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Medical Device

Electric Field Therapy for Metastatic Breast Cancer

N/A
Recruiting
Led By Kurt A Jaeckle, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed diagnosis of leptomeningeal metastases (LM) with positive cerebrospinal fluid (CSF) cytology for malignancy and meningeal enhancement (type 1A, 1B, and 1C)
Prior tissue diagnosis of breast cancer
Must not have
Must not have received radiation therapy (RT) to the brain or spinal cord within 2 weeks of initiation of TTF
Patients with uncontrolled or untreated infection including active hepatitis, and human immunodeficiency virus (HIV)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Summary

This trial tests a portable device that uses electric fields to stop cancer cells from growing in patients with breast cancer that has spread to the spine. The goal is to see if this treatment is safe and effective.

Who is the study for?
This trial is for adults with breast cancer that has spread to the spine. Participants must be willing to wear a treatment device for at least 18 hours daily, have good liver and kidney function, an ECOG status of 0-3, and a life expectancy over 6 weeks. They should not be pregnant or breastfeeding, have uncontrolled infections like HIV or hepatitis, allergies to certain gels used in the study, spinal surgical hardware in the treatment area, or recent other treatments.
What is being tested?
The trial tests a portable device called Novo TTF-200T which emits electric fields aimed at stopping tumor growth in patients with leptomeningeal metastases from breast cancer. It involves wearing the device on the body targeting spinal areas and monitoring its safety and effectiveness through MRI scans and other assessments.
What are the potential side effects?
Potential side effects may include skin irritation where the device attaches, discomfort from wearing it long-term each day, possible headaches or neurological symptoms if affecting brain function due to proximity to spine but specific side effects will be monitored throughout.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has spread to the lining of my brain and spinal cord.
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I have been previously diagnosed with breast cancer through a tissue test.
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I am 18 years old or older.
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I can care for myself but may not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had brain or spinal cord radiation in the last 2 weeks.
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I do not have any untreated infections like hepatitis or HIV.
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I am not pregnant or breastfeeding and willing to use birth control.
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I have surgical hardware like rods or screws in my spine.
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I am not on high-dose methotrexate, thiotepa, or cytarabine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of TTFs - estimated the number of patients who are unable to complete at least 30 days of TTF therapy
Incidence of significant toxicity of tumor treating fields (TTFs)
Secondary study objectives
Preliminary signals of activity (defined as either suspicious or positive cytology).
Preliminary signals of activity by Leptomeningeal Assessment in Neuro-Oncology scoring and the M. D. Anderson Symptom Inventory -spine module data (MDASI-SP)
Preliminary signals of activity by Leptomeningeal Assessment in Neuro-Oncology scoring and the M. D. Anderson Symptom Inventory -spine module data (MDASI-SP) and adverse events.
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (TTFields, digital photos)Experimental Treatment4 Interventions
Patients have transducer arrays applied and digital photographs taken of placement on study. Patients wear the NovoTTF-200T portable system on study. Patients also undergo MRI and may undergo LP during screening and on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lumbar Puncture
2016
Completed Phase 3
~510
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Medical Device Usage and Evaluation
2021
N/A
~160

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for breast cancer include endocrine therapy, chemotherapy, targeted therapy, and radiation therapy. Endocrine therapy, such as tamoxifen or aromatase inhibitors, blocks hormone receptors or reduces hormone production, slowing the growth of hormone receptor-positive cancers. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, including cancer cells. Targeted therapies, like trastuzumab, specifically target molecular markers on cancer cells, such as HER2, to inhibit their growth and survival. Radiation therapy uses high-energy rays to destroy cancer cells. Tumor Treating Fields (TTF) disrupt the mitotic process of tumor cells by applying electric fields, which interfere with cell division. Understanding these mechanisms is crucial for breast cancer patients as it helps tailor treatments to the specific characteristics of their cancer, potentially improving outcomes and minimizing side effects.
Endocrine and targeted manipulation of breast cancer: summary statement for the Sixth Cambridge Conference.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,312 Previous Clinical Trials
2,956,585 Total Patients Enrolled
84 Trials studying Breast Cancer
14,796 Patients Enrolled for Breast Cancer
Kurt A Jaeckle, M.D.Principal InvestigatorMayo Clinic
Kurt A JaecklePrincipal InvestigatorMayo Clinic

Media Library

Novo TTF-200T device (Medical Device) Clinical Trial Eligibility Overview. Trial Name: NCT05746325 — N/A
Breast Cancer Research Study Groups: Treatment (TTFields, digital photos)
Breast Cancer Clinical Trial 2023: Novo TTF-200T device Highlights & Side Effects. Trial Name: NCT05746325 — N/A
Novo TTF-200T device (Medical Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05746325 — N/A
~2 spots leftby Mar 2026