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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00393939




Trial ID
NCT00393939
Ethics application status
Date submitted
30/10/2006
Date registered
30/10/2006
Date last updated
13/07/2012

Titles & IDs
Public title
Study Of Sunitinib In Combination With Docetaxel Vs Docetaxel In Patients With Advanced Breast Cancer
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
Secondary ID [1] 0 0
A6181064
Universal Trial Number (UTN)
Trial acronym
SUN 1064
Linked study record

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

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) - 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.
Timepoint [1] 0 0
Baseline up to Month 33
Secondary outcome [1] 0 0
Percentage of Participants With Objective Response - 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.
Timepoint [1] 0 0
Baseline up to Month 33
Secondary outcome [2] 0 0
Duration of Response (DR) - 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.
Timepoint [2] 0 0
Baseline up to Month 33
Secondary outcome [3] 0 0
Overall Survival (OS) - 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.
Timepoint [3] 0 0
Baseline to date of death from any cause (up to Month 33)
Secondary outcome [4] 0 0
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score - 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.
Timepoint [4] 0 0
Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)
Secondary outcome [5] 0 0
Change From Baseline in EORTC-QLQ Breast Cancer Module (EORTC-QLQ-BR23) Score - 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.
Timepoint [5] 0 0
Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)
Secondary outcome [6] 0 0
Change From Baseline European Quality of Life 5-dimensional Self-Report Questionnaire (EQ-5D) Score - 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.
Timepoint [6] 0 0
Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)

Eligibility
Key inclusion criteria
- Breast cancer with evidence of unresectable locally recurrent, or metastatic disease

- Her-2 negative tumors
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients for whom docetaxel is contraindicated

- Clinical presentation of inflammatory carcinoma with no other measurable disease

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Tweed Heads
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Redcliffe
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Adelaide
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Brighton
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Malvern
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Ringwood East
Recruitment hospital [7] 0 0
Pfizer Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [2] 0 0
4020 - Redcliffe
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3186 - Brighton
Recruitment postcode(s) [5] 0 0
3144 - Malvern
Recruitment postcode(s) [6] 0 0
3135 - Ringwood East
Recruitment postcode(s) [7] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
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California
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United States of America
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Louisiana
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United States of America
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Texas
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Argentina
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Buenos Aires
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Argentina
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Burnos Aires
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Austria
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Salzburg
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Austria
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Wien
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Belgium
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Brasschaat
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Belgium
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Bruxelles
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Belgium
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Verviers
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Canada
State/province [11] 0 0
British Columbia
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Canada
State/province [12] 0 0
Ontario
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Colombia
State/province [13] 0 0
Cundinamarca
Country [14] 0 0
Colombia
State/province [14] 0 0
Risaralda
Country [15] 0 0
Colombia
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Valle del Cauca
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Czech Republic
State/province [16] 0 0
Brno
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Czech Republic
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Novy Jicin
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Czech Republic
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Praha 5
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Czech Republic
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Praha 8
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Finland
State/province [20] 0 0
Tampere
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Finland
State/province [21] 0 0
Turku
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France
State/province [22] 0 0
Bordeaux CEDEX
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France
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Dijon
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France
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NANTES Cedex 2
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France
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Reims
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France
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Saint Cloud
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France
State/province [27] 0 0
Saint-Priest-en-Jarez Cedex
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France
State/province [28] 0 0
Strasbourg
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France
State/province [29] 0 0
Tours
Country [30] 0 0
France
State/province [30] 0 0
Villejuif
Country [31] 0 0
Germany
State/province [31] 0 0
Berlin
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Germany
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Chemnitz
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Germany
State/province [33] 0 0
Essen
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Germany
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Hildesheim
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Germany
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Karlsruhe
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Germany
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Leverkusen
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Germany
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Magdeburg
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Germany
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Marburg
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Germany
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Oldenburg
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Germany
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Ravensburg
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Germany
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Rosenheim
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Germany
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Wuerzburg
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Hungary
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Budapest
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Hungary
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Kaposvar
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Hungary
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Szentes
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Ireland
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Dublin
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Ireland
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Galway
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Catania
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Italy
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Cattolica (RN)
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Italy
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Cefalu' (PA)
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Italy
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Chieti Scalo
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Italy
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Lecce
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Italy
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Livorno
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Italy
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Macerata
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Italy
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Napoli
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Italy
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Palermo
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Italy
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Pavia
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Italy
State/province [58] 0 0
Rimini
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Italy
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Roma
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Seoul
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Netherlands
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Nijmegen
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Netherlands
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Utrecht
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Netherlands
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Venlo
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Panama
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Panama
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Poland
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Gdansk
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Poland
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Lubin
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Poland
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Poznan
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Poland
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Rybnik
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Warszawa
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Portugal
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Coimbra
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Portugal
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Lisboa
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Portugal
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Porto
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Portugal
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Santa Maria da Feira
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Cluj
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Romania
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Dolj
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Sector 2
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Leningrad region
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Russian Federation
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Moscow
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Saint Petersburg
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Russian Federation
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St. Petersburg
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Banska Bystrica
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Slovakia
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Bratislava
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Nitra
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Baleares
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Barcelona
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Santa Cruz de Tenerife
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Toledo
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Spain
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Valencia
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Zaragoza
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Sweden
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Helsingborg
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Sweden
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Karlstad
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Stockholm
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Ankara
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Gaziantep
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Istanbul
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Ukraine
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Dnipropetrovsk
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Ukraine
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Donetsk
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kyiv
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Ukraine
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Lviv
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Kent
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M20 4bx
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Merseyside
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Shropshire
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Surrey
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West Sussex
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London
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United Kingdom
State/province [114] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00393939
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries