e12026 Background: The aim of this study was to evaluate the efficacy and safety of epirubicin/cyclophosphamide (EC) followed by docetaxel as the primary systemic therapy for locally advanced breast cancer. We previously reported pathological and objective response of patients receiving this treatment (Anticancer Res 28:4137-42, 2008). Another follow-up period of 5 years (5y) has since passed, and 5y overall survival (OS) and relapse-free survival (RFS) rates were determined. Methods: The primary endpoints were pathological and objective response in the breast and axilla, and toxicities. The secondary endpoints were the rate of breast-conserving surgery and the 5y OS and RFS rates. Patients with histologically diagnosed invasive breast cancer of T2-4 (>3 cm) or N1-3 were included in this study. The expected rate of pCR was 25%, and the sample size was calculated using the Simon method, with a type I error of 5% and a study power of 80%. The target enrollment was estimated to be 40 evaluable patients. pCR was defined as no evidence of residual invasive cancer, either in the breast or axilla. Patients received E (90 mg/m2) and C (600 mg/m2) every 3 weeks for 4 cycles followed by docetaxel (70 mg/m2) every 3 weeks for 4 cycles. Trastuzumab was not added to the regimen. Results: Forty-six patients were enrolled in this study. pCR were observed in 6 patients and the pCR rate was 13.0% (95% confidence interval, 3.4-22.7%). In particular, patients with HER2 positive tumor had a significantly higher rate of pCR than others (40.0% vs. 5.6%; p=0.0096). Overall, 5y OS was 93.2% and 5y RFS was 72.9%. According to ER, PgR, HER2 status, the following 4 subtypes were classified: luminal (ER and/or PgR+, HER2-; n=28), luminal-HER2 (ER and/or PgR+, HER2+; n=3), HER2 (ER and PgR-, HER2+; n=7) and triple negative (ER, PgR and HER2-; n=8). 5y OS and RFS were 96.4% and 70.6% in luminal type, 100% and 50% in luminal-HER2, 71.4% and 57.1% in HER2, 100% and 100% in triple negative, respectively. Conclusions: EC followed by docetaxel was an effective and well-tolerated treatment, and it is suggested that this treatment provides survival benefit especially for patients with triple-negative breast cancer.