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

Inclusion Criteria:

1. Age: 18-65 years old;

2. Clinically and pathologically confirmed cT2- cT4d, or cT1c with axillary lymph nodemetastasis;

3. 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)

4. Clinically measurable lesions: Measurable lesions displayed by ultrasound, mammography, or MR (optional) within onemonth prior to screening;

5. Organ and bone marrow function tests within 2 weeks before chemotherapy indicate nocontraindications 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 areabnormalities, T3 and T4 levels should be examined. If T3 and T4 levels arenormal, they can be selected

• Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5ULN, while meeting international standards Normalization ratio (INR) ≤ 1.5 ULN (not receiving anticoagulant therapy);

6. Cardiac ultrasound EF value ≥ 55%;

7. Women of childbearing age who tested negative for serum pregnancy test 14 daysbefore randomization;

8. ECOG score ≤ 1 point;

9. Voluntary signing of informed consent

Exclusion Criteria:

1. There is evidence of metastatic breast cancer (in order to exclude metastatic breastcancer, chest and abdomen CT and bone scanning should be performed at any time pointbefore diagnosis and randomization; PET/CT scanning can be used as an alternativeimaging inspection method);

2. Have Received chemotherapy, endocrine therapy, targeted therapy, radiation therapy,etc. for this disease;

3. The patient has a second primary malignant tumor, in addition to: fully treated skincancer;

4. Received treatment with anti-PD-1, anti-PDL1, anti-PD-L2 drugs, or otherimmunotherapy;

5. Diagnosed with immunodeficiency or autoimmune diseases;

6. Severe lung or heart disease;

7. Hepatitis B and C are in active phase;

8. History of organ transplantation or bone marrow transplantation;

9. Pregnant or lactating women;

10. Due to serious and uncontrollable medical conditions, researchers believe there arecontraindications to chemotherapy;

11. Screening for clinically significant bleeding symptoms or significant bleedingtendencies within the previous month;

12. Screening for arteriovenous thrombosis events such as deep vein thrombosis andpulmonary embolism that occurred within the previous 3 months.