HER2 Positive Breast CancerPhase 3HER2CLIMB-05NCT05132582
A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer
A Phase 3 study testing Tucatinib, Trastuzumab and Pertuzumab in people with HER2 Positive Breast Cancer, run by Seagen, a wholly owned subsidiary of Pfizer at 307 sites in 23 countries.
Trial summary
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. 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, Trastuzumab and Pertuzumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 654 participants
- Where
- 307 sitesin 23 countries
- Study dates
- 7 Mar 2022to 28 Sep 2027
- Phase
- Phase 3
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
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
307 sites in 23 countries.
307 sites in 23 countries
United States76 sites
AdventHealth Altamonte Infusion Center
Altamonte Springs, Florida, 32701
AdventHealth Medical Group Altamonte(second location)
Altamonte Springs, Florida, 32701
AdventHealth Medical Group Altamonte
Altamonte Springs, Florida, 32701
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University Clinic
Atlanta, Georgia, 30322
Winship Cancer Institute
Atlanta, Georgia, 30322
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Mercy Medical Center
Baltimore, Maryland, 21202
UCLA Hematology/Oncology - Beverly Hills
Beverly Hills, California, 90212
UCLA Hematology/Oncology - Burbank
Burbank, California, 91505
University of Illinois Hospital and Health Systems (Investigational Drug Pharmacy)
Chicago, Illinois, 60612
University of Illinois Hospital and Health Systems (Outpatient Cancer Center)
Chicago, Illinois, 60612
University of Illinois Hospital and Health Systems
Chicago, Illinois, 60612
Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
UCSD Medical Center - Encinitas
Encinitas, California, 92024
Tennessee Oncology, PLLC
Gallatin, Tennessee, 37066
Oncology Hematology West PC dba Nebraska Cancer Specialists
Grand Island, Nebraska, 68803
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island
Grand Island, Nebraska, 68803
Mayo Clinic Florida
Jacksonville, Florida, 32224
RWJBarnabas Health- Jersey City Medical Center
Jersey City, New Jersey, 07302
Saint Luke's Cancer Institute.
Kansas City, Missouri, 64111
Sulpizio Cardiovascular Center at UC San Diego Health
La Jolla, California, 92037
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
La Jolla, California, 92037
UCSD Koman Family Outpatient Pavilion
La Jolla, California, 92037
UCSD Perlman Medical Offices
La Jolla, California, 92037
UC San Diego Moores Cancer Center
La Jolla, California, 92093
UCLA Hematology/Oncology - Laguna Hills
Laguna Hills, California, 92653
RWJBarnabas Health- Monmouth Medical Center-Southern Campus
Lakewood, New Jersey, 08701
Central Arkansas Radiation Therapy Institute Inc d.b.a CARTI
Little Rock, Arkansas, 72205
RWJBarnabas Health- Cooperman Barnabas Medical Center
Livingston, New Jersey, 07039
RWJBarnabas Health- Monmouth Medical Center
Long Branch, New Jersey, 07740
Administrative Address: UCLA Hematology/Oncology
Los Angeles, California, 90095
UCLA Hematology/Oncology
Los Angeles, California, 90095
Norton Cancer Institute - Downtown
Louisville, Kentucky, 40202
Norton Cancer Institute, Downtown
Louisville, Kentucky, 40202
Norton Cancer Institute, St Matthews Campus
Louisville, Kentucky, 40207
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, 40207
Norton Cancer Institute, Brownsboro Hospital Campus
Louisville, Kentucky, 40241
Froedtert Hospital/Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Tennessee Oncology, PLLC
Murfreesboro, Tennessee, 37129
Sarah Cannon Research Institute- Pharmacy
Nashville, Tennessee, 37203
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
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
AdventHealth Medical Group Orlando
Orlando, Florida, 32804
AdventHealth Orlando Infusion Center
Orlando, Florida, 32804
Oncology Hematology West PC dba Nebraska Cancer Specialists
Papillion, Nebraska, 68046
Mayo Clinic Hospital
Phoenix, Arizona, 85054
Mayo Clinic
Rochester, Minnesota, 55905
UCSD Medical Center - Bankers Hill
San Diego, California, 912101
UC San Diego Medical Center - Hillcrest
San Diego, California, 92103
UCLA Hematology/Oncology - San Luis Obispo
San Luis Obispo, California, 93401
UCLA Hematology/Oncology- Santa Barbara
Santa Barbara, California, 93101
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, 90404
UCLA Hematology/Oncology Parkside
Santa Monica, California, 90404
Mayo Clinic
Scottsdale, Arizona, 85259
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
University of Washington Medical Center
Seattle, Washington, 98195
Tennessee Oncology, PLLC
Shelbyville, Tennessee, 37160
RWJBarnabas Health-Robert Wood Johnson University Hospital, Somerset
Somerville, New Jersey, 08876
Steeplechase Cancer Center
Somerville, New Jersey, 08876
Cleveland Clinic Cancer Center - Strongsville
Strongsville, Ohio, 44136
Montefiore Einstein Comprehensive Cancer Center
The Bronx, New York, 10461
RWJBarnabas Health - Community Medical Center
Toms River, New Jersey, 08755
Clinical And Translational Research Center
Torrance, California, 90502
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502
Harbor-UCLA Medical Center
Torrance, California, 90509
UCLA Hematology/Oncology - Santa Clarita
Valencia, California, 91355
UCSD Medical Center - Vista
Vista, California, 92081
Satellite Infusion Center-Monmouth Medical Center Vantage Point Infusion Center
West Long Branch, New Jersey, 07764
UCLA Hematology/Oncology- Westlake
Westlake Village, California, 91361
Asplundh Cancer Pavillion
Willow Grove, Pennsylvania, 19090
China29 sites
Affiliated Hospital of Hebei University
Baoding, Hebei, 071000
Beijing Hospital
Beijing, 100010
Beijing Hospital
Beijing, 100730
The First Hospital of Jilin University
Changchun, Jilin, 130021
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
The first Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570102
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310052
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601
Jinan Central Hospital
Jinan, Shandong, 250013
Linyi Cancer Hospital
Linyi, Shandong, 276034
Liuzhou People's Hospital
Liuzhou, Guangxi, 545006
Meizhou People's Hospital
Meizhou, Guangdong, 514031
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330008
Nanjing Medical University (NMU) - Jiangsu Province Hospital
Nanjing, Jiangsu, 210036
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, 530021
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
Shanghai, Other, 200025
Fudan University Shanghai Cancer Center
Shanghai, 200032
Liaoning Cancer Hospital & Insitute
Shenyang, Liaoning, 110042
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110167
Tianjin Cancer Hospital Binhai Campus
Tianjin, 300181
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, 430030
Hubei Cancer Hospital
Wuhan, Hubei, 430079
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 710068
Henan Cancer Hospital
Zhengzhou, Henan, 450003
France25 sites
Institut Sainte-Catherine.
Avignon, Other, 84918
Sainte Catherine lnstitut du Cancer Avignon Provence
Avignon, Other, 84918
CHU Besancon
Besançon, 25000
Hopital Avicenne
Bobigny, 93009 Cedex
Institut Bergonie
Bordeaux, Cedex, 33076
CENTRE FRANCOIS BACLESSE - Service lmagerie medicale
Caen, 14076 Cedex 5
Centre Francois Baclesse
Caen, 14076 Cedex 5
Centre de Lutte contre le Cancer - François Baclesse
Caen, 14076
Centre Jean Perrin
Clermont-Ferrand, 63000
Center Georges-Francois Leclerc
Dijon, Other, 21079
Centre Oscar Lambret
Lille, 59020 Cedex
Center Leon Berard
Lyon, 69373 Cedex 08
Centre de Cancérologie du Grand Montpellier
Montpellier, Languedoc-roussillon, 34070
Institut Regional du Cancer de Montpellier Service lmagerie medicale
Montpellier, 34298 Cedex 5
Institut Régional du Cancer de Montpellier
Montpellier, 34298
Centre Antoine Lacassagne
Nice, 06189
Hospices Civils de Lyon
Pierre-Bénite, 69310
"CARIO - Centre Armoricain de Radiotherapie lmagerie medicate et d'Oncologie -Hopital Prive des
Plérin, 22190
Centre Eugene Marquis
Rennes, cedex 35042
Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
Rouen, Brittany Region, 76038
Centre Henri Becquerel
Rouen, 76038 Cedex 1
Institut Curie - site St-Cloud
Saint-Cloud, 92210
Institut de Cancerologie de lOuest - Site Rene Gauducheau
Saint-Herblain, Loire-atlantique, 44800
