A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer
Status:
Completed
Trial end date:
2012-05-01
Target enrollment:
Participant gender:
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.