Objective: The aim of this study was to evaluate the anti-tumor activity and safety of Gemcitabine (GEM) combined with Vinorelbine (NVB) in patients with advanced TNABC after chemotherapy. Methods: Thirty-seven patients with immunohistochemical proved TNABC were enrolled. The patients received 21-day cycles of NVB 25 mg/m2 i.v. with GEM 1000 mg/m2 i.v. on days 1 and 8. Results: A total of 136 cycles were given to 37 patients (median 4 cycles, ranged 2–6 cycles). The treatment response was evaluable in all patients. Of the 37 patients, 1 received complete remission (CR), 8 received partial remission (PR), 20 had stable disease (SD), 9 had progressive disease (PD). Overall objective response (CR + PR) were 24.3 %. The median time to progress (TTP) was 6 months (95% CI, 4–8 months). The median overall survival was 24 months (95% CI, 11–37 months). The median 1-year survival rate was (66.24 ± 8.43)%. The median 3-year survival rate was (28.77 ± 11.96)%. The major adverse events were grade I–II myelosuppression, peripheral neurologic toxicities, nausea and vomiting. Some patients had rash and hepatic dysfunction. A total of 40% of patients experienced flu-like symptoms. Alopecia and diarrhea were rare. Conclusion: The combination of GEM and NVB is an effective and well tolerated regimen for the patients with TNABC.
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