Institut de Cancerologie de lOuest-Saint Herblain
Saint-Herblain, Loire-atlantique, 44805
Institut de Cancerologie Strasbourg Europe
Strasbourg, 67033
Spain22 sites
Hospital General Universitario Alicante
Alicante, Valencia, 03010
Fundación Privada Instituto de Investigación Oncológica de Vall Hebron
Barcelona, Other, 08035
Fundacio de Gestio Sanitaria de I'Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca
Barcelona, 08035
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Hospital Universitario de Basurto
Bilbao, 48013
Hospital San Pedro de Alcantara
Cáceres, Other, 10003
Hospital Universitario Virgen De La Arrixaca
EI Palmar, Murcia, 30120
Institut Catala d'Oncologia Girona - ICO Girona
Girona, 17007
Hospital Universitario Virgen de las Nieves
Granada, 18014
Hospital Universitario de Canarias
La Laguna Tenerife, Santa CRUZ DE Tenerife, 38320
Hospital Universitari Arnau de Vilanova
Lleida, 25198
Hospital Universitario Ramon y Cajal
Madrid, Other, 28034
Hospital General Universitario Gregorio Maranon
Madrid, 28007
Hospital El Angel Grupo Hla, S.L.U
Málaga, Andalusia, 29016
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07120
Hospital Universitario de Salamanca (Spain Salamanca)
Salamanca, 37007
Hospital Universitario Virgen del Rocio
Seville, 41013
Hospital Clinico Universitario de Valencia
Valencia, Other, 46010
Fundacion lnstituto Valenciano de Oncologia
Valencia, 46009
Brazil17 sites
Fundacao Pio XII, Hospital do Amor de Barretos
Barretos, São Paulo, CEP: 14784-400
CRIO - Centro Regional lntegrado de Oncologia
Fortaleza, Ceará, 60336-232
Hospital Araujo Jorge
Goiânia, Goiás, 74605-070
Fundacao Dr Amaral Carvalho
Jaú, São Paulo, CEP: 17210-080
Hospital Do Cancer De Londrina
Londrina, Paraná, 86015-520
Liga Norte-Rio Grandense Contra o Cancer
Natal, Rio Grande do Norte, 59075-740
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital do Cancer Mae de Deu
Porto Alegre, Rio Grande do Sul, CEP 90110-270
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital do Cancer Mae de Deu
Porto Alegre, Rio Grande do Sul, CEP 90850-170
Irmandade da Santa Casa de Misericordia de Porto Alegre centro Multidisciplinar de pesquisa clinica
Porto Alegre/RS, 90050-170
CEPHO- Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo André, São Paulo, 09060-650
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo André, São Paulo, 09060-870
Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, 15090-000
ICESP- Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira
São Paulo, 01246-000
Sao Camilo Oncologia
São Paulo, 04014-002
Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecologica e Mamária Ltda.
São Paulo, CEP: 01317-000
A.C. Camargo Câncer Center
Sao Paulo/SP, Other, 01.509-010
Italy16 sites
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
Bologna, 40138
SSD Oncologia Medica Addarii - Zamagni, Policlinico Sant'Orsola - Malpighi
Bologna, 40138
Humanitas lstituto Clinico Catanese
Catania (CT), Sicily, 95045
IRCCS Ospedale Policlinico, San Martino
Genoa, Liguria, 16132
Oncologia Medica Azienda Usl Toscana Nord Ovest - Ospedali Riuniti di Livor
Livorno, Tuscany, 57124
Istituto Clinico Humanitas
Milan, 20089
Divisione di Senologia Medica; Istituto Europeo di Oncologia
Milan, 20141
ASST Monza Ospedale San Gerardo Centro Ricerca di Fase 1
Monza (MB), Lombardy, 20900
Azienda Ospedaliera Universitaria Federico II
Naples, Campania, 80131
lstituto Nazionale Tumori IRCCS - Fondazione Pascale U.O.C. Oncologia Medica Senologica
Naples, Campania, 80131
UOC di Oncologia Medica, Azienda Ospedaliero Universitaria (AOU) di Parma
Parma, 43126
Istituti Clinici Scientifici Maugeri IRCCS
Pavia, 27100
S.O.C. Oncologia Medica - Nuovo Ospedale di Prato Santo Stefano
Prato, Tuscany, 59100
Azienda Ospedaliero Universitaria delle Marche SOD Clinica Oncologica
Torrette, The Marches, 60126
Divisione Oncologia Medica, Ospedale di Trento - Presidio Ospedaliero (PO) Santa Chiara
Trento, Trentino-Alto Adige, 38122
SOC Farmacia, Ospedale di Trento - Presidio Ospedaliero (PO)
Trento, Trentino-Alto Adige, 38122
Japan16 sites
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
St. Luke's International Hospital.
