Nab-P+Cb+PD1 Inhibitors Combined/not Combined with Bevacizumab 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；

• Urine test: Urine protein<2+; If urine protein is ≥ 2+, the 24-hour urineprotein quantification display must show protein ≤ 1g

• 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. Urine routine shows that urine protein is ≥ 2+and confirms that 24-hour urineprotein quantification is>1g;

13. Suffering from serious cardiovascular and cerebrovascular diseases, including butnot limited to those that meet NYHA criteria (Grade III or higher), or myocardialinfarction or cerebrovascular accident (cerebral ischemia, symptomatic cerebralinfarction, etc.) that occurred within 3 months before the first administration, orunstable arrhythmia or unstable angina pectoris accompanied by coronary arterydisease that occurred within 1 month before the first administration, or congestiveheart failure outside of the above criteria, or symptomatic superior vena cavasyndrome, etc;

14. Individuals with hypertension who cannot achieve good control with singleantihypertensive medication (systolic blood pressure>140 mmHg, diastolic bloodpressure>90 mmHg); Individuals with a history of unstable angina pectoris; Newlydiagnosed with angina pectoris within the first 3 months of screening orexperiencing myocardial infarction events within the first 6 months of screening;Arrhythmia (including QTcF: ≥ 450 ms for males and ≥ 470 ms for females) requireslong-term use of antiarrhythmic drugs and New York Heart Association classificationof ≥ II heart failure;

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