclesse, Caen

15006

Fakultni nemocnice v Motole Onkologicka klinika 2. LF UK a FN Motol, Praha 5 - Motol

15123

IASO General Clinic Oncology Clinic, Marousi

16132

IRCCS Ospedale Policlinico, San Martino, Genoa

16247

The Catholic University of Korea, St. Vincent's Hospital, Suwon

16499

Ajou University Hospital, Suwon

17007

Institut Catala d'Oncologia Girona - ICO Girona, Girona

18014

Hospital Universitario Virgen de las Nieves, Granada

18537

Metaxa Anticancer Hospital of Piraeus, Pireaus

19090

Asplundh Cancer Pavillion, Willow Grove

20089

Istituto Clinico Humanitas, Milan

20141

Divisione di Senologia Medica; Istituto Europeo di Oncologia, Milan

20246

Universitatsklinikum Hamburg-Eppendorf (UKE), Hamburg

20900

ASST Monza Ospedale San Gerardo Centro Ricerca di Fase 1, Monza (MB)

21202

Mercy Medical Center, Baltimore

21565

Gachon University Gil Medical Center, Incheon

22190

"CARIO - Centre Armoricain de Radiotherapie lmagerie medicate et d'Oncologie -Hopital Prive des", Plérin

25000

CHU Besancon, Besançon

25198

Hospital Universitari Arnau de Vilanova, Lleida

26426

Yonsei University Wonju Severance Christian Hospital, Wŏnju

26504

University General Hospital of Patras, Oncology Department, Internal Medicine Clinic, Patra

27100

Istituti Clinici Scientifici Maugeri IRCCS, Pavia

28007

Hospital General Universitario Gregorio Maranon, Madrid

28034

Hospital Universitario Ramon y Cajal, Madrid

28644

Chungbuk Nationl University Hospital, Cheongju-si

29016

Hospital El Angel Grupo Hla, S.L.U, Málaga

30120

Hospital Universitario Virgen De La Arrixaca, EI Palmar

30308

Emory University Hospital Midtown, Atlanta

30322

Emory University Clinic, Atlanta

Winship Cancer Institute, Atlanta

30342

Emory Saint Joseph's Hospital, Atlanta

32224

Mayo Clinic Florida, Jacksonville

32701

AdventHealth Altamonte Infusion Center, Altamonte Springs

AdventHealth Medical Group Altamonte(second location), Altamonte Springs

AdventHealth Medical Group Altamonte, Altamonte Springs

32804

AdventHealth Medical Group Orlando, Orlando

AdventHealth Orlando Infusion Center, Orlando

33076

Institut Bergonie, Bordeaux

33520

Tampere University Hospital, FONK/RSYO, Tampere

34070

Centre de Cancérologie du Grand Montpellier, Montpellier

34298

Institut Régional du Cancer de Montpellier, Montpellier

37007

Hospital Universitario de Salamanca (Spain Salamanca), Salamanca

37066

Tennessee Oncology, PLLC, Gallatin

37129

Tennessee Oncology, PLLC, Murfreesboro

37160

Tennessee Oncology, PLLC, Shelbyville

37203

Sarah Cannon Research Institute- Pharmacy, Nashville

Tennessee Oncology, PLLC, Nashville

38122

Divisione Oncologia Medica, Ospedale di Trento - Presidio Ospedaliero (PO) Santa Chiara, Trento

SOC Farmacia, Ospedale di Trento - Presidio Ospedaliero (PO), Trento

38320

Hospital Universitario de Canarias, La Laguna Tenerife

40138

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

SSD Oncologia Medica Addarii - Zamagni, Policlinico Sant'Orsola - Malpighi, Bologna

40202

Norton Cancer Institute - Downtown, Louisville

Norton Cancer Institute, Downtown, Louisville

40207

Norton Cancer Institute, St Matthews Campus, Louisville

40241

Norton Cancer Institute, Brownsboro Hospital Campus, Louisville

41013

Hospital Universitario Virgen del Rocio, Seville

41110

University General Hospital of Larissa, Oncology Clinic, Larissa

43126

UOC di Oncologia Medica, Azienda Ospedaliero Universitaria (AOU) di Parma, Parma

44106

Cleveland Clinic Taussig Cancer Center Investigational Pharmacy, Cleveland

44136

Cleveland Clinic Cancer Center - Strongsville, Strongsville

44195

Cleveland Clinic, Cleveland

44800

Institut de Cancerologie de lOuest - Site Rene Gauducheau, Saint-Herblain

44805

Institut de Cancerologie de lOuest-Saint Herblain, Saint-Herblain

46009

Fundacion lnstituto Valenciano de Oncologia, Valencia

46010

Hospital Clinico Universitario de Valencia, Valencia

48013

Hospital Universitario de Basurto, Bilbao

48148

University Hospital Muenster Senology, Münster

49201

Dong-A University Hospital, Busan

53226

Froedtert Hospital/Medical College of Wisconsin, Milwaukee

55905

Mayo Clinic, Rochester

57124

Oncologia Medica Azienda Usl Toscana Nord Ovest - Ospedali Riuniti di Livor, Livorno

