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.
Primary Purpose: Treatment
Matthew D. Volm, MD
New York University School of Medicine
United States: Federal Government
|NYU School of Medicine's Kaplan Comprehensive Cancer Center||New York, New York 10016|