Anatomic Stage IV Breast Cancer AJCC v8NCT05746325
Tumor Treating Fields for the Treatment of Leptomeningeal Metastases of the Spine in Patients With Breast or Lung Cancer
A study testing Digital Photography, Lumbar Puncture and Magnetic Resonance Imaging in people with Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This clinical trial evaluates the safety and feasibility of tumor treating fields (TTF) in the treatment of spinal leptomeningeal disease in patients with breast or lung cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Malignant Neoplasm in the Leptomeninges
- What is being tested?
- Digital Photography, Lumbar Puncture and Magnetic Resonance Imaging
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2023to 1 Jun 2027
- 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
- Age >= 18
- Prior tissue diagnosis of breast cancer or lung cancer
- Confirmed diagnosis of leptomeningeal metastases (LM) with positive cerebrospinal fluid (CSF) cytology for malignancy and meningeal enhancement (type 1A, 1B, and 1C)
- Radiographic evidence on MRI of leptomeningeal enhancement within the cervical, thoracic or lumbar spine on spinal MRI
- Life expectancy of at least 6 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2, or 3
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- Recovery from any neurotoxic effects of prior therapy
- Platelet count greater than 25 x 10^9/L
- Absolute neutrophil count (ANC) greater than 0.5 x 10^9/L
- Patients must have adequate liver function, total bilirubin < 2.5 mg/dL, unless elevated total bilirubin is due to elevated indirect bilirubin from known Gilbert's disease, aspartate aminotransferase (AST) =< 3.5 times upper limits of normal; adequate renal function [calculated estimated glomerular filtration rate (eGFR) >= 30 mL/min/ body surface area (BSA)]
- Patients or legal medical representative must provide written informed consent
- Patients must have suitable body habitus for placement of transducer arrays
- Patients must be willing to wear the device for at least 18 hours a day (averaged over monthly)
- Patients must be willing to return for the scheduled evaluations and perform the required assessments
- Patients are without other disease or situation which would significantly compromise adequate assessment of safety and feasibility of the TTF
- Patient willing to start a study treatment with TTF =< 14 days from registration
Who cannot join
- Concomitant therapy:
- Must not be receiving concurrent high-dose methotrexate (>= 3 g/m^2), high dose thiotepa, or high-dose cytarabine (>= 3 g/m^2). Any other systemic chemotherapy, targeted treatment, hormonal or immunotherapy directed at the primary systemic malignancy is permitted
- Must not have received radiation therapy (RT) to the brain or spinal cord within 2 weeks of initiation of TTF
- Must be at least 1 week from cessation of any prior intrathecal chemotherapy
- Women of childbearing age who are pregnant or lactating. (Male and female patients who are fertile must be willing to use an effective means of birth control to avoid pregnancy)
- Patients with uncontrolled or untreated infection including active hepatitis, and human immunodeficiency virus (HIV)
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- 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
- Patients known to be allergic to the hydrophilic gel utilized for transducer attachment
- Patients with surgical hardware within the planned area of treatment in the spine (e.g., titanium rods, screws, fixation devices)
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
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Wendy J. Sherman, MD
About this study
Official title: Pilot Feasibility Study of Tumor Treating Fields in Treatment of Leptomeningeal Metastases Involving the Spine
This clinical trial evaluates the safety and feasibility of tumor treating fields (TTF) in the treatment of spinal leptomeningeal disease in patients with breast or lung cancer that has spread from where it first started (primary site) to other places in the body (metastatic). 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 from this study will help researchers develop a better treatment for leptomeningeal metastases in the future.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine whether the TTF device can be successfully placed in the three protocol-specified treatment field arrays (cervical, thoracic, and lumbar) and worn by the study patients for a meaningful period of time in the treatment of leptomeningeal metastases within the spine.
SECONDARY OBJECTIVE:
- To document any preliminary signals of activity, as measured by radiographic and clinical response, or durable stability of objective neurologic examination, utilizing Leptomeningeal Assessment in Neuro-Oncology (LANO) criteria, magnetic resonance imaging (MRI) imaging, cerebrospinal fluid (CSF) cytologic examination, and patient-reported symptom assessment (M. D. Anderson Symptom Inventory [MDASI]-spine module).
OUTLINE:
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 during screening and on study and may undergo lumbar puncture (LP) and collection of cerebrospinal fluid (CSF) samples during screening if no CSF testing for malignancy has been done previously.
