Herceptin and Paclitaxel in Locally Advanced Breast Cancer With Her-2 Overexpression

OBJECTIVES: I. Determine the safety and toxicity of preoperative trastuzumab (Herceptin) and paclitaxel followed by postoperative doxorubicin and cyclophosphamide in women with locally advanced breast cancer with HER2 overexpression. II. Determine tumor response in these patients treated with this regimen. III. Assess the effect of this regimen on tumor histology and the potential molecular determinants of response in these patients.

OUTLINE: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes followed by paclitaxel IV over 60 minutes on day 1. Treatment continues every 7 days for a total of 10 courses in the absence of disease progression or unacceptable toxicity. Patients undergo a modified radical mastectomy or a lumpectomy with axillary node dissection. Beginning 14 days after surgery, patients receive doxorubicin IV and cyclophosphamide IV over 15-30 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses. After completion of chemotherapy, patients with hormone receptor-positive disease receive oral tamoxifen daily for 5 years. Patients are followed at 6 months.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.