59100

S.O.C. Oncologia Medica - Nuovo Ospedale di Prato Santo Stefano, Prato

60126

Azienda Ospedaliero Universitaria delle Marche SOD Clinica Oncologica, Torrette

60612

University of Illinois Hospital and Health Systems (Investigational Drug Pharmacy), Chicago

University of Illinois Hospital and Health Systems (Outpatient Cancer Center), Chicago

University of Illinois Hospital and Health Systems, Chicago

63000

Centre Jean Perrin, Clermont-Ferrand

64111

Saint Luke's Cancer Institute., Kansas City

67033

Institut de Cancerologie Strasbourg Europe, Strasbourg

68046

Oncology Hematology West PC dba Nebraska Cancer Specialists, Papillion

68114

Oncology Hematology West PC dba Nebraska Cancer Specialists, Omaha

68124

Oncology Hematology West PC dba Nebraska Cancer Specialists, Omaha

68130

Oncology Hematology West PC dba Nebraska Cancer Specialists, Omaha

68167

Pharmacy:Fortuna Herstellung GmbH, Mannheim

Universitätsmedizin Mannheim Universitätsfrauenklinik, Manheim

68803

Oncology Hematology West PC dba Nebraska Cancer Specialists, Grand Island

Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island, Grand Island

69310

Hospices Civils de Lyon, Pierre-Bénite

72205

Central Arkansas Radiation Therapy Institute Inc d.b.a CARTI, Little Rock

76038

Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer, Rouen

80131

Azienda Ospedaliera Universitaria Federico II, Napoli

lstituto Nazionale Tumori IRCCS - Fondazione Pascale U.O.C. Oncologia Medica Senologica, Napoli

81675

Klinikum Rechts der Isar der Technischen Universitaet Muenchen, München

84918

Institut Sainte-Catherine., Avignon

85054

Mayo Clinic Hospital, Phoenix

85259

Mayo Clinic, Scottsdale

86156

"Universitatsklinikum Augsburg Klinik fur Frauenheilkunde und Geburtshilfe", Augsburg

89075

Universitatsklinikum Ulm Klinik fur Frauenheilkunde und Geburtshilfe, Ulm

90095

Administrative Address: UCLA Hematology/Oncology, Los Angeles

UCLA Hematology/Oncology, Los Angeles

90212

UCLA Hematology/Oncology - Beverly Hills, Beverly Hills

90404

UCLA Hematology/Oncology - Santa Monica, Santa Monica

UCLA Hematology/Oncology Parkside, Santa Monica

90502

Clinical And Translational Research Center, Torrance

The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance

90509

Harbor-UCLA Medical Center, Torrance

91355

UCLA Hematology/Oncology - Santa Clarita, Valencia

91361

UCLA Hematology/Oncology- Westlake, Westlake Village

91505

UCLA Hematology/Oncology - Burbank, Burbank

92024

UCSD Medical Center - Encinitas, Encinitas

92037

Sulpizio Cardiovascular Center at UC San Diego Health, La Jolla

UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion), La Jolla

UCSD Koman Family Outpatient Pavilion, La Jolla

UCSD Perlman Medical Offices, La Jolla

92081

UCSD Medical Center - Vista, Vista

92093

UC San Diego Moores Cancer Center, La Jolla

92103

UC San Diego Medical Center - Hillcrest, San Diego

92210

Institut Curie - site St-Cloud, Saint-Cloud

Institut Curie, Saint-Cloud

92653

UCLA Hematology/Oncology - Laguna Hills, Laguna Hills

93101

UCLA Hematology/Oncology- Santa Barbara, Santa Barbara

93401

UCLA Hematology/Oncology - San Luis Obispo, San Luis Obispo

95045

Humanitas lstituto Clinico Catanese, Catania (CT)

97080

Universitatsklinikum Wurzburg Frauenklinik und Poliklinik, Würzburg

Universitatsklinikum Wurzburg, Comprehensive Cancer Center - Mainfranken (CCCMF), Würzburg