After completion of study intervention, patients are followed up every 3 months or every 6 months.
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Malignant Neoplasm in the Leptomeninges, Metastatic Lung Carcinoma, Stage IV Lung Cancer AJCC v8
- Being tested
- Digital Photography, Lumbar Puncture, Magnetic Resonance Imaging, Medical Device Usage and Evaluation, Biospecimen Collection
- Medical subject headings
- Breast Neoplasms, Meningeal Carcinomatosis, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital PhotographyOther
Digital photographs taken of array placement
Lumbar PunctureProcedure or surgery
Also called LP, Spinal Tap
Undergo LP
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR
Undergo MRI
Medical Device Usage and EvaluationDevice
Transducer arrays applied and wear NovoTTF-200T
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Specimen Collection
Undergo collection of cerebrospinal fluid (CSF) during screening if no CSF testing for malignancy has been done previously
| Study group | Role | What they receive |
|---|---|---|
| Treatment (TTFields, digital photos) | Experimental | 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. Receives: Other: Digital Photography; Procedure: Lumbar Puncture; Procedure: Magnetic Resonance Imaging; Device: Medical Device Usage and Evaluation; Procedure: Biospecimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of significant toxicity of tumor treating fields (TTFs)
Will be measured by incidence of grade 3 or greater non-hematologic adverse events that persist despite temporary interruption of treatment and maximal medical management (i.e., grade 3 or greater non-hematologic toxicities that are not responsive to cessation of treatment and administration of supportive care). Toxicities will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Up to 3 years
Feasibility of TTFs - completion of at least 28 days of TTF therapy
Assessed by the number of patients who are unable to complete at least 28 days of TTF therapy (a composite average for the 28 days of at least 50% of array 'on' time) due to unacceptable adverse events. Treatment with TTF will be considered feasible if the stopping rule is not reached, as defined per protocol.
Measured: Up to 28 days
Secondary outcomes (6)
Preliminary signals of activity - CSF cytologic response
Descriptive analyses will be performed to assess preliminary signals of activity. CSF cytologic response will be assessed for patients who had positive CSF cytology at baseline.
Measured: Up to 3 years
Preliminary signals of activity - MRI radiographic response
Descriptive analyses will be performed. Assessed by MRI radiographic response within the TTF field
Measured: Up to 3 years
Preliminary signals of activity - time to CSF cytologic repsonse
Descriptive analyses will be performed. Assessed by time to CSF cytologic response (patients with positive baseline CSF cytology only), defined as the date of initiation of TTF to the last date of three consecutive negative CSF cytologic examinations).
Measured: Up to 3 years
Preliminary signals of activity - duration of CSF cytologic response
Descriptive analyses will be performed. Assessed by time from the date of the third consecutive negative CSF to CSF cytologic relapse (defined as either suspicious or positive cytology).
Measured: Up to 3 years
Preliminary signals of activity - neurologic progression-free survival
Descriptive analyses will be performed. Assessed by neurologic progression-free survival, the time from study enrollment to documented worsening of neurological symptoms or signs of disease progression.
Measured: Up to 3 years
Preliminary signals of activity (defined as either suspicious or positive cytology).
Descriptive analyses will be performed. Data evaluated will include: Duration of cytologic response (time from the date of the third consecutive negative CSF to CSF cytologic relapse (defined as either suspicious or positive cytology).
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start5 May 2023
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage IV Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wendy J. Sherman, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746325
- Sponsor's protocol ID
- MC210303
- Other IDs
- 21-005732
- Status last verified
- Oct 2026
- First submitted
- 14 Feb 2023
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility Study of Tumor Treating Fields in Treatment of Leptomeningeal Metastases Involving the Spine
- ClinicalTrials.gov ID
- NCT05746325
- Acronym / sponsor ID
- MC210303
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Malignant Neoplasm in the Leptomeninges, Metastatic Lung Carcinoma, Stage IV Lung Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 5 May 2023 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 27 Feb 2023 (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 clinical trial evaluates the safety and feasibility of tumor treating fields (TTF) in the treatment of spinal leptomeningeal disease in patients with breast or lung cancer that has spread from where it first started (primary site) to other places in the body (metastatic). 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 from this study will help researchers develop a better treatment for leptomeningeal metastases in the future.
