Pulsed Electric Field Ablation for Metastatic Breast Cancer
brief summary
This is a phase I trial of the safety of image-guided pulsed electric field (PEF) ablation for the locoregional treatment of superficial soft tissue lesions in adults with metastatic breast cancer using the AliyaTM Pulsed Electric Field System.
detailed description
PRIMARY OBJECTIVE:
I. To assess the safety of PEF for locoregional treatment of soft tissue metastatic breast cancer lesions.
SECONDARY OBJECTIVE:
I. To assess the effect of PEF on patient-reported symptoms and quality of life.
II. To assess the feasibility of performing PEF for superficial soft tissue metastases.
EXPLORATORY OBJECTIVE:
I. To explore blood-based biomarker responses to PEF.
II. To explore the efficacy of PEF in treating locoregional disease, as well as its effect on untreated lesions.
OUTLINE:
Participants will receive a single treatment of PEF ablation delivered to up to 3 soft metastatic breast cancer lesion(s). After the treatment, participants are followed at Day 0, week 2, week 4, and up to 1 year post ablation.
official title
Image-Guided Pulsed Electric Field (PEF) Ablation of Soft Tissue Lesions in Metastatic Breast Cancer: A Pilot Study