Neoadjuvant chemotherapy (NAC) with
anthracyclines followed by
taxane chemotherapy has become the standard treatment for patients with locally advanced, operable
breast cancer. Recently, the efficacy of nanoparticle
albumin-bound paclitaxel (nab-PTX) for metastatic
breast cancer was reported. However, there are still few studies of a neoadjuvant regimen including nab-PTX. Thus, the present phase II study evaluated the efficacy and safety of
5-fluorouracil,
epirubicin and
cyclophosphamide (FEC regimen) followed by nab-PTX as
neoadjuvant treatment for operable
human epidermal growth factor receptor 2 (HER2)-negative
breast cancer. Women with operable HER2-negative
breast cancer (clinical stage T1a-4N1-3) received 4 cycles of FEC (
5-fluorouracil 500 mg/m2,
epirubicin 100 mg/m2 and
cyclophosphamide 500 mg/m2 every 21 days), followed by 4 cycles of nab-PTX at 260 mg/m2 every 21 days. The patients then underwent
mastectomy or
breast-conserving surgery (BCS). The primary endpoint was pathological complete response (pCR) rate. The secondary endpoints included clinical response rate, pathological response rate, BCS rate and safety. A total of 16 patients were evaluated and 3 patients (18%) achieved pCR (1 patient with
estrogen receptor-positive
cancer and 2 with
estrogen receptor-negative
cancer). The pCR rate was 12 and 25% in patients with
estrogen receptor-positive and -negative
cancers, respectively. The clinical response rate was 100% (clinical complete and partial response in 6 and 10 patients, respectively). The BCS rate was 31.25%. Three patients experienced grade 3
neutropenia during FEC
therapy, and no grade 3/4 events occurred during nab-PTX
therapy. Thus,
neoadjuvant therapy with FEC followed by nab-PTX for operable HER2-negative
breast cancer was found to be a safe and effective option.