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- Histologically- or cytologically-proven diagnosis of breast adenocarcinoma that is not amenable to surgery, radiation, or combined modality therapy with curative intent
- Measurable disease as per RECIST. Measurable lesions that have been previously irradiated will not be considered target lesions unless increase in size has been observed following completion of radiation therapy.
- Prior treatment with an anthracycline and a taxane in the neoadjuvant, adjuvant or metastatic disease settings.
- Histology of inflammatory carcinoma with no other measurable disease. Patients with
histology of inflammatory carcinoma are allowed on study if they have measurable
disease.
- Brain metastases, spinal cord compression, or carcinomatous meningitis, or
leptomeningeal disease.
- Prior treatment with 5-fluorouracil (5-FU) and 5-FU derivatives such as Furtulon
(5'-DFUR), Futraful/ Sunfural (tegafur), UFT/UFT-E (tegafur/uracil), TS-1
(tegafur/gimeracil/oteracil) or Mifurol (carmofur) in metastatic disease setting
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Descriptive Information | ||||
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Brief Title ICMJE | Study Of Sunitinib With Capecitabine In Breast Cancer | |||
Official Title ICMJE | A Phase II Study Of Sunitinib Malate In Combination With Capecitabine In Patients With Advanced Or Metastatic Breast Cancer | |||
Brief Summary | To evaluate efficacy, safety and pharmacokinetics of sunitinib plus Capecitabine in Japanese patients with advanced/metastatic breast cancer. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Advanced/Metastatic Breast Cancer | |||
Intervention ICMJE |
| |||
Study Arms ICMJE | Experimental: 1
Interventions:
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Publications * | Not Provided | |||
* 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 | 63 | |||
Original Estimated Enrollment ICMJE | 62 | |||
Actual Study Completion Date ICMJE | May 2012 | |||
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 |
| |||
Ages ICMJE | 20 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 | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00662025 | |||
Other Study ID Numbers ICMJE | A6181163 | |||
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 | May 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |