Serplulimab Combined With Chemotherapy for Early-stage HR+/HER2- Breast Cancer

The neoadjuvant treatment options commonly used for HR+/HER2- breast cancer are mainly anthracycline sequential or combined with paclitaxel chemotherapy regimens. Several clinical studies have confirmed that albumin paclitaxel is more effective than solvent-based paclitaxel, and therefore, albumin paclitaxel in combination with epirubicin has also become a commonly used chemotherapy regimen in clinical practice. The aim of this study was to explore the efficacy and safety of the Serplulimab combined with nab-paclitaxel and epirubicin in the neoadjuvant treatment of HR+/HER2- breast cancer

3.1 Inclusion Criteria Patients must meet all of the following criteria to be eligible: Age: ≥18 years old. Clinical-pathological confirmation: cT2-cT4 breast cancer, or cT1c with axillary lymph node metastasis. Histopathologically confirmed HR+/HER2- invasive breast cancer: ER and/or PR positive (IHC nuclear staining ≥1%). HER2-negative (IHC 0 or 1+ without FISH testing, or IHC 2+ with FISH-negative amplification). Ki67 ≥20%. Clinically measurable lesions: Measurable lesions confirmed by ultrasound, mammography, or MRI (optional) within 1 month prior to randomization. Adequate organ and bone marrow function (within 1 month prior to chemotherapy): Absolute neutrophil count (ANC) ≥2.0 × 10\^9/L. Hemoglobin ≥90 g/L. Platelet count ≥100 × 10\^9/L. Total bilirubin \