Pilot Study of Neoadjuvant Chemotherapy Combined With Immunotherapy and Multimodal Thermal Therapy for HER2-negative Breast Cancer

Inclusion Criteria: 1. Female，age 18-70 years. 2. Histologically confirmed invasive cancer of the breast, and patients meeting cT2-4N+M0 criteria; 3. TNBC non-immunoregulation subtype or HR+/HER2- status were measured by immunohistochemistry (IHC); 4. At least one measurable lesion according to RECIST 1.1 criteria; 5. Normal organ and marrow function: Hemoglobin (HB) ≥90 g/L (No blood was transfused within 14 days), Absolute neutrophil count ≥ 1500/μL, Platelets ≥ 75,000/μL, Total bilirubin ≤ 1.5 x ULN), aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ≤ 3 x ULN, creatinine \< 1 x ULN, endogenous creatinine clearance \> 50 ml/min (Cockcroft-Gault formula); 6. LVEF ≥55%; 7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 8. Non-pregnant and non-lactating, fertile female subjects were required to use a medically approved contraceptive method for the duration of the study treatment and at least 3 months after the last use of the study drug; 9. Ability to understand and willingness to sign a written informed consent. Exclusion Criteria: 1. Previous cytotoxic chemotherapy, endocrine therapy, biological therapy or radiotherapy for any reason; 2. Patients with New York Heart Association (NYHA) grade II or above heart disease (including grade II); 3. Patients with severe systemic infections or other serious diseases; 4. Patients with known allergy or intolerance to the study drug or its excipients; 5. Other malignant tumors in the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer; 6. Pregnant or lactating patients of childbearing age who refused to take appropriate contraceptive measures during the course of the study; 7. Participated in other trial studies within 30 days before the administration of the first dose of the study drug; 8. Endocrine system disorders; 9. Patients who were judged by the investigator to be unsuitable for this study.