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: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Capecitabine; Docetaxel

Criteria

Inclusion Criteria:

• 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 Criteria:

• previous treatment with Xeloda, continuous 5-fluorouracil infusion, or other oral fluoropyrimidines;

• previous treatment with paclitaxel or docetaxel for advanced/metastatic disease.