Abstract: Objective To compare the therapeutic and adverse effects of capecitabine alone or in combination with other drugs for treatment of recurrent and metastatic breast cancer. Methods A capecitabine monotherapy group（n=20）was given the drug at a dose of 2 510mg/m2 twice a day for two weeks，followed by one week of rest as one cycle.Combination therapy groups received capecitabine together with gemcitabine（GX group，n=17），vinorelbine（NX group，n=15） or docetaxel（TX group，n=20）.Patients in each group were given at least two treatment cycles. Results In the capecitabine monotherapy group，treatment efficacy was 25%， and median time to progression（TTP） was 3.2 months.Treatment efficacy and median TTP were 29% and 3.7 months for the GX group， 30.8% and 3.5 months for the NX group，and 35% and 3.8 months for the TX group.The results for the combination therapy groups did not differ significantly from those of the monotherapy group.The major adverse drug reactions included leukopenia， handfoot syndrome，skin pigmentation，nausea，vomiting，anorexia and fatigue. In addition，stomatitis，dizziness，diarrhea，and chest tightness were observed in a few patients.Degree Ⅲ-Ⅳ leukopenia occurred mainly in the TX group，where its frequency was 15%. Conclusions Capecitabine monotherapy or capecitabine-based polytherapy can achieve treatment efficacy rates above 25% against recurrent and metastatic breast cancer.Combination therapy was associated with slightly higher efficacy rates and longer remission time than was monotherapy，but these differences did not achieve statistical significance.Both capecitabine mono-and polytherapy are well tolerated in patients.

Key words: Breast neoplasms, Recurrent and metastatic breast cancer, Capecitabine, Docetaxel, Gemcitabine, Vinorelbine, Combination therapy