A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer
HER2CLIMB-05
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)
3 other identifiers
interventional
654
22 countries
298
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2022
Longer than P75 for phase_3
298 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2021
CompletedFirst Posted
Study publicly available on registry
November 24, 2021
CompletedStudy Start
First participant enrolled
March 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 5, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2027
ExpectedApril 20, 2026
April 1, 2026
3.5 years
November 12, 2021
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS) by investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
The time from the date of randomization to the investigator assessment of disease progression according to RECIST v1.1 or death from any cause
Up to approximately 3 years
Secondary Outcomes (11)
Overall survival (OS)
Up to approximately 5 years
PFS by blinded independent central review (BICR) per RECIST v1.1
Up to approximately 3 years
Time to deterioration of health-related quality of life (HRQoL)
Up to approximately 3 years
Central nervous system (CNS) PFS
Up to approximately 3 years
Incidence of adverse events (AEs)
Through 30 days after last study treatment, approximately 18 months
- +6 more secondary outcomes
Study Arms (2)
Tucatinib + trastuzumab + pertuzumab
EXPERIMENTALTucatinib + trastuzumab + pertuzumab
Placebo + trastuzumab + pertuzumab
ACTIVE COMPARATORPlacebo + trastuzumab + pertuzumab
Interventions
300mg given by mouth (orally) twice daily
6mg/kg given into the vein (IV; intravenously) or 600mg injected under the skin (SC; subcutaneous) every 21 days
420mg given by IV every 21 days
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.
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (307)
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
Mayo Clinic
Scottsdale, Arizona, 85259, United States
Central Arkansas Radiation Therapy Institute Inc d.b.a CARTI
Little Rock, Arkansas, 72205, United States
UCLA Hematology/Oncology - Beverly Hills
Beverly Hills, California, 90212, United States
UCLA Hematology/Oncology - Burbank
Burbank, California, 91505, United States
UCSD Medical Center - Encinitas
Encinitas, California, 92024, United States
Sulpizio Cardiovascular Center at UC San Diego Health
La Jolla, California, 92037, United States
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
La Jolla, California, 92037, United States
UCSD Koman Family Outpatient Pavilion
La Jolla, California, 92037, United States
UCSD Perlman Medical Offices
La Jolla, California, 92037, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
UCLA Hematology/Oncology - Laguna Hills
Laguna Hills, California, 92653, United States
Administrative Address: UCLA Hematology/Oncology
Los Angeles, California, 90095, United States
UCLA Hematology/Oncology
Los Angeles, California, 90095, United States
UCSD Medical Center - Bankers Hill
San Diego, California, 912101, United States
UC San Diego Medical Center - Hillcrest
San Diego, California, 92103, United States
UCLA Hematology/Oncology - San Luis Obispo
San Luis Obispo, California, 93401, United States
UCLA Hematology/Oncology- Santa Barbara
Santa Barbara, California, 93101, United States
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, 90404, United States
UCLA Hematology/Oncology Parkside
Santa Monica, California, 90404, United States
Clinical And Translational Research Center
Torrance, California, 90502, United States
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502, United States
Harbor-UCLA Medical Center
Torrance, California, 90509, United States
UCLA Hematology/Oncology - Santa Clarita
Valencia, California, 91355, United States
UCSD Medical Center - Vista
Vista, California, 92081, United States
UCLA Hematology/Oncology- Westlake
Westlake Village, California, 91361, United States
AdventHealth Altamonte Infusion Center
Altamonte Springs, Florida, 32701, United States
AdventHealth Medical Group Altamonte(second location)
Altamonte Springs, Florida, 32701, United States
AdventHealth Medical Group Altamonte
Altamonte Springs, Florida, 32701, United States
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
AdventHealth Medical Group Orlando
Orlando, Florida, 32804, United States
AdventHealth Orlando Infusion Center
Orlando, Florida, 32804, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University Clinic
Atlanta, Georgia, 30322, United States
Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342, United States
University of Illinois Hospital and Health Systems (Investigational Drug Pharmacy)
Chicago, Illinois, 60612, United States
University of Illinois Hospital and Health Systems (Outpatient Cancer Center)
Chicago, Illinois, 60612, United States
University of Illinois Hospital and Health Systems
Chicago, Illinois, 60612, United States
Norton Cancer Institute - Downtown
Louisville, Kentucky, 40202, United States
Norton Cancer Institute, Downtown
Louisville, Kentucky, 40202, United States
Norton Cancer Institute, St Matthews Campus
Louisville, Kentucky, 40207, United States
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, 40207, United States
Norton Cancer Institute, Brownsboro Hospital Campus
Louisville, Kentucky, 40241, United States
Mercy Medical Center
Baltimore, Maryland, 21202, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Saint Luke's Cancer Institute.
