OBJECTIVES:

• Evaluate the feasibility of using cDNA microarray as a measure of a tumor's biological response to neoadjuvant docetaxel and capecitabine followed by surgery and adjuvant doxorubicin and cyclophosphamide by characterizing the cDNA expression patterns before and after chemotherapy in patients with stage II or III breast cancer.
• Determine the toxic effects of this regimen in these patients.
• Determine the clinical and pathologic response rate of patients treated with this regimen.
• Determine the feasibility of obtaining clinical material for exploratory studies using cDNA microarray and proteomic approaches in these patients.

OUTLINE: Patients receive docetaxel IV over 1 hour on day 1 and oral capecitabine twice daily on days 2-15 every 21 days for 4 courses. After surgery, patients receive doxorubicin IV and cyclophosphamide IV over 30 minutes on day 1 every 21 days for 4 courses. Patients who undergo lumpectomy and axillary lymph node dissection receive standard radiotherapy after the completion of chemotherapy. Patients who undergo a modified radical mastectomy may receive chest wall radiation. Patients with estrogen or progesterone receptor-positive disease receive oral tamoxifen daily for 5 years. Post-menopausal patients with a contraindication to tamoxifen may receive anastrozole daily for 5 years. After 2-5 years of tamoxifen therapy, patients may recieve letrozole, exemestane, or anastrazole.

Tumor tissue is collected at baseline, day 2 of course 1 of neoadjuvant chemotherapy, prior to course 2 of neoadjuvant chemotherapy, and at surgery. These samples are subjected to reverse transcriptase polymerase chain reaction, cDNA microarray analysis, and proteomic expression analysis using surface-enhanced laser desorption/ionization-time of flight mass spectrometry in order to evaluate gene expression ratios before and after chemotherapy.

Patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 18-36 patients will be accrued for this study within 18 months.