The Safety and Efficacy of Multimodal Thermal Therapy in the Treatment of Early-stage Invasive Breast Cancer

Inclusion criteria

• Female，age 18-80 years.
• Invasive carcinoma confirmed by core biopsy.
• Newly diagnosed breast cancer patients, without neoadjuvant therapy.
• Imaging findings showed an unifocal breast tumor with a maximum diameter of 2 cm, with no distant metastasis, no calcification, no skin or nipple adhesion, and no invasion of chest wall.
• The functional level of major organs must meet the following requirements: blood routine: neutrophil (ANC)≥1.5×10^9/L; platelet count (PLT) ≥ (PLT)≥90×10^9/L; hemoglobin (Hb) ≥90g/L; coagulation: international normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN; activated partial thromboplastin time (APTT) ≤1.5×ULN.

Exclusion criteria

• Tumor involving skin, ulceration, inflammatory breast cancer patients.
• Tumor involving the superficial layer of the skin.
• KPS score < 70, or ECOG score > 2
• Prior radiotherapy or prior use of investigational drugs or other immunosuppressive agents.
• Heart, brain, lung, kidney and other vital organ failure.
• Uncorrectable severe coagulopathy
• Patient is pregnant or lactating
• Poor glycemic control in diabetes
• Patients with foreign body implantation around the tumor (such as breast augmentation injections or prostheses).
• Patients with severe scars on the skin of the treatment area (protruding from the skin surface, width ≥ 1 cm)
• Human immunodeficiency virus (HIV) infection, active hepatitis B (hepatitis B indicates antigen positive and HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower limit of detection of the analytical method).
• Concurrent medical conditions that, in the judgment of the investigator, would jeopardize the subject's safety, could confound the study results, or affect the subject's completion of this study.