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1

Photon Craniospinal Irradiation for Metastatic Breast Cancer with Leptomeningeal Disease

Phase II Trial of Photon Craniospinal Irradiation for Leptomeningeal Disease Secondary to Solid Tumor Malignancy

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of craniospinal irradiation (CSI) for leptomeningeal disease.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the <span class="highlight">leptomeninges</span> (leptomeningeal metastasis or leptomeningeal disease). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Craniospinal irradiation (CSI), 10 sessions within 2-3 weeks</li> <li class="seamTextUnorderedListItem">CSF samples</li> <li class="seamTextUnorderedListItem">MRI scans</li> <li class="seamTextUnorderedListItem">Questionnaires, 2 times in 1 month, then every 3 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leptomeningeal metastases are when cancer spreads to the membranes surrounding the brain and/or the spinal cord <span class="highlight">(leptomeninges)</span> or to the fluid surrounding the brain (cerebrospinal fluid or CSF).</li> <li class="seamTextUnorderedListItem">Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors.</li> <li class="seamTextUnorderedListItem">Craniospinal irradiation (CSI) is radiation therapy directed at the brain and spinal cord to kill tumor cells.</li> <li class="seamTextUnorderedListItem">CSI may be able to target all of the areas of possible leptomeningeal tumor spread.</li> <li class="seamTextUnorderedListItem">CSF is collected during a procedure called a lumbar puncture (spinal tap) or with an Ommaya reservoir.</li> <li class="seamTextUnorderedListItem">Ommaya reservoirs are very small plastic devices put under the scalp to give access to CSF.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">This trial is also available in Spanish.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06910761' target='_blank'>ClinicalTrials.gov</a> </li></ul>
1

Photon Craniospinal Irradiation for Metastatic Breast Cancer with Leptomeningeal Disease

Phase II Trial of Photon Craniospinal Irradiation for Leptomeningeal Disease Secondary to Solid Tumor Malignancy
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Nearest Location:
353 miles
City of Hope Medical Center
Duarte, CA

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Visits:
At least 10 visits within 2-3 weeks

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ClinicalTrials.gov: NCT06910761

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Phase II

2

PET/MRI Scan to Determine Response to Treatment for People with Metastatic HER2+ Breast Cancer with Brain or <span class="highlight">Leptomeninges</span> Metastasis

Pilot Study to Evaluate 64Cu-DOTA-Trastuzumab Imaging in Patients With HER2+ Breast Cancer With Brain Metastatsis Treated With Fam-Trastuzumab Deruxtecan

Purpose: To find HER2+ breast cancer that has spread to the brain and predict response to treatment with trastuzumab deruxtecan (Enhertu®), an antibody drug conjugate (ADC).

Who is this for?: People with metastatic (stage IV) HER2 positive (HER2+) breast cancer that has spread to the brain or <span class="highlight">leptomeninges</span> (brain or leptomeningeal metastasis) who are planning to receive treatment with trastuzumab deruxtecan (Enhertu®). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, 1 time</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">64Cu-DOTA-trastuzumab, by IV, 1 time</li> <li class="seamTextUnorderedListItem">PET/MRI scan, 1 time</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain MRI scan, every 1.5 months for 6 months, then every 2 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®), by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">64Cu-DOTA-trastuzumab is an experimental tracer that detects cancer cells during imaging scans.</li> <li class="seamTextUnorderedListItem">A positron emission tomography (PET) scan is an imaging test that uses a radioactive tracer to look for and attach to cancer cells.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy.</li> <li class="seamTextUnorderedListItem">The results of your PET/MRI scan will find the cancer in your brain and may predict your response to treatment.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is a type of anti-HER2 targeted therapy used to treat HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) is an antibody-drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®)'s antibody targets HER2 and delivers an anti-cancer drug called deruxtecan.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05376878' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cedars-sinai.org/programs/imaging-center/exams/nuclear-medicine/pet-mri.html' target='_blank'>Cedars-Sinai: PET/MRI Scan</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/enhertu' target='_blank'>Breastcancer.org: Trastuzumab deruxtecan (Enhertu®)</a> </li></ul>
2

PET/MRI Scan to Determine Response to Treatment for People with Metastatic HER2+ Breast Cancer with Brain or <span class="highlight">Leptomeninges</span> Metastasis

Pilot Study to Evaluate 64Cu-DOTA-Trastuzumab Imaging in Patients With HER2+ Breast Cancer With Brain Metastatsis Treated With Fam-Trastuzumab Deruxtecan
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Nearest Location:
353 miles
City of Hope Medical Center
Duarte, CA

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Visits:
1 visit every 1-2 months

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ClinicalTrials.gov: NCT05376878

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Phase IV

3

Proton Craniospinal Irradiation for Metastatic Breast Cancer with Leptomeningeal Metastasis

A Phase III Randomized Clinical Trial of Proton Craniospinal Irradiation Versus Involved-Field Radiotherapy for Patients With Breast Cancer or Non-Small Cell Lung Cancer Leptomeningeal Metastasis (RADIATE-LM)

Purpose: To compare the safety, effects (good and bad), and anti-cancer activity of proton craniospinal irradiation (pCSI), an experimental radiation therapy, and involved-field radiation therapy (IFRT).

