What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as chemotherapy, radiation therapy, and targeted therapies, often come with a range of side effects. Chemotherapy can cause nausea, fatigue, hair loss, and increased risk of infection. Radiation therapy may lead to skin irritation, fatigue, and localized pain. Targeted therapies, which include drugs like trastuzumab, can cause heart problems, diarrhea, and liver issues. Tumor Treating Fields (TTF), which disrupt the mitotic process of tumor cells, are generally well-tolerated but can cause skin irritation at the site of device application. It's important for patients to discuss these potential side effects with their healthcare provider to manage them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer that target the mitotic process of tumor cells, similar to the mechanism of Tumor Treating Fields (TTF). One such class of drugs includes microtubule inhibitors like paclitaxel and docetaxel, which disrupt cell division by stabilizing microtubules. Additionally, CDK4/6 inhibitors such as palbociclib, ribociclib, and abemaciclib have been approved; these drugs inhibit cyclin-dependent kinases involved in cell cycle progression. While TTF is a novel approach using electric fields to disrupt mitosis, these pharmacological treatments also aim to halt tumor growth by interfering with cell division.

What other types of research exist?

Promising novel alternatives to Novo TTF-200T for breast cancer patients include: 1) Combination of TAK228 (an mTORC1/2 inhibitor) with eribulin, which has shown synergistic effects in triple-negative breast cancer (TNBC) cell lines and patient-derived xenografts. 2) Dabrafenib plus trametinib for patients with BRAFV600E-mutated tumors, which has demonstrated efficacy in various cancer types, including breast cancer. 3) PD-1 blockade with nivolumab, particularly for patients with high PD-L1 expression or mismatch repair deficiency, which has shown promising results in clinical trials.

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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 9Eligibility criteria met

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.