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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
Date last updated
28/08/2024
Titles & IDs
Public title
A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer
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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)
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Secondary ID [1]
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SGNTUC-028
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Universal Trial Number (UTN)
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Trial acronym
HER2CLIMB-05
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HER2 Positive Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free survival (PFS) by investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
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Assessment method [1]
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The time from the date of randomization to the investigator assessment of disease progression according to RECIST v1.1 or death from any cause
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Timepoint [1]
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Up to approximately 3 years
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Secondary outcome [1]
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Overall survival (OS)
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Assessment method [1]
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The time from randomization to death from any cause.
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Timepoint [1]
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Up to approximately 5 years
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Secondary outcome [2]
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PFS by blinded independent central review (BICR) per RECIST v1.1
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Assessment method [2]
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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
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Timepoint [2]
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Up to approximately 3 years
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Secondary outcome [3]
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Time to deterioration of health-related quality of life (HRQoL)
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Assessment method [3]
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Will be measured based on patient reported outcomes (PROs) according to the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ C30).
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Timepoint [3]
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Up to approximately 3 years
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Secondary outcome [4]
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Central nervous system (CNS) PFS
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Assessment method [4]
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The time from randomization to investigator assessed disease progression in brain (RECIST v1.1), or death from any cause
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Timepoint [4]
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Up to approximately 3 years
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Secondary outcome [5]
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Incidence of adverse events (AEs)
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Assessment method [5]
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Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
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Timepoint [5]
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Through 30 days after last study treatment, approximately 18 months
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Secondary outcome [6]
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Incidence of laboratory abnormalities
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Assessment method [6]
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To be summarized using descriptive statistics.
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Timepoint [6]
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Through 30 days after last study treatment, approximately 18 months
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Secondary outcome [7]
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Incidence of tucatinib dose alterations
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Assessment method [7]
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To be summarized using descriptive statistics.
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Timepoint [7]
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Through 30 days after last study treatment, approximately 18 months
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Secondary outcome [8]
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Incidence of trastuzumab dose alterations
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Assessment method [8]
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To be summarized using descriptive statistics.
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Timepoint [8]
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Through 30 days after last study treatment, approximately 18 months
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Secondary outcome [9]
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Incidence of pertuzumab dose alterations
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Assessment method [9]
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To be summarized using descriptive statistics.
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Timepoint [9]
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Through 30 days after last study treatment, approximately 18 months
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Secondary outcome [10]
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Maximum concentration (Cmax)
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Assessment method [10]
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To be summarized using descriptive statistics.
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Timepoint [10]
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Through 30 days after last study treatment, approximately 18 months
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Secondary outcome [11]
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Trough concentration (Ctrough)
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Assessment method [11]
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To be summarized using descriptive statistics.
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Timepoint [11]
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Through 30 days after last study treatment, approximately 18 months
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/03/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/06/2027
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Actual
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Sample size
Target
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Accrual to date
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Final
654
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Recruitment in Australia
Recruitment state(s)
Othe
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Recruitment hospital [1]
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Cancer Research South Australia - Adelaide
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Recruitment hospital [2]
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Flinders Medical Centre - Bedford Park
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Box Hill Hospital - Box Hill
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Recruitment hospital [4]
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Chris O'Brien Lifehouse - Camperdown
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Peninsula and South East Oncology - Frankston
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Austin Health - Heidelberg
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Macquarie University Hospital - Macquarie University
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Recruitment hospital [8]
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St John of God Subiaco Hospital - Subiaco
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Recruitment hospital [9]
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Westmead Hospital - Sydney
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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5042 - Bedford Park
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Recruitment postcode(s) [3]
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3128 - Box Hill
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Recruitment postcode(s) [4]
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2050 - Camperdown
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Recruitment postcode(s) [5]
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3199 - Frankston
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3084 - Heidelberg
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Recruitment postcode(s) [7]
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2109 - Macquarie University
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Recruitment postcode(s) [8]
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6008 - Subiaco
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Recruitment postcode(s) [9]
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2145 - Sydney
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Recruitment outside Australia
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Arizona
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Arkansas
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California
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Florida
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Illinois
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Seagen Inc.
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Address
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Commercial sector/industry
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Name [1]
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Merck Sharp & Dohme LLC
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05132582
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Monitor
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Address
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Seagen Inc.
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Contact person for public queries
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Seagen Trial Information Support
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Phone
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866-333-7436
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
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
Download to PDF