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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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) - Time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occured first.
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) - Time from randomization to first documentation of objective tumor progression.
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) - OR was defined as the number of participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.0) for at least 4 weeks, confirmed by repeat tumor assessments. CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to (>=) 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
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) - Time from the first documentation of OR (CR or PR) that was subsequently confirmed to the first documentation of tumor progression or death due to any cause. CR was defined as disappearance of all target lesions. PR was defined as a >= 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions.
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) - Time from randomization to the first documentation of objective tumor response (CR or PR) that was subsequently confirmed. CR was defined as disappearance of all target lesions. PR was defined as a >= 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions.
Timepoint [4] 0 0
From time of randomization to every 6 weeks thereafter through 22 months
Secondary outcome [5] 0 0
Overall Survival (OS) - Average time from randomization to first documentation of death due to any cause.
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) - EORTC QLQ-C30 scales: functional (physical/role/cognitive/emotional/social), symptom (fatigue/nausea/vomiting/pain), global health/QOL, cancer symptom (dyspnea/insomnia/appetite loss/constipation/diarrhea).
Feelings in past week: response range: not at all to very much, global/QOL range: very poor to excellent. Scales/single-items averaged, score 0 to 100. Higher functional/global=better functioning and symptom=greater degree of symptoms.
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) - BR23: measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much.
Scale score range: 0 to 100. Higher symptom score implied a greater degree of symptoms.
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
Gender
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
Terminated
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 - 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
Country [5] 0 0
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
Country [9] 0 0
Brazil
State/province [9] 0 0
RS
Country [10] 0 0
Brazil
State/province [10] 0 0
SP
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Sofia
Country [12] 0 0
Bulgaria
State/province [12] 0 0
Stara Zagora
Country [13] 0 0
Canada
State/province [13] 0 0
Nova Scotia
Country [14] 0 0
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
State/province [18] 0 0
Cundinamarca
Country [19] 0 0
France
State/province [19] 0 0
Bayonne
Country [20] 0 0
France
State/province [20] 0 0
Besancon
Country [21] 0 0
France
State/province [21] 0 0
Clermont Ferrand
Country [22] 0 0
France
State/province [22] 0 0
Lille
Country [23] 0 0
France
State/province [23] 0 0
Neuilly Sur Seine
Country [24] 0 0
France
State/province [24] 0 0
Nice
Country [25] 0 0
France
State/province [25] 0 0
Rennes Cedex
Country [26] 0 0
Germany
State/province [26] 0 0
Berlin
Country [27] 0 0
Germany
State/province [27] 0 0
Frankfurt
Country [28] 0 0
Germany
State/province [28] 0 0
Freiburg
Country [29] 0 0
Germany
State/province [29] 0 0
Jena
Country [30] 0 0
Germany
State/province [30] 0 0
Kiel
Country [31] 0 0
Germany
State/province [31] 0 0
Leer
Country [32] 0 0
Germany
State/province [32] 0 0
Luebeck
Country [33] 0 0
Germany
State/province [33] 0 0
Magdeburg
Country [34] 0 0
Germany
State/province [34] 0 0
Mainz
Country [35] 0 0
Germany
State/province [35] 0 0
Meiningen
Country [36] 0 0
Germany
State/province [36] 0 0
Muenchen
Country [37] 0 0
Germany
State/province [37] 0 0
Offenburg
Country [38] 0 0
Germany
State/province [38] 0 0
Tuebingen
Country [39] 0 0
Hong Kong
State/province [39] 0 0
Hong Kong
Country [40] 0 0
Hong Kong
State/province [40] 0 0
Kowloon
Country [41] 0 0
Hong Kong
State/province [41] 0 0
Tuen Mun
Country [42] 0 0
Hong Kong
State/province [42] 0 0
Wan Chai,
Country [43] 0 0
India
State/province [43] 0 0
Gujarat
Country [44] 0 0
India
State/province [44] 0 0
Karnataka
Country [45] 0 0
India
State/province [45] 0 0
Punjab
Country [46] 0 0
India
State/province [46] 0 0
Rajasthan
Country [47] 0 0
India
State/province [47] 0 0
Uttar Pradesh
Country [48] 0 0
Italy
State/province [48] 0 0
Firenze
Country [49] 0 0
Italy
State/province [49] 0 0
Milano
Country [50] 0 0
Italy
State/province [50] 0 0
Napoli
Country [51] 0 0
Italy
State/province [51] 0 0
Reggio Emilia
Country [52] 0 0
Japan
State/province [52] 0 0
Aichi
Country [53] 0 0
Japan
State/province [53] 0 0
Ehime
Country [54] 0 0
Japan
State/province [54] 0 0
Fukuoka
Country [55] 0 0
Japan
State/province [55] 0 0
Osaka
Country [56] 0 0
Japan
State/province [56] 0 0
Saitama
Country [57] 0 0
Japan
State/province [57] 0 0
Tokyo
Country [58] 0 0
Korea, Republic of
State/province [58] 0 0
Gyeonggi-do
Country [59] 0 0
Korea, Republic of
State/province [59] 0 0
Daegu
Country [60] 0 0
Korea, Republic of
State/province [60] 0 0
Incheon
Country [61] 0 0
Korea, Republic of
State/province [61] 0 0
Pusan
Country [62] 0 0
Korea, Republic of
State/province [62] 0 0
Seoul
Country [63] 0 0
Mexico
State/province [63] 0 0
DF
Country [64] 0 0
Mexico
State/province [64] 0 0
Estado de Mexico
Country [65] 0 0
Mexico
State/province [65] 0 0
Guerrero
Country [66] 0 0
Mexico
State/province [66] 0 0
Michoacan
Country [67] 0 0
Mexico
State/province [67] 0 0
Sonora
Country [68] 0 0
Mexico
State/province [68] 0 0
Chihuahua
Country [69] 0 0
Mexico
State/province [69] 0 0
Puebla
Country [70] 0 0
Peru
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Lima
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Philippines
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Quezon City
Country [72] 0 0
Philippines
State/province [72] 0 0
San Juan City
Country [73] 0 0
Singapore
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Singapore
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South Africa
State/province [74] 0 0
Parktown
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South Africa
State/province [75] 0 0
Sandton
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Spain
State/province [76] 0 0
Barcelona
Country [77] 0 0
Spain
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Cantabria
Country [78] 0 0
Spain
State/province [78] 0 0
Madrid
Country [79] 0 0
Spain
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Vizcaya
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Spain
State/province [80] 0 0
Cordoba
Country [81] 0 0
Spain
State/province [81] 0 0
Gerona
Country [82] 0 0
Spain
State/province [82] 0 0
Jaen
Country [83] 0 0
Spain
State/province [83] 0 0
La Coruña
Country [84] 0 0
Spain
State/province [84] 0 0
Las Palmas de Gran Canaria
Country [85] 0 0
Spain
State/province [85] 0 0
Malaga
Country [86] 0 0
Spain
State/province [86] 0 0
Salamanca
Country [87] 0 0
Taiwan
State/province [87] 0 0
Changhua
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Taiwan
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Kaohsiung
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Taiwan
State/province [89] 0 0
Tainan
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Taiwan
State/province [90] 0 0
Taipei
Country [91] 0 0
Taiwan
State/province [91] 0 0
Taoyuan
Country [92] 0 0
Turkey
State/province [92] 0 0
Ankara
Country [93] 0 0
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
State/province [95] 0 0
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/show/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/show/NCT00373113