Chuo-ku, Tokyo, 104-8560
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, 811-1395
Fukushima Medical University Hospital
Fukushima, Fukushima, 960-1295
Tesshokai Kameda General Hospital
Kamogawa, Chiba, 296-8602
Ishikawa Prefectural Central Hospital
Kanazawa, Ishikawa-ken, 920-8530
National Cancer Center Hospital East
Kashiwa-Shi, Chiba, 277-8577
NHO Shikoku Cancer Center
Matsuyama, Ehime, 791-0280
Toranomon Hospital
Minato-ku, Tokyo, 105-8470
Naha Nishi Clinic
Naha, Okinawa, 901-0154
Kindai University Hospital
Osakasayama-shi, Osaka, 589-8511
Kindai University Hospital
Sakai, Osaka, 590-0197
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804
Showa University Hospital
Shinagawa-ku, Tokyo, 142-8666
University of Tsukuba Hospital
Tsukuba, Ibaraki, 305-8576
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515
South Korea15 sites
Dong-A University Hospital
Busan, 49201
Chungbuk Nationl University Hospital
Cheongju-si, North Chungcheong, 28644
National Cancer Center
Goyang-si, Gyeonggi-do, 10408
Gachon University Gil Medical Center
Incheon, 21565
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Seoul National University Hospital
Seoul, Other, 03080
Asan Medical Center
Seoul, Other, 05505
Gangnam Severance Hospital, Yonsei University Health System
Seoul, Other, 06273
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Other, 06591
Ewha Womans University Mokdong Hospital
Seoul, Other, 07985
Severance Hospital Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], 03722
Korea University Anam Hospital
Seoul, 02841
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247
Ajou University Hospital
Suwon, Gyeonggi-do, 16499
Yonsei University Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426
Taiwan13 sites
Changhua Christian Medical Foundation Changhua Christian Hospital
Changhua, 500 (R.O.C.)
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
New Taipei City, 23561 (R.O.C)
Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
New Taipei City, 23561 (R.O.C.)
China Medical University Hospital
Taichung, 40447 (R.O.C.)
National Cheng Kung University Hospital
Tainan, Other, 704
Chi Mei Medical Center
Tainan, Tainan, 710
MacKay Medical Foundation The Presbyterian Church in Taiwan MacKay Memorial Hospital
Taipei, Other, 10449
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Other, 112
National Taiwan University Hospital
Taipei, R.o.c, 100
Taipei Veterans General Hospital
Taipei, 11217
Tri-Service General Hospital
Taipei, 11490, R.O.C.
Chang Gung Memorial Hospital LinKou
Taoyuan City, 333
Germany11 sites
"Universitatsklinikum Augsburg Klinik fur Frauenheilkunde und Geburtshilfe"
Augsburg, 86156
Charite Universtitatsmedizin Berlin Klinik fur Gynakologie mit Brustzentrum
Berlin, 10117
Charite - Universitatsmedizin Berlin
Berlin, 13353
Universitatsklinikum Hamburg-Eppendorf (UKE)
Hamburg, 20246
Universitätsmedizin Mannheim Universitätsfrauenklinik
Manheim, Other, 68167
Pharmacy:Fortuna Herstellung GmbH
Mannheim, Other, 68167
Klinik und Poliklinik fur Frauenheilkunde der Technischen Universitat Munchen
München, 81675
University Hospital Muenster Senology
Münster, North Rhine-Westphalia, 48149
Universitatsklinikum Ulm Klinik fur Frauenheilkunde und Geburtshilfe
Ulm, 89075
Universitatsklinikum Wurzburg Frauenklinik und Poliklinik
Würzburg, 97080
Universitatsklinikum Wurzburg, Comprehensive Cancer Center - Mainfranken (CCCMF)
Würzburg, 97080
Australia9 sites
Cancer Research SA
Adelaide, South Australia, 5000
St Andrews Medical Centre
Adelaide, South Australia, 5000
Flinders Medical Centre
Bedford Park, South Australia, 5042
Box Hill Hospital
Box Hill, Victoria, 3128
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050
Austin Health
Heidelberg, Victoria, 3084
Macquarie University Clinical Trials Unit.
