Neoadjuvant Study of HIFU With or Without PD-1 Inhibitors Followed by Abraxane Plus Carboplatin in Triple-Negative Breast Cancer.

Inclusion criteria

• Female patients aged ≥18 and ≤70 years.
• Histologically confirmed invasive breast cancer, classified as Stage II-III triple-negative breast cancer (TNBC) according to the 8th edition AJCC TNM staging.
• At least one measurable lesion as per RECIST v1.1 criteria.
• No prior chemotherapy, immunotherapy, endocrine therapy, radical surgery, or radiotherapy for breast cancer.
• ECOG performance status of 0 or 1.
• Adequate organ function, defined as:

• Hemoglobin ≥90 g/L
• White blood cell count ≥3.5×10^9/L
• Platelet count ≥100×10^9/L
• Absolute neutrophil count ≥1.5×10^9/L
• AST and ALT ≤3× upper limit of normal (ULN)
• Total bilirubin ≤1.5× ULN
• Serum creatinine ≤1.5× ULN
• No evidence of pneumonia on chest CT
• Adequate cardiac function, defined as:

• No myocardial ischemia on ECG
• NYHA class I
• LVEF ≥55% on echocardiogram
• Normal cardiac markers (cTnI and BNP)
• Normal thyroid function (T3, T4, FT3, FT4, TSH).
• Willing and able to provide written informed consent.

Exclusion criteria

• Male or inflammatory breast cancer.
• Metastatic (Stage IV) breast cancer.
• History of active autoimmune or inflammatory diseases requiring systemic treatment within the past 2 years (e.g., systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory bowel disease, Hashimoto's thyroiditis). Exceptions: type I diabetes, hypothyroidism controlled with hormone replacement therapy, or skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis).
• Concurrent other malignancies or history of other malignancies within the past 5 years (except adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix).
• Any other serious non-malignant disease that may compromise compliance or place the patient at risk.
• Major surgery within 4 weeks prior to study initiation or anticipated need for major surgery during the study.
• Prior radiotherapy, chemotherapy, targeted therapy, endocrine therapy, or major surgery for breast cancer.
• Known hypersensitivity to any component of the study drugs.
• Poorly controlled cardiac disease (e.g., NYHA class II+ heart failure, unstable angina, myocardial infarction within the past year, or clinically significant arrhythmias requiring intervention).
• History of interstitial lung disease (ILD), current ILD, or suspected ILD on imaging during screening.
• Active infections, including:

• HIV positive
• Active tuberculosis
• Active hepatitis B (HBV-DNA > 10^3 IU/mL)
• Active hepatitis C (HCV antibody positive with detectable HCV-RNA)
• Active autoimmune disease requiring systemic treatment.
• Dementia, significant intellectual impairment, or any psychiatric condition that impairs understanding of the informed consent.
• Unhealed wounds, ulcers, or fractures within 4 weeks prior to signing consent; or any history of clinically significant bleeding or bleeding tendency.
• Any other condition deemed by the investigator to be unsuitable for trial participation.