A phase II tolerability trial of neoadjuvant docetaxel with carboplatin and capecitabine in locally advanced breast cancer

This multicenter phase II trial evaluated the tolerability and efficacy of neoadjuvant chemotherapy in locally advanced breast cancer with four 28-day cycles of dose-dense chemotherapy: weekly docetaxel (30 mg/m²) and carboplatin (AUC 2) on days 1, 8, and 15, plus capecitabine (625 mg/m²) twice daily on days 5-18. The primary endpoint was pathologic complete response (pCR). Among the 49 treated patients, 89% of intended chemotherapy doses (including capecitabine) were administered. In the intent-to-treat patients, grade 4 toxicities were depression (2%) and leukopenia (8%). There were no neutropenic fevers or treatment-related deaths. Of the 41 evaluable patients who received all four chemotherapy cycles, 6 (15%) achieved a pCR; all of them had negative axillary nodes. None of the patients with pCR had developed recurrent disease at a median follow-up of 48 months. We conclude that preoperative docetaxel, carboplatin, and capecitabine has an acceptable toxicity profile and a pCR rate comparable with that seen in many other phase II neoadjuvant chemothera.