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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00393939
Registration number
NCT00393939
Ethics application status
Date submitted
30/10/2006
Date registered
31/10/2006
Date last updated
19/07/2012
Titles & IDs
Public title
Study Of Sunitinib In Combination With Docetaxel Vs Docetaxel In Patients With Advanced Breast Cancer
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Scientific title
A Randomized Phase 3 Study Of Docetaxel In Combination With Sunitinib Versus Docetaxel In The First-Line Treatment Of Advanced Breast Cancer Patients
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Secondary ID [1]
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A6181064
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Universal Trial Number (UTN)
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Trial acronym
SUN 1064
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms
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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 - Sunitinib malate
Treatment: Drugs - Taxotere
Experimental: A -
Active Comparator: B -
Treatment: Drugs: Sunitinib malate
Sunitinib 37.5 mg daily by oral capsule in schedule 2/1 with Docetaxel 75 mg/m2 every 3 weeks or 37. 5 mg daily in continuous dosing (in absence of docetaxel)
Treatment: Drugs: Taxotere
Docetaxel 100 mg/m2 every 3 weeks in the comparator arm
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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)
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Assessment method [1]
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PFS defined as time from date of randomization to date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS calculated as (Months) = (first event date minus randomization date plus 1) divided by 30.4.
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Timepoint [1]
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Baseline up to Month 33
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Secondary outcome [1]
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Percentage of Participants With Objective Response
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Assessment method [1]
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Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all tumor lesions (target and non-target). PR defined as greater than or equal to 30 percent (=30%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions with a non-progressive disease status of the non-target lesions.
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Timepoint [1]
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Baseline up to Month 33
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Secondary outcome [2]
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Duration of Response (DR)
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Assessment method [2]
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DR defined as time from first objective documentation of complete or partial response that was subsequently confirmed to first documentation of disease progression or to death due to any cause, whichever occurred first. DR calculated (Months) = (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4.
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Timepoint [2]
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0
Baseline up to Month 33
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Secondary outcome [3]
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Overall Survival (OS)
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Assessment method [3]
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Time from randomization to date of death due to any cause. OS calculated as (Months) = (death date minus date of first dose of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored at last contact.
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Timepoint [3]
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Baseline to date of death from any cause (up to Month 33)
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Secondary outcome [4]
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Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score
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Assessment method [4]
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EORTC QLQ-C30 measured 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnoea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. For functional domains and global health status, scores ranged from 0 to 100 where higher scores represented a better level of functioning. For symptoms scales, scores ranged from 0 to 100 where higher scores represented a greater degree of symptoms. Change from baseline = score for Cycle/Day minus baseline score.
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Timepoint [4]
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Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)
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Secondary outcome [5]
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Change From Baseline in EORTC-QLQ Breast Cancer Module (EORTC-QLQ-BR23) Score
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Assessment method [5]
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EORTC-QLQ-BR23 measured multi-item functional scales for body image, sexual functioning, sexual enjoyment, and future perspective and measured single item symptoms scales which assessed systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss. For functional scales, scores ranged from 0 to 100 where higher scores represented a better level of functioning. For symptoms scales, scores ranged from 0 to 100 where higher scores represented a greater degree of symptoms. Change from baseline = score for Cycle/Day minus baseline score.
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Timepoint [5]
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Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)
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Secondary outcome [6]
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Change From Baseline European Quality of Life 5-dimensional Self-Report Questionnaire (EQ-5D) Score
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Assessment method [6]
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EQ-5D: standardized, participant-administered 2 part measure of health outcome. Part 1: descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), used 3 levels (no, some, extreme problems) and a single index value characterized current health status using formula that weighted the dimensions. Part 2: overall rating of participant's current health used Visual Analog Scale with endpoints labeled 'best imaginable health state' and 'worst imaginable health state'. Change from baseline = score for Cycle/Day minus baseline score.
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Timepoint [6]
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Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)
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Eligibility
Key inclusion criteria
- Breast cancer with evidence of unresectable locally recurrent, or metastatic disease
- Her-2 negative tumors
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Patients for whom docetaxel is contraindicated
- Clinical presentation of inflammatory carcinoma with no other measurable disease
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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
Open (masking not used)
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Who is / are masked / blinded?
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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
Completed
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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
1/02/2007
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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
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Actual
1/07/2011
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Sample size
Target
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Accrual to date
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Final
594
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Pfizer Investigational Site - Tweed Heads
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Pfizer Investigational Site - Redcliffe
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Pfizer Investigational Site - Ringwood East
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Pfizer Investigational Site - Perth
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2485 - Tweed Heads
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4020 - Redcliffe
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5000 - Adelaide
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3186 - Brighton
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3144 - Malvern
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3135 - Ringwood East
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6000 - Perth
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London
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United Kingdom
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of sunitinib
combined with docetaxel versus docetaxel, administered as first-line treatment, in patients
with unresectable locally recurrent or metastatic breast cancer.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00393939
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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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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00393939
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