Macquarie University, New South Wales, 2109
St John of God Subiaco Hospital Clinical Trials Unit Bendat Family Comprehensive Cancer Centre
Subiaco, Washington, 6008
Western Sydney Local Health District (WSLHD), Westmead Hospital
Westmead, New South Wales, 2145
Canada8 sites
Centre integre universitaire de sante et de services sociaux du Saguenay-Lac-Saint-Jean
Chicoutimi, Quebec, G7H 5H6
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
BC Cancer Agency
Kelowna, British Columbia, V1Y 5L3
Centre Hospitalier de l'Universite de Motreal (CHUM)
Montreal, Quebec, H2X 3E4
Jewish General Hospital
Montreal, Quebec, H3T 1E2
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Czechia6 sites
Ustavni lekarna Masarykuv onkologicky ustav
Brno, Other, 656 53
Masarykuv Onkologicky Ustav
Brno, 656 53
Vseobecna fakultni nemocnice v Praze
Prague, 128 08
Fakultni Thomayerova nemocnice Onkologicka klinika 1. LF UK a FTN
Praha 4 - Krc, Other, 14059
Fakultni nemocnice v Motole Onkologicka klinika 2. LF UK a FN Motol
Praha 5 - Motol, 15006
Nemocnicni lekarna Fakultni nemocnice v Motole
Praha 5 - Motol, 15006
Poland6 sites
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214
Narodowy lnstytut Onkologii im. Marii Sklodowskiej-Curie-Panstwowy lnstytut Badawczy
Gliwice, Silesian Voivodeship, 44-102
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz, Other, 93-513
Salve Medica Apteka Szpitalna
Lodz, 91-211
Salve Medica
Lodz, 91-211
SP ZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego w Opolu
Opole, 45-061
United Kingdom6 sites
Academic Oncology
London, England, NW3 2QG
Finchley Memorial Hospital
London, N12 0JE
University College London Hospital (UCLH) NHS Foundation Trust
London, NW1 2PG
The Royal Marsden
London, SW3 6JJ
Christie Hospital NHS Foundation Trust
Manchester, M20 4BX
The Royal Marsden
Sutton, Surrey, SM2 5PT
Austria5 sites
Medizinische Universität Graz
Graz, A-8010
Medizinische Universitat Graz
Graz, A-8036
Ordensklinikum Linz GmbH Barmherzige Schwestern
Linz, A-4010
Ordination Priv.-Doz. Dr. Michael Hubalek
Schwaz, Other, A-6130
Medizinische Universitat Wien Universitatsklinik Fur Frauenheilkunde
Vienna, A-1090
Chile5 sites
Centro de Investigacion Clínica Bradford Hill
Recoleta, Santiago Metropolitan, 8420323
Clinica Universidad Catolica del Maule
Talca, 3460000
Clinica Alemana Temuco
Temuco, 4810297
James Lind Centro De Investigacion Del Cancer
Temuco, 4810469
Oncocentro Apys
Viña del Mar, Valparaiso
Greece5 sites
General Hospital of Athens "Alexandra" Clinical Therapeutics Department, Hematology/Oncology Unit
Athens, Attica, 11528
University General Hospital of Larissa, Oncology Clinic
Larissa, 41110
IASO General Clinic Oncology Clinic
Marousi, 15123
University General Hospital of Patras, Oncology Department, Internal Medicine Clinic
Patra, Peloponnese, 26504
Metaxa Anticancer Hospital of Piraeus
Pireaus, 18537
Belgium4 sites
Jules Bordet lnstituut
Anderlecht, 1070
Universitair Ziekenhuis Brussel (UZ Brussel)
Brussels, 1090
Cliniques Universitaires Saint-Luc
Brussels, 1200
Clinique St-Pierre
Ottignies, 1340
Netherlands4 sites
Albert Schweitzer Hospital
Doedrecht, South Holland, 3318AT
Albert Schweitzer Ziekenhuis
Dordrecht, 3318 AT
St. Antonius Hospital
Utrecht, 3543 AZ
VieCuri Medsich Centrum
Venlo, 5912 BL
Portugal4 sites
Centro Clinico Academico Braga Hospital de Braga
Braga, Other, 4710-243
Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE (IPO, Coimbra)
Coimbra, 3000-075
Hospital CUF Descobertas
Lisbon, Other, 1998-018
Fundacao Champalimaud
Lisbon, 1400-038
Switzerland3 sites
Kantonsspital Baden.
