ABSTRACT
Objective Observing the effect of Shuganyishen formula on hormone-dependant metastatic breast cancer and the mechanisms of anti-resistance and endocrine therapy. Methods 226 ITT cases were divided into two cohorts by treatment. 126 cases were treated with the combination of Shuganyishen formula and standard western medicine including endocrine therapy, and 100 cases were treated with western medicine alone. The end points were time to progress (TTP) and overall survival and quality of life (QOF). The effect of Shuganyishen formula on growth of TAM-resistance cell line in vitro was observed. Results There were statistical significances of median TTP between combination and western medicine in Luminal A (ER+ /PR+, HER2-) as well as Luminal B (ER+/PR+, HER2+), but no significances of OS; The extent and incidence of hot flush, sweat and syndromes related to bone were decreased significantly in combination treated group. Shuganyishen formula could reverse resistance to TAM. Conclusion Patients with LuminalA and LuminalB metastatic breast cancer benefit from Shuganyishen formula, which maybe related with its reverse resistance to endocrine therapy.