Breast Cancer Clinical Trial
Official title:
Herceptin and Paclitaxel in Locally Advanced Breast Cancer With Her-2 Overexpression
RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill
them or deliver tumor-killing substances to them without harming normal cells. Drugs used in
chemotherapy use different ways to stop tumor cells from dividing so they stop growing or
die. Combining monoclonal antibody therapy with combination chemotherapy may be an effective
treatment for locally advanced breast cancer.
PURPOSE: Phase I trial to study the effectiveness of trastuzumab plus paclitaxel followed by
surgery and combination chemotherapy in treating women who have locally advanced breast
cancer.
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
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