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the <span class="highlight">leptomeninges</span> (leptomeningeal metastasis or leptomeningeal disease) who have not yet received treatment for leptomeningeal metastasis. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Involved-field radiation therapy (IFRT)</li> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">MRI scans</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Proton craniospinal irradiation (pCSI), 10 times within 2 weeks</li> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">MRI scans</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leptomeningeal metastases are when cancer spreads to the membranes surrounding the brain and/or the spinal cord <span class="highlight">(leptomeninges)</span> or to the fluid surrounding the brain (cerebrospinal fluid or CSF).</li> <li class="seamTextUnorderedListItem">Radiation therapy (RT) uses high energy x-rays to kill cancer cells and shrink tumors.</li> <li class="seamTextUnorderedListItem">Involved-field radiation therapy (IFRT) is standard of care radiation that uses x-rays to treat specific areas of leptomeningeal metastases (LM) and to reduce and/or prevent symptoms.</li> <li class="seamTextUnorderedListItem">Proton craniospinal irradiation (pCSI) uses protons which may be more accurate than x-rays.</li> <li class="seamTextUnorderedListItem">pCSI may also treat the entire central nervous system space containing the cerebrospinal fluid (CSF), brain, and spinal cord.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06500481' target='_blank'>ClinicalTrials.gov</a> </li></ul>
3

Proton Craniospinal Irradiation for Metastatic Breast Cancer with Leptomeningeal Metastasis

A Phase III Randomized Clinical Trial of Proton Craniospinal Irradiation Versus Involved-Field Radiotherapy for Patients With Breast Cancer or Non-Small Cell Lung Cancer Leptomeningeal Metastasis (RADIATE-LM)
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Nearest Location:
436 miles
UC San Diego Health System - Encinitas
Encinitas, CA

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Visits:
10 visits within 2 weeks

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ClinicalTrials.gov: NCT06500481

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Phase III

4

Radiation to Reduce Side Effects for People with Metastatic Breast Cancer with Leptomeningeal Metastases

A Multi-Center Phase 2 Study of Hippocampal Avoidance in Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumors

Purpose: To study if radiation to the brain and spinal cord is an effective treatment while also reducing side effects for people with leptomeningeal metastases.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the <span class="highlight">leptomeninges</span> (leptomeningeal disease). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation to brain and spinal cord, 10 times within 2 weeks</li> <li class="seamTextUnorderedListItem">Lumbar puncture to collect CSF</li> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">MRI scans</li> <li class="seamTextUnorderedListItem">Questionnaires, 4 times in 1 year</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation therapy can reduce symptoms of leptomeningeal metastases.</li> <li class="seamTextUnorderedListItem">However, the type of radiation therapy typically used does not prevent the spread of leptomeningeal disease.</li> <li class="seamTextUnorderedListItem">Craniospinal irradiation (CSI) is radiation therapy directed at the brain and spinal cord. It may be able to target all potential areas of leptomeningeal tumor spread.</li> <li class="seamTextUnorderedListItem">It may also reduce side effects of radiation because it avoids the part of the brain called the hippocampus.</li> <li class="seamTextUnorderedListItem">Cerebrospinal fluid (CSF) is the fluid that surrounds your brain and spinal cord. CSF is typically collected during a procedure called a lumbar puncture, also known as a spinal tap.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06518057' target='_blank'>ClinicalTrials.gov</a> </li></ul>
4

Radiation to Reduce Side Effects for People with Metastatic Breast Cancer with Leptomeningeal Metastases

A Multi-Center Phase 2 Study of Hippocampal Avoidance in Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumors
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Nearest Location:
682 miles
Fred Hutch/University of Washington Cancer Consortium
Seattle, WA

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Visits:
10 visits within 2 weeks

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ClinicalTrials.gov: NCT06518057

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Phase II

5

Rhenium-186 NanoLiposome Radioactive Drug for <span class="highlight">Leptomeninges</span> Metastases

A Multicenter Phase 1 Study to Determine the Safety and Efficacy of Multiple Doses at Defined Intervals of Rhenium (186Re) Obisbemeda (Rhenium-186 NanoLiposome, 186RNL) Administered Via Intraventricular Catheter for Any Primary Solid Tumor Cancer With Leptomeningeal Metastases (CA2024-LM-001)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of rhenium (186Re) obisbemeda (rhenium-186 nanoliposome), an experimental radioactive drug.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the <span class="highlight">leptomeninges.</span> You must not have received radiation to the whole brain. Other types of radiation to the brain are allowed. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Rhenium (186Re) obisbemeda (rhenium-186 nanoliposome), by catheter into the brain, multiple times over 13 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The <span class="highlight">leptomeninges</span> are the inner layers of tissue that line the brain and spinal cord.</li> <li class="seamTextUnorderedListItem">Rhenium (186Re) obisbemeda (rhenium-186 nanoliposome) is an experimental radiopharmaceutical or radioactive drug.</li> <li class="seamTextUnorderedListItem">Radiopharmaceuticals deliver radiation therapy directly and specifically to cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07098806' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://ir.plustherapeutics.com/static-files/415202a9-4f0f-4478-a604-ea0a183c34b7' target='_blank'>Plus Therapeutics: Rhenium (186Re) Obisbemeda (Rhenium-186 Nanoliposome)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/mbc-radiopharmaceuticals/' target='_blank'>What Are Radiopharmaceuticals and How Are They Used in MBC?</a> </li></ul>
5

