Percutaneous Irreversible Electroportion for Unresectable Breast Cancer

Breast Cancer Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT02340858
• Study type: Interventional
• Source: Fuda Cancer Hospital, Guangzhou
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Completion date: January 1, 2021