Artificial Intelligence Model-Guided Neoadjuvant Anti-HER2 Targeted Therapy: A Randomized, Controlled, Open-Label, Multicenter Phase III Clinical Study
Based on total pathologic complete response (tpCR) after surgery, to evaluate the efficacy of an artificial intelligence model-matched anti-HER2 targeted treatment strategy (investigational arm) versus nab-paclitaxel + carboplatin + trastuzumab + pertuzumab (PCbHP, control arm) as neoadjuvant therapy for patients with early or locally advanced human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
• Female patients aged 18 to 75 years.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Histologically confirmed unilateral primary invasive breast cancer, staged as at least cT2 or cN1 (i.e., AJCC 8th edition stage II-III), and M0.
• Pathologically confirmed HER2-positive breast cancer, defined as HER2 IHC 3+, or IHC 2+ with positive in situ hybridization (ISH).
• At least one measurable lesion according to RECIST version 1.1.
• Adequate major organ function, meeting all of the following criteria: Hematology criteria (without blood transfusion or hematopoietic growth factor support within 7 days before screening): hemoglobin (HB) \>= 90 g/L; absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L; platelet count (PLT) \>= 75 x 10\^9/L.
• Biochemistry criteria: total bilirubin (TBIL) \<= 1.5 x upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<= 3 x ULN; serum creatinine (Cr) \<= 1.5 x ULN; endogenous creatinine clearance \> 50 mL/min (Cockcroft-Gault formula).
• 12-lead electrocardiogram: Fridericia-corrected QT interval (QTcF) \< 470 msec; echocardiography: left ventricular ejection fraction (LVEF) \>= 55%.
• Women of childbearing potential must use at least one medically accepted contraceptive method during study treatment and for at least 3 months after the last dose of study drug.
• Subjects must voluntarily participate in the study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up.