Neoadjuvant Chemotherapy with Nab-paclitaxel Plus Trastuzumab Followed by 5-Fluorouracil/epirubicin/cyclophosphamide for HER2-positive Operable Breast Cancer: A Multicenter Phase II Trial

Aim: This study was conducted in order to evaluate the efficacy and safety of nanoparticle albuminbound paclitaxel (nab-paclitaxel) plus trastuzumab followed by 5-fluorouracil/epirubicin/cyclophosphamide (FEC) in a neoadjuvant chemotherapy (NAC) setting for patients with human epidermal growth factor receptor 2 (HER2)-positive operable breast cancer. Patients and Methods: Each patient received four cycles of 260 mg/m(2) nab-paclitaxel with 6 mg/kg trastuzumab (8 mg/kg as the loading dose) every 3 weeks (q3w) followed by four cycles of FEC (500/100/500 mg/m(2)) q3w. The primary endpoint was pathological complete response (pCR) rate. Results: Twenty-nine patients were analyzed for the efficacy and safety of this treatment. All patients completed four cycles of nab-paclitaxel and trastuzumab, and 28 patients completed four cycles of FEC. Twenty-seven patients subsequently underwent surgery. The pCR rate was 74.0%. The most frequent toxicity was sensory neuropathy (96.6%), but grade 3 neuropathy rate was 3.4%. Conclusion: Nab-paclitaxel plus trastuzumab followed by FEC in patients with HER2-positive operable breast cancer is considerably effective and well tolerated.