To investigate clinical effect of Fukangling(health-restoring and detoxin Chinese medical compound ) in combination with a new chemotherapy on breast cancer.Methods:In a 3-cycle trial, patients in phase Ⅱ～Ⅲ were randomized to 2 regimen: Fukangling+ CTF, CTF. At the end of study, efficacy as well as expression of P-gp and GST-πwere observed using immunohistochemistry methods.Results:treatment group: complete remission rate=12.1%, total remission rate=72.7% vs. control group: complete remission rate=0%, total remission rate=45%(P<0.05)；After addition of new chemotherapy, P-gp and GST-πpositive rate raised (P<0.05)；P-gp positive rates were 12.1% vs. 40.0% (P<0.05); GST-πpositive rates were 36.4% vs. 55.0% (P>0.05).Conclusion:The new chemotherapy can shrink tumor, lower clinical severity grade and facilitate operation. When Fukangling adds on to the chemo, partial gene expression was reversed to achieve higher efficacy and lower grade adverse reaction.