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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
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)
Timepoint [1] 0 0
Baseline up to Month 33
Secondary outcome [1] 0 0
Percentage of Participants With Objective Response
Timepoint [1] 0 0
Baseline up to Month 33
Secondary outcome [2] 0 0
Duration of Response (DR)
Timepoint [2] 0 0
Baseline up to Month 33
Secondary outcome [3] 0 0
Overall Survival (OS)
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
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
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
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
Sex
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
1/02/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2011
Sample size
Target
Accrual to date
Final
594
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
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
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
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Ontario
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Colombia
State/province [13] 0 0
Cundinamarca
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Colombia
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Risaralda
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Colombia
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Valle del Cauca
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Czech Republic
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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
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Tampere
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Finland
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Turku
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France
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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
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Saint-Priest-en-Jarez Cedex
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France
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Strasbourg
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France
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Tours
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France
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Villejuif
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Germany
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Berlin
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Germany
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Chemnitz
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Germany
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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
State/province [41] 0 0
Rosenheim
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Germany
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Wuerzburg
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Hungary
State/province [43] 0 0
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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Italy
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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
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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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Seoul
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Netherlands
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Nijmegen
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Utrecht
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Venlo
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Panama
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Poland
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Gdansk
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Lubin
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Poznan
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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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Romania
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Cluj
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Romania
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Dolj
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Romania
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Sector 2
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Russian Federation
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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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Slovakia
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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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Madrid
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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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Sweden
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Stockholm
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Sweden
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Uppsala
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Turkey
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Ankara
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Gaziantep
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Turkey
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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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United Kingdom
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Gloucestershire
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United Kingdom
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Kent
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United Kingdom
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M20 4bx
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United Kingdom
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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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United Kingdom
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London
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United Kingdom
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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/ct2/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