Pulsed Electric Field Ablation for Metastatic Breast Cancer

NCT07487844 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: 259216NCI-2026-01819
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Breast Cancer; Breast Cancer

Keywords

Image Guided Ablation; Tumor Ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Mean change of score on European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Breast Cancer Module (EORTC QLQ BR-23)

  Up to 4 weeks

• Mean change of score on EuroQol five-dimensional Questionnaire (EQ-5D)

  Up to 4 weeks

• Mean technical success rate of Pulsed Electric Field (PEF) ablation

  Up to 1 day

Study Arms (1)

Image-Guided Pulsed Electric Field (PEF) Ablation

EXPERIMENTAL

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; Behavioral: Questionnaires; Procedure: Tumor Ablation

Interventions

Pulsed Electric Field (PEF) System DEVICE

Pulsed electric field (PEF) delivers short, high frequency electrical pulses that are intended to shrink or destroy tumors

Also known as: PEF, Aliya™ PEF System

Image-Guided Pulsed Electric Field (PEF) Ablation

Questionnaires BEHAVIORAL

Participants will complete health related, quality of life questionnaires

Image-Guided Pulsed Electric Field (PEF) Ablation

Tumor Ablation PROCEDURE

Undergo ablation via PEF

Also known as: Ablation

Image-Guided Pulsed Electric Field (PEF) Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Adequate Bone Marrow Function:
• Absolute neutrophil count ≥1,500/microliter (mcL).
• Platelets ≥100,000/mcL.
• Not on or able to withhold anticoagulation or antiplatelet therapy per Society of Interventional Radiology periprocedural guideline.
• 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.
• 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.
• 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).
• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Galvanize Therapeutics, Inc.: collaborator
• Society of Interventional Radiology Foundation: collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Drug Delivery Systems; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ryan Kohlbrenner, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maya Aslam

CONTACT

877-827-3222; maya.aslam@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 23, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)