A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer (HER2CLIMB-05)

September 4, 2026 updated by: Seagen, a wholly owned subsidiary of Pfizer

A Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy for Metastatic HER2+ Breast Cancer (HER2CLIMB-05)

This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease.

Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).

In this study, all participants will get either tucatinib or placebo. Participants will be assigned randomly to a group. This is a blinded study, so patients and their doctors will not know which group a participant is in.

All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat this type of cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Control arm: Placebo given orally twice daily plus trastuzumab and pertuzumab every 21 days

Experimental arm: Tucatinib 300 mg given orally twice daily plus trastuzumab and pertuzumab every 21 days

Trastuzumab and pertuzumab will be administered as follows:

• Trastuzumab will be given intravenously (IV) at a dose of 6 mg/kg or subcutaneously (SC) at a fixed dose of 600 mg, once every 21 days.

AND

  • Pertuzumab will be given IV at 420 mg every 21 days. OR
  • Fixed dose combination of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase will be given SC, once every 21 days, in lieu of trastuzumab and pertuzumab individually.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
654

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Chris O'Brien Lifehouse
      • Macquarie University, New South Wales, Australia, 2109
        • Macquarie University Clinical Trials Unit.
      • Westmead, New South Wales, Australia, 2145
        • Western Sydney Local Health District (WSLHD), Westmead Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Cancer Research SA
      • Adelaide, South Australia, Australia, 5000
        • St Andrews Medical Centre
      • Bedford Park, South Australia, Australia, 5042
        • Flinders Medical Centre
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Heidelberg, Victoria, Australia, 3084
        • Austin Health
    • Washington
      • Subiaco, Washington, Australia, 6008
        • St John of God Subiaco Hospital Clinical Trials Unit Bendat Family Comprehensive Cancer Centre
  • Austria
      • Graz, Austria, A-8010
        • Medizinische Universität Graz
      • Graz, Austria, A-8036
        • Medizinische Universitat Graz
      • Linz, Austria, A-4010
        • Ordensklinikum Linz GmbH Barmherzige Schwestern
      • Vienna, Austria, A-1090
        • Medizinische Universitat Wien Universitatsklinik Fur Frauenheilkunde
    • Other
      • Schwaz, Other, Austria, A-6130
        • Ordination Priv.-Doz. Dr. Michael Hubalek
  • Belgium
      • Anderlecht, Belgium, 1070
        • Jules Bordet lnstituut
      • Brussels, Belgium, 1090
        • Universitair Ziekenhuis Brussel (UZ Brussel)
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
      • Ottignies, Belgium, 1340
        • Clinique St-Pierre
  • Brazil
      • Porto Alegre/RS, Brazil, 90050-170
        • Irmandade da Santa Casa de Misericordia de Porto Alegre centro Multidisciplinar de pesquisa clinica
      • São José do Rio Preto, Brazil, 15090-000
        • Faculdade Regional de Medicina de Sao Jose do Rio Preto
      • São Paulo, Brazil, 01246-000
        • ICESP- Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira
      • São Paulo, Brazil, 04014-002
        • Sao Camilo Oncologia
      • São Paulo, Brazil, CEP: 01317-000
        • Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecologica e Mamária Ltda.
    • Ceará
      • Fortaleza, Ceará, Brazil, 60336-232
        • CRIO - Centro Regional lntegrado de Oncologia
    • Goiás
      • Goiânia, Goiás, Brazil, 74605-070
        • Hospital Araujo Jorge
    • Other
      • Sao Paulo/SP, Other, Brazil, 01.509-010
        • A.C. Camargo Câncer Center
    • Paraná
      • Londrina, Paraná, Brazil, 86015-520
        • Hospital Do Cancer De Londrina
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59075-740
        • Liga Norte-Rio Grandense Contra o Cancer
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brazil, CEP 90110-270
        • Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital do Cancer Mae de Deu
      • Porto Alegre, Rio Grande do Sul, Brazil, CEP 90850-170
        • Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital do Cancer Mae de Deu
    • São Paulo
      • Barretos, São Paulo, Brazil, CEP: 14784-400
        • Fundacao Pio XII, Hospital do Amor de Barretos
      • Jaú, São Paulo, Brazil, CEP: 17210-080
        • Fundacao Dr Amaral Carvalho
      • Santo André, São Paulo, Brazil, 09060-650
        • CEPHO- Centro de Estudos e Pesquisas de Hematologia e Oncologia
      • Santo André, São Paulo, Brazil, 09060-870
        • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • BC Cancer Agency
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital Cancer Centre
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Research Institute
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Centre integre universitaire de sante et de services sociaux du Saguenay-Lac-Saint-Jean
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
      • Montreal, Quebec, Canada, H2X 3E4
        • Centre Hospitalier de l'Universite de Motreal (CHUM)
  • Chile
      • Talca, Chile, 3460000
        • Clinica Universidad Catolica del Maule
      • Temuco, Chile, 4810297
        • Clinica Alemana Temuco
      • Temuco, Chile, 4810469
        • James Lind Centro De Investigacion Del Cancer
    • Santiago Metropolitan
      • Recoleta, Santiago Metropolitan, Chile, 8420323
        • Centro de Investigacion Clínica Bradford Hill
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile
        • Oncocentro Apys
  • China
      • Beijing, China, 100730
        • Beijing Hospital
      • Beijing, China, 100010
        • Beijing Hospital
      • Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center
      • Tianjin, China, 300181
        • Tianjin Cancer Hospital Binhai Campus
    • Anhui
      • Hefei, Anhui, China, 230601
        • The Second Hospital of Anhui Medical University
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Guangdong Provincial People's Hospital
      • Meizhou, Guangdong, China, 514031
        • Meizhou People's Hospital
    • Guangxi
      • Liuzhou, Guangxi, China, 545006
        • Liuzhou People's Hospital
      • Nanning, Guangxi, China, 530021
        • The People's Hospital of Guangxi Zhuang Autonomous Region
      • Nanning, Guangxi, China, 530021
        • Guangxi Medical University Affiliated Tumor Hospital
    • Hainan
      • Haikou, Hainan, China, 570102
        • The first Affiliated Hospital of Hainan Medical University
    • Hebei
      • Baoding, Hebei, China, 071000
        • Affiliated Hospital of Hebei University
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Hubei Cancer Hospital
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
    • Hunan
      • Changsha, Hunan, China, 410011
        • The Second Xiangya Hospital of Central South University
    • Jiangsu
      • Nanjing, Jiangsu, China, 210036
        • Nanjing Medical University (NMU) - Jiangsu Province Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China, 330008
        • The Second Affiliated Hospital of Nanchang University
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
    • Liaoning
      • Shenyang, Liaoning, China, 110042
        • Liaoning Cancer Hospital & Insitute
      • Shenyang, Liaoning, China, 110167
        • The First Affiliated Hospital of China Medical University
    • Other
      • Shanghai, Other, China, 200025
        • Ruijin Hospital of Shanghai Jiaotong University School of Medicine
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • The First Affiliated Hospital of Xi'an Jiaotong University
      • Xi'an, Shaanxi, China, 710068
        • Shaanxi Provincial People's Hospital
    • Shandong
      • Jinan, Shandong, China, 250013
        • Jinan Central Hospital
      • Linyi, Shandong, China, 276034
        • Linyi Cancer Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, China, 310005
        • Zhejiang Cancer Hospital
      • Hangzhou, Zhejiang, China, 310052
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
  • Czechia
      • Brno, Czechia, 656 53
        • Masarykuv Onkologicky Ustav
      • Prague, Czechia, 128 08
        • Vseobecna fakultni nemocnice v Praze
      • Praha 5 - Motol, Czechia, 15006
        • Nemocnicni lekarna Fakultni nemocnice v Motole
      • Praha 5 - Motol, Czechia, 15006
        • Fakultni nemocnice v Motole Onkologicka klinika 2. LF UK a FN Motol
    • Other
      • Brno, Other, Czechia, 656 53
        • Ustavni lekarna Masarykuv onkologicky ustav
      • Praha 4 - Krc, Other, Czechia, 14059
        • Fakultni Thomayerova nemocnice Onkologicka klinika 1. LF UK a FTN
  • Finland
      • Tampere, Finland
        • Tampere University Hospital
      • Tampere, Finland, 33520
        • Tampere University Hospital, FONK/RSYO
  • France
      • Besançon, France, 25000
        • CHU Besancon
      • Bobigny, France, 93009 Cedex
        • Hopital Avicenne
      • Caen, France, 14076 Cedex 5
        • CENTRE FRANCOIS BACLESSE - Service lmagerie medicale
      • Caen, France, 14076
        • Centre de Lutte contre le Cancer - François Baclesse
      • Caen, France, 14076 Cedex 5
        • Centre Francois Baclesse
      • Clermont-Ferrand, France, 63000
        • Centre Jean Perrin
      • Lille, France, 59020 Cedex
        • Centre Oscar Lambret
      • Lyon, France, 69373 Cedex 08
        • Center Leon Berard
      • Montpellier, France, 34298 Cedex 5
        • Institut Regional du Cancer de Montpellier Service lmagerie medicale
      • Montpellier, France, 34298
        • Institut Régional du Cancer de Montpellier
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Pierre-Bénite, France, 69310
        • Hospices Civils de Lyon
      • Plérin, France, 22190
        • "CARIO - Centre Armoricain de Radiotherapie lmagerie medicate et d'Oncologie -Hopital Prive des
      • Rennes, France, cedex 35042
