Abstract: Objective To study the clinical efficiency and safety of calcium folinate combined with 5-fluorouracil in advanced breast cancer patients. Methods Thirty-one advanced breast cancer patients were enrolled，with median age was 48.0 years (27~66 years), who had progressed diseases after treatments of anthracycline compounds and paclitaxel.Estrogen receptor(ER) and (or) progesterone receptor(PR) were positive in 12 cases(ER+,9 cases;PR+,5 cases;ER+ and PR+,2 cases),ER and PR were negative in 19 cases.The patients were treated with CF［150 mg/(m²·d)］ and 5-Fu［(600 mg/(m²·d)］ by venous infusion for more than 12 hours with D1~5.This therapeutic regimen was 28 days per 1 cycle. Results Complete response(CR),partial response(PR),stable disease (SD) and progressive disease (PD) was achieved in 2 patients (6.4%),7 patients(22.58%),6 patients(19.35%) and 16 patients(51.61%),respectively.Overall response rate(CR+PR) was 29.0% and the clinical benefit rate(CR+PR+SD) was 48.4%.It was more obvious that patients with negative hormone receptor had increased response rate(P<0.05).The median duration of response was 2.3 months（95% CI:1.1~4.1） and median survival time was 9.5 months（95%CI:4.7~14.8）.The quality of life was improved in 15 cases(48.4%),stable in 6 cases(19.4%) and decreased in 10 cases(32.3%).The main toxic effects were gastrointestinal side-effect (11 cases),bone marrow suppression(4 cases) and stomatitis(9 cases). Conclusion The combination of CF and 5-Fu given by continuous venous infusion every 4 weeks was active in terms of objective response rate against advanced breast cancer with well-tolerance.