Electric Field Therapy for Metastatic Breast Cancer

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: High-dose methotrexate, thiotepa, cytarabine

Disqualifiers: Pregnancy, Uncontrolled infection, Surgical hardware, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Up to 30 days

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and use of the Novo TTF-200T device, which uses electric fields to slow tumor growth in individuals with breast or lung cancer that has spread to the spine. The trial focuses on treating leptomeningeal metastases, where cancer spreads to the brain and spinal cord lining. Suitable candidates have breast or lung cancer that has spread in this manner and are willing to wear the device for most of the day. Participants will help researchers determine if this treatment can become a better option for similar conditions in the future. As an unphased trial, this study allows patients to contribute to groundbreaking research that could lead to new treatment options.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications, except for high-dose methotrexate, high-dose thiotepa, or high-dose cytarabine. Other treatments for your primary cancer are allowed.

What prior data suggests that the Novo TTF-200T device is safe for treating metastatic cancer?

Research shows that the Novo TTF-200T device stops cancer cells from growing by using electric fields. In past studies, most patients tolerated this device well. Reports suggest that combining it with certain cancer drugs, like taxanes, might be safe and beneficial. Although the device is being tested for various cancers, including lung cancer, it has not yet received approval for these uses. Existing safety data indicates it has been used without serious side effects in similar situations, but ongoing trials continue to gather more information about its safety for different conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for metastatic breast cancer, which often involve chemotherapy and hormone therapy, the NovoTTF-200T device uses Tumor Treating Fields (TTFields). This innovative approach uses electric fields to disrupt cancer cell division, potentially slowing or stopping tumor growth without the systemic side effects of conventional treatments. Researchers are excited because this non-invasive method targets cancer cells specifically, offering a treatment option that might be less taxing on the body while providing a new way to combat metastatic breast cancer.

What evidence suggests that the Novo TTF-200T device is effective for treating metastatic breast cancer?

Research shows that Tumor Treating Fields (TTFields) therapy, such as the Novo TTF-200T device, effectively treats cancer noninvasively. Studies have found that TTFields can slow tumor growth using electric fields. In one study with 30 patients, the average time without disease progression was 9.3 months, and the average survival time was 15.8 months. Additionally, 66% of patients were still alive one year after treatment. In this trial, participants will receive treatment with the Novo TTF-200T device, which may offer promise for advanced conditions like spinal leptomeningeal disease from breast cancer. ^{3 4 6 7 8}

Who Is on the Research Team?

Wendy J. Sherman, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My body shape allows for the placement of medical sensor pads.

I have been previously diagnosed with breast cancer through a tissue test.

My cancer has spread to the lining of my brain and spinal cord.

Exclusion Criteria

I haven't had brain or spinal cord radiation in the last 2 weeks.

I do not have any untreated infections like hepatitis or HIV.

Patients receiving any other investigational agents and must not have received any other investigational agent within 14 days prior to registration. The 14-day period should be extended if the investigational agent is known to have delayed toxicity

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants wear the NovoTTF-200T portable system and undergo MRI and possibly lumbar puncture

Up to 30 days

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including radiographic and clinical response assessments

Up to 3 years

Regular visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Novo TTF-200T device

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment (TTFields, digital photos) Experimental Treatment 5 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.

Novo TTF-200T device is already approved in United States, European Union for the following indications:

Approved in United States as Novo TTF-200T device for:

• Glioblastoma
• Mesothelioma
• Breakthrough designation for unresectable or metastatic liver cancer in combination with atezolizumab and bevacizumab

Approved in European Union as Novo TTF-200T device for:

• Glioblastoma
• Mesothelioma

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Tumor treating fields (TTF) therapy is a novel, nonchemical treatment for cancer that uses electric fields to disrupt tumor cell division, and it is FDA-approved for patients with recurrent glioblastoma who have no other treatment options left.

TTF therapy is delivered noninvasively through a portable device with transducer arrays placed on the skin, marking a significant advancement in cancer treatment modalities beyond traditional methods like surgery and chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive application of alternating electric fields in glioblastoma: a fourth cancer treatment modality. Gutin, PH., Wong, ET.[2022]

Tumor treating fields (TTFields) significantly reduced the number of lung metastases and increased survival in animal models of cancer, indicating their potential effectiveness in preventing the spread of tumors.

In addition to inhibiting tumor growth, TTFields treatment led to increased immune cell infiltration in tumors, suggesting a possible mechanism for their ability to prevent metastasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternating electric fields (TTFields) inhibit metastatic spread of solid tumors to the lungs. Kirson, ED., Giladi, M., Gurvich, Z., et al.[2021]

Tumor Treating Fields (TTF) have been shown to effectively inhibit tumor growth in glioblastoma (GBM) by disrupting mitosis and inducing cell death, with clinical trials demonstrating improved progression-free and overall survival when combined with standard chemotherapy.

TTF treatment is non-invasive and has minimal systemic toxicity, making it a safe option for patients with GBM, as evidenced by randomized phase III trials that showed no significant adverse events compared to traditional chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor treating fields: a novel and effective therapy for glioblastoma: mechanism, efficacy, safety and future perspectives. Zhu, P., Zhu, JJ.[2018]

In the DESTINY-Breast01 study involving 184 participants with metastatic HER2-positive breast cancer, the treatment trastuzumab deruxtecan (T-DXd) led to a significant reduction in tumor growth, with 60.9% of participants experiencing tumor shrinkage or disappearance.