        • Centre Eugene Marquis
      • Rouen, France, 76038 Cedex 1
        • Centre Henri Becquerel
      • Saint-Cloud, France, 92210
        • Institut Curie - site St-Cloud
      • Strasbourg, France, 67033
        • Institut de Cancerologie Strasbourg Europe
    • Brittany Region
      • Rouen, Brittany Region, France, 76038
        • Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
    • Cedex
      • Bordeaux, Cedex, France, 33076
        • Institut Bergonie
    • Languedoc-roussillon
      • Montpellier, Languedoc-roussillon, France, 34070
        • Centre de Cancérologie du Grand Montpellier
    • Loire-atlantique
      • Saint-Herblain, Loire-atlantique, France, 44800
        • Institut de Cancerologie de lOuest - Site Rene Gauducheau
      • Saint-Herblain, Loire-atlantique, France, 44805
        • Institut de Cancerologie de lOuest-Saint Herblain
    • Other
      • Avignon, Other, France, 84918
        • Institut Sainte-Catherine.
      • Avignon, Other, France, 84918
        • Sainte Catherine lnstitut du Cancer Avignon Provence
      • Dijon, Other, France, 21079
        • Center Georges-Francois Leclerc
  • Germany
      • Augsburg, Germany, 86156
        • "Universitatsklinikum Augsburg Klinik fur Frauenheilkunde und Geburtshilfe"
      • Berlin, Germany, 10117
        • Charite Universtitatsmedizin Berlin Klinik fur Gynakologie mit Brustzentrum
      • Berlin, Germany, 13353
        • Charite - Universitatsmedizin Berlin
      • Hamburg, Germany, 20246
        • Universitatsklinikum Hamburg-Eppendorf (UKE)
      • München, Germany, 81675
        • Klinik und Poliklinik fur Frauenheilkunde der Technischen Universitat Munchen
      • Ulm, Germany, 89075
        • Universitatsklinikum Ulm Klinik fur Frauenheilkunde und Geburtshilfe
      • Würzburg, Germany, 97080
        • Universitatsklinikum Wurzburg Frauenklinik und Poliklinik
      • Würzburg, Germany, 97080
        • Universitatsklinikum Wurzburg, Comprehensive Cancer Center - Mainfranken (CCCMF)
    • North Rhine-Westphalia
      • Münster, North Rhine-Westphalia, Germany, 48149
        • University Hospital Muenster Senology
    • Other
      • Manheim, Other, Germany, 68167
        • Universitätsmedizin Mannheim Universitätsfrauenklinik
      • Mannheim, Other, Germany, 68167
        • Pharmacy:Fortuna Herstellung GmbH
  • Greece
      • Larissa, Greece, 41110
        • University General Hospital of Larissa, Oncology Clinic
      • Marousi, Greece, 15123
        • IASO General Clinic Oncology Clinic
      • Pireaus, Greece, 18537
        • Metaxa Anticancer Hospital of Piraeus
    • Attica
      • Athens, Attica, Greece, 11528
        • General Hospital of Athens "Alexandra" Clinical Therapeutics Department, Hematology/Oncology Unit
    • Peloponnese
      • Patra, Peloponnese, Greece, 26504
        • University General Hospital of Patras, Oncology Department, Internal Medicine Clinic
  • Italy
      • Bologna, Italy, 40138
        • Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
      • Bologna, Italy, 40138
        • SSD Oncologia Medica Addarii - Zamagni, Policlinico Sant'Orsola - Malpighi
      • Milan, Italy, 20089
        • Istituto Clinico Humanitas
      • Milan, Italy, 20141
        • Divisione di Senologia Medica; Istituto Europeo di Oncologia
      • Parma, Italy, 43126
        • UOC di Oncologia Medica, Azienda Ospedaliero Universitaria (AOU) di Parma
      • Pavia, Italy, 27100
        • Istituti Clinici Scientifici Maugeri IRCCS
    • Campania
      • Naples, Campania, Italy, 80131
        • Azienda Ospedaliera Universitaria Federico II
      • Naples, Campania, Italy, 80131
        • lstituto Nazionale Tumori IRCCS - Fondazione Pascale U.O.C. Oncologia Medica Senologica
    • Liguria
      • Genoa, Liguria, Italy, 16132
        • IRCCS Ospedale Policlinico, San Martino
    • Lombardy
      • Monza (MB), Lombardy, Italy, 20900
        • ASST Monza Ospedale San Gerardo Centro Ricerca di Fase 1
    • Sicily
      • Catania (CT), Sicily, Italy, 95045
        • Humanitas lstituto Clinico Catanese
    • The Marches
      • Torrette, The Marches, Italy, 60126
        • Azienda Ospedaliero Universitaria delle Marche SOD Clinica Oncologica
    • Trentino-Alto Adige
      • Trento, Trentino-Alto Adige, Italy, 38122
        • Divisione Oncologia Medica, Ospedale di Trento - Presidio Ospedaliero (PO) Santa Chiara
      • Trento, Trentino-Alto Adige, Italy, 38122
        • SOC Farmacia, Ospedale di Trento - Presidio Ospedaliero (PO)
    • Tuscany
      • Livorno, Tuscany, Italy, 57124
        • Oncologia Medica Azienda Usl Toscana Nord Ovest - Ospedali Riuniti di Livor
      • Prato, Tuscany, Italy, 59100
        • S.O.C. Oncologia Medica - Nuovo Ospedale di Prato Santo Stefano
  • Japan
    • Chiba
      • Kamogawa, Chiba, Japan, 296-8602
        • Tesshokai Kameda General Hospital
      • Kashiwa-Shi, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0280
        • NHO Shikoku Cancer Center
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 811-1395
