Percutaneous Irreversible Electroportion for Unresectable Breast Cancer

Fuda Cancer Hospital, Guangzhou

Status: Completed

Conditions: Breast Cancer

Treatments: Device: NanoKnife LEDC System

Study type: Interventional

Funder types: Other

Identifiers

NCT02340858

JF-20150112(3)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

NanoKnife LEDC System

Experimental group

Description:

90 pulses of 70 microseconds each in duration will be administered per electrode pair.

Treatment:

Device: NanoKnife LEDC System

Control

No Intervention group

Description:

The patients without treatment