Register a trial

Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05132582




Registration number
NCT05132582
Ethics application status
Date submitted
12/11/2021
Date registered
24/11/2021

Titles & IDs
Public title
A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer
Scientific 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)
Secondary ID [1] 0 0
C4251007
Secondary ID [2] 0 0
SGNTUC-028
Universal Trial Number (UTN)
Trial acronym
HER2CLIMB-05
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HER2 Positive Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tucatinib
Treatment: Drugs - Trastuzumab
Treatment: Drugs - Pertuzumab
Treatment: Drugs - Combination product: Trastuzumab + Pertuzumab
Treatment: Drugs - Placebo

Experimental: Tucatinib + trastuzumab + pertuzumab - Tucatinib + trastuzumab + pertuzumab

Active comparator: Placebo + trastuzumab + pertuzumab - Placebo + trastuzumab + pertuzumab


Treatment: Drugs: Tucatinib
300mg given by mouth (orally) twice daily

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

Treatment: Drugs: Pertuzumab
420mg given by IV every 21 days

Treatment: Drugs: 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.

Treatment: Drugs: Placebo
Given orally twice daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS) by investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timepoint [1] 0 0
Up to approximately 3 years
Secondary outcome [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [2] 0 0
PFS by blinded independent central review (BICR) per RECIST v1.1
Timepoint [2] 0 0
Up to approximately 3 years
Secondary outcome [3] 0 0
Time to deterioration of health-related quality of life (HRQoL)
Timepoint [3] 0 0
Up to approximately 3 years
Secondary outcome [4] 0 0
Central nervous system (CNS) PFS
Timepoint [4] 0 0
Up to approximately 3 years
Secondary outcome [5] 0 0
Incidence of adverse events (AEs)
Timepoint [5] 0 0
Through 30 days after last study treatment, approximately 18 months
Secondary outcome [6] 0 0
Incidence of laboratory abnormalities
Timepoint [6] 0 0
Through 30 days after last study treatment, approximately 18 months
Secondary outcome [7] 0 0
Incidence of tucatinib dose alterations
Timepoint [7] 0 0
Through 30 days after last study treatment, approximately 18 months
Secondary outcome [8] 0 0
Incidence of trastuzumab dose alterations
Timepoint [8] 0 0
Through 30 days after last study treatment, approximately 18 months
Secondary outcome [9] 0 0
Incidence of pertuzumab dose alterations
Timepoint [9] 0 0
Through 30 days after last study treatment, approximately 18 months
Secondary outcome [10] 0 0
Maximum concentration (Cmax)
Timepoint [10] 0 0
Through 30 days after last study treatment, approximately 18 months
Secondary outcome [11] 0 0
Trough concentration (Ctrough)
Timepoint [11] 0 0
Through 30 days after last study treatment, approximately 18 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/09/2027
Actual
Sample size
Target
Accrual to date
Final
650
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WashingtonWA
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Macquarie University Clinical Trials Unit. - Macquarie University
Recruitment hospital [3] 0 0
Macquarie University Hospital - Macquarie University
Recruitment hospital [4] 0 0
Baxter Healthcare Pty Limited - Old Tonggabbie
Recruitment hospital [5] 0 0
Pharmacy Macquarie University Hospital - Sydney
Recruitment hospital [6] 0 0
Westmead Hospital - Sydney
Recruitment hospital [7] 0 0
Western Sydney Local Health District (WSLHD), Westmead Hospital - Westmead
Recruitment hospital [8] 0 0
Cancer Research SA - Adelaide
Recruitment hospital [9] 0 0
HPS Pharmacies -Adelaide (South Tee) (lnvestigational Product storage and dispensing) - Adelaide
Recruitment hospital [10] 0 0
St Andrews Medical Centre - Adelaide
Recruitment hospital [11] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [12] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [13] 0 0
Austin Health - Heidelberg
Recruitment hospital [14] 0 0
St John of God Subiaco Hospital Clinical Trials Unit Bendat Family Comprehensive Cancer Centre - Subiaco
Recruitment hospital [15] 0 0
St John of God Subiaco Hospital - Subiaco
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2109 - Macquarie University
Recruitment postcode(s) [3] 0 0
2146 - Old Tonggabbie
Recruitment postcode(s) [4] 0 0
2109 - Sydney
Recruitment postcode(s) [5] 0 0
2145 - Sydney
Recruitment postcode(s) [6] 0 0
2145 - Westmead
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
5042 - Bedford Park
Recruitment postcode(s) [9] 0 0
3128 - Box Hill
Recruitment postcode(s) [10] 0 0
3084 - Heidelberg
Recruitment postcode(s) [11] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Nebraska
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
United States of America
State/province [17] 0 0
Wisconsin
Country [18] 0 0
Austria
State/province [18] 0 0
Other
Country [19] 0 0
Austria
State/province [19] 0 0
Graz
Country [20] 0 0
Austria
State/province [20] 0 0
Linz
Country [21] 0 0
Austria
State/province [21] 0 0
Schwaz
Country [22] 0 0
Austria
State/province [22] 0 0
Wien
Country [23] 0 0
Belgium
State/province [23] 0 0
Brussels
Country [24] 0 0
Belgium
State/province [24] 0 0
Oost-vlaanderen
Country [25] 0 0
Belgium
State/province [25] 0 0
Walloon Brabant
Country [26] 0 0
Belgium
State/province [26] 0 0
Anderlecht
Country [27] 0 0
Belgium
State/province [27] 0 0
Brussel
Country [28] 0 0
Belgium
State/province [28] 0 0
Ottignies
Country [29] 0 0
Brazil
State/province [29] 0 0
Ceara
Country [30] 0 0
Brazil
State/province [30] 0 0
Goias
Country [31] 0 0
Brazil
State/province [31] 0 0
Other
Country [32] 0 0
Brazil
State/province [32] 0 0
Parana
Country [33] 0 0
Brazil
State/province [33] 0 0
RIO Grande DO Norte
Country [34] 0 0
Brazil
State/province [34] 0 0
RIO Grande DO SUL
Country [35] 0 0
Brazil
State/province [35] 0 0
SAO Paulo
Country [36] 0 0
Brazil
State/province [36] 0 0
Porto Alegre/RS
Country [37] 0 0
Brazil
State/province [37] 0 0
Sao Jose do Rio Preto
Country [38] 0 0
Brazil
State/province [38] 0 0
Sao Paulo
Country [39] 0 0
Brazil
State/province [39] 0 0
São Paulo/SP
Country [40] 0 0
Brazil
State/province [40] 0 0
São Paulo
Country [41] 0 0
Canada
State/province [41] 0 0
Alberta
Country [42] 0 0
Canada
State/province [42] 0 0
British Columbia
Country [43] 0 0
Canada
State/province [43] 0 0
Ontario
Country [44] 0 0
Canada
State/province [44] 0 0
Quebec
Country [45] 0 0
Chile
State/province [45] 0 0
Cautin
Country [46] 0 0
Chile
State/province [46] 0 0
Santiago
Country [47] 0 0
Chile
State/province [47] 0 0
Valparaíso
Country [48] 0 0
Chile
State/province [48] 0 0
