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

This study mainly compared the efficacy and safety of 6*TCb (docetaxel+carboplatin)+carrelizumab regimen and 6*TCb regimen in neoadjuvant chemotherapy for triple-negative breast cancer.

Patients who met the inclusion criteria were randomly assigned to the experimental group and the control group in a 2:1 ratio.

• The experimental group received 6 cycles of TCb+carrelizumab (docetaxel 75mg/m2 on the first day + carboplatin AUC=6, on the first day; camrelizumab 200mg on the third day) regimen neoadjuvant chemotherapy, every 21 days is a cycle.
• The control group received 6 cycles of TCb (docetaxel 75mg/m2 on the first day + carboplatin AUC=6 on the first day) regimen neoadjuvant chemotherapy, every 21 days as a cycle.

The efficacy and safety of the two chemotherapy regimens on neoadjuvant chemotherapy for triple-negative breast cancer were evaluated by PCR, EFS, DFS, DDFS and ORR after surgery.

Inclusion criteria

• Age: 18-70 years old
• cT2 - cT4d, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically；
• 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 by FISH)；
• Has clinically measurable lesions:Measurable lesions on ultrasound, mammography, or MR (optional) within 1 month before randomization；
• Organ and bone marrow function tests within 1 month before chemotherapy suggest no contraindications to chemotherapy；
• Cardiac ultrasound EF value ≧55%；
• Females of childbearing age, with a negative serum pregnancy test 14 days before randomization;
• ECOG score≤1 point;
• Sign informed consent；

Exclusion criteria

• The patient has evidence of metastatic breast cancer；
• For this disease, chemotherapy, endocrine therapy, targeted therapy, radiation therapy, etc. have been received;
• The patient has a second primary malignancy other than adequately treated skin cancer;
• 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 other immunotherapy；
• The patient has been diagnosed with immunodeficiency disease or autoimmune disease;
• The patient has severe lung or heart disease;
• The patient has active hepatitis B and C;
• The patient has a history of organ transplantation or bone marrow transplantation;
• pregnant or breastfeeding women;
• The investigators considered chemotherapy contraindicated due to serious, uncontrolled other medical conditions.