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+
- 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.
- 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.