98109

Fred Hutchinson Cancer Center, Seattle

98195

University of Washington Medical Center, Seattle

100730

Beijing Hospital, Beijing

110001

The First Hospital of China Medical University, Shenyang

110042

Liaoning Cancer Hospital & Insitute, Shenyang

130021

The First Hospital of Jilin University, Changchun

200025

Ruijin Hospital of Shanghai Jiaotong University School of Medicine, Shanghai

200032

Fudan University Shanghai Cancer Center, Shanghai

210036

Nanjing Medical University (NMU) - Jiangsu Province Hospital, Nanjing

230601

The Second Hospital of Anhui Medical University, Hefei

250013

Jinan Central Hospital, Jinan

276034

Linyi Cancer Hospital, Linyi

300181

Tianjin Medical University Cancer Institute & Hospital, Tianjin

310005

Zhejiang Cancer Hospital, Hangzhou

310016

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou

310052

The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou

330008

The Second Affiliated Hospital of Nanchang University, Nanchang

410011

The Second Xiangya Hospital of Central South University, Changsha

430030

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan

430079

Hubei Cancer Hospital, Wuhan

450003

Henan Cancer Hospital, Zhengzhou

510080

Guangdong Provincial People's Hospital, Guangzhou

514031

Meizhou People's Hospital, Meizhou

530021

Guangxi Medical University Affiliated Tumor Hospital, Nanning

The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning

545006

Liuzhou People's Hospital, Liuzhou

570102

The first Affiliated Hospital of Hainan Medical University, Haikou

710061

The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an

912101

UCSD Medical Center - Bankers Hill, San Diego

3460000

Clinica Universidad Catolica del Maule, Talca

4810469

James Lind Centro De Investigacion Del Cancer, Temuco

07302

RWJBarnabas Health- Jersey City Medical Center, Jersey City

08701

RWJBarnabas Health- Monmouth Medical Center-Southern Campus, Lakewood

07039

RWJBarnabas Health- Cooperman Barnabas Medical Center, Livingston

07740

RWJBarnabas Health- Monmouth Medical Center, Long Branch

08903

Rutgers Cancer Institute of New Jersey, New Brunswick

07112

Newark Beth Israel Medical Center, Newark

08876

RWJBarnabas Health-Robert Wood Johnson University Hospital, Somerset, Somerville

Steeplechase Cancer Center, Somerville

08755

RWJBarnabas Health - Community Medical Center, Toms River

07764

Satellite Infusion Center-Monmouth Medical Center Vantage Point Infusion Center, West Long Branch

A-6130

Ordination Priv.-Doz. Dr. Michael Hubalek, Schwaz

A-8036

Medizinische Universitat Graz, Graz

A-4010

Ordensklinikum Linz GmbH Barmherzige Schwestern, Linz

A-1090

Medizinische Universitat Wien Universitatsklinik Fur Frauenheilkunde, Vienna

60336-232

CRIO - Centro Regional lntegrado de Oncologia, Fortaleza

74605-070

Hospital Araujo Jorge, Goiânia

86015-520

Hospital Do Cancer De Londrina, Londrina

59075-740

Liga Norte-Rio Grandense Contra o Cancer, Natal

90035-903

Hospital de Clinicas de Porto Alegre, Porto Alegre

CEP 90110-270

Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital do Cancer Mae de Deu, Porto Alegre

CEP 90850-170

Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital do Cancer Mae de Deu, Porto Alegre

CEP: 14784-400

Fundacao Pio XII, Hospital do Amor de Barretos, Barretos

CEP: 17210-080

Fundacao Dr Amaral Carvalho, Jaú

09060-650

CEPHO- Centro de Estudos e Pesquisas de Hematologia e Oncologia, Santo André

09060-870

CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia, Santo André

90050-170

Irmandade da Santa Casa de Misericordia de Porto Alegre centro Multidisciplinar de pesquisa clinica, Porto Alegre/RS

15090-000

Faculdade Regional de Medicina de Sao Jose do Rio Preto, São José do Rio Preto

01246-000

ICESP- Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira, São Paulo

04014-002

Sao Camilo Oncologia, São Paulo

CEP: 01317-000

Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecologica e Mamária Ltda., São Paulo

01.509-010

A.C. Camargo Câncer Center, São Paulo/SP

T6G 1Z2

Cross Cancer Institute, Edmonton

V1Y 5L3

BC Cancer Agency, Kelowna

K1H 8L6

The Ottawa Hospital Cancer Centre, Ottawa

M4N 3M5

Sunnybrook Research Institute, Toronto

M5G 1X5

Mount Sinai Hospital, Toronto

G7H 5H6

Centre integre universitaire de sante et de services sociaux du Saguenay-Lac-Saint-Jean, Chicoutimi