Talca
Country [49] 0 0
Chile
State/province [49] 0 0
Temuco
Country [50] 0 0
China
State/province [50] 0 0
Anhui
Country [51] 0 0
China
State/province [51] 0 0
Guangdong
Country [52] 0 0
China
State/province [52] 0 0
Guangxi
Country [53] 0 0
China
State/province [53] 0 0
Hainan
Country [54] 0 0
China
State/province [54] 0 0
Hebei
Country [55] 0 0
China
State/province [55] 0 0
Henan
Country [56] 0 0
China
State/province [56] 0 0
Hubei
Country [57] 0 0
China
State/province [57] 0 0
Hunan
Country [58] 0 0
China
State/province [58] 0 0
Jiangsu
Country [59] 0 0
China
State/province [59] 0 0
Jiangxi
Country [60] 0 0
China
State/province [60] 0 0
Jilin
Country [61] 0 0
China
State/province [61] 0 0
Liaoning
Country [62] 0 0
China
State/province [62] 0 0
Other
Country [63] 0 0
China
State/province [63] 0 0
Shaanxi
Country [64] 0 0
China
State/province [64] 0 0
Shandong
Country [65] 0 0
China
State/province [65] 0 0
Zhejiang
Country [66] 0 0
China
State/province [66] 0 0
Beijing
Country [67] 0 0
China
State/province [67] 0 0
Binjiang District
Country [68] 0 0
China
State/province [68] 0 0
Changchun
Country [69] 0 0
China
State/province [69] 0 0
Nanjing
Country [70] 0 0
China
State/province [70] 0 0
Nanning
Country [71] 0 0
China
State/province [71] 0 0
Shanghai
Country [72] 0 0
China
State/province [72] 0 0
Tianjin City
Country [73] 0 0
Czechia
State/province [73] 0 0
Praha 2
Country [74] 0 0
Czechia
State/province [74] 0 0
Brno
Country [75] 0 0
Czechia
State/province [75] 0 0
Praha 4 - Krc
Country [76] 0 0
Czechia
State/province [76] 0 0
Praha 5 - Motol
Country [77] 0 0
Finland
State/province [77] 0 0
Tampere
Country [78] 0 0
France
State/province [78] 0 0
Bretagne
Country [79] 0 0
France
State/province [79] 0 0
Cedex
Country [80] 0 0
France
State/province [80] 0 0
Languedoc-roussillon
Country [81] 0 0
France
State/province [81] 0 0
Loire-atlantique
Country [82] 0 0
France
State/province [82] 0 0
Lyon
Country [83] 0 0
France
State/province [83] 0 0
Mainet-et-loire
Country [84] 0 0
France
State/province [84] 0 0
Other
Country [85] 0 0
France
State/province [85] 0 0
Provence Alpes COTE D-azur
Country [86] 0 0
France
State/province [86] 0 0
Avignon Cedex 9
Country [87] 0 0
France
State/province [87] 0 0
Avignon
Country [88] 0 0
France
State/province [88] 0 0
Besancon
Country [89] 0 0
France
State/province [89] 0 0
Besangon
Country [90] 0 0
France
State/province [90] 0 0
Bobigny
Country [91] 0 0
France
State/province [91] 0 0
Caen Cedex 5
Country [92] 0 0
France
State/province [92] 0 0
Caen
Country [93] 0 0
France
State/province [93] 0 0
Clermont Ferrand
Country [94] 0 0
France
State/province [94] 0 0
Clermont-Ferrand
Country [95] 0 0
France
State/province [95] 0 0
Cotes d'Armor
Country [96] 0 0
France
State/province [96] 0 0
Dijon
Country [97] 0 0
France
State/province [97] 0 0
Lille
Country [98] 0 0
France
State/province [98] 0 0
Montpellier Cedex 5
Country [99] 0 0
France
State/province [99] 0 0
Montpellier
Country [100] 0 0
France
State/province [100] 0 0
Nice cedex 2
Country [101] 0 0
France
State/province [101] 0 0
Nice
Country [102] 0 0
France
State/province [102] 0 0
Paris
Country [103] 0 0
France
State/province [103] 0 0
Pierre Benite
Country [104] 0 0
France
State/province [104] 0 0
Plerin
Country [105] 0 0
France
State/province [105] 0 0
Rennes
Country [106] 0 0
France
State/province [106] 0 0
Rouen
Country [107] 0 0
France
State/province [107] 0 0
Saint-Cloud
Country [108] 0 0
France
State/province [108] 0 0
Strasbourg
Country [109] 0 0
France
State/province [109] 0 0
Île-de-france
Country [110] 0 0
Germany
State/province [110] 0 0
North Rhine-westphalia
Country [111] 0 0
Germany
State/province [111] 0 0
Other
Country [112] 0 0
Germany
State/province [112] 0 0
Augsburg
Country [113] 0 0
Germany
State/province [113] 0 0
Berlin
Country [114] 0 0
Germany
State/province [114] 0 0
Hamburg
Country [115] 0 0
Germany
State/province [115] 0 0
Manheim
Country [116] 0 0
Germany
State/province [116] 0 0
Muenchen
Country [117] 0 0
Germany
State/province [117] 0 0
Munster
Country [118] 0 0
Germany
State/province [118] 0 0
Ulm
Country [119] 0 0
Germany
State/province [119] 0 0
Wurzburg
Country [120] 0 0
Greece
State/province [120] 0 0
Attica
Country [121] 0 0
Greece
State/province [121] 0 0
Other
Country [122] 0 0
Greece
State/province [122] 0 0
Peloponnese
Country [123] 0 0
Greece
State/province [123] 0 0
Athens
Country [124] 0 0
Greece
State/province [124] 0 0
Larissa
Country [125] 0 0
Greece
State/province [125] 0 0
Maroussi
Country [126] 0 0
Greece
State/province [126] 0 0
Pireaus
Country [127] 0 0
Italy
State/province [127] 0 0
Campania
Country [128] 0 0
Italy
State/province [128] 0 0
Liguria
Country [129] 0 0
Italy
State/province [129] 0 0
Lombardia
Country [130] 0 0
Italy
State/province [130] 0 0
Lombardy
Country [131] 0 0
Italy
State/province [131] 0 0
Marche
Country [132] 0 0
Italy
State/province [132] 0 0
Milan
Country [133] 0 0
Italy
State/province [133] 0 0
MI
Country [134] 0 0
Italy
State/province [134] 0 0
Monza AND Brianza
Country [135] 0 0
Italy
State/province [135] 0 0
Sicily
Country [136] 0 0
Italy
State/province [136] 0 0
Trentino
Country [137] 0 0
Italy
State/province [137] 0 0
Tuscany
Country [138] 0 0
Italy
State/province [138] 0 0
Bologna
Country [139] 0 0
Italy
State/province [139] 0 0
Genova
Country [140] 0 0
Italy
State/province [140] 0 0
Livorno
Country [141] 0 0
Italy
State/province [141] 0 0
Milano
Country [142] 0 0
Italy
State/province [142] 0 0
Parma
Country [143] 0 0
Italy
State/province [143] 0 0
Pavia
Country [144] 0 0
Japan
State/province [144] 0 0
Chiba-ken
Country [145] 0 0
Japan
State/province [145] 0 0
Chiba
Country [146] 0 0
Japan
State/province [146] 0 0
Ehime-ken
Country [147] 0 0
Japan
State/province [147] 0 0
Ehime
Country [148] 0 0
Japan
State/province [148] 0 0
Fukuoka
Country [149] 0 0
Japan
State/province [149] 0 0
Fukushima
Country [150] 0 0
Japan
State/province [150] 0 0
Hokkaido
Country [151] 0 0
Japan
State/province [151] 0 0
Ishikawa
Country [152] 0 0
Japan
State/province [152] 0 0
Kanagawa
Country [153] 0 0
Japan
State/province [153] 0 0
Lbaraki-ken
Country [154] 0 0
Japan
State/province [154] 0 0
Okinawa-ken
Country [155] 0 0
Japan
State/province [155] 0 0
Okinawa
Country [156] 0 0
Japan
State/province [156] 0 0
Osaka-fu
Country [157] 0 0
Japan
State/province [157] 0 0
Tokyo-to
Country [158] 0 0
Japan
State/province [158] 0 0
Tokyo
Country [159] 0 0
Korea, Republic of
State/province [159] 0 0
Chungcheongbuk-do
Country [160] 0 0
Korea, Republic of
State/province [160] 0 0
Gangwon-do
Country [161] 0 0
Korea, Republic of
State/province [161] 0 0
Gyeonggi-do
Country [162] 0 0