Baden, 5404
Kantonsspital Winterthur
Winterthur, Canton of Zurich, 8401
Brust-Zentrum AG
Zurich, 8008
Finland2 sites
Tampere University Hospital, FONK/RSYO
Tampere, 33520
Tampere University Hospital
Tampere
About this study
Official title: 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).
Read more
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.
Read the 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.
- Conditions
- HER2 Positive Breast Cancer
- Being tested
- Tucatinib, Trastuzumab, Pertuzumab, Combination product: Trastuzumab + Pertuzumab, Placebo
- Keywords
- HER2+ breast cancer, Breast Cancer, Metastatic breast cancer, Seattle Genetics
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TucatinibDrug
Also called TUKYSA, ONT-380, ARRY-380
300mg given by mouth (orally) twice daily
TrastuzumabDrug
Also called Herceptin, Herceptin Hylecta
6mg/kg given into the vein (IV; intravenously) or 600mg injected under the skin (SC; subcutaneous) every 21 days
PertuzumabDrug
Also called Perjeta
420mg given by IV every 21 days
Combination product: Trastuzumab + PertuzumabDrug
Also called Phesgo
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.
PlaceboDrug
Given orally twice daily
| Study group | Role | What they receive |
|---|---|---|
| Tucatinib + trastuzumab + pertuzumab | Experimental | Tucatinib + trastuzumab + pertuzumab Receives: Drug: Tucatinib; Drug: Trastuzumab; Drug: Pertuzumab; Drug: Combination product: Trastuzumab + Pertuzumab |
| Placebo + trastuzumab + pertuzumab | Active comparator | Placebo + trastuzumab + pertuzumab Receives: Drug: Trastuzumab; Drug: Pertuzumab; Drug: Combination product: Trastuzumab + Pertuzumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) as Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
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.
Measured: 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 outcomes (10)
Overall Survival (OS)
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).
Measured: 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
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.
Measured: 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 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.
Measured: Approximately 66.7 months
Central Nervous System (CNS) PFS as Assessed by Investigator Per RECIST v1.1
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.
Measured: 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)
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.
Measured: 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
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).
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Concentration at Trough was defined as predose/trough concentration observed directly from data.
Measured: Pre-dose on Day 1 of Cycles 2, 3, 4, 5 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start7 Mar 2022
- Primary completion5 Sep 2025
- Study completion28 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HER2 Positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Seagen, a wholly owned subsidiary of PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 654 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen, a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132582
- Sponsor's protocol ID
- SGNTUC-028
- Other IDs
- C4251007, 2023-503826-37-00, 2023
- Acronym
- HER2CLIMB-05
- Status last verified
- Sep 2026
- First submitted
- 12 Nov 2021
- Last updated
- 29 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Dieras V, Curigliano G, Martin M, Lerebours F, Tsurutani J, Savard MF, Jerzak KJ, Hu X, Martins de Aquino Pimentel LC, O'Sullivan CC, Tokunaga E, Okines A, Huang CS, Jacot W, Sohn J, Cronemberger Silva E, Mueller V, Yang S, Granata G, Shen Q, Santarpia L, Hamilton E; HER2CLIMB-05 Investigators. HER2CLIMB-05: A Phase III Study of Tucatinib Versus Placebo in Combination With Trastuzumab and Pertuzumab as First-Line Maintenance Therapy for HER2+ Metastatic Breast Cancer. J Clin Oncol. 2026 Jun 10;44(17):1597-1607. doi: 10.1200/JCO-25-02600. Epub 2025 Dec 10.
PubMed 41369677