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

Exclusion Criteria

• •1. Tumor involving skin, ulceration, inflammatory breast cancer patients.
• •2. Tumor involving the superficial layer of the skin.
• •3. KPS score \< 70, or ECOG score \> 2
• •4. Prior radiotherapy or prior use of investigational drugs or other immunosuppressive agents.
• •5. Heart, brain, lung, kidney and other vital organ failure.
• •6. Uncorrectable severe coagulopathy
• •7. Patient is pregnant or lactating
• •8. Poor glycemic control in diabetes
• •9. Patients with foreign body implantation around the tumor (such as breast augmentation injections or prostheses).
• •10. Patients with severe scars on the skin of the treatment area (protruding from the skin surface, width ≥ 1 cm)
• •11. 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).
• •12. 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.