        • National Hospital Organization Kyushu Cancer Center
    • Fukushima
      • Fukushima, Fukushima, Japan, 960-1295
        • Fukushima Medical University Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 003-0804
        • National Hospital Organization Hokkaido Cancer Center
    • Ibaraki
      • Tsukuba, Ibaraki, Japan, 305-8576
        • University of Tsukuba Hospital
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8530
        • Ishikawa Prefectural Central Hospital
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-8515
        • Kanagawa Cancer Center
    • Okinawa
      • Naha, Okinawa, Japan, 901-0154
        • Naha Nishi Clinic
    • Osaka
      • Osakasayama-shi, Osaka, Japan, 589-8511
        • Kindai University Hospital
      • Sakai, Osaka, Japan, 590-0197
        • Kindai University Hospital
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
      • Chuo-ku, Tokyo, Japan, 104-8560
        • St. Luke's International Hospital.
      • Minato-ku, Tokyo, Japan, 105-8470
        • Toranomon Hospital
      • Shinagawa-ku, Tokyo, Japan, 142-8666
        • Showa University Hospital
  • Netherlands
      • Dordrecht, Netherlands, 3318 AT
        • Albert Schweitzer Ziekenhuis
      • Utrecht, Netherlands, 3543 AZ
        • St. Antonius Hospital
      • Venlo, Netherlands, 5912 BL
        • VieCuri Medsich Centrum
    • South Holland
      • Doedrecht, South Holland, Netherlands, 3318AT
        • Albert Schweitzer Hospital
  • Poland
      • Gdansk, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne
      • Lodz, Poland, 91-211
        • Salve Medica
      • Lodz, Poland, 91-211
        • Salve Medica Apteka Szpitalna
      • Opole, Poland, 45-061
        • SP ZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego w Opolu
    • Other
      • Lodz, Other, Poland, 93-513
        • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
    • Silesian Voivodeship
      • Gliwice, Silesian Voivodeship, Poland, 44-102
        • Narodowy lnstytut Onkologii im. Marii Sklodowskiej-Curie-Panstwowy lnstytut Badawczy
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE (IPO, Coimbra)
      • Lisbon, Portugal, 1400-038
        • Fundacao Champalimaud
    • Other
      • Braga, Other, Portugal, 4710-243
        • Centro Clinico Academico Braga Hospital de Braga
      • Lisbon, Other, Portugal, 1998-018
        • Hospital CUF Descobertas
  • South Korea
      • Busan, South Korea, 49201
        • Dong-A University Hospital
      • Incheon, South Korea, 21565
        • Gachon University Gil Medical Center
      • Seoul, South Korea, 02841
        • Korea University Anam Hospital
    • Gangwon-do
      • Wŏnju, Gangwon-do, South Korea, 26426
        • Yonsei University Wonju Severance Christian Hospital
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, South Korea, 10408
        • National Cancer Center
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Seoul National University Bundang Hospital
      • Suwon, Gyeonggi-do, South Korea, 16247
        • The Catholic University of Korea, St. Vincent's Hospital
      • Suwon, Gyeonggi-do, South Korea, 16499
        • Ajou University Hospital
    • North Chungcheong
      • Cheongju-si, North Chungcheong, South Korea, 28644
        • Chungbuk Nationl University Hospital
    • Other
      • Seoul, Other, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, Other, South Korea, 05505
        • Asan Medical Center
      • Seoul, Other, South Korea, 06273
        • Gangnam Severance Hospital, Yonsei University Health System
      • Seoul, Other, South Korea, 06591
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Seoul, Other, South Korea, 07985
        • Ewha Womans University Mokdong Hospital
    • Seoul-teukbyeolsi [seoul]
      • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03722
        • Severance Hospital Yonsei University Health System
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 08035
        • Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca
      • Barcelona, Spain, 08025
        • Fundacio de Gestio Sanitaria de I'Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain, 08041
        • Hospital de la Santa Creu i Sant Pau
      • Bilbao, Spain, 48013
        • Hospital Universitario de Basurto
      • Girona, Spain, 17007
        • Institut Catala d'Oncologia Girona - ICO Girona
      • Granada, Spain, 18014
        • Hospital Universitario Virgen de las Nieves
      • Lleida, Spain, 25198
        • Hospital Universitari Arnau de Vilanova
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon
      • Málaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
      • Salamanca, Spain, 37007
        • Hospital Universitario de Salamanca (Spain Salamanca)
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain, 46009
        • Fundacion lnstituto Valenciano de Oncologia
    • Andalusia
      • Málaga, Andalusia, Spain, 29016
        • Hospital El Angel Grupo Hla, S.L.U
    • Balearic Islands
      • Palma de Mallorca, Balearic Islands, Spain, 07120
        • Hospital Universitario Son Espases