H2X 3E4

Centre Hospitalier de l'Universite de Motreal (CHUM), Montreal

H3T 1E2

Jewish General Hospital, Montreal

Unknown

Oncocentro Apys, Viña del Mar

Centro de Investigacion Clínica Bradford Hill, Recoleta

Shaanxi Provincial People's Hospital, Xi'an

071000

Affiliated Hospital of Hebei University, Baoding

656 53

Masarykuv Onkologicky Ustav, Brno

Ustavni lekarna Masarykuv onkologicky ustav, Brno

128 08

Vseobecna fakultni nemocnice v Praze, Prague

93009 Cedex

Hopital Avicenne, Bobigny

14076 Cedex 5

CENTRE FRANCOIS BACLESSE - Service lmagerie medicale, Caen

21079 Cedex

Center Georges-Francois Leclerc, Dijon

59020 Cedex

Centre Oscar Lambret, Lille

69373 Cedex 08

Center Leon Berard, Lyon

34298 Cedex 5

Institut Regional du Cancer de Montpellier Service lmagerie medicale, Montpellier

06189

Centre Antoine Lacassagne, Nice

cedex 35042

Centre Eugene Marquis, Rennes

76038 Cedex 1

Centre Henri Becquerel, Rouen

296-8602

Tesshokai Kameda General Hospital, Kamogawa

277-8577

National Cancer Center Hospital East, Kashiwa-Shi

791-0280

NHO Shikoku Cancer Center, Matsuyama

811-1395

National Hospital Organization Kyushu Cancer Center, Fukuoka

960-1295

Fukushima Medical University Hospital, Fukushima

003-0804

National Hospital Organization Hokkaido Cancer Center, Sapporo

920-8530

Ishikawa Prefectural Central Hospital, Kanazawa

241-8515

Kanagawa Cancer Center, Yokohama

305-8576

University of Tsukuba Hospital, Tsukuba

901-0154

Naha Nishi Clinic, Naha

589-8511

Kindai University Hospital, Osakasayama-shi

104-0045

National Cancer Center Hospital, Chuo-ku

104-8560

St. Luke's International Hospital., Chuo-ku

105-8470

Toranomon Hospital, Minato-ku

142-8666

Showa University Hospital, Shinagawa-ku

3318AT

Albert Schweitzer Hospital, Doedrecht

3318 AT

Albert Schweitzer Ziekenhuis, Dordrecht

3543 AZ

St. Antonius Hospital, Utrecht

5912 BL

VieCuri Medsich Centrum, Venlo

44-102

Narodowy lnstytut Onkologii im. Marii Sklodowskiej-Curie-Panstwowy lnstytut Badawczy, Gliwice

80-214

Uniwersyteckie Centrum Kliniczne, Gdansk

93-513

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Lodz

45-061

SP ZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego w Opolu, Opole

4710-243

Centro Clinico Academico Braga Hospital de Braga, Braga

3000-075

Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE (IPO, Coimbra), Coimbra

1400-038

Fundacao Champalimaud, Lisbon

1998-018

Hospital CUF Descobertas, Lisbon

02841

Korea University Anam Hospital, Seoul

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06273

Gangnam Severance Hospital, Yonsei University Health System, Seoul

06591

The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul

07985

Ewha Womans University Mokdong Hospital, Seoul

07120

Hospital Universitario Son Espases, Palma de Mallorca

08035

Fundación Privada Instituto de Investigación Oncológica de Vall Hebron, Barcelona

Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca, Barcelona

Hospital Universitari Vall d'Hebron, Barcelona

03010

Hospital General Universitario Alicante, Alicante

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

500 (R.O.C.)

Changhua Christian Medical Foundation Changhua Christian Hospital, Changhua

23561 (R.O.C.)

Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare, New Taipei City

40447 (R.O.C.)

China Medical University Hospital, Taichung

11490, R.O.C.

Tri-Service General Hospital, Taipei

NW3 2QG

Academic Oncology, London

SM2 5PT

The Royal Marsden NHS Foundation Trust (Surrey), London

The Royal Marsden, Sutton

N12 0JE

Finchley Memorial Hospital, London

NW1 2PG

University College London Hospital (UCLH) NHS Foundation Trust, London

SW3 6JJ

The Royal Marsden, London

M20 4BX

Christie Hospital NHS Foundation Trust, Manchester

All Listed Sponsors
lead

Seagen, a wholly owned subsidiary of Pfizer

INDUSTRY