Pulsed Electric Field Ablation for Metastatic Breast Cancer (NCT07487844) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Pulsed Electric Field Ablation for Metastatic Breast Cancer
United States20 participantsStarted 2026-05-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participants must have histologically or cytologically confirmed metastatic breast cancer.
✓. 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.
✓. There are no limits on the amount of prior or concurrent anti-cancer therapies, but patients must be medically able (in the opinion of referring provider and treating investigator) to withhold their systemic therapy for breast cancer one week before the PEF ablation and for 2 weeks after the procedure.
✓. Age ≥18 years
✓. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
✕. Has not recovered from adverse events due to prior/concurrent systemic anti-cancer therapy to ≤ Grade 2 (CTCAE v5.0) or baseline (other than alopecia).
✕. Individuals with pacemakers or other electronic implant devices.
✕. Individuals who are unable or unwilling, or with medical contraindication, to undergo moderate sedation and local anesthesia.
What they're measuring
1
Proportion of participants with treatment-emergent adverse events
✕. Pregnant individuals are excluded from this study because there is unknown risk of PEF on fetus.
✕. Breastfeeding/chestfeeding individuals are excluded from this study because there is unknown risk on nursing infants; breastfeeding/chestfeeding should be discontinued prior to initiating study treatment.
✕. Individuals with any condition or social circumstance that, in the opinion of the treating investigator, would impair the participant's ability to comply with study procedures.