A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer

A Randomized, Open-label Study of the Effect of Adjuvant Therapy With Adriamycin Plus Cytoxan Followed by Taxotere or Taxotere Plus Xeloda on Overall Survival in Female Patients With High-risk Breast Cancer

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.

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.