Kansas City, Missouri, 64111, United States
Oncology Hematology West PC dba Nebraska Cancer Specialists
Grand Island, Nebraska, 68803, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island
Grand Island, Nebraska, 68803, United States
Oncology Hematology West PC dba Nebraska Cancer Specialists
Omaha, Nebraska, 68114, United States
Oncology Hematology West PC dba Nebraska Cancer Specialists
Omaha, Nebraska, 68124, United States
Oncology Hematology West PC dba Nebraska Cancer Specialists
Omaha, Nebraska, 68130, United States
Oncology Hematology West PC dba Nebraska Cancer Specialists
Papillion, Nebraska, 68046, United States
RWJBarnabas Health- Jersey City Medical Center
Jersey City, New Jersey, 07302, United States
RWJBarnabas Health- Monmouth Medical Center-Southern Campus
Lakewood, New Jersey, 08701, United States
RWJBarnabas Health- Cooperman Barnabas Medical Center
Livingston, New Jersey, 07039, United States
RWJBarnabas Health- Monmouth Medical Center
Long Branch, New Jersey, 07740, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
RWJBarnabas Health-Robert Wood Johnson University Hospital, Somerset
Somerville, New Jersey, 08876, United States
Steeplechase Cancer Center
Somerville, New Jersey, 08876, United States
RWJBarnabas Health - Community Medical Center
Toms River, New Jersey, 08755, United States
Satellite Infusion Center-Monmouth Medical Center Vantage Point Infusion Center
West Long Branch, New Jersey, 07764, United States
Montefiore Einstein Comprehensive Cancer Center
The Bronx, New York, 10461, United States
Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Cleveland Clinic Cancer Center - Strongsville
Strongsville, Ohio, 44136, United States
Asplundh Cancer Pavillion
Willow Grove, Pennsylvania, 19090, United States
Tennessee Oncology, PLLC
Gallatin, Tennessee, 37066, United States
Tennessee Oncology, PLLC
Murfreesboro, Tennessee, 37129, United States
Sarah Cannon Research Institute- Pharmacy
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC
Shelbyville, Tennessee, 37160, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Froedtert Hospital/Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050, Australia
Macquarie University Clinical Trials Unit.
