Percutaneous Irreversible Electroportion for Unresectable Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a phase I/II non-randomized exploratory study. All fully eligible and registered patients will undergo imaging by mammography, ultrasound, and breast MRI. The primary and secondary objectives of the study are described below. OBJECTIVES Primary Treatment efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria by Computed Tomography (CT) or Magnetic Resonance (MR) imaging. secondary Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria. To describe the adverse events associated with IRE To prospectively gather pain assessment data on cryoablation and surgical resection Explore technical variables that may affect the success of IRE

Official Title
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Safety and Efficacy of Irreversible Electroporation (IRE) for Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: NanoKnife LEDC System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women 18 years or older with unresectable breast cancer, not amenable/willing to adenomammectomy. breast carcinoma diagnosed by core needle biopsy. Any menopausal status. No history of en bloc open surgical biopsy and/or lumpectomy for diagnostic/treatment of the index breast cancer. Tumor size ≤ 5.0 cm in greatest diameter. Largest size measured by required scans (mammogram, ultrasound and MRI) will be used to determine eligibility. Tumor enhancement on pre-study MRI. Tumor with < 25% intraductal components in the aggregate. Progressed within 12 months from prior adjuvant or progressed within 1 month from prior advanced/metastatic endocrine breast cancer therapy, Non-pregnant and non-lactating. Patients of childbearing potential must have a negative serum or urine pregnancy test. 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. Adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures Patient must agree to provide tumor tissue from metastatic tissue at baseline. Exclusion Criteria: Patients with multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, or evidence of excessive DCIS. History of rotational vacuum assisted core biopsies, en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer. Prior or planned neoadjuvant chemotherapy for breast cancer. Patients with thrombocytopenia and or any other coagulation abnormality

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NanoKnife LEDC System<br>90 pulses of 70 microseconds each in duration will be administered per electrode pair. | Device: NanoKnife LEDC System<br>* Irreversible electroporation (IRE) is a method to induce irreversible disruption of cell membrane integrity (loss of cell homeostasis) resulting in cell death without the need for additional pharmacological injury. Because IRE is a non-thermal technique, changes associated with perfusion-mediated tissue cooling (or heating) are not relevant. While cells in the ablation region are destroyed, the underlying extracellular matrix is not damaged thus allowing tissues in the ablation zone to heal normally.<br>* Other names: NanoKnife;|
| No Intervention: Control<br>The patients without treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria by Computed Tomography (CT) or Magnetic Resonance (MR) imaging. |  | 3 months post treatment to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria. |  | 1 day post treatment to 3 weeks |