Abstract:[Objectives ] To observe the efficacy and safety of fulvestrant plus exemestane in the treatment of hormone receptor-positive recurrent or metastatic breast cancer progressing on prior nonsteroidal aromatase inhibitors (NSAIs). [Methods] 2014.10.10- 2016.10.20 47 eligible patients were randomly assigned to experimental arm(24caes) and control arm(23cases) . Patients in the experimental arm received fulvestrant 500mg at d0,d14,d28,then every 28 days , plus exemestane 2.5 mg per day; in the control arm patients received exemestane 2.5 mg/day only. The primary end point was progression-free survival(PFS). [Results] The disease control rate(DCR) in the experimental arm and control arm were 54.2% and 21.7% respectively, with statistical difference (p =0.023); the median PFS were 6.5 months (95% CI=3.86-9.14) and 3.0 months (95%CI= 2.37 -3.63) respectively, with statistically difference(p=0.046); there were no statistical difference of common adverse events were observed between the two arms. [Conclusion] Fulvestrant plus exemestane can significantly improve the DCR and PFS in hormone receptor-positive, recurrent or metastatic breast cancer progressing on prior NSAIs with reasonable tolerance.