Rhenium-186 NanoLiposome Radioactive Drug for <span class="highlight">Leptomeninges</span> Metastases

A Multicenter Phase 1 Study to Determine the Safety and Efficacy of Multiple Doses at Defined Intervals of Rhenium (186Re) Obisbemeda (Rhenium-186 NanoLiposome, 186RNL) Administered Via Intraventricular Catheter for Any Primary Solid Tumor Cancer With Leptomeningeal Metastases (CA2024-LM-001)
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Nearest Location:
1481 miles
The Cancer Therapy and Research Center at UTHSCSA
San Antonio, TX

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT07098806

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Phase I

6

Interviews to Understand the Experience and Priorities of People with CNS Metastases

Patient and Caregiver Priorities in Neuro-Oncology Care

Purpose: To study the experience and priorities of people living with brain, spine, and leptomeningeal metastases and their caregivers.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) or <span class="highlight">leptomeninges</span> (leptomeningeal disease). Your caregiver is also able to participate in the trial (optional). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will complete the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Interviews, 2 times</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">These results will help doctors find areas where patients and caregivers may need more support.</li> <li class="seamTextUnorderedListItem">Brain and leptomeningeal metastases are called central nervous system (CNS) metastases.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06676306' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>
6

Interviews to Understand the Experience and Priorities of People with CNS Metastases

Patient and Caregiver Priorities in Neuro-Oncology Care
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Nearest Location:
1615 miles
Mayo Clinic in Rochester
Rochester, MN

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06676306

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Phase NA

7

Developing a Nervous System Exam for People With Leptomeningeal Metastasis

Standardized Clinical Assessment of Patients With Leptomeningeal Metastasis (NANO-LM)

Purpose: To develop a nervous system (neurological) exam for people with leptomeningeal metastases.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the <span class="highlight">leptomeninges</span> (leptomeningeal metastasis or leptomeningeal disease). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nervous system exam</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The nervous system exam being developed in this study may be used in clinical trials and routine care.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06417710' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>
7

Developing a Nervous System Exam for People With Leptomeningeal Metastasis

Standardized Clinical Assessment of Patients With Leptomeningeal Metastasis (NANO-LM)
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Nearest Location:
1643 miles
MD Anderson Cancer Center
Houston, TX

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Visits:
1 visit

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ClinicalTrials.gov: NCT06417710

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Phase NA

8

Radiation Therapy and HER2-Targeted Therapies Infused Directly into the Brain for HER2+ Breast Cancer with Leptomeningeal Metastases

Phase I/II Study of Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in the Management of HER2+ Breast Leptomeningeal Disease

Purpose: To study the anti-cancer activity and side effects of giving two anti-HER2 targeted therapies directly into the brain after giving radiation therapy to the brain or spine.

Who is this for?: People with metastatic (stage IV) HER2-positive (HER2+) breast cancer with leptomeningeal disease -- breast cancer that has spread to the <span class="highlight">leptomeninges</span> (see below for the definition). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation therapy to the brain or spine, 5 to 10 times</li> <li class="seamTextUnorderedListItem">Surgery to place a device (Ommaya reservoir) similar to a chemotherapy port under your scalp</li> <li class="seamTextUnorderedListItem">followed by pertuzumab (Perjeta®) and trastuzumab (Herceptin®), by Ommaya reservoir, twice a week for one month, then once a week for one month, then every two weeks, ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to kill tumor cells that remain after surgery or other times in the treatment process. </li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®) is a HER2 targeted therapy commonly used to treat HER2-positive breast cancer.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy commonly used to treat HER2+ breast cancer. </li> <li class="seamTextUnorderedListItem">Leptomeningeal metastases are when cancer spreads to the membranes surrounding the brain and/or the spinal cord <span class="highlight">(leptomeninges)</span> or to the cerebrospinal fluid.</li> <li class="seamTextUnorderedListItem">Ommaya reservoirs are very small plastic devices put under the scalp to give access to cerebrospinal fluid (CSF) -- the fluid or liquid surrounding your brain and spinal cord.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of HER2+ cancer that have spread to the <span class="highlight">leptomeninges.</li></ul></span>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04588545' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/secondary-cancer/leptomeningeal-metastases/what-are#:~:text=Leptomeningeal%20metastases%20mean%20cancer%20cells,leptomeningeal%20disease' target='_blank'>Cancer Research UK: What are Leptomeningeal Metastases?</a> </li><li class='seