Clinical trial · Interventional
Percutaneous Irreversible Electroportion for Unresectable Breast Cancer
Safety and Efficacy of Irreversible Electroporation (IRE) for Breast Cancer
NCT02340858CI-TRIAL-00053688completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial is studying how well Irreversible Electroportion (IRE) therapy works in treating patients with breast cancer. IRE kills tumor cells by Electrical impulses creating nano-pore on the cell membrane and inducing target cell death.This may be an effective treatment for patients with unresectable breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NanoKnife LEDC System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NanoKnife LEDC System
- description
- 90 pulses of 70 microseconds each in duration will be administered per electrode pair.
- interventionNames
- Device: NanoKnife LEDC System
- type
- NO_INTERVENTION
- label
- Control
- description
- The patients without treatment
Primary outcomes (1)
- measure
- Treatment efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria by Computed Tomography (CT) or Magnetic Resonance (MR) imaging.
- timeFrame
- 3 months post treatment to 24 months
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women 18 years or older with unresectable breast cancer, not amenable/willing to adenomammectomy. 2. breast carcinoma diagnosed by core needle biopsy. 3. Any menopausal status. 4. No history of en bloc open surgical biopsy and/or lumpectomy for diagnostic/treatment of the index breast cancer. 5. Tumor size ≤ 5.0 cm in greatest diameter. Largest size measured by required scans (mammogram, ultrasound and MRI) will be used to determine eligibility. 6. Tumor enhancement on pre-study MRI. 7. Tumor with \< 25% intraductal components in the aggregate. 8. Progressed within 12 months from prior adjuvant or progressed within 1 month from prior advanced/metastatic endocrine breast cancer therapy, 9. Non-pregnant and non-lactating. Patients of childbearing potential must have a negative serum or urine pregnancy test. 10. Adequate breast size for safe IRE. Male breast cancer patients and female breast cancer patients with breasts too small to allow safe IRE are not eligible as the minimal thickness of the breast tissue does not lend itself to IRE. NOTE: For patients with breast implants, the treating physician must document that adequate distance exists between the lesion and the implant to ensure that the ablated lesion will not contact or jeopardize the implant. 11. Adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures 12. Patient must agree to provide tumor tissue from metastatic tissue at baseline. Exclusion Criteria: 1. Patients with multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, or evidence of excessive DCIS. 2. History of rotational vacuum assisted core biopsies, en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer. 3. Prior or planned neoadjuvant chemotherapy for breast cancer. 4. Patients with thrombocytopenia and or any other coagulation abnormality
References
Publications (0)
Data not yet available
No reference posted for this study.