A phase II study of epirubicin and cyclophosphamide followed by weekly paclitaxel with or without trastuzumab as primary systemic therapy in locally advanced breast cancer.

Background: The aim of this study was to evaluate the activity and toxicity of epirubicin and cyclophosphamide followed by weekly paclitaxel with or without trastuzumab as primary systemic therapy in locally advanced breast cancer.

Patients And Methods: Patients with T2-4 (>3 cm) or N1-3 breast cancer received epirubicin (100 mg/m(2)) and cyclophosphamide (600 mg/m(2)) every three weeks for four cycles followed by paclitaxel (80 mg/m(2)) every week for twelve cycles. Trastuzumab (initially 4 mg/kg, then 2 mg/kg) was added to paclitaxel in HER2-positive patients. The primary endpoint was the pathological complete response (pCR) rate in the breast and axilla, and secondary endpoints were the breast-conserving rate and toxicity.

Results: Forty-three patients were enrolled into this study and 3 patients withdrew. The pCR rate was 20.0% (95% confidence interval, 10.5-34.8%). Patients with HER2-positive tumours had a significantly higher pCR rate than the others (62.5% vs. 9.4%; p=0.0008). Twenty-four patients (60.0%) underwent breast-conserving surgery. Grade 4 neutropenia was recorded in 30.0% of the patients, and febrile neutropenia occurred in 7 patients (17.5%).

Conclusion: Epirubicin and cyclophosphamide followed by weekly paclitaxel, either with or without trastuzumab, was an active and well-tolerated treatment for locally advanced breast cancer.