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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00373113




Registration number
NCT00373113
Ethics application status
Date submitted
5/09/2006
Date registered
7/09/2006
Date last updated
25/06/2012

Titles & IDs
Public title
A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine
Scientific title
Phase III Randomized, Multi Center Study Of Sunitinib Malate (SU 011248) Or Capecitabine In Subjects With Advanced Breast Cancer Who Failed Both A Taxane And An Anthracycline Chemotherapy Regimen Or Failed With A Taxane And For Whom Further Anthracycline Therapy Is Not Indicated
Secondary ID [1] 0 0
A6181107
Universal Trial Number (UTN)
Trial acronym
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 - Capecitabine
Treatment: Drugs - Sunitinib malate

Active comparator: A - 1250 mg/m\^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles

Experimental: B - 37.5 mg daily, continuous dosing


Treatment: Drugs: Capecitabine
1250 mg/m\^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles

Treatment: Drugs: Sunitinib malate
37.5 mg daily, continuous dosing
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
From time of randomization to every 6 weeks thereafter through 22 months or until death
Secondary outcome [1] 0 0
Time to Tumor Progression (TTP)
Timepoint [1] 0 0
From time of randomization to every 6 weeks thereafter through 22 months
Secondary outcome [2] 0 0
Number of Participants With Overall Response (OR)
Timepoint [2] 0 0
From time of randomization to every 6 weeks thereafter through 22 months
Secondary outcome [3] 0 0
Duration of Response (DR)
Timepoint [3] 0 0
From time of randomization to every 6 weeks thereafter through 22 months or death
Secondary outcome [4] 0 0
Time to Tumor Response (TTR)
Timepoint [4] 0 0
From time of randomization to every 6 weeks thereafter through 22 months
Secondary outcome [5] 0 0
Overall Survival (OS)
Timepoint [5] 0 0
From time of randomization until death
Secondary outcome [6] 0 0
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)
Timepoint [6] 0 0
From Day 1 of Cycle 1, then odd numbered cycles thereafter
Secondary outcome [7] 0 0
EORTC QLQ Breast Cancer Module (BR23)
Timepoint [7] 0 0
From Day 1 of Cycle 1, then odd numbered cycles thereafter

Eligibility
Key inclusion criteria
* breast adenocarcinoma
* prior treatment with an anthracycline and a taxane either concurrently or sequentially in the neoadjuvant, adjuvant and or/ advanced disease treatment settings. No more than 1 chemotherapy regimen in the advanced setting
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior treatment with regimens of chemotherapy in the advanced/metastatic disease setting beyond those containing anthracyclines and taxanes or multiple anthracyclines/ taxanes treatments.
* Any prior regimen with capecitabine

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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2011
Sample size
Target
Accrual to date
Final
482
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Darlinghurst
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Herston
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Adelaide
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Heidelberg
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Parkville
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment postcode(s) [6] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Prov. de Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Rio Negro
Country [3] 0 0
Argentina
State/province [3] 0 0
Santa Fé
Country [4] 0 0
Argentina
State/province [4] 0 0
Buenos Aires
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Argentina
State/province [5] 0 0
Cordoba
Country [6] 0 0
Argentina
State/province [6] 0 0
Tucuman
Country [7] 0 0
Brazil
State/province [7] 0 0
PR
Country [8] 0 0
Brazil
State/province [8] 0 0
RJ
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Brazil
State/province [9] 0 0
RS
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Brazil
State/province [10] 0 0
SP
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Bulgaria
State/province [11] 0 0
Sofia
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Bulgaria
State/province [12] 0 0
Stara Zagora
Country [13] 0 0
Canada
State/province [13] 0 0
Nova Scotia
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Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
Chile
State/province [16] 0 0
IX Región
Country [17] 0 0
Colombia
State/province [17] 0 0
Antioquia
Country [18] 0 0
Colombia
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Cundinamarca
Country [19] 0 0
France
State/province [19] 0 0
Bayonne
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France
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Besancon
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France
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Clermont Ferrand
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France
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Lille
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France
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Neuilly Sur Seine
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France
State/province [24] 0 0
Nice
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France
State/province [25] 0 0
Rennes Cedex
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Germany
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Berlin
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Germany
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Frankfurt
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Germany
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Freiburg
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Germany
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Jena
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Germany
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Kiel
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Germany
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Leer
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Germany
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Luebeck
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Germany
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Magdeburg
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Germany
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Mainz
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Germany
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Meiningen
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Germany
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Muenchen
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Germany
State/province [37] 0 0
Offenburg
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Germany
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Tuebingen
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Hong Kong
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Hong Kong
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Hong Kong
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Kowloon
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Hong Kong
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Tuen Mun
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Hong Kong
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Wan Chai,
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India
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Gujarat
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India
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Karnataka
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India
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Punjab
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India
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Rajasthan
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India
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Uttar Pradesh
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Italy
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Firenze
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Italy
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Milano
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Italy
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Napoli
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Italy
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Reggio Emilia
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Japan
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Aichi
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Japan
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Ehime
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Japan
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Fukuoka
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Osaka
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Japan
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Saitama
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Japan
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Tokyo
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Korea, Republic of
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Gyeonggi-do
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Daegu
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Incheon
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Pusan
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Korea, Republic of
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Seoul
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DF
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Mexico
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Estado de Mexico
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Mexico
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Guerrero
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Michoacan
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Sonora
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Chihuahua
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Puebla
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Lima
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Quezon City
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Philippines
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San Juan City
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Singapore
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Singapore
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South Africa
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Parktown
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South Africa
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Sandton
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Spain
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Barcelona
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Spain
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Cantabria
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Spain
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Madrid
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Spain
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Vizcaya
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Spain
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Cordoba
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Spain
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Gerona
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Jaen
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La Coruña
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Las Palmas de Gran Canaria
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Malaga
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Spain
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Salamanca
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Taiwan
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Changhua
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Kaohsiung
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Tainan
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Taipei
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Taiwan
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Taoyuan
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Turkey
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Ankara
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Turkey
State/province [93] 0 0
Istanbul
Country [94] 0 0
United Kingdom
State/province [94] 0 0
South Wales
Country [95] 0 0
United Kingdom
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London
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Nottingham
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Somerset

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

Ethics approval
Ethics application status

Summary
Brief summary
To compare efficacy and safety of Sunitinib and Capecitabine in subjects with advanced breast cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for whom further anthracycline therapy is not indicated
Trial website
https://clinicaltrials.gov/study/NCT00373113
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00373113