Phase 2
Completed N=470
A Study to Assess Capecitabine (Xeloda®) in Patients With Locally Advanced or Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT00077857 ↗Enrolled (actual)
470
Serious AEs
20.2%
Results posted
May 2013
Primary outcomePrimary: Time to Progression of Disease or Death — 7.9; 5.8 Months
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Progression of Disease or Death |
7.9; 5.8 | — |
| SECONDARY Percentage of Participants With Best Overall Response Being Complete Response (CR) or Partial Response (PR) |
45.1; 37.4 | — |
| SECONDARY Time to Overall Response |
25; 30; 48; 30; 20; 17 | — |
| SECONDARY Duration of Overall Response |
6.9; 6.9 | — |
| SECONDARY Time to Treatment Failure |
5.1; 4.6 | — |
| SECONDARY Overall Survival |
16.4; 15.1 | — |
| SECONDARY Number of Participants With Adverse Events and Serious Adverse Events |
206; 234; 41; 53 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00077857). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.