Safety and feasibility of irreversible electroporation (IRE) for early-stage breast cancer

Safety and Feasibility of Irreversible Electroporation for Early-stage Breast Cancer: a Prospective, Open-Label, Single-Arm, Exploratory Study

This trial will test whether irreversible electroporation (IRE) can be safely used before surgery to treat women with small (≤2.0 cm), treatment-naïve invasive ductal breast cancer visible on ultrasound and MRI.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: First Affiliated Hospital of Zhejiang University (other)
• Locations: 2 sites (Hangzhou, Zhejiang and 1 other locations)
• Trial ID: NCT07263451 on ClinicalTrials.gov

What this trial studies

This is a prospective, open-label, single-arm exploratory trial in which eligible patients receive image-guided IRE ablation followed by standard surgical resection. The trial enrolls adult women with unifocal invasive ductal carcinoma ≤2.0 cm that is well visualized on breast ultrasound and DCE-MRI and who are fit for general anesthesia (ECOG 0-1). Outcomes related to safety, feasibility, and preliminary efficacy will be recorded and analyzed according to predefined primary and secondary endpoints. Patients with significant coagulopathy or implanted active cardiac electronic devices are excluded.

Who should consider this trial

Good fit: Women aged 18 or older with treatment-naïve, unifocal invasive ductal carcinoma ≤2.0 cm that is clearly seen on both ultrasound and MRI and who are medically fit for surgery and general anesthesia (ECOG 0-1).

Not a fit: Patients with implanted cardiac electronic devices, significant coagulopathy, multifocal or larger tumors (>2.0 cm), prior local breast cancer treatment, or tumors not well visualized on ultrasound/MRI are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, IRE could offer a less destructive, image-guided local treatment that preserves surrounding tissue and may reduce surgical morbidity for small breast tumors.

How similar studies have performed: IRE has produced promising results in small series for other solid organs and there are limited pilot reports in breast tissue, but broad clinical evidence for IRE in breast cancer remains limited.

Eligibility criteria

Inclusion Criteria:

1. Female, aged 18 years or older.
2. Medically fit for both surgery and general anesthesia, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
3. Treatment-naïve, primary, unifocal breast cancer with a maximum diameter of ≤ 2.0 cm as assessed by MRI.
4. Pathologically confirmed diagnosis of Invasive Ductal Carcinoma (IDC) within 3 months prior to enrollment.
5. Tumor that presents as a well-defined, localized mass and is clearly visualized on both breast ultrasound (for intraoperative guidance) and breast DCE-MRI (for baseline measurement and treatment planning).
6. The subject must be able to understand the purpose of the trial, voluntarily participate, and provide written informed consent.

Exclusion Criteria:

1. Known coagulopathy or bleeding diathesis (defined as a platelet count \< 50×10⁹/L or an International Normalized Ratio (INR) \> 1.5).
2. Presence of an implanted cardiac pacemaker, defibrillator, or any other active electronic medical device.
3. 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.
4. Patients who are pregnant, lactating, or planning a pregnancy during the study period.
5. Known severe allergy or anaphylactic reaction to MRI contrast agents.
6. Known high-risk genetic susceptibility to breast cancer (e.g., BRCA1/2 mutation carrier) associated with an increased risk of ipsilateral breast tumor recurrence following ablation.
7. Presence of distant metastases.
8. Any other medical or psychiatric condition that, in the investigator's judgment, would compromise the patient's safety or compliance with the study protocol.

Where this trial is running

Hangzhou, Zhejiang and 1 other locations

• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Tian'an Jiang, PhD

Conditions: Breast Cancer, IRE, Irreversible Electroporation