Macquarie University, New South Wales, 2109, Australia
Western Sydney Local Health District (WSLHD), Westmead Hospital
Westmead, New South Wales, 2145, Australia
Cancer Research SA
Adelaide, South Australia, 5000, Australia
St Andrews Medical Centre
Adelaide, South Australia, 5000, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
St John of God Subiaco Hospital Clinical Trials Unit Bendat Family Comprehensive Cancer Centre
Subiaco, Washington, 6008, Australia
Ordination Priv.-Doz. Dr. Michael Hubalek
Schwaz, Other, A-6130, Austria
Medizinische Universität Graz
Graz, A-8010, Austria
Medizinische Universitat Graz
Graz, A-8036, Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern
Linz, A-4010, Austria
Medizinische Universitat Wien Universitatsklinik Fur Frauenheilkunde
Vienna, A-1090, Austria
Jules Bordet lnstituut
Anderlecht, 1070, Belgium
Universitair Ziekenhuis Brussel (UZ Brussel)
Brussels, 1090, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Clinique St-Pierre
Ottignies, 1340, Belgium
CRIO - Centro Regional lntegrado de Oncologia
Fortaleza, Ceará, 60336-232, Brazil
Hospital Araujo Jorge
Goiânia, Goiás, 74605-070, Brazil
A.C. Camargo Câncer Center
Sao Paulo/SP, Other, 01.509-010, Brazil
Hospital Do Cancer De Londrina
Londrina, Paraná, 86015-520, Brazil
Liga Norte-Rio Grandense Contra o Cancer
Natal, Rio Grande do Norte, 59075-740, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital do Cancer Mae de Deu
Porto Alegre, Rio Grande do Sul, CEP 90110-270, Brazil
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital do Cancer Mae de Deu
Porto Alegre, Rio Grande do Sul, CEP 90850-170, Brazil
Fundacao Pio XII, Hospital do Amor de Barretos
Barretos, São Paulo, CEP: 14784-400, Brazil
Fundacao Dr Amaral Carvalho
Jaú, São Paulo, CEP: 17210-080, Brazil
CEPHO- Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo André, São Paulo, 09060-650, Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo André, São Paulo, 09060-870, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre centro Multidisciplinar de pesquisa clinica
Porto Alegre/RS, 90050-170, Brazil
Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, 15090-000, Brazil
ICESP- Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira
São Paulo, 01246-000, Brazil
Sao Camilo Oncologia
São Paulo, 04014-002, Brazil
Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecologica e Mamária Ltda.
São Paulo, CEP: 01317-000, Brazil
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
BC Cancer Agency
Kelowna, British Columbia, V1Y 5L3, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5, Canada
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
Centre integre universitaire de sante et de services sociaux du Saguenay-Lac-Saint-Jean
Chicoutimi, Quebec, G7H 5H6, Canada
Centre Hospitalier de l'Universite de Motreal (CHUM)
Montreal, Quebec, H2X 3E4, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Centro de Investigacion Clínica Bradford Hill
Recoleta, Santiago Metropolitan, 8420323, Chile
Oncocentro Apys
Viña del Mar, Valparaiso, Chile
Clinica Universidad Catolica del Maule
Talca, 3460000, Chile
Clinica Alemana Temuco
Temuco, 4810297, Chile
James Lind Centro De Investigacion Del Cancer
Temuco, 4810469, Chile
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
Meizhou People's Hospital
Meizhou, Guangdong, 514031, China
Liuzhou People's Hospital
Liuchow, Guangxi, 545006, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, 530021, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021, China
The first Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570102, China
Affiliated Hospital of Hebei University
Baoding, Hebei, 071000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450003, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, 430030, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
Nanjing Medical University (NMU) - Jiangsu Province Hospital
Nanjing, Jiangsu, 210036, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330008, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
Liaoning Cancer Hospital & Insitute
Shenyang, Liaoning, 110042, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110167, China
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
Shanghai, Other, 200025, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 710068, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
Linyi Cancer Hospital
Linyi, Shandong, 276034, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310052, China
Beijing Hospital
Beijing, 100010, China
Beijing Hospital
Beijing, 100730, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Tianjin Cancer Hospital Binhai Campus
Tianjin, 300181, China
Ustavni lekarna Masarykuv onkologicky ustav
Brno, Other, 656 53, Czechia
Fakultni Thomayerova nemocnice Onkologicka klinika 1. LF UK a FTN
Praha 4 - Krc, Other, 14059, Czechia
Masarykuv Onkologicky Ustav
Brno, 656 53, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 128 08, Czechia
Fakultni nemocnice v Motole Onkologicka klinika 2. LF UK a FN Motol
Praha 5 - Motol, 15006, Czechia
Nemocnicni lekarna Fakultni nemocnice v Motole
Praha 5 - Motol, 15006, Czechia
Tampere University Hospital, FONK/RSYO
Tampere, 33520, Finland
Tampere University Hospital
Tampere, Finland
Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
Rouen, Brittany Region, 76038, France
Institut Bergonie
Bordeaux, Cedex, 33076, France
Centre de Cancérologie du Grand Montpellier
Montpellier, Languedoc-roussillon, 34070, France
Institut de Cancerologie de lOuest - Site Rene Gauducheau
Saint-Herblain, Loire-atlantique, 44800, France
Institut de Cancerologie de lOuest-Saint Herblain
Saint-Herblain, Loire-atlantique, 44805, France
Institut Sainte-Catherine.
Avignon, Other, 84918, France
Sainte Catherine lnstitut du Cancer Avignon Provence
Avignon, Other, 84918, France
Center Georges-Francois Leclerc
Dijon, Other, 21079, France
CHU Besancon
Besançon, 25000, France
Hopital Avicenne
Bobigny, 93009 Cedex, France
CENTRE FRANCOIS BACLESSE - Service lmagerie medicale
Caen, 14076 Cedex 5, France
Centre Francois Baclesse
Caen, 14076 Cedex 5, France
Centre de Lutte contre le Cancer - François Baclesse
Caen, 14076, France
Centre Jean Perrin
Clermont-Ferrand, 63000, France
Centre Oscar Lambret
Lille, 59020 Cedex, France
Center Leon Berard
Lyon, 69373 Cedex 08, France
Institut Regional du Cancer de Montpellier Service lmagerie medicale
Montpellier, 34298 Cedex 5, France
Institut Régional du Cancer de Montpellier
Montpellier, 34298, France
Centre Antoine Lacassagne
Nice, 06189, France
Hospices Civils de Lyon
Pierre-Bénite, 69310, France
"CARIO - Centre Armoricain de Radiotherapie lmagerie medicate et d'Oncologie -Hopital Prive des
Plérin, 22190, France
Centre Eugene Marquis
Rennes, cedex 35042, France
Centre Henri Becquerel
Rouen, 76038 Cedex 1, France
Institut Curie - site St-Cloud
Saint-Cloud, 92210, France
Centre de Lutte contre le Cancer Paul Strauss - CPS
Strasbourg, 67033, France
University Hospital Muenster Senology
Münster, North Rhine-Westphalia, 48149, Germany
Universitätsmedizin Mannheim Universitätsfrauenklinik
Manheim, Other, 68167, Germany
Pharmacy:Fortuna Herstellung GmbH
Mannheim, Other, 68167, Germany
"Universitatsklinikum Augsburg Klinik fur Frauenheilkunde und Geburtshilfe"
Augsburg, 86156, Germany
Charite Universtitatsmedizin Berlin Klinik fur Gynakologie mit Brustzentrum
Berlin, 10117, Germany
Charite - Universitatsmedizin Berlin
Berlin, 13353, Germany
Universitatsklinikum Hamburg-Eppendorf (UKE)
Hamburg, 20246, Germany
Klinik und Poliklinik fur Frauenheilkunde der Technischen Universitat Munchen
München, 81675, Germany
Universitatsklinikum Ulm Klinik fur Frauenheilkunde und Geburtshilfe
Ulm, 89075, Germany
Universitatsklinikum Wurzburg Frauenklinik und Poliklinik
Würzburg, 97080, Germany
Universitatsklinikum Wurzburg, Comprehensive Cancer Center - Mainfranken (CCCMF)
Würzburg, 97080, Germany
General Hospital of Athens "Alexandra" Clinical Therapeutics Department, Hematology/Oncology Unit
Athens, Attica, 11528, Greece
University General Hospital of Patras, Oncology Department, Internal Medicine Clinic
Patra, Peloponnese, 26504, Greece
University General Hospital of Larissa, Oncology Clinic
Larissa, 41110, Greece
IASO General Clinic Oncology Clinic
Marousi, 15123, Greece
Metaxa Anticancer Hospital of Piraeus
Pireaus, 18537, Greece
Azienda Ospedaliera Universitaria Federico II
Naples, Campania, 80131, Italy
lstituto Nazionale Tumori IRCCS - Fondazione Pascale U.O.C. Oncologia Medica Senologica
Naples, Campania, 80131, Italy
IRCCS Azienda Ospedaliera Metropolitana
Genova, Genoa, 16132, Italy
ASST Monza Ospedale San Gerardo Centro Ricerca di Fase 1
Monza (MB), Lombardy, 20900, Italy
Humanitas lstituto Clinico Catanese
Catania (CT), Sicily, 95045, Italy
Azienda Ospedaliero Universitaria delle Marche SOD Clinica Oncologica
Torrette, The Marches, 60126, Italy
Divisione Oncologia Medica, Ospedale di Trento - Presidio Ospedaliero (PO) Santa Chiara
Trento, Trentino-Alto Adige, 38122, Italy
SOC Farmacia, Ospedale di Trento - Presidio Ospedaliero (PO)
Trento, Trentino-Alto Adige, 38122, Italy
Oncologia Medica Azienda Usl Toscana Nord Ovest - Ospedali Riuniti di Livor
Livorno, Tuscany, 57124, Italy
S.O.C. Oncologia Medica - Nuovo Ospedale di Prato Santo Stefano
Prato, Tuscany, 59100, Italy
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
Bologna, 40138, Italy
SSD Oncologia Medica Addarii - Zamagni, Policlinico Sant'Orsola - Malpighi
Bologna, 40138, Italy
Istituto Clinico Humanitas
Milan, 20089, Italy
Divisione di Senologia Medica; Istituto Europeo di Oncologia
Milan, 20141, Italy
UOC di Oncologia Medica, Azienda Ospedaliero Universitaria (AOU) di Parma
Parma, 43126, Italy
Istituti Clinici Scientifici Maugeri IRCCS
Pavia, 27100, Italy
Tesshokai Kameda General Hospital
Kamogawa, Chiba, 296-8602, Japan
National Cancer Center Hospital East
Kashiwa-Shi, Chiba, 277-8577, Japan
NHO Shikoku Cancer Center
Matsuyama, Ehime, 791-0280, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, 811-1395, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, 960-1295, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804, Japan
University of Tsukuba Hospital
Tsukuba, Ibaraki, 305-8576, Japan
Ishikawa Prefectural Central Hospital
Kanazawa, Ishikawa-ken, 920-8530, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515, Japan
Naha Nishi Clinic
Naha, Okinawa, 901-0154, Japan
Kindai University Hospital
Osakasayama-shi, Osaka, 589-8511, Japan
Kindai University Hospital
Sakai, Osaka, 590-0197, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045, Japan
St. Luke's International Hospital.
Chuo-ku, Tokyo, 104-8560, Japan
Toranomon Hospital
Minato-ku, Tokyo, 105-8470, Japan
Showa University Hospital
Shinagawa-ku, Tokyo, 142-8666, Japan
Albert Schweitzer Hospital
Doedrecht, South Holland, 3318AT, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, 3318 AT, Netherlands
St. Antonius Hospital
Utrecht, 3543 AZ, Netherlands
VieCuri Medsich Centrum
Venlo, 5912 BL, Netherlands
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz, Other, 93-513, Poland
Narodowy lnstytut Onkologii im. Marii Sklodowskiej-Curie-Panstwowy lnstytut Badawczy
Gliwice, Silesian Voivodeship, 44-102, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214, Poland
Salve Medica Apteka Szpitalna
Lodz, 91-211, Poland
Salve Medica
Lodz, 91-211, Poland
SP ZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego w Opolu
Opole, 45-061, Poland
Centro Clinico Academico Braga Hospital de Braga
Braga, Other, 4710-243, Portugal
Hospital CUF Descobertas
Lisbon, Other, 1998-018, Portugal
Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE (IPO, Coimbra)
Coimbra, 3000-075, Portugal
Fundacao Champalimaud
Lisbon, 1400-038, Portugal
Yonsei University Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426, South Korea
National Cancer Center
Goyang-si, Gyeonggi-do, 10408, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, 16499, South Korea
Chungbuk Nationl University Hospital
Cheongju-si, North Chungcheong, 28644, South Korea
Seoul National University Hospital
Seoul, Other, 03080, South Korea
Asan Medical Center
Seoul, Other, 05505, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, Other, 06273, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Other, 06591, South Korea
Ewha Womans University Mokdong Hospital
Seoul, Other, 07985, South Korea
Severance Hospital Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], 03722, South Korea
Dong-A University Hospital
