International Journal of Medicine and Data

Objective To compare the efficacy and cardiac safety of trastuzumab biosimilar (Hankyu) versus originator trastuzumab (Herceptin) combined with docetaxel and carboplatin in neoadjuvant therapy for early-stage HER2-positive breast cancer, and to provide evidence-based support for the clinical application of Hankyu. Methods This open-label, randomized, head-to-head prospective trial enrolled 32 patients with stage II-III HER2-positive breast cancer, who were randomly assigned to the Hankyu group (n=14) or Herceptin group (n=18). Baseline characteristics (age, ECOG performance status, LVEF) were balanced between groups (P>0.05). The treatment regimen consisted of trastuzumab (Herceptin/Hankyu) combined with docetaxel (75 mg/m²) and carboplatin (AUC 5), administered every 3 weeks for 6 cycles. Efficacy was evaluated using RECIST 1.1 criteria and Miller & Payne (MP) grading. Cardiac safety was monitored via left ventricular ejection fraction (LVEF) measurements before and after treatment. Results There was no significant difference in MP grading distribution between the Hankyu and Herceptin groups (G3: 1 vs. 2; G4: 7 vs. 6; G5: 6 vs. 10; χ²=0.99, p=0.61). All patients achieved partial response (PR, 100%). Pre-treatment LVEF was 62.9±2.6% in the Hankyu group and 63.0±3.5% in the Herceptin group (p=0.950). Post-treatment LVEF values were 61.8±2.0% vs. 63.1±4.1% (p=0.294), with no statistically significant intergroup difference (p=0.469). Conclusion Hankyu combined with chemotherapy demonstrated equivalent efficacy and safety to the Herceptin regimen, providing direct evidence for the clinical use of trastuzumab biosimilars.

Hankyu; Herceptin; HER2-positive breast cancer; Neoadjuvant therapy