Status:
COMPLETED
A Study to Assess Capecitabine (Xeloda®) in Patients With Locally Advanced or Metastatic Breast Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This 2 arm study compared the efficacy and safety of label dose of capecitabine (Xeloda®) to that of a lower dose of Xeloda® plus docetaxel (Taxotere®) in patients with locally advanced or metastatic ...
Eligibility Criteria
Inclusion
- women \>=18 years of age;
- \>=1 target lesion;
- locally advanced or metastatic breast cancer;
- demonstrated resistance to anthracycline;
- \>=2 regimens of chemotherapy for advanced/metastatic disease.
Exclusion
- previous treatment with Xeloda, continuous 5-fluorouracil infusion, or other oral fluoropyrimidines;
- previous treatment with paclitaxel or docetaxel for advanced/metastatic disease.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
470 Patients enrolled
Trial Details
Trial ID
NCT00077857
Start Date
July 1 2003
End Date
March 1 2010
Last Update
May 10 2013
Active Locations (94)
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1
Birmingham, Alabama, United States, 35233
2
Hoover, Alabama, United States, 35216
3
Tucson, Arizona, United States, 85715
4
Berkeley, California, United States, 94704