    • Murcia
      • EI Palmar, Murcia, Spain, 30120
        • Hospital Universitario Virgen De La Arrixaca
    • Other
      • Barcelona, Other, Spain, 08035
        • Fundación Privada Instituto de Investigación Oncológica de Vall Hebron
      • Cáceres, Other, Spain, 10003
        • Hospital San Pedro de Alcantara
      • Madrid, Other, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Valencia, Other, Spain, 46010
        • Hospital Clinico Universitario de Valencia
    • Santa CRUZ DE Tenerife
      • La Laguna Tenerife, Santa CRUZ DE Tenerife, Spain, 38320
        • Hospital Universitario de Canarias
    • Valencia
      • Alicante, Valencia, Spain, 03010
        • Hospital General Universitario Alicante
  • Switzerland
      • Baden, Switzerland, 5404
        • Kantonsspital Baden.
      • Zurich, Switzerland, 8008
        • Brust-Zentrum AG
    • Canton of Zurich
      • Winterthur, Canton of Zurich, Switzerland, 8401
        • Kantonsspital Winterthur
  • Taiwan
      • Changhua, Taiwan, 500 (R.O.C.)
        • Changhua Christian Medical Foundation Changhua Christian Hospital
      • Kaohsiung City, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • New Taipei City, Taiwan, 23561 (R.O.C.)
        • Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
      • New Taipei City, Taiwan, 23561 (R.O.C)
        • Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
      • Taichung, Taiwan, 40447 (R.O.C.)
        • China Medical University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 11490, R.O.C.
        • Tri-Service General Hospital
      • Taoyuan City, Taiwan, 333
        • Chang Gung Memorial Hospital LinKou
    • Other
      • Tainan, Other, Taiwan, 704
        • National Cheng Kung University Hospital
      • Taipei, Other, Taiwan, 10449
        • MacKay Medical Foundation The Presbyterian Church in Taiwan MacKay Memorial Hospital
      • Taipei, Other, Taiwan, 112
        • Koo Foundation Sun Yat-Sen Cancer Center
    • R.o.c
      • Taipei, R.o.c, Taiwan, 100
        • National Taiwan University Hospital
    • Tainan
      • Tainan, Tainan, Taiwan, 710
        • Chi Mei Medical Center
  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • The Royal Marsden
      • London, United Kingdom, N12 0JE
        • Finchley Memorial Hospital
      • London, United Kingdom, NW1 2PG
        • University College London Hospital (UCLH) NHS Foundation Trust
      • Manchester, United Kingdom, M20 4BX
        • Christie Hospital NHS Foundation Trust
    • England
      • London, England, United Kingdom, NW3 2QG
        • Academic Oncology
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • The Royal Marsden
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Hospital
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Central Arkansas Radiation Therapy Institute Inc d.b.a CARTI
    • California
      • Beverly Hills, California, United States, 90212
        • UCLA Hematology/Oncology - Beverly Hills
      • Burbank, California, United States, 91505
        • UCLA Hematology/Oncology - Burbank
      • Encinitas, California, United States, 92024
        • UCSD Medical Center - Encinitas
      • La Jolla, California, United States, 92093
        • UC San Diego Moores Cancer Center
      • La Jolla, California, United States, 92037
        • Sulpizio Cardiovascular Center at UC San Diego Health
      • La Jolla, California, United States, 92037
        • UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
      • La Jolla, California, United States, 92037
        • UCSD Perlman Medical Offices
      • La Jolla, California, United States, 92037
        • UCSD Koman Family Outpatient Pavilion
      • Laguna Hills, California, United States, 92653
        • UCLA Hematology/Oncology - Laguna Hills
      • Los Angeles, California, United States, 90095
        • UCLA Hematology/Oncology
      • Los Angeles, California, United States, 90095
        • Administrative Address: UCLA Hematology/Oncology
      • San Diego, California, United States, 92103
        • UC San Diego Medical Center - Hillcrest
      • San Diego, California, United States, 912101
        • UCSD Medical Center - Bankers Hill
      • San Luis Obispo, California, United States, 93401
        • UCLA Hematology/Oncology - San Luis Obispo
      • Santa Barbara, California, United States, 93101
        • UCLA Hematology/Oncology- Santa Barbara
      • Santa Monica, California, United States, 90404
        • UCLA Hematology/Oncology - Santa Monica
      • Santa Monica, California, United States, 90404
        • UCLA Hematology/Oncology Parkside
      • Torrance, California, United States, 90509
        • Harbor-UCLA Medical Center
      • Torrance, California, United States, 90502
        • The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
      • Torrance, California, United States, 90502
        • Clinical And Translational Research Center
      • Valencia, California, United States, 91355
        • UCLA Hematology/Oncology - Santa Clarita
      • Vista, California, United States, 92081
        • UCSD Medical Center - Vista
      • Westlake Village, California, United States, 91361
        • UCLA Hematology/Oncology- Westlake
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • AdventHealth Altamonte Infusion Center
      • Altamonte Springs, Florida, United States, 32701
        • AdventHealth Medical Group Altamonte(second location)
      • Altamonte Springs, Florida, United States, 32701
        • AdventHealth Medical Group Altamonte
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Florida
      • Orlando, Florida, United States, 32804
        • AdventHealth Orlando Infusion Center
      • Orlando, Florida, United States, 32804
        • AdventHealth Medical Group Orlando
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University Hospital Midtown
      • Atlanta, Georgia, United States, 30342
        • Emory Saint Joseph's Hospital
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute
      • Atlanta, Georgia, United States, 30322
        • Emory University Clinic
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois Hospital and Health Systems
      • Chicago, Illinois, United States, 60612
        • University of Illinois Hospital and Health Systems (Outpatient Cancer Center)
      • Chicago, Illinois, United States, 60612
        • University of Illinois Hospital and Health Systems (Investigational Drug Pharmacy)
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Norton Cancer Institute, St. Matthews Campus
      • Louisville, Kentucky, United States, 40207
        • Norton Cancer Institute, St Matthews Campus
      • Louisville, Kentucky, United States, 40241
        • Norton Cancer Institute, Brownsboro Hospital Campus
      • Louisville, Kentucky, United States, 40202
        • Norton Cancer Institute, Downtown
      • Louisville, Kentucky, United States, 40202
        • Norton Cancer Institute - Downtown
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Mercy Medical Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Cancer Institute.
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island
      • Grand Island, Nebraska, United States, 68803
        • Oncology Hematology West PC dba Nebraska Cancer Specialists
      • Omaha, Nebraska, United States, 68130
        • Oncology Hematology West PC dba Nebraska Cancer Specialists
      • Omaha, Nebraska, United States, 68124
        • Oncology Hematology West PC dba Nebraska Cancer Specialists
      • Omaha, Nebraska, United States, 68114
        • Oncology Hematology West PC dba Nebraska Cancer Specialists
      • Papillion, Nebraska, United States, 68046
        • Oncology Hematology West PC dba Nebraska Cancer Specialists
    • New Jersey
      • Jersey City, New Jersey, United States, 07302
        • RWJBarnabas Health- Jersey City Medical Center
      • Lakewood, New Jersey, United States, 08701
        • RWJBarnabas Health- Monmouth Medical Center-Southern Campus
      • Livingston, New Jersey, United States, 07039
        • RWJBarnabas Health- Cooperman Barnabas Medical Center
      • Long Branch, New Jersey, United States, 07740
        • RWJBarnabas Health- Monmouth Medical Center
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Cancer Institute of New Jersey
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel Medical Center
      • Somerville, New Jersey, United States, 08876
        • Steeplechase Cancer Center
      • Somerville, New Jersey, United States, 08876
        • RWJBarnabas Health-Robert Wood Johnson University Hospital, Somerset
      • Toms River, New Jersey, United States, 08755
        • RWJBarnabas Health - Community Medical Center
      • West Long Branch, New Jersey, United States, 07764
        • Satellite Infusion Center-Monmouth Medical Center Vantage Point Infusion Center
    • New York
      • The Bronx, New York, United States, 10461
        • Montefiore Einstein Comprehensive Cancer Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, United States, 44106
        • Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
      • Strongsville, Ohio, United States, 44136
        • Cleveland Clinic Cancer Center - Strongsville
    • Pennsylvania
      • Willow Grove, Pennsylvania, United States, 19090
        • Asplundh Cancer Pavillion
    • Tennessee
      • Gallatin, Tennessee, United States, 37066
        • Tennessee Oncology, PLLC
      • Murfreesboro, Tennessee, United States, 37129
        • Tennessee Oncology, PLLC
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology, PLLC
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute- Pharmacy
      • Shelbyville, Tennessee, United States, 37160
        • Tennessee Oncology, PLLC
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Hospital/Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Centrally confirmed HER2+ breast carcinoma according to the 2018 American Society of Clinical Oncologists (ASCO) College of American Pathologists (CAP) guidelines prior to randomization (defined as a 3+ score on immunohistochemistry (IHC) and/or 2+ IHC and concurrent positive by ISH).

  • Have unresectable locally advanced or metastatic disease.

    • If recurrent (after [neo]adjuvant therapy), must be at least 6 month treatment free from any trastuzumab and pertuzumab received in the early breast cancer setting for advanced HER2+ disease.

  • Have received 4-8 cycles of pre-study induction therapy including only trastuzumab, pertuzumab, and taxane as first-line of therapy for the treatment of advanced breast cancer prior to study enrollment. Participants are eligible provided they are without evidence of disease progression following completion of induction therapy.

  • Known hormone receptor status (per local guidelines; may be hormone receptor positive [HR+] or negative [HR-])

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

  • CNS Inclusion - Based on screening contrast-enhanced brain magnetic resonance imaging (MRI), participants may have any of the following:

    • No evidence of brain metastases

    • Untreated brain metastases which are asymptomatic not needing immediate local treatment and, if identified on prior brain imaging, without evidence of progression since starting first-line induction therapy with trastuzumab, pertuzumab, and taxane

    • Previously treated brain metastases which are asymptomatic

      • Brain metastases previously treated with local therapy must not have progressed since treatment

Exclusion Criteria:

  • Prior treatment with any tyrosine kinase inhibitor targeting HER2 and/or epidermal growth factor receptor (EGFR) including pyrotinib, lapatinib, tucatinib, neratinib, and afatinib (except neratinib if given in extended adjuvant setting and ≥ 12 months have elapsed since last neratinib dose prior to start of study drug)

  • Unable to undergo contrast-enhanced MRI of the brain

  • CNS Exclusion - Based on screening brain MRI and clinical assessment

    • Symptomatic brain metastasis after CNS-directed local therapy
    • Progression of brain metastases since starting first line trastuzumab, pertuzumab, and taxane
    • Ongoing use of systemic corticosteroids at a total daily dose of >2 mg of dexamethasone (or equivalent)
    • Any untreated brain lesion in an anatomic site which may pose risk to participant
    • Known or suspected leptomeningeal disease (LMD)
    • Poorly controlled (>1/week) seizures, or other persistent neurologic symptoms

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tucatinib + trastuzumab + pertuzumab

Tucatinib + trastuzumab + pertuzumab
Drug: Tucatinib

300mg given by mouth (orally) twice daily

Other Names:
  • TUKYSA, ONT-380, ARRY-380
Drug: Trastuzumab

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

Other Names:
  • Herceptin, Herceptin Hylecta
Drug: Pertuzumab

420mg given by IV every 21 days

Other Names:
  • Perjeta
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.

Other Names:
  • Phesgo
Active Comparator: Placebo + trastuzumab + pertuzumab

Placebo + trastuzumab + pertuzumab
Drug: Trastuzumab

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

Other Names:
  • Herceptin, Herceptin Hylecta
Drug: Pertuzumab

420mg given by IV every 21 days

Other Names:
  • Perjeta
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.

Other Names:
  • Phesgo
Drug: Placebo

Given orally twice daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS) as Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
Time Frame: From randomization until the first documentation of PD or death from any cause or censoring date, whichever occurred first (maximum treatment exposure was of 41.3 months)

PFS: time from randomization to the first documented disease progression (PD) (as assessed by investigator per RECIST 1.1) or death from any cause, whichever occurred first. PD: >=20% increase in sum of diameters of target lesions, taking as reference the smallest sum of diameter recorded since the treatment started or the appearance of 1 or more new lesions. Participants without documentation of PD/ death at the time of analysis, were censored at date of last tumor assessment with an overall response of complete response (CR), partial response (PR), stable disease (SD), non-CR/non-PD or no evidence of disease (NED). CR: disappearance of all target lesions; PR: >=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameter since the treatment started. Kaplan-Meier method was used for analysis.
From randomization until the first documentation of PD or death from any cause or censoring date, whichever occurred first (maximum treatment exposure was of 41.3 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From the date of randomization until date of death or censoring date (approximately 66.7 months)

OS: time from randomization to death due to any cause. For a participant who would not known to have died by the end of study follow-up, observation of OS would be censored on the date the participant was last known to be alive (i.e., the date of last contact).
From the date of randomization until date of death or censoring date (approximately 66.7 months)
PFS as Assessed by Blinded Independent Central Review (BICR) Per RECIST v1.1
Time Frame: From randomization until the first documentation of PD or death from any cause or censoring date, whichever occurred first (maximum treatment exposure was of 41.3 months)