While T-DXd showed promising efficacy with an average treatment response duration of nearly 15 months, it also resulted in adverse events in nearly all participants, with nausea being the most common and serious side effects including lung toxicity reported in 22.8% of participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trastuzumab deruxtecan in previously treated HER2-positive metastatic breast cancer: Plain language summary of the DESTINY-Breast01 study. Modi, S.[2021]

A review of 81 clinical trials involving over 45,000 patients revealed that the reporting of adverse events (AEs) for targeted therapies and immunotherapies is often inadequate, particularly regarding recurrent/late toxicities and the duration of AEs.

The study highlights that more than 90% of trials failed to adequately report the timing and occurrence of all-grade AEs, indicating a need for improved transparency and detail in AE reporting in future oncology trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review of adverse events reporting in clinical trials leading to approval of targeted therapy and immunotherapy. Bossi, P., Botta, L., Bironzo, P., et al.[2020]

Tumor Treating Fields (TTFields) effectively reduced the viability of both wild type and multidrug-resistant (MDR) cancer cells, indicating its potential as a treatment for drug-resistant tumors.

When combined with chemotherapeutic agents like paclitaxel and doxorubicin, TTFields further enhanced the reduction in cell survival for both types of cells, suggesting a synergistic effect without affecting drug accumulation in MDR cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TTFields alone and in combination with chemotherapeutic agents effectively reduce the viability of MDR cell sub-lines that over-express ABC transporters. Schneiderman, RS., Shmueli, E., Kirson, ED., et al.[2021]

The NovoTTF-100A device, which delivers low-intensity electric fields, showed comparable efficacy to traditional chemotherapy in treating recurrent glioblastoma, with a median survival of 6.6 months for TTF compared to 6.0 months for chemotherapy, although this difference was not statistically significant.

Patients using the TTF device experienced fewer severe adverse events (6%) compared to those receiving chemotherapy (16%), and quality of life assessments generally favored the TTF treatment, indicating it may be a safer alternative for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Stupp, R., Wong, ET., Kanner, AA., et al.[2022]

Fam-trastuzumab deruxtecan-nxki (ENHERTU) received accelerated FDA approval for treating HER2-positive breast cancer in patients who have already undergone two or more anti-HER2 therapies, based on a study involving 184 patients that showed a confirmed overall response rate of 60.3%.

While ENHERTU is effective, it carries significant risks, including severe interstitial lung disease and neutropenia, highlighting the importance of monitoring for serious side effects during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Fam-Trastuzumab Deruxtecan-Nxki for the Treatment of Unresectable or Metastatic HER2-Positive Breast Cancer. Narayan, P., Osgood, CL., Singh, H., et al.[2022]

The combination of tumor treating fields (TTF) therapy and radiotherapy (RT) significantly inhibited pancreatic cancer cell growth more effectively than either treatment alone, as demonstrated in two pancreatic cancer cell lines (CFPAC-I and HPAF-II).

This combined treatment not only enhanced cancer cell death (apoptosis) but also showed a synergistic effect on cell survival, suggesting it could be a promising alternative for treating difficult pancreatic cancer cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor treating fields (TTF) treatment enhances radiation-induced apoptosis in pancreatic cancer cells. Jo, Y., Oh, G., Gi, Y., et al.[2021]

Tumor Treating Fields (TTFields) therapy is a noninvasive treatment that uses electric fields to disrupt cancer cell processes, showing promise in enhancing the efficacy of standard chemotherapy without increasing systemic toxicity.

TTFields therapy primarily causes manageable localized skin reactions, making it a safer option to combine with other treatments like taxanes for cancers such as non-small cell lung cancer, ovarian cancer, and pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor Treating Fields (TTFields) Therapy Concomitant with Taxanes for Cancer Treatment. Vergote, I., Macarulla, T., Hirsch, FR., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02973789

NCT02973789 | Effect of Tumor Treating Fields (TTFields) ... The effect of treatment compliance with NovoTTF-200T on overall survival and progression free survival outcomes, 4 years. Adverse events, severity and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11093503/

Advancements and current trends in tumor treating fields TTFields therapy is a novel and effective noninvasive cancer therapy, and it has been approved by FDA in the treatment of recurrent and newly diagnosed ...

3. academic.oup.com academic.oup.com/oncolo/article/30/2/oyae227/7821273

Recent advances in Tumor Treating Fields (TTFields) therapy ... For the latter, results from a 30-patient study showed a median PFS of 9.3 months, median OS of 15.8 months, and 1-year survival of 66% ( ...

4. mayo.edu mayo.edu/research/clinical-trials/cls-20540776

Clinical Trials Patients wear the portable Novo TTF-200T device that produces electric fields to target areas on the body to stop the growth of tumor cells. The ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9913762/

Tumor Treating Fields (TTFields) Therapy Concomitant ... TTFields therapy usage was high with 77% of patients using it for 18 h/day in the first 3 months, and there were no paclitaxel dose reductions, suggesting good ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/P230042b.pdf

Tumor Treatment Fields II. Device Tr - accessdata.fda.gov TTFields physically disrupt the rapid cell division exhibited by cancer cells. Optune Lua delivers TTFields at 150 kHz to the entire chest ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05746325

Tumor Treating Fields for the Treatment of Leptomeningeal ... Patients wear the portable Novo TTF-200T device that produces electric fields to target areas on the body to stop the growth of tumor cells. The information ...

8. novocuretrials.com novocuretrials.com/cancer-clinical-trials/non-small-cell-lung-cancer-clinical-trial-lunar

LUNAR - NSCLC Clinical Trial The use of the NovoTTF-200T device for the treatment of non-small cell lung cancer (NSCLC) is investigational; it has not been approved for this use. The safety ...