A Structured Classification of Pyrotinib-Containing Neoadjuvant Regimens for HER2-Positive Breast Cancer: Efficacy, Safety, and Regimen Selection.

This structured review presents a classification framework for pyrotinib-containing neoadjuvant regimens in HER2-positive breast cancer. Studies were identified through a comprehensive literature search and categorized into four strategies: pyrotinib plus chemotherapy, pyrotinib plus trastuzumab with chemotherapy, pyrotinib combined with cell-cycle inhibitors, and pyrotinib combined with antibody-drug conjugates (ADCs). We summarized the pathological complete response(pCR) rates and adverse event profiles of these approaches for neoadjuvant treatment of HER2-positive breast cancer. The pCR rates vary substantially across categories, ranging from approximately 28% to 74%, as do the grade ≥3 toxicity patterns. Therefore, the key to selecting an optimal pyrotinib-based neoadjuvant regimen is to match the regimen choice with tumor characteristics such as hormone receptor status, HER2 immunohistochemical level, intrinsic molecular subtype, and early response to initial therapy, while balancing efficacy and safety and considering patient-specific factors like age and cardiac risk. Existing studies are generally limited by small sample sizes and a lack of long-term survival data, and high-level evidence directly comparing pyrotinib-based strategies with trastuzumab plus pertuzumab is scarce. Future research should prioritize biomarker-driven patient selection, response-adaptive trial designs, and standardized toxicity management to optimize clinical decision-making.