Low-risk early breast cancer
Conditions
Interventions
Experimental group:co-ablation
Control group:breast-conserving surgery
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Participate voluntarily under the free will of the patient or the legal representative, and sign the patient's informed consent; 2. The patient is over 18 years old (subject to the date of signing the informed consent form); 3. Early-stage low-risk breast cancer: single lesion, diameter = 70; 7. Those who can correctly describe and are willing to participate in the follow-up; 8. Have sufficient organ function and meet the following conditions: (1) Blood routine: Neutrophil (ANC)>=1.5x10^9/L; Platelet count (PLT)>=90x10^9/L; Hemoglobin (Hb)>=90g/L; (2) Biochemical: total bilirubin (TBIL)<=Upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST)<=1.5xULN; alkaline phosphatase<=2.5xULN; blood urea Nitrogen (BUN) and serum creatinine (Cr)<=1.5xULN; (3) Coagulation function: International Normalized Ratio (INR) or Prothrombin Time (PT)<=1.5xULN; Activated Partial Thromboplastin Time (APTT)<=1.5xULN; Urinalysis: Urine protein <2+.
Exclusion criteria
Exclusion criteria: 1. Patients with chest trauma that may cause surgical infection; 2. Patients with severe infections and severe heart and brain diseases; 3. Human immunodeficiency virus (HIV) infection, active hepatitis B (antigen-positive hepatitis B and HBV DNA >= 500 IU/ml), active hepatitis C (hepatitis C antibody positive and HCV-RNA higher than analytical method detection limit); 4. Patients with lesions close to chest muscles, nipples or large blood vessels; 5. The patient is pregnant or breastfeeding; 6. Patients with other cancers; 7. The ipsilateral breast mass has received surgery or other invasive treatment within 3 months; 8. Diabetic patients with poor blood sugar control; 9. Implantation of foreign bodies around the tumor, which is expected to affect patients undergoing ablation or surgery; 10. Patients with old scars, damage and ulcers in the skin of the treatment area; 11. Other conditions that make the patient unsuitable for compound thermal ablation; 12. Patients who are considered by the investigator to be unsuitable to participate in this clinical study; 13. Invasive lobular carcinoma, mucinous adenocarcinoma and extensive intraductal carcinoma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local recurrence rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Appearance satisfaction;disease-free survival rate;overall survival rate;Maximum ice hockey coverage rate in combined co-ablation; | — |
Countries
China
Contacts
Public ContactZhao Jin
China-Japan Friendship Hospital
Outcome results
None listed