A Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Breast Cancer
NCT00435409
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- Locally advanced or metastatic disease that can be measured. Patients with bone-only disease are also allowed to enter the study.
- Previous treatment with an anthracycline and a taxane in any setting
- Progression on first or second line regimen or adjuvant regimen if disease free interval less than 12 months
- History of inflammatory carcinoma if there is no other measurable disease
- More than 2 chemotherapy agents in the advanced disease setting
- Brain metastases
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Descriptive Information | ||||
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Brief Title ICMJE | A Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Breast Cancer | |||
Official Title ICMJE | A Randomized, Phase 3 Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Previously Treated Breast Cancer | |||
Brief Summary | The treatment received with sunitinib plus capecitabine could delay tumor growth longer than with treatment with capecitabine alone. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Breast Neoplasms | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Crown JP, Diéras V, Staroslawska E, Yardley DA, Bachelot T, Davidson N, Wildiers H, Fasching PA, Capitain O, Ramos M, Greil R, Cognetti F, Fountzilas G, Blasinska-Morawiec M, Liedtke C, Kreienberg R, Miller WH Jr, Tassell V, Huang X, Paolini J, Kern KA, Romieu G. Phase III trial of sunitinib in combination with capecitabine versus capecitabine monotherapy for the treatment of patients with pretreated metastatic breast cancer. J Clin Oncol. 2013 Aug 10;31(23):2870-8. doi: 10.1200/JCO.2012.43.3391. Epub 2013 Jul 15. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 442 | |||
Original Enrollment ICMJE | 430 | |||
Actual Study Completion Date ICMJE | June 2011 | |||
Actual Primary Completion Date | December 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Poland, Romania, Russian Federation, Spain, United Kingdom, United States | |||
Removed Location Countries | Puerto Rico | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00435409 | |||
Other Study ID Numbers ICMJE | A6181099 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | June 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |