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Archive > Volume 33 Issue 2 > 2026,33(2):199-208. DOI:10.3872/j.issn.1007-385X.2026.02.012 Prev Next
Clinical Research
Efficacy and safety of HLX02 versus Herceptin combined with pertuzumab in neoadjuvant therapy for HER-2 positive breast cancer: a multicenter study based on propensity score matching
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Abstract:
[Abstract] Objective: To assess the efficacy and safety of neoadjuvant therapy (NAT) with HLX02 (Zercepac? ) in combination with pertuzumab and chemotherapy for patients with HER-2-positive invasive breast carcinoma of no special type (IBC-NST), and to compare these outcomes with those of the originator trastuzumab (Herceptin? ) combined with pertuzumab. Methods: This multicenter retrospective cohort study included 132 patients with HER-2-positive breast cancer who received neoadjuvant dual HER2-targeted therapy (HLX02 or Herceptin? , both in combination with pertuzumab and chemotherapy) between May 2020 and September 2024 at the affiliated hospital of Putian University and Zhangzhou Zhengxing Hospital. The primary endpoint was the pathological complete response (pCR) rate, defined as Miller-Payne grade 5. Secondary endpoints included objective response rate (ORR, RECIST 1.1),incidence of adverse events (graded by CTCAE v5.0 and PRO-CTCAE), quality of life (EORTC QLQ-C30), and treatment costs. Statistical analysis was conducted using SPSS 27.0. To minimize baseline imbalances, propensity score matching (PSM, 1∶1 ratio) was performed to match the baseline characteristics between groups. Results: A total of 117 patients were eligible for analysis after screening (65 in the HLX02 group, 52 in the Herceptin? group). Following PSM, 42 patients remained in each group with balanced baseline characteristics. There were no significant differences in the pCR rates of the HLX02 and Herceptin? groups (66.67% vs 69.05%, P = 0.815). ORR (83.33% vs 85.71%, P = 0.763), adverse event incidence, and quality-of-life scores also showed no significant differences (all P > 0.05). However, the mean out-of-pocket cost was significantly lower in the HLX02 group compared with that in the Herceptin? group ([40 358.82 ± 15 042.69] CNY vs [51 170.20 ± 15 664.63] CNY, P = 0.002). Conclusion: This real-world study demonstrated that, in neoadjuvant therapy, HLX02 combined with pertuzumab showed comparable efficacy and similar safety compared with Herceptin? combined with pertuzumab in patients with HER-2 positive IBC-NST, and could significantly reduce the economic burden of patients, providing evidence-based medical evidence for the clinical application of domestic biosimilars.
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