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

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 \<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.