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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; Metastatic Breast Cancer
• Intervention / Treatment: Device: Pulsed Electric Field (PEF) System; Behavioral: Questionnaires; Procedure: Tumor Ablation

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maya Aslam; Phone Number: 877-827-3222; Email: Maya.Aslam@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California San Francisco
      • Principal Investigator: Ryan Kohlbrenner, MD
      • Contact: Email: cancertrials@ucsf.edu
      • Contact: Maya Aslam; Phone Number: 877-827-3222; Email: Maya.Aslam@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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.
4. Age ≥18 years
5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

6. Adequate Bone Marrow Function:

   1. Absolute neutrophil count ≥1,500/microliter (mcL).
   2. Platelets ≥100,000/mcL.
7. Not on or able to withhold anticoagulation or antiplatelet therapy per Society of Interventional Radiology periprocedural guideline.
8. Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months (as documented in the medical record) are eligible for this trial.
9. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy (as documented in the medical record), if indicated.
10. Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load (as documented in the medical record).
11. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
12. The effects of pulsed electric field on the developing human fetus are unknown. For this reason individuals of reproductive potential must agree to use adequate contraception: (e.g., hormonal or barrier method of birth control; abstinence, etc.) for the duration of study participation and for 4 weeks after last administration of study treatment. Should a study participant become pregnant or suspect pregnancy while participating in this study, they should inform their treating physician immediately.

Exclusion Criteria:

1. 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).
2. Individuals with pacemakers or other electronic implant devices.
3. Individuals who are unable or unwilling, or with medical contraindication, to undergo moderate sedation and local anesthesia.
4. Pregnant individuals are excluded from this study because there is unknown risk of PEF on fetus.
5. 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.
6. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Image-Guided Pulsed Electric Field (PEF) Ablation; Participants undergo a single treatment of PEF ablation delivered to up to 3 soft tissue metastatic breast cancer lesion(s). Ablation parameters, immediate adverse events, and post-ablation imaging will be collected during the ablation treatment.	Device: Pulsed Electric Field (PEF) System; Pulsed electric field (PEF) delivers short, high frequency electrical pulses that are intended to shrink or destroy tumors; Other Names: PEF; Aliya™ PEF System; Behavioral: Questionnaires; Participants will complete health related, quality of life questionnaires; Procedure: Tumor Ablation; Undergo ablation via PEF; Other Names: Ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with treatment-emergent adverse events	Proportion of participants who experience adverse event from the Pulsed Electric Field (PEF) ablation treatment. Standard deviation and 95% confidence intervals will be reported.	Up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change of score on European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Breast Cancer Module (EORTC QLQ BR-23)	EORTC QLQ-BR23 incorporates five multi-item scales to assess body image, sexual functioning, systemic therapy side effects, breast symptoms, and arm symptoms. In addition, single items assess sexual enjoyment, future perspective and being upset by hair loss. All of the scales and single-item measures range in score from 0 to 100. The mean and standard deviation of the change in EORTC QLQ-BR23 scores, along with the 95% confidence interval, will be reported.	Up to 4 weeks
Mean change of score on EuroQol five-dimensional Questionnaire (EQ-5D)	EQ-5D is a standardized instrument for measuring generic health status. The health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondents self-rate their level of severity for each dimension by selecting one of the following responses: no problems (0), slight problems (1), mild problems (2), moderate problems (3), or severe problems (4) with a particular dimension. The mean and standard deviation of the change in EQ-5D scores, along with the 95% confidence interval, will be reported.	Up to 4 weeks
Mean technical success rate of Pulsed Electric Field (PEF) ablation	Immediately after PEF ablation, the technical success rate and any procedural technical challenges will be recorded. Mean, standard deviation of technical success rate for PEF ablation and 95% confidence will be reported.	Up to 1 day

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Society of Interventional Radiology Foundation; Galvanize Therapeutics, Inc.
• Investigators: Principal Investigator: Ryan Kohlbrenner, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 23, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Image Guided Ablation; Tumor Ablation
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Therapeutics; Drug Therapy; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Drug Delivery Systems; Surveys and Questionnaires
• Other Study ID Numbers: 259216; NCI-2026-01819 (Registry Identifier: NCI Clinical Trials Reporting System (CTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes