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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03975647
Registration number
NCT03975647
Ethics application status
Date submitted
4/06/2019
Date registered
5/06/2019
Date last updated
7/08/2025
Titles & IDs
Public title
A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer
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Scientific title
Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Subjects With Unresectable Locally-advanced or Metastatic HER2+ Breast Cancer (HER2CLIMB-02)
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Secondary ID [1]
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C4251001
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Secondary ID [2]
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SGNTUC-016
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Universal Trial Number (UTN)
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Trial acronym
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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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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - tucatinib
Treatment: Drugs - placebo
Treatment: Drugs - T-DM1
Experimental: Tucatinib + T-DM1 - Tucatinib + T-DM1
Active comparator: Placebo + T-DM1 - Placebo + T-DM1
Treatment: Drugs: tucatinib
300mg given twice per day by mouth (orally)
Treatment: Drugs: placebo
Given twice per day orally
Treatment: Drugs: T-DM1
3.6 mg/kg given into the vein (IV; intravenously) every 21 days
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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) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 Based on Investigator Assessment
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Assessment method [1]
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PFS as per investigator was defined as the time from the date of randomization to the investigator assessment of disease progression (PD) as per RECIST v1.1 or death from any cause, whichever occurred first. PD: at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimiter (mm). Participants without documentation of PD, or death at the time of analysis were censored at the date of the last tumor assessment.
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Timepoint [1]
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From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 43 months)
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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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OS was defined as the time from randomization to death due to any cause. For a participant who was not known to have died by the end of study follow-up, observation of OS was censored on the date the participant was last known to be alive (i.e., the date of last contact).
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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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Progression-Free Survival as Per RECIST v1.1 in Participants With Brain Metastases at Baseline Based on Investigator Assessment
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Assessment method [2]
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PFS as per investigator was defined as the time from the date of randomization to the investigator assessment of PD as per RECIST v1.1 or death from any cause, whichever occurred first. PD: at least a 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Participants without documentation of PD, or death at the time of analysis were censored at the date of the last tumor assessment. PFS was analyzed in participants with presence or history of brain metastases.
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Timepoint [2]
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0
From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 45 months)
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Secondary outcome [3]
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Objective Response Rate (ORR) as Per RECIST v1.1 Based on Investigator Assessment
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Assessment method [3]
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ORR was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than (\<)10 mm. PR: a greater than equal (\>=) 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response. ORR by investigator assessment is based on investigator response assessments. Two-sided 95% exact confidence interval, computed using the Clopper-Pearson method.
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Timepoint [3]
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From the date of first CR or PR until the date of the first documentation of PD or death, whichever occurred first (maximum up to 43 months)
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Secondary outcome [4]
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Overall Survival in Participants With Brain Metastases at Baseline
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Assessment method [4]
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OS was defined as the time from randomization to death due to any cause. For a participant who was not known to have died by the end of study follow-up, observation of OS was censored on the date the participant was last known to be alive (i.e., the date of last contact). OS was analyzed in participants with presence or history of brain metastases.
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Timepoint [4]
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0
Up to approximately 5 years
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Secondary outcome [5]
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Progression-Free Survival as Per RECIST v1.1 Determined by Blinded Independent Committee Review (BICR)
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Assessment method [5]
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PFS as per BICR was defined as the time from the date of randomization to the centrally-reviewed documented PD as per RECIST v1.1 or death from any cause, whichever occurred first. PD: at least a 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Participants without documented progression of PD or death at the time of analysis were censored at the date of the last tumor assessment.
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Timepoint [5]
0
0
From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 43 months)
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Secondary outcome [6]
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Progression-Free Survival in Participants With Brain Metastases at Baseline as Per RECIST v1.1 Determined by BICR
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Assessment method [6]
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PFS as per BICR was defined as the time from the date of randomization to the centrally-reviewed documented PD as per RECIST v1.1 or death from any cause, whichever occurred first. PD: at least a 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PFS was analyzed in participants with presence or history of brain metastases.
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Timepoint [6]
0
0
From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 43 months)
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Secondary outcome [7]
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0
Objective Response Rate as Per RECIST v1.1 Determined by BICR
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Assessment method [7]
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ORR was defined as the percentage of participants with confirmed CR or PR according to RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: A \>= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR per BICR is based on BICR response assessments.
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Timepoint [7]
0
0
From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 43 months)
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Secondary outcome [8]
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Duration of Response (DOR) as Per RECIST v1.1 Based on Investigator Assessment
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Assessment method [8]
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DOR was defined as the time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD as per RECIST v1.1 PD: at least a 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Participants without documentation of PD, or death at the time of analysis were censored at the date of the last tumor assessment. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: A\>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. DOR per investigator was based on investigator response assessments.
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Timepoint [8]
0
0
Up to approximately 5 years
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Secondary outcome [9]
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0
Duration of Response as Per RECIST v1.1 by BICR
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Assessment method [9]
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DOR was defined as the time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD as per RECIST v1.1 PD: at least a 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Participants without documentation of PD, or death at the time of analysis were censored at the date of the last tumor assessment. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: A\>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. DOR per BICR was based on BICR response assessments.
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Timepoint [9]
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0
Up to approximately 5 years
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Secondary outcome [10]
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Clinical Benefit Rate (CBR) Per RECIST v1.1 Based on Investigator Assessment
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Assessment method [10]
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CBR was defined as the percentage of participants with stable disease (SD) or non-CR or non-PD \>= 6 months or best response of CR or PR according to RECIST v1.1. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: A \>= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CBR was based on investigator assessment.
