Status:
COMPLETED
Study Of Sunitinib With Capecitabine In Breast Cancer
Lead Sponsor:
Pfizer
Conditions:
Advanced/Metastatic Breast Cancer
Eligibility:
FEMALE
20+ years
Phase:
PHASE2
Brief Summary
To evaluate efficacy, safety and pharmacokinetics of sunitinib plus Capecitabine in Japanese patients with advanced/metastatic breast cancer.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00662025
Start Date
April 1 2008
End Date
May 1 2012
Last Update
May 27 2013
Active Locations (17)
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1
Pfizer Investigational Site
Anjo, Aichi-ken, Japan
2
Pfizer Investigational Site
Nagoya, Aichi-ken, Japan
3
Pfizer Investigational Site
Okazaki, Aichi-ken, Japan
4
Pfizer Investigational Site
Toyoake, Aichi-ken, Japan