This is a prospective, open-label, single-arm, exploratory clinical trial conducted at our institution to investigate the use of Irreversible Electroporation (IRE) for the treatment of breast cancer.
Female, aged 18 years or older.
Medically fit for both surgery and general anesthesia, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Treatment-naïve, primary, unifocal breast cancer with a maximum diameter of ≤ 2.0 cm as assessed by MRI.
Pathologically confirmed diagnosis of Invasive Ductal Carcinoma (IDC) within 3 months prior to enrollment.
Known coagulopathy or bleeding diathesis (defined as a platelet count < 50×10⁹/L or an International Normalized Ratio (INR) > 1.5).
Presence of an implanted cardiac pacemaker, defibrillator, or any other active electronic medical device.
History of significant cardiac disease, including but not limited to: uncontrolled cardiac arrhythmias or congestive heart failure classified as New York Heart Association (NYHA) Class III or IV.
Patients who are pregnant, lactating, or planning a pregnancy during the study period.
Tian'an Jiang
Lead sponsor
First Affiliated Hospital of Zhejiang University
Sponsor institution