Busan, 49201, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Hospital El Angel Grupo Hla, S.L.U
Málaga, Andalusia, 29016, Spain
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07120, Spain
Hospital Universitario Virgen De La Arrixaca
EI Palmar, Murcia, 30120, Spain
Fundación Privada Instituto de Investigación Oncológica de Vall Hebron
Barcelona, Other, 08035, Spain
Hospital San Pedro de Alcantara
Cáceres, Other, 10003, Spain
Hospital Universitario Ramon y Cajal
Madrid, Other, 28034, Spain
Hospital Clinico Universitario de Valencia
Valencia, Other, 46010, Spain
Hospital Universitario de Canarias
La Laguna Tenerife, Santa CRUZ DE Tenerife, 38320, Spain
Hospital General Universitario Alicante
Alicante, Valencia, 03010, Spain
Fundacio de Gestio Sanitaria de I'Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca
Barcelona, 08035, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041, Spain
Hospital Universitario de Basurto
Bilbao, 48013, Spain
Institut Catala d'Oncologia Girona - ICO Girona
Girona, 17007, Spain
Hospital Universitario Virgen de las Nieves
Granada, 18014, Spain
Hospital Universitari Arnau de Vilanova
Lleida, 25198, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28007, Spain
Hospital Universitario Virgen de la Victoria
Málaga, 29010, Spain
Hospital Universitario de Salamanca (Spain Salamanca)
Salamanca, 37007, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Fundacion lnstituto Valenciano de Oncologia
Valencia, 46009, Spain
Kantonsspital Winterthur
Winterthur, Canton of Zurich, 8401, Switzerland
Kantonsspital Baden.
Baden, 5404, Switzerland
Brust-Zentrum AG
Zurich, 8008, Switzerland
National Cheng Kung University Hospital
Tainan, Other, 704, Taiwan
MacKay Medical Foundation The Presbyterian Church in Taiwan MacKay Memorial Hospital
Taipei, Other, 10449, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Other, 112, Taiwan
National Taiwan University Hospital
Taipei, R.o.c, 100, Taiwan
Chi Mei Medical Center
Tainan, Tainan, 710, Taiwan
Changhua Christian Medical Foundation Changhua Christian Hospital
Changhua, 500 (R.O.C.), Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
New Taipei City, 23561 (R.O.C), Taiwan
Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
New Taipei City, 23561 (R.O.C.), Taiwan
China Medical University Hospital
Taichung, 40447 (R.O.C.), Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Tri-Service General Hospital
Taipei, 11490, R.O.C., Taiwan
Chang Gung Memorial Hospital LinKou
Taoyuan, 333, Taiwan
Academic Oncology
London, England, NW3 2QG, United Kingdom
The Royal Marsden
Sutton, Surrey, SM2 5PT, United Kingdom
Finchley Memorial Hospital
London, N12 0JE, United Kingdom
University College London Hospital (UCLH) NHS Foundation Trust
London, NW1 2PG, United Kingdom
The Royal Marsden
London, SW3 6JJ, United Kingdom
Christie Hospital NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Related Publications (1)
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. 2025 Dec 10:JCO2502600. doi: 10.1200/JCO-25-02600. Online ahead of print.
PMID: 41369677DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2021
First Posted
November 24, 2021
Study Start
March 7, 2022
Primary Completion
September 5, 2025
Study Completion (Estimated)
September 28, 2027
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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.