Clinical Study of Camrelizumab Combined With TCb Versus TCb in Neoadjuvant Treatment of Triple-negative Breast Cancer

Inclusion Criteria:

1. Age: 18-70 years old

2. cT2 - cT4d, or cT1c with axillary lymph node metastasis confirmed clinically andpathologically；

3. Pathologically proven triple negative breast cancer: Triple-negative breast cancer is defined as:

• Negative for ER and PR (IHC nuclear staining <10%)

• Her-2 negative (IHC 0, 1+ without FISH, or IHC 2+ with no amplification byFISH)；

4. Has clinically measurable lesions:Measurable lesions on ultrasound, mammography, orMR (optional) within 1 month before randomization；

5. Organ and bone marrow function tests within 1 month before chemotherapy suggest nocontraindications to chemotherapy；

6. Cardiac ultrasound EF value ≧55%；

7. Females of childbearing age, with a negative serum pregnancy test 14 days beforerandomization;

8. ECOG score≤1 point;

9. Sign informed consent；

Exclusion Criteria:

1. The patient has evidence of metastatic breast cancer；

2. For this disease, chemotherapy, endocrine therapy, targeted therapy, radiationtherapy, etc. have been received;

3. The patient has a second primary malignancy other than adequately treated skincancer;

4. The patient has been treated with anti-programmed cell death protein 1 (anti-PD-1),anti-programmed death ligand 1 (anti-PD-L1) or anti-PD-L2 drugs, or otherimmunotherapy；

5. The patient has been diagnosed with immunodeficiency disease or autoimmune disease;

6. The patient has severe lung or heart disease;

7. The patient has active hepatitis B and C;

8. The patient has a history of organ transplantation or bone marrow transplantation;

9. pregnant or breastfeeding women;

10. The investigators considered chemotherapy contraindicated due to serious,uncontrolled other medical conditions.