A Phase II Trial of Xeloda, Every Three Week Taxol and Herceptin in Metastatic Breast Cancer

OBJECTIVES: I. Determine the maximum tolerated dose of capecitabine when administered in combination with paclitaxel and trastuzumab (Herceptin) in patients with metastatic breast cancer. II. Determine the response rate of these patients to this treatment regimen. III. Determine the median time to treatment failure in these patients with this treatment regimen. IV. Determine the incidence of cardiac toxicity in these patients with this treatment regimen. V. Assess the quality of life in these patients.

OUTLINE: This is a dose escalation study of capecitabine. Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, and 15; paclitaxel IV over 3 hours on day 2; and oral capecitabine on days 3-16. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Once the MTD is determined, additional patients are accrued. Quality of life is assessed at baseline and after 3 courses of treatment.

PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for the phase I dose escalation portion of this study. A total of 28-41 patients will be accrued for the phase II portion of this study.