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
• 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 \<1.5 × ULN (upper limit of normal).
• Creatinine \<1.5 × ULN.
• AST/ALT \<1.5 × ULN.
• Cardiac function: Left ventricular ejection fraction (LVEF) ≥55% by echocardiography.
• Reproductive status: Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to randomization.
• ECOG performance status: ≤1.
• Informed consent: Signed written informed consent.