Korea, Republic of
State/province [162] 0 0
Gyeonggido [kyonggi-do]
Country [163] 0 0
Korea, Republic of
State/province [163] 0 0
Busan
Country [164] 0 0
Korea, Republic of
State/province [164] 0 0
Incheon
Country [165] 0 0
Korea, Republic of
State/province [165] 0 0
Seoul
Country [166] 0 0
Netherlands
State/province [166] 0 0
Other
Country [167] 0 0
Netherlands
State/province [167] 0 0
Zuid-holland
Country [168] 0 0
Netherlands
State/province [168] 0 0
Dordrecht
Country [169] 0 0
Netherlands
State/province [169] 0 0
Utrecht
Country [170] 0 0
Netherlands
State/province [170] 0 0
Venlo
Country [171] 0 0
Poland
State/province [171] 0 0
Gdansk
Country [172] 0 0
Poland
State/province [172] 0 0
Lodz
Country [173] 0 0
Poland
State/province [173] 0 0
Opole
Country [174] 0 0
Poland
State/province [174] 0 0
Slaskie
Country [175] 0 0
Portugal
State/province [175] 0 0
Braga
Country [176] 0 0
Portugal
State/province [176] 0 0
Coimbra
Country [177] 0 0
Portugal
State/province [177] 0 0
Lisboa
Country [178] 0 0
Portugal
State/province [178] 0 0
Lisbon
Country [179] 0 0
Spain
State/province [179] 0 0
Comunidad Valenciana
Country [180] 0 0
Spain
State/province [180] 0 0
Islas Baleares
Country [181] 0 0
Spain
State/province [181] 0 0
Murcia
Country [182] 0 0
Spain
State/province [182] 0 0
Santa CRUZ DE Tenerife
Country [183] 0 0
Spain
State/province [183] 0 0
Barcelona
Country [184] 0 0
Spain
State/province [184] 0 0
Bilbao
Country [185] 0 0
Spain
State/province [185] 0 0
Caceres
Country [186] 0 0
Spain
State/province [186] 0 0
Girona
Country [187] 0 0
Spain
State/province [187] 0 0
Granada
Country [188] 0 0
Spain
State/province [188] 0 0
Lleida
Country [189] 0 0
Spain
State/province [189] 0 0
Madrid
Country [190] 0 0
Spain
State/province [190] 0 0
Malaga
Country [191] 0 0
Spain
State/province [191] 0 0
Salamanca
Country [192] 0 0
Spain
State/province [192] 0 0
Sevilla
Country [193] 0 0
Spain
State/province [193] 0 0
Valencia
Country [194] 0 0
Switzerland
State/province [194] 0 0
Zurich
Country [195] 0 0
Switzerland
State/province [195] 0 0
Baden
Country [196] 0 0
Switzerland
State/province [196] 0 0
Zürich
Country [197] 0 0
Taiwan
State/province [197] 0 0
Other
Country [198] 0 0
Taiwan
State/province [198] 0 0
Changhua City
Country [199] 0 0
Taiwan
State/province [199] 0 0
Kaohsiung
Country [200] 0 0
Taiwan
State/province [200] 0 0
New Taipei City
Country [201] 0 0
Taiwan
State/province [201] 0 0
Taichung
Country [202] 0 0
Taiwan
State/province [202] 0 0
Tainan City
Country [203] 0 0
Taiwan
State/province [203] 0 0
Tainan
Country [204] 0 0
Taiwan
State/province [204] 0 0
Taipei City
Country [205] 0 0
Taiwan
State/province [205] 0 0
Taipei
Country [206] 0 0
Taiwan
State/province [206] 0 0
Taoyuan City
Country [207] 0 0
Taiwan
State/province [207] 0 0
Taoyuan
Country [208] 0 0
United Kingdom
State/province [208] 0 0
England
Country [209] 0 0
United Kingdom
State/province [209] 0 0
Surrey
Country [210] 0 0
United Kingdom
State/province [210] 0 0
London
Country [211] 0 0
United Kingdom
State/province [211] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Seagen, a wholly owned subsidiary of Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Seagen Trial Information Support
Address 0 0
Country 0 0
Phone 0 0
866-333-7436
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05132582