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.
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