Early-stage Invasive Breast Cancer
Conditions
Interventions
Intervention group:Multimodal Tumor Thermal Therapy
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Female, 18-80 years old; 2. Biopsy confirmed invasive breast cancer; 3. Patients with newly diagnosed breast cancer who have not received neoadjuvant therapy; 4. Imaging examination showed unilateral, solitary tumor less than 2 cm, no distant metastasis, no calcification, no skin, nipple adhesion and chest wall invasion; 5. The function of major organs must meet the following requirements: blood routine: neutrophil (ANC) >=1.5×10^9/L; Platelet count (PLT) >=90×10^9/L; Hemoglobin (Hb) >=90g/L; Coagulation function: international normalized ratio (INR) or prothrombin time (PT) <=1.5×ULN; Activated partial thromboplastin time (APTT) <=1.5×ULN.
Exclusion criteria
Exclusion criteria: 1. Patients with skin ulcers and inflammatory breast cancer; 2. Tumors involving the superficial layer of the skin; 3. KPS score 2; 4. Patients who have received radiotherapy or used investigational drugs or other immunosuppressants in the past; 5. Failure of vital organs such as heart, brain, lungs, and kidneys; 6. Severe uncorrectable coagulation disorder; 7. Pregnant or lactating women; 8. Diabetic patients with poor glycemic control; 9. Patients with foreign body implantation (such as injection of breast augmentation or prosthesis) around the tumor; 10. Patients with severe scarring of the skin in the treatment area (protruding from the skin surface, width = 1 cm); 11. Infection with human immunodeficiency virus (HIV), active hepatitis B (hepatitis B refers to surface antigen positive and HBV DNA = 500 IU/ml), hepatitis C (hepatitis C antibody positive and HCV-RNA exceeds the lower limit of the detection method); 12. Other medical conditions that, in the judgment of the investigator, may endanger the safety of the subject, may interfere with the results of the study, or affect the subject's completion of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete ablation rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Breast MRI confirmed complete ablation.;Breast self evaluation;Assessment of immune activating response; | — |
Countries
China
Contacts
Public ContactZhiming Shao
Fudan University Shanghai Cancer Center
Outcome results
None listed