e11536 Background: Clinical response of advanced or metastatic cancer can be improved by combination chemotherapy. Recently, the combination of capecitabine (C) and vinorelbine (V) has been expected as a first or a second-line in inoperable breast cancer. METHODS We reviewed the following studies: 1) A prospective observational trial (C: 500 mg/m2 bid, d1-14, V : 60mg/m2 IV, d 1+8; q3w, S. Gampenrieder et al. 2010). 2) An international, open-label, phase II trial (C: 1,000mg/m2 bid, d 1-14, V: 80mg/m2 p.o., days 1+8; q3w; N. Tubiana-Mathieu et al. 2009. 3) An open-label, phase II trial (C: 1,000mg/m2 bid, d1-14, V: 20mg /m2 IV, d 1+8; q3w, n=39; G. Orphanos et al. 2009). 4) An open-label, international, multicenter, phase II trial (C: 1,000mg/m2 bid d 1-14, V: 60mg/m2 p.o., d 1, 8, 15; q3w; A. Jones et al. 2009). RESULTS In these studies, overall response rate (ORR) were around 20% and 53.9%. Clinical benefit rate/disease control rate (CBR: CR+PR+SD≥6mo/DCR: CR+PR+SD) were around 62.5% and 83.3% (Table). Multiple comparison of Study1-4 showed significant differences in ORR. Regimen in 2 and 3 indicated better response rate than in 4. However, no significant differences were seen in CBR/DCR. Comparing a first-line group and a second-line group, chi-square test showed no significant differences in ORR and CBR/DCR. In Jones et al, they demonstrated that patients classified failure to anthracycline-taxane treatment have an ORR of 40%, with a DCR of 60%. Treatment-related adverse events were generally well tolerated in all these studies. CONCLUSIONS These data suggested that the combination of C+V was effective and safe as both a first-line and a second-line in inoperable breast cancer. We expect this therapy would establish as a second-line treatment effective against anthracycline-taxane resistant breast cancer. [Table: see text].