20 Participants NeededMy employer runs this trial

Pulsed Electric Field Ablation for Breast Cancer

MA
Overseen ByMaya Aslam
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Francisco
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach called Pulsed Electric Field (PEF) Ablation to treat specific breast cancer spots that have spread near the skin. The researchers aim to determine if this method is safe for individuals with metastatic breast cancer, where the cancer has spread from its original site. Individuals with confirmed breast cancer that has spread to or just below the skin and is clearly visible on imaging may be suitable candidates.

As an unphased trial, this study provides patients the opportunity to contribute to pioneering research that could lead to new treatment options.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop your systemic therapy for breast cancer one week before the procedure and for 2 weeks after it. Additionally, you must be able to withhold anticoagulation or antiplatelet therapy as per guidelines.

What prior data suggests that pulsed electric field ablation is safe for treating metastatic breast cancer?

Research has shown that pulsed electric field (PEF) ablation is generally safe for treating cancer. Previous studies have found PEF to be a minimally invasive and effective treatment, particularly beneficial when breast cancer becomes resistant to other therapies.

In one study, PEF treatment was successfully delivered before surgery every time, achieving a 100% technical success rate. Another study confirmed its safety but noted the need for more research with larger groups to validate these findings.

A specific case report described a long-lasting positive response in breast cancer following PEF ablation, suggesting enduring effects. Importantly, PEF treatment maintained a good safety record, with no significant side effects directly related to the treatment.

Overall, current research suggests PEF ablation is well-tolerated and safe, but ongoing studies will further confirm its safety in humans.12345

Why are researchers excited about this trial?

Unlike the standard treatments for metastatic breast cancer, such as chemotherapy, radiation, and surgery, Pulsed Electric Field (PEF) Ablation represents a novel approach. PEF Ablation uses electrical pulses to target and destroy cancerous cells without damaging surrounding healthy tissue. This targeted method reduces collateral damage and could potentially lead to fewer side effects, which is why researchers are excited about its potential. Moreover, the treatment is delivered in a single session, which could offer a more convenient option for patients compared to the often lengthy cycles of chemotherapy or radiation therapy.

What evidence suggests that pulsed electric field ablation is effective for metastatic breast cancer?

Research has shown that pulsed electric field (PEF) ablation can shrink or destroy tumors by delivering short bursts of electrical energy. In studies with mice, PEF not only slowed breast cancer growth but also enhanced the immune system's ability to combat the cancer. A case report demonstrated that a patient with advanced breast cancer experienced a lasting positive response to PEF treatment. Compared to radiofrequency (RF) ablation, PEF improved the body's ability to recognize and fight specific cancer cells. Early findings suggest that PEF holds promise for treating breast cancer by both targeting tumors and boosting the immune system. Participants in this trial will receive a single PEF ablation treatment applied to up to three soft tissue metastatic breast cancer lesions.13678

Who Is on the Research Team?

RK

Ryan Kohlbrenner, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults (18+) with metastatic breast cancer who have at least one soft tissue tumor between 1-5 cm that can be reached by imaging. Participants must be able to pause their cancer treatment briefly, have good blood counts, and not be pregnant or breastfeeding. People with pacemakers or certain medical conditions can't join.

Inclusion Criteria

I have another cancer that does not affect my current treatment or safety.
I can safely pause my breast cancer treatment before and after the procedure.
I am 18 years old or older.
See 9 more

Exclusion Criteria

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 pacemakers or other electronic implant devices
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a single treatment of PEF ablation delivered to up to 3 soft tissue metastatic breast cancer lesions

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year
Visits at Day 0, week 2, week 4, and up to 1 year post ablation

What Are the Treatments Tested in This Trial?

Interventions

  • Pulsed Electric Field Ablation

Trial Overview

The study is testing the safety of a new procedure called pulsed electric field (PEF) ablation using the AliyaTM system to treat up to three accessible tumors in people with metastatic breast cancer. The procedure uses electrical pulses guided by imaging.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Image-Guided Pulsed Electric Field (PEF) AblationExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Galvanize Therapeutics, Inc.

Industry Sponsor

Trials
5
Recruited
280+

Society of Interventional Radiology Foundation

Collaborator

Trials
6
Recruited
2,300+

Citations

Pulsed Electric Field Ablation for Metastatic Breast Cancer

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

Pulsed Electric Field Ablation versus Radiofrequency ...

Abstract 6392: combination of pulsed electric field, immunotherapy and cisplatin significantly prolongs survival in an orthotopic breast cancer mouse model.

Case Report: durable response to pulsed electric field ... - PMC

Here, we report a case of metastatic hormone receptor-positive, HER2-low breast cancer demonstrating a durable response following PEF ablation combined with ...

Pulsed Electric Field Ablation versus Radiofrequency ...

PEF increased systemic adaptive immunity, including activated and antigen-specific T cells, and decreased regulatory T cells compared with RF ablation. •. PEF ...

Pulsed Electric Field Ablation versus Radiofrequency Thermal ...

RESULTS: PEF elicited distinct immunomodulatory effects, with clear differences in serum and tumor cytokine profiles compared with RF ablation, including ...

Pulsed electric fields: a sharp sword in the battle against cancers

PEFs effectively overcome chemoresistance in breast cancer while offering a minimally invasive, safe, and efficacious therapeutic approach. For ...

Case Report: durable response to pulsed electric field ...

Here, we report a case of metastatic hormone receptor-positive, HER2-low breast cancer demonstrating a durable response following PEF ablation combined with ...

Pulsed Electric Field Ablation May Show Feasibility, Safety ...

Data from the INCITE-ES study show 100% technical success with pulsed electric field energy delivery before surgical resection.