Immunotherapy plus chemo shows promise in aggressive breast cancer trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. Exclusion Criteria: 1. 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). 2. Prior Anti-Cancer Therapy: Any prior chemotherapy, endocrine therapy, targeted therapy, or radiotherapy for the current breast cancer. 3. Second Primary Malignancy: Presence of a second primary malignancy, except for: 4. Adequately treated non-melanoma skin carcinoma. 5. Prior Immunotherapy: Previous treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or any other immunomodulatory therapy. 6. Immunodeficiency or Autoimmune Disease: Diagnosed immunodeficiency or active autoimmune disease requiring systemic treatment. 7. Severe Comorbidities: Severe or uncontrolled pulmonary or cardiac disease. 8. Active Hepatitis: Active Hepatitis B or Hepatitis C infection. 9. Transplantation History: History of solid organ or bone marrow transplantation. 10. Pregnancy/Lactation: Pregnant or lactating women. 11. Other Medical Conditions: Any other severe, uncontrolled medical condition that, in the investigator's judgment, constitutes a contraindication to chemotherapy.