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

Inclusion criteria

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

Exclusion criteria

• Metastatic Disease: Evidence of metastatic breast cancer. (To exclude metastasis, CT scans of the chest and abdomen, and a bone scan must be performed at any time point from diagnosis to randomization; PET/CT may serve as an alternative imaging modality).
• Prior Anti-Cancer Therapy: Any prior chemotherapy, endocrine therapy, targeted therapy, or radiotherapy for the current breast cancer.
• Second Primary Malignancy: Presence of a second primary malignancy, except for:
• Adequately treated non-melanoma skin carcinoma.
• Prior Immunotherapy: Previous treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or any other immunomodulatory therapy.
• Immunodeficiency or Autoimmune Disease: Diagnosed immunodeficiency or active autoimmune disease requiring systemic treatment.
• Severe Comorbidities: Severe or uncontrolled pulmonary or cardiac disease.
• Active Hepatitis: Active Hepatitis B or Hepatitis C infection.
• Transplantation History: History of solid organ or bone marrow transplantation.
• Pregnancy/Lactation: Pregnant or lactating women.
• Other Medical Conditions: Any other severe, uncontrolled medical condition that, in the investigator's judgment, constitutes a contraindication to chemotherapy.