NCT07487844

Pulsed Electric Field Ablation for Metastatic Breast Cancer

Image-Guided Pulsed Electric Field (PEF) Ablation of Soft Tissue Lesions in Metastatic Breast Cancer: A Pilot Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Breast Cancer
• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Pulsed Electric Field (PEF) System	Pulsed electric field (PEF) delivers short, high frequency electrical pulses that are intended to shrink or destroy tumors
BEHAVIORAL	Questionnaires	Participants will complete health related, quality of life questionnaires
PROCEDURE	Tumor Ablation	Undergo ablation via PEF

Timeline

• Start date: 2026-05-15
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2026-03-23
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study