Metastatic Breast CancerNCT07487844
Pulsed Electric Field Ablation for Metastatic Breast Cancer
A study testing Pulsed Electric Field (PEF) System, Questionnaires and Tumor Ablation in people with Metastatic Breast Cancer and Breast Cancer, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Breast Cancer
- What is being tested?
- Pulsed Electric Field (PEF) System, Questionnaires and Tumor Ablation
- Type of treatment
- Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2026to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California San Francisco
San Francisco, California, 94143
Maya Aslam, 877-827-3222, Maya.Aslam@ucsf.edu
cancertrials@ucsf.edu
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess the safety of PEF for locoregional treatment of soft tissue metastatic breast cancer lesions.
SECONDARY OBJECTIVE:
- 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:
- 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
- Being tested
- Pulsed Electric Field (PEF) System, Questionnaires, Tumor Ablation
- Keywords
- Image Guided Ablation, Tumor Ablation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Electric Field (PEF) SystemDevice
Also called PEF, Aliya™ PEF System
Pulsed electric field (PEF) delivers short, high frequency electrical pulses that are intended to shrink or destroy tumors
QuestionnairesBehavioural
Participants will complete health related, quality of life questionnaires
Tumor AblationProcedure or surgery
Also called Ablation
Undergo ablation via PEF
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Pulsed Electric Field (PEF) System; Behavioral: Questionnaires; Procedure: Tumor Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: Up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start29 Jun 2026
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Galvanize Therapeutics, Inc., Society of Interventional Radiology Foundation
- Responsible party
- Sponsor
- Investigators
- Ryan Kohlbrenner, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487844
- Sponsor's protocol ID
- 259216
- Other IDs
- NCI-2026-01819
- Status last verified
- Sep 2026
- First submitted
- 17 Mar 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image-Guided Pulsed Electric Field (PEF) Ablation of Soft Tissue Lesions in Metastatic Breast Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT07487844
- Acronym / sponsor ID
- 259216
- Conditions
- Metastatic Breast Cancer, Breast Cancer
- Keywords
- Image Guided Ablation, Tumor Ablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Galvanize Therapeutics, Inc., Society of Interventional Radiology Foundation
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess the safety of PEF for locoregional treatment of soft tissue metastatic breast cancer lesions.
SECONDARY OBJECTIVE:
- 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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Image-Guided Pulsed Electric Field (PEF) Ablation | Experimental | Device: Pulsed Electric Field (PEF) System, Behavioral: Questionnaires, Procedure: Tumor AblationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed Electric Field (PEF) SystemAlso: PEF, Aliya™ PEF SystemPulsed electric field (PEF) delivers short, high frequency electrical pulses that are intended to shrink or destroy tumors | Device | Image-Guided Pulsed Electric Field (PEF) Ablation |
| QuestionnairesParticipants will complete health related, quality of life questionnaires | Behavioural | Image-Guided Pulsed Electric Field (PEF) Ablation |
| Tumor AblationAlso: AblationUndergo ablation via PEF | Procedure or surgery | Image-Guided Pulsed Electric Field (PEF) Ablation |
Primary outcome
Proportion of participants with treatment-emergent adverse events
Time frame: Up to 4 weeks
Proportion of participants who experience adverse event from the Pulsed Electric Field (PEF) ablation treatment. Standard deviation and 95% confidence intervals will be reported.
3 secondary outcomes
Mean change of score on European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Breast Cancer Module (EORTC QLQ BR-23)
Time frame: Up to 4 weeks
Mean change of score on EuroQol five-dimensional Questionnaire (EQ-5D)
Time frame: Up to 4 weeks
Mean technical success rate of Pulsed Electric Field (PEF) ablation
Time frame: Up to 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ryan Kohlbrenner, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Electric Field (PEF) System, Questionnaires and Tumor Ablation in people with Metastatic Breast Cancer and Breast Cancer, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maya Aslam (877-827-3222, maya.aslam@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with treatment-emergent adverse events (time frame: Up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.