Comparison of four cycles epirubicin and cyclophosphamide (EC) followed by four cycles docetaxel (T) versus six cycles docetaxel and carboplatin (TP) as adjuvant chemotherapy for women with operable triple negative breast cancer.

Abstract

1068Background: To determine optimal adjuvant chemotherapy for early triple negative breast cancer depends on efficacy and toxicity. We sought to examine if six cycles TP is non-inferior to standard four cylces EC followed by four cycles T but with shorter treatment duration and reduced toxicity. Methods: Pts with operable triple negative breast cancer were enrolled and randomized (1:1) to receive either six cycles TP (docetaxel:75 mg/m2; carboplatin: AUC = 5, day 1) or four cycles EC(epirubicin: 90 mg/m2; cyclophosphamide :600mg/m2 , day 1) followed by four cycles T (docetaxel : 100mg/m2 , day 1). Both regimens were repeated every three weeks. Randomization was stratified by lymph node status. The primary end point was median DFS. A sample size of 500 patients were required to detect the difference (a = 0.05, β = 80%). Results: From June 2010 to Jan 2015, 298 pts were enrolled in the study including 152 pts in EC-T arm and 146 pts in ET arm. Patients’ characteristics were well balanced between two arms. ...