Final results from phase II trial of neoadjuvant docetaxel and capecitabine given sequentially or concurrently for...

The combination of docetaxel and capecitabine has been demonstrated to improve progression-free survival (PFS) and overall survival (OS) in patients with metastatic breast cancer compared with docetaxel alone. We hypothesized that the combination of docetaxel and capecitabine, given concomitantly or sequentially, would present a nonanthracycline-based treatment option for patients with early stage and locally advanced breast cancer.

Patients with stage I to stage IIIC, human epidermal growth factor receptor 2-negative (HER2(-)) breast cancer were randomly assigned to receive either docetaxel followed by capecitabine (D → C) or docetaxel administered concomitantly with capecitabine (DC).

Between April 2007 and July 2009, 51 patients were accrued to the trial at an academic center, a county hospital, and community sites. Median tumor size was 3.8 cm and > 70% of patients had axillary lymph node involvement. Fifty-seven percent of patients accrued were African American. Twenty-one of the 51 subjects had triple-negative breast cancer. The pathologic complete response (pCR) rate was 8% in the D → C arm; 12% in the DC arm. The pCR rate among patients with triple-negative breast cancer was 19%.

The combination of docetaxel and capecitabine has modest activity in the neoadjuvant setting. These results are consistent with other trials using this combination in the neoadjuvant setting.