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Timepoint [10]
0
0
Up to approximately 5 years
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Secondary outcome [11]
0
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Clinical Benefit Rate as Per RECIST v1.1 by BICR
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Assessment method [11]
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CBR was defined as the percentage of participants with SD or non-CR or non-PD \>= 6 months or best response of CR or PR according to RECIST v1.1. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: A \>= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CBR per BICR is based on BICR response assessments.
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Timepoint [11]
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Up to approximately 5 years
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Secondary outcome [12]
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Number of Participants With Treatment Emergent Adverse Events (AEs)
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Assessment method [12]
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An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE was defined as AE that is newly occurred or worsened after the start of study treatment.
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Timepoint [12]
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From start of treatment up to 30 days after the last study treatment (approximately 43 months)
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Eligibility
Key inclusion criteria
*
* Histologically confirmed HER2+ breast carcinoma as determined by a sponsor-designated central laboratory
* History of prior treatment with a taxane and trastuzumab in any setting, separately or in combination
* Have progression of unresectable locally advanced/metastatic breast cancer after last systemic therapy, or be intolerant of last systemic therapy
* Measurable or non-measurable disease assessable by RECIST v1.1
* ECOG performance status score of 0 or 1
* CNS Inclusion - Based on screening contrast brain magnetic resonance imaging (MRI), participants must have at least one of the following:
(a) No evidence of brain metastases
(b) Untreated brain metastases not needing immediate local therapy
(c) Previously treated brain metastases
1. Brain metastases previously treated with local therapy may either be stable since treatment or may have progressed since prior local CNS therapy, provided that there is no clinical indication for immediate re-treatment with local therapy
2. Participants treated with CNS local therapy for newly identified lesions or previously treated and progressing lesions may be eligible to enroll if all of the following criteria are met:
(i) Time since SRS is at least 7 days prior to first dose of study treatment, time since WBRT is at least 14 days prior to first dose, or time since surgical resection is at least 28 days.
(ii) Other sites of evaluable disease are present
3. Relevant records of any CNS treatment must be available to allow for classification of target and non-target lesions
*
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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 tucatinib, afatinib, trastuzumab deruxtecan (DS-8201a), or any other investigational anti-HER2, anti-EGFR, or HER2 TKI agent. Prior treatment with lapatinib or neratinib within 12 months of starting study treatment (except in cases where they were given for =21 days and was discontinued for reasons other than disease progression or severe toxicity). Prior treatment with pyrotinib for recurrent of mBC (except in cases where pyrotinib was given for =21 days and was discontinued for reasons other than disease progression or severe toxicity).
* CNS Exclusion - Based on screening contrast brain magnetic resonance imaging (MRI), participants must not have any of the following:
1. Any untreated brain lesions >2 cm in size
2. Ongoing use of corticosteroids for control of symptoms of brain metastases at a total daily dose of >2 mg of dexamethasone (or equivalent).
3. Any brain lesion thought to require immediate local therapy
4. Known or concurrent leptomeningeal disease as documented by the investigator
5. Poorly controlled generalized or complex partial seizures
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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
2/10/2019
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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
10/03/2029
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Actual
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Sample size
Target
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Accrual to date
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Final
466
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Patricia Ritchie Centre for Cancer Care and Research Mater Hospital Sydney - North Sydney
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Recruitment hospital [2]
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The Crown Princess Mary Cancer Centre, Westmead Hospital - Westmead
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Recruitment hospital [3]
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Austin Health - Heidelberg
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [5]
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The Royal Melbourne Hospital - Parkville
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Recruitment hospital [6]
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Epic Pharmacy Hollywood - Nedlands
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Recruitment hospital [7]
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Hollywood Private Hospital - Nedlands
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Recruitment hospital [8]
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Starcevich Day Clinic, Hollywood Private Hospital - Nedlands
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Recruitment hospital [9]
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Breast Cancer Research Centre - WA - Nedlands
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Recruitment postcode(s) [1]
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2060 - North Sydney
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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3084 - Heidelberg
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Recruitment postcode(s) [4]
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3000 - Melbourne
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Recruitment postcode(s) [5]
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3050 - Parkville
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Recruitment postcode(s) [6]
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6009 - Nedlands
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Recruitment outside Australia
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Illinois
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Edegem
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China
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Tianjin Municipality
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China
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Zhejiang
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Nanning
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Tianjin
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Other
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Denmark
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Herlev
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Denmark
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Vejle
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France
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Besançon
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Brest
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France
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Caen
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France
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Dijon
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France
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Le Mans
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France
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Lyon
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Marseille
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France
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Montélimar
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Paris
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France
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France
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France
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Trévenans
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Germany
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Other
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Germany
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Kiel
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Germany
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Germany
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Israel
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Italy
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Ancona
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Italy
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Emilia-Romagna
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Italy
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Lazio
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Italy
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Ravenna
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Italy
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Rimini
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Italy
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Milan
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Aichi-ken
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Fukuoka
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Valencia
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J0nkoping
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Lausanne
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Cornwall
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United Kingdom
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Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Seagen, a wholly owned subsidiary of Pfizer
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Address
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Ethics approval
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Summary
Brief summary
This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. All patients in the study will get T-DM1, a drug that is often used to treat this cancer. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle.
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Trial website
https://clinicaltrials.gov/study/NCT03975647
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Public notes
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Contacts
Principal investigator
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Pfizer CT.gov Call Center
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Pfizer
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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 protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/47/NCT03975647/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/47/NCT03975647/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03975647
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