PFS per BICR was defined as the time from the date of randomization to the documented disease progression assessed by BICR according to RECIST v1.1 or death from any cause, whichever occurred first. As per RECIST v1.1, PD: >=20% increase in sum of diameter of target lesions, taking as reference the smallest sum of diameters recorded since treatment started or appearance of 1 or more new lesions, unequivocal progression of existing non-target lesions. Participants without documentation of PD/ death were censored at date of last tumor assessment with an overall response of CR, PR, SD, non-CR/non-PD or NED. CR: disappearance of all target lesions; PR: >=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameter since the treatment started. Kaplan-Meier method was used for analysis.
From randomization until the first documentation of PD or death from any cause or censoring date, whichever occurred first (maximum treatment exposure was of 41.3 months)
Time to Deterioration (TTD) of Health-Related Quality of Life (HRQoL)
Time Frame: Approximately 66.7 months

Time to deterioration of HRQoL was defined as time to 10-point decrease in the global health status/QoL scale of the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-C30). EORTC QLQ-C30 is 30 item questionnaires composed of 5 multi-item functional domains (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, nausea, and vomiting) and 6 single items for symptoms (shortness of breath, loss of appetite, sleep disturbance, constipation, diarrhea and financial impact of the disease), 2 global items (health, overall QoL). Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
Approximately 66.7 months
Central Nervous System (CNS) PFS as Assessed by Investigator Per RECIST v1.1
Time Frame: From randomization until the first documentation of PD or death from any cause or censoring date, whichever occurred first (maximum treatment exposure was of 41.3 months)

CNS-PFS was defined as the time from randomization to investigator assessed disease progression in brain according to RECIST v1.1, or death from any cause, whichever occurred first. As per RECIST v1.1, PD: >= 20% increase in sum of diameter of target lesions, taking as reference the smallest sum of diameters recorded since the treatment started or appearance of 1 or more new lesions, unequivocal progression of existing non-target lesions. Participants without documentation of PD/ death at the time of analysis were censored at date of last tumor assessment with an overall response of CR, PR, SD, non-CR/non-PD or NED. CR: disappearance of all target lesions; PR: >=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameter since the treatment started. Kaplan-Meier method was used for analysis.
From randomization until the first documentation of PD or death from any cause or censoring date, whichever occurred first (maximum treatment exposure was of 41.3 months)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 42.3 months)

An adverse event (AE) was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily had a causal relationship with this treatment. TEAEs were defined as events that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. AEs included both Serious AE (SAEs) and all other AEs. An AE should be classified as a serious SAE if it meets one of the following criteria: fatal, life threatening, requires or prolongs hospitalization, disabling/ incapacitating, congenital anomaly or birth defect, medically significant.
From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 42.3 months)
Number of Participants With Treatment Emergent Laboratory Abnormalities
Time Frame: From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)

TEAEs were defined as events that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. Treatment emergent laboratory abnormalities include: hematology (hemoglobin decreased, hemoglobin increased, leukocytes decreased, neutrophils decreased, platelets decreased); chemistry (alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, creatinine increased, potassium decreased, potassium increased, sodium decreased, sodium increased, total bilirubin increased).
From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
Number of Participants With TEAEs Leading to Dose Discontinuations
Time Frame: From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)

TEAEs were defined as events that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. In this outcome measure, number of participants with TEAEs leading to dose discontinuations with study treatment will be reported.
From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
Number of Participants With TEAEs Leading to Dose Hold
Time Frame: From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)

TEAEs were defined as events that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. In this outcome measure, number of participants with TEAEs leading to dose hold with study treatment will be reported. Dose hold requirements are defined per protocol.
From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
Number of Participants With TEAEs Leading to Dose Reductions
Time Frame: From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)

TEAEs were defined as events that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. In this outcome measure, number of participants with TEAEs leading to dose reductions with tucatinib, trastuzumab and pertuzumab are reported. Dose reduction requirements are defined per protocol.
From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
Trough Concentration (Ctrough) of Tucatinib
Time Frame: Pre-dose on Day 1 of Cycles 2, 3, 4, 5 and 6

Concentration at Trough was defined as predose/trough concentration observed directly from data.
Pre-dose on Day 1 of Cycles 2, 3, 4, 5 and 6

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With TEAEs: Through Study Completion
Time Frame: From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)

An AE was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily had a causal relationship with this treatment. TEAEs were defined as events that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. AEs included both SAEs and all other AEs. An AE should be classified as a serious SAE if it meets one of the following criteria: fatal, life threatening, requires or prolongs hospitalization, disabling/ incapacitating, congenital anomaly or birth defect, medically significant.
From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seagen, a wholly owned subsidiary of Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 5, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 28, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 24, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SGNTUC-028
  • C4251007 (Other Identifier: Alias Study Number)
  • 2023-503826-37-00 (Registry Identifier: CTIS (EU))
  • 2023 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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