University of California, San Francisco
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.
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…
Inclusion Criteria: 1. Participants must have histologically or cytologically confirmed metastatic breast cancer. 2. Confirmed documented soft tissue involvement via imaging or biopsy, with at least one measurable lesion with a cutaneous and/or subcutaneous component that is at least 1 cm in size but no greater than 5 cm in size and that can be safely accessed under image guidance. Up to 3 lesions that meet these criteria may be treated with PEF ablation therapy. 3. There are no limits on the amount of prior or concurrent anti-cancer therapies, but patients must be medically able (in the opin…
Pulsed electric field (PEF) delivers short, high frequency electrical pulses that are intended to shrink or destroy tumors
Participants will complete health related, quality of life questionnaires
Undergo ablation via PEF
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