To evaluate the efficacy and safety of compound preparation Biolosion in combination with standard neoadjuvant therapy for locally advanced triple-negative breast cancer
Women aged 1.18 years and above, diagnosed with triple-negative breast cancer (ER≤10%, PR≤10%, HER-2 negative) by pathology;
Patients must have tumor specimens (formalin-fixed, paraffin-embedded, or fresh pre-treated tumor tissue) available for PD-L1 expression testing;
Researchers assess indications for neoadjuvant chemotherapy, with staging from IIA to IIIC, based on imaging or pathological evaluation of cT1c, N1-3, or cT2~cT4, cN0~N3, and patients with no distant metastasis as evaluated by imaging;
Patients must not have received chemotherapy or targeted therapy for advanced breast cancer;
There is a clear distant transfer;
A history of autoimmune diseases;
Acute or chronic active hepatitis B (defined as positive hepatitis B surface antigen and/or hepatitis B core antibody, with hepatitis B virus DNA copy number ≥1×10³ copies/ml or ≥200 IU/ml) or positive antibodies for acute or chronic active hepatitis C, with positive hepatitis C antibodies but negative RNA testing allowed for enrollment.
Previous treatment with immune checkpoint inhibitors;
Parallel
Biolosion (oral probiotic compound preparation)
Other interventionBiolosion (oral probiotic compound preparation) will be administered in the experimental arm. Biolosion will be taken every night from day 1 to day 21 after each cycle of immunotherapy-chemotherapy.
Pathological complete remission
ypT0N0, ypTisN0 after surgery
overall survival
The length of time from the date of the start of treatment until death.
Disease Free Survival
Time from treatment until the recurrence of disease (or death) after undergoing curative-intent treatment.
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