A Study to Assess Capecitabine (Xeloda®) in Patients With Locally Advanced or Metastatic Breast Cancer
Status:
Completed
Trial end date:
2010-03-01
Target enrollment:
Participant gender:
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 breast cancer after failure of chemotherapy with an anthracycline. Patients
were randomized to receive either 1250 mg/m^2 or 825 mg/m^2 orally twice a day (po bid) on
days 1-14 of each 3 week cycle, in combination with Taxotere® 75 mg/m2 intravenous (iv) on
day 1 of each 3 week cycle. The anticipated time on study treatment was until disease
progression and the target sample size was 440 individuals.