At a glance
ClinicalIndex Comparison Record- ✓Women aged 18 years or older
- ✓At least one measurable target lesion
- ✓Locally advanced or metastatic breast cancer
- ✓Documented resistance to anthracycline therapy
- ✕Prior treatment with capecitabine (Xeloda), continuous 5-fluorouracil infusion, or other oral fluoropyrimidines
- ✕Prior paclitaxel or docetaxel for advanced or metastatic disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Open-label Study of the Effect of Different Dosing Regimens of Xeloda® in Combination With Taxotere® on Disease Progression in Patients With Locally Advanced and/or Metastatic Breast Cancer
In Brief
A Phase 2 clinical trial evaluating capecitabine (Xeloda®) and docetaxel (Taxotere®) for Breast Cancer. Completed, enrolled 470 participants across 94 sites in 9 countries.
Detailed 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.
Study Details
Timeline
Interventions
825 mg/m\^2 or 1250 mg/m2 orally twice a day on days 1 to 14 of each 3 week cycle.
75 mg/m\^2 intravenous on day 1 of each 3 week cycle