Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer

Inclusion Criteria:

1. Women aged 1.18 years and above, diagnosed with triple-negative breast cancer (ER≤10%, PR≤10%, HER-2 negative) by pathology;

2. Patients must have tumor specimens (formalin-fixed, paraffin-embedded, or freshpre-treated tumor tissue) available for PD-L1 expression testing;

3. Researchers assess indications for neoadjuvant chemotherapy, with staging from IIAto IIIC, based on imaging or pathological evaluation of cT1c, N1-3, or cT2cT4,cN0N3, and patients with no distant metastasis as evaluated by imaging;

4. Patients must not have received chemotherapy or targeted therapy for advanced breastcancer;

5. ECOG PS: 0-2;

6. Expected survival of ≥12 weeks;

7. Major organ function levels must meet the following criteria:

1. Hematological examination standards must meet: ANC≥1.5×10^9/L, PLT≥75×10^9/L,Hb≥90g/L (no blood transfusions or blood products within 14 days, and no use ofG-CSF or other hematopoietic growth factors for correction) 2) Biochemicalexamination must meet the following standards: TBIL<1.5×ULN, ALT, AST<2.5×ULN, forpatients with liver metastasis, ALT, AST may be <5×ULN, BUN and Cr≤1×ULN orendogenous creatinine clearance ≥50ml/min (Cockcroft-Gault formula); 8. Women ofchildbearing age must have taken reliable contraceptive measures or undergone apregnancy test (serum or urine) within 7 days prior to enrollment, with a negativeresult, and must be willing to use appropriate contraceptive methods during thetrial and for 8 weeks after the last administration of the investigational drug.

9. Participants voluntarily join this study, demonstrate good compliance, and cooperatewith follow-up.

Exclusion Criteria:

1. There is a clear distant transfer;

2. A history of autoimmune diseases;

3. Acute or chronic active hepatitis B (defined as positive hepatitis B surface antigenand/or hepatitis B core antibody, with hepatitis B virus DNA copy number ≥1×10³copies/ml or ≥200 IU/ml) or positive antibodies for acute or chronic activehepatitis C, with positive hepatitis C antibodies but negative RNA testing allowedfor enrollment.

4. Previous treatment with immune checkpoint inhibitors;

5. Received systemic immunostimulants, systemic corticosteroids, or immunosuppressantswithin the last 4 weeks;

6. Any severe underlying disease, comorbidities, and active infections, or patientswith severe metabolic disorders;

7. Currently receiving other antitumor treatments;

8. Known comorbidities (e.g., chronic diarrhea, inflammatory bowel disease, etc.) that,in the investigator's assessment, would increase the risk associated with theadministration of the study drug or interfere with the interpretation of studyresults.

9. Currently using or planning to use probiotics, yogurt, or bacterial-enhanced foodsduring the treatment period.

10. A history of epilepsy or seizure-inducing states;

11. Pregnant or breastfeeding patients;

12. Poor compliance or inability to undergo normal follow-up;

13. Individuals allergic to the study drug;

14. Diagnosis of other malignancies within the past 5 years, with the exception of:surgically removed non-melanoma skin cancer, adequately treated cervical carcinomain situ, locally curative prostate cancer, surgically treated ductal carcinoma insitu, or malignancies diagnosed 2 years prior to randomization without evidence ofdisease and untreated for ≤2 years;

15. The investigator's judgment on other conditions that may affect the conduct of theclinical study and the determination of study results.