FMD and Neoadjuvant Chemo-immunotherapy in TNBC

Exclusion Criteria

• •Previous administration of any systemic anti-cancer therapy, including cytotoxic chemotherapy, targeted therapy, immunotherapy, or investigational treatment.
• •Prior radiotherapy for breast cancer.
• •Documented evidence (pathological or radiological) of distant metastasis prior to treatment initiation.
• •History of another malignancy within the five years preceding treatment initiation in this study, except for carcinoma in situ of the cervix, cured basal cell carcinoma, or urothelial tumors of the bladder (including Ta and Tis).
• •Known allergy or hypersensitivity to any component of the investigational drugs or products.
• •Active autoimmune disease requiring systemic treatment (e.g., systemic lupus erythematosus, psoriasis, etc.).
• •Body Mass Index (BMI) \< 19 kg/m².
• •Unintentional weight loss ≥5% within the past 3 months, unless the patient's BMI \>22 kg/m² and weight loss at study entry is \<10%; or unintentional weight loss ≥10% within the past 3 months, unless the patient's BMI \>25 kg/m² and weight loss at study entry is \<15%. In either case, weight must have been stable for at least one month prior to enrollment.
• •Eating disorders, including anorexia nervosa, bulimia nervosa, etc.
• •Baseline fasting blood glucose ≤60 mg/dL (3.33 mmol/L).
• •Severe infection within 4 weeks prior to enrollment, including but not limited to hospitalization for infectious complications, bacteremia, or severe pneumonia.
• •Type 1 or Type 2 diabetes mellitus requiring medication (including but not limited to insulin or insulin secretagogues), with the exception of metformin.
• •Any unstable systemic disease, including: uncontrolled hypertension, unstable angina, angina pectoris with onset within the last 3 months, congestive heart failure, myocardial infarction (within 6 months prior to enrollment).
• •Severe arrhythmia requiring medication, or significant hepatic, renal, or metabolic disease.
• •Known infection with Human Immunodeficiency Virus (HIV).
• •Active, uncontrolled hepatitis B or hepatitis C.
• •Pregnant or lactating women.
• •History of diagnosed neurological or psychiatric disorders, including epilepsy or dementia.
• •Any other condition deemed by the investigator as unsuitable for participation.