Randomized study of tailored neoadjuvant chemotherapy according to the expression of tau, topo II α, and ERCC1 versus standard chemotherapy in HER2-negative breast cancer.

Abstract

1025 Background: We hypothesized that selecting chemotherapy (CT) agents according to the expressions of drug sensitivity predictive biomarkers from tumor sample may improve the treatment efficacy for breast cancer (BC). Methods: Patients (pts) with stage II/III HER2 negative BC were eligible. Tumor biopsy samples were tested with immunohistochemistry study for the expression of tau, topo II α, and ERCC1. Four cycles of neoadjuvant CT were given after randomization, followed by operation. For control arm, Docetaxel (T)/ epirubicin (E) was given. For tailored arm, 1 of the 7 different CT regimens that containing 2 drugs among T, E, cisplatin, vinorelbine, and weekly high dose 5FU/leucovorin were given according to the expression of tumor biomarkers. After operation, 2-4 cycles of adjuvant CT were given and the choice of regimens were at investigators discretion. The primary endpoint was the primary tumor (T) pathological complete response (pCR) rate, and 268 pts were planned to be recruited. In the pre-pla...