Detailed description
PRIMARY OBJECTIVE:
- To determine whether the TTF device can be successfully placed in the three protocol-specified treatment field arrays (cervical, thoracic, and lumbar) and worn by the study patients for a meaningful period of time in the treatment of leptomeningeal metastases within the spine.
SECONDARY OBJECTIVE:
- To document any preliminary signals of activity, as measured by radiographic and clinical response, or durable stability of objective neurologic examination, utilizing Leptomeningeal Assessment in Neuro-Oncology (LANO) criteria, magnetic resonance imaging (MRI) imaging, cerebrospinal fluid (CSF) cytologic examination, and patient-reported symptom assessment (M. D. Anderson Symptom Inventory [MDASI]-spine module).
OUTLINE:
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 during screening and on study and may undergo lumbar puncture (LP) and collection of cerebrospinal fluid (CSF) samples during screening if no CSF testing for malignancy has been done previously.
After completion of study intervention, patients are followed up every 3 months or every 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (TTFields, digital photos) | Experimental | Other: Digital Photography, Procedure: Lumbar Puncture, Procedure: Magnetic Resonance Imaging, Device: Medical Device Usage and Evaluation, Procedure: Biospecimen CollectionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age >= 18
- Prior tissue diagnosis of breast cancer or lung cancer
- Confirmed diagnosis of leptomeningeal metastases (LM) with positive cerebrospinal fluid (CSF) cytology for malignancy and meningeal enhancement (type 1A, 1B, and 1C)
- Radiographic evidence on MRI of leptomeningeal enhancement within the cervical, thoracic or lumbar spine on spinal MRI
- Life expectancy of at least 6 weeks
Key exclusion criteria (9 listed)
- Concomitant therapy:
- Women of childbearing age who are pregnant or lactating. (Male and female patients who are fertile must be willing to use an effective means of birth control to avoid pregnancy)
- Patients with uncontrolled or untreated infection including active hepatitis, and human immunodeficiency virus (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
- Patients known to be allergic to the hydrophilic gel utilized for transducer attachment
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 |
|---|---|---|
| Digital PhotographyDigital photographs taken of array placement | Other | Treatment (TTFields, digital photos) |
| Lumbar PunctureAlso: LP, Spinal TapUndergo LP | Procedure or surgery | Treatment (TTFields, digital photos) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRUndergo MRI | Procedure or surgery | Treatment (TTFields, digital photos) |
| Medical Device Usage and EvaluationTransducer arrays applied and wear NovoTTF-200T | Device | Treatment (TTFields, digital photos) |
| Biospecimen CollectionAlso: Biological Sample Collection, Specimen CollectionUndergo collection of cerebrospinal fluid (CSF) during screening if no CSF testing for malignancy has been done previously | Procedure or surgery | Treatment (TTFields, digital photos) |
Primary outcome
Incidence of significant toxicity of tumor treating fields (TTFs)
Time frame: Up to 3 years
Will be measured by incidence of grade 3 or greater non-hematologic adverse events that persist despite temporary interruption of treatment and maximal medical management (i.e., grade 3 or greater non-hematologic toxicities that are not responsive to cessation of treatment and administration of supportive care). Toxicities will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Feasibility of TTFs - completion of at least 28 days of TTF therapy
Time frame: Up to 28 days
Assessed by the number of patients who are unable to complete at least 28 days of TTF therapy (a composite average for the 28 days of at least 50% of array 'on' time) due to unacceptable adverse events. Treatment with TTF will be considered feasible if the stopping rule is not reached, as defined per protocol.
6 secondary outcomes
Preliminary signals of activity - CSF cytologic response
Time frame: Up to 3 years
Preliminary signals of activity - MRI radiographic response
Time frame: Up to 3 years
Preliminary signals of activity - time to CSF cytologic repsonse
Time frame: Up to 3 years
Preliminary signals of activity - duration of CSF cytologic response
Time frame: Up to 3 years
Preliminary signals of activity - neurologic progression-free survival
Time frame: Up to 3 years
Preliminary signals of activity (defined as either suspicious or positive cytology).
Time frame: Up to 3 years
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 30 Oct 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Wendy J. Sherman, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Photography, Lumbar Puncture and Magnetic Resonance Imaging in people with Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma, run by Mayo Clinic 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 16 inclusion and 9 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 30 Oct 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 Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of significant toxicity of tumor treating fields (TTFs) (time frame: Up to 3 years). The study lists 2 primary outcomes in all. 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 30 Oct 2026.