Toripalimab Combined With Anthracycline-free or Anthracycline-containing Chemotherapy as Neoadjuvant Chemotherapy for Early Triple Negative Breast Cancer

Inclusion Criteria

• •1. Age: 18-70 years.
• •2. Disease Status: Clinical pathological confirmation of cT2-cT4d, or cT1c with axillary lymph node metastasis.
• •3. Pathology: Histopathologically confirmed triple-negative, invasive breast carcinoma.
• •4. Definition of Triple-Negative Breast Cancer:
• •5. ER and PR negative (IHC nuclear staining \<10%).
• •6. Her-2 negative (IHC 0 or 1+ without FISH, or IHC 2+ with FISH demonstrating no amplification).
• •7. Measurable Disease: Presence of clinically measurable lesion(s) confirmed by ultrasound, mammography, or optional MRI within 1 month prior to randomization.
• •8. Adequate Organ and Bone Marrow Function (within 1 month prior to chemotherapy), indicating no contraindications for chemotherapy:
• •9. Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L
• •10. Hemoglobin (Hb) ≥ 90 g/L
• •11. Platelet count (PLT) ≥ 100 × 10⁹/L
• •12. Total Bilirubin (TBIL) \< 1.5 × ULN (Upper Limit of Normal)
• •13. Serum Creatinine (Cr) \< 1.5 × ULN
• •14. Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) \< 1.5 × ULN
• •15. Cardiac Function: Left ventricular ejection fraction (LVEF) ≥ 50% as measured by echocardiogram.
• •16. Pregnancy Status: For women of childbearing potential, a negative serum pregnancy test within 14 days prior to randomization.
• •17. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1.
• •18. Informed Consent: Signed informed consent obtained.