ABSTRACT: This meta-analysis was designed to compare the efficacy and safety of gemcitabine-based regimens for the treatment advanced breast cancer (ABC). Altogether 15 studies involving 8195 ABC patients were retrieved for analysis. Compared with non-gemcitabine-based chemotherapies, patients receiving gemcitabine-based therapy exhibited better overall survival (OS), progression free survival (PFS), and objective response rate (ORR) (HR = 1.12, 95% CI 1.05 to 1.19; HR = 1.16, 95% CI 1.03 to 1.30; HR = 1.14, 95% CI 1.04 to 1.24). Grade 3/4 hematologic toxicity was significantly high but manageable in gemcitabine-based groups. Subgroup analysis revealed that patients with first-line gemcitabine-based chemotherapy had better OS (HR = 1.19, 95% CI 1.07 to 1.32), PFS (HR = 1.17, 95% CI 1.08 to 1.27), and ORR (RR = 1.16, 95% CI 1.02 to 1.32). In addition, additional gemcitabine chemotherapy also showed better OS (HR = 1.17, 95% CI 1.06 to 1.30), PFS (HR = 1.20, 95% CI 1.11 to 1.30) and ORR (RR = 1.23, 95% CI 1.06 to 1.42) than gemcitabine replacement therapy. Furthermore, patients receiving gemcitabine-taxanes-based regimens had better OS (HR = 1.17, 95% CI 1.06 to 1.28), PFS (HR = 1.12, 95% CI 1.04 to 1.20) and ORR (RR = 1.17, 95% CI 1.01 to 1.35) than patients with non-gemcitabine-taxanes-based chemotherapy. These findings indicate that gemcitabine combination regimens could serve as a promising regimen for ABC patients, though increased hematologic toxicity should be considered with caution.