Nab-P+Cb+PD1 Inhibitors as Neoadjuvant Therapy for Early TNBC

Prior treatment

• Have Received chemotherapy, endocrine therapy, targeted therapy, radiation therapy, etc. for this disease;
• Received treatment with anti-PD-1, anti-PDL1, anti-PD-L2 drugs, or other immunotherapy;
• Screening for clinically significant bleeding symptoms or significant bleeding tendencies within the previous month;
• Screening for arteriovenous thrombosis events such as deep vein thrombosis and pulmonary embolism that occurred within the previous 3 months.

Other illness

• There is evidence of metastatic breast cancer (in order to exclude metastatic breast cancer, chest and abdomen CT and bone scanning should be performed at any time point before diagnosis and randomization; PET/CT scanning can be used as an alternative imaging inspection method);
• The patient has a second primary malignant tumor, in addition to: fully treated skin cancer;
• Diagnosed with immunodeficiency or autoimmune diseases;
• Severe lung or heart disease;
• Hepatitis B and C are in active phase;
• History of organ transplantation or bone marrow transplantation;
• Due to serious and uncontrollable medical conditions, researchers believe there are contraindications to chemotherapy;

Other

• Pregnant or lactating women;

• Age: 18-65 years old;
• Clinically and pathologically confirmed cT2- cT4d, or cT1c with axillary lymph node metastasis;
• Three negative type and invasive breast cancer confirmed by histopathology;
  • Three negative breast cancer is defined as:
  • ER and PR negative (IHC nuclear staining\<10%)
  • Her-2 negative (IHC 0, 1+without FISH, or IHC 2+without FISH amplification)
• Clinically measurable lesions:
  • Measurable lesions displayed by ultrasound, mammography, or MR (optional) within one month prior to screening;
• Organ and bone marrow function tests within 2 weeks before chemotherapy indicate no contraindications for chemotherapy:
  • Absolute value of neutrophil count ≥ 2.0 × 109/L
  • Hemoglobin ≥ 100g/L
  • Platelet count ≥ 100 × 109/L
  • Total bilirubin\<1.5 ULN (upper limit of normal)
  • Creatinine\<1.5 × ULN
  • AST/ALT \< 1.5×ULN；
  • Thyroid stimulating hormone (TSH) ≤ upper limit of normal (ULN); If there are abnormalities, T3 and T4 levels should be examined. If T3 and T4 levels are normal, they can be selected
  • Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 ULN, while meeting international standards Normalization ratio (INR) ≤ 1.5 ULN (not receiving anticoagulant therapy);
• Cardiac ultrasound EF value ≥ 55%;
• Women of childbearing age who tested negative for serum pregnancy test 14 days before randomization;
• ECOG score ≤ 1 point;
• Voluntary signing of informed consent