Phase 3
Completed N=2,611
A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer
Source: ClinicalTrials.gov NCT00089479 ↗Enrolled (actual)
2,611
Serious AEs
17.9%
Results posted
Jun 2011
Primary outcomePrimary: Disease Free Survival [Number of Events] — 164; 140; 1140; 1167 participants
Summary
This 2 arm study will compare the efficacy and safety of Taxotere + Xeloda, versus Taxotere alone, following a regimen of Adriamycin plus Cytoxan in women with high-risk breast cancer. Following 4 cycles of Adriamycin and Cytoxan, patients will be randomized to receive either 1)Taxotere 75mg/m2 iv on day 1 and Xeloda 825mg/m2 po bid on days 1-14 of each 3 week cycle or 2) Taxotere 100mg/m2 iv alone on day 1 of each 3 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Free Survival [Number of Events] |
164; 140; 1140; 1167 | — |
| PRIMARY Disease Free Survival [Time to Event] |
NA; NA | — |
| SECONDARY Overall Survival [Number of Events] |
108; 75; 1196; 1232 | — |
| SECONDARY Overall Survival [Time to Event] |
NA; NA | — |
| SECONDARY Breast Cancer Free Survival [Number of Events] |
158; 144; 1146; 1163 | — |
| SECONDARY Breast Cancer Free Survival [Time to Event] |
NA; NA | — |
| SECONDARY Disease Free Survival Including New Primary Breast Cancer as Event [Number of Events] |
169; 154; 1135; 1153 | — |
| SECONDARY Disease Free Survival Including New Primary Breast Cancer as Event [Time to Event |
NA; NA | — |
| SECONDARY Disease Free Survival Including Any New Cancer as Event [Number of Events] |
200; 177; 1104; 1130 | — |
| SECONDARY Disease Free Survival Including Any New Cancer as Event [Time to Event] |
NA; NA | — |
Eligibility Criteria
Inclusion Criteria
- female patients 18-70 years of age;
- adenocarcinoma of the breast;
- previous invasive breast cancer if diagnosed >5 years before entering study;
- no evidence of metastatic disease.
Exclusion Criteria
- history of severe hypersensitivity reaction to Taxotere;
- previous treatment with anthracycline, anthracenedione (mitoxantrone), or taxane;
- treatment with fluoropyrimidine (5-fluorouracil) within the last 5 years.
Data sourced from ClinicalTrials.gov (NCT00089479). 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.