Objective   This study aims to compare the efficacy and the toxicity of YH-16+GP and GP regimens for metastatic triple-negative breast cancer (TNBC).

  Methods   Fifty-five metastatic TNBC patients with anthracycline and taxane resistance were randomly divided into two groups and received YH-16+GP or GP treatment. The YH-16+GP regimen was composed of YH-16 (15 mg dl,-14), gemcitabine (1000 mg/m² dl, 8), and cisplatin (40 mg/m² dl, 2), administered for 21 days per cycle. The GP regimen only included gemcitabine and cisplatin. The clinical responses of the patients were assessed after two cycles of chemotherapy.

  Results   In the YH-16+GP group, 3 cases with complete response (CR) (11.1%) and 9 cases with partial response (PR) (33.3%) were identified. The total response rate (CR+PR) was 44.4%. In the GP group, 1 CR case (3.5%) and 9 PR cases (32.1%), with total response rate (CR+PR) of 35.7%, were recorded. The median time for the progression of the disease was 7.0 and 5.2 months, respectively, for the two groups. Significant differences in disease-free survival rate were found between the two groups (P=0.001). Drug-related toxicity was denoted by gastrointestinal tract reaction and bone marrow depression, but no significant differences were found between the two groups (P > 0.05).

  Conclusion   The YH-16+GP regimen has better short-term efficacy, has acceptable toxicity, and improves the TTP regimen. Thus, the YH-16+GP regimen can be considered a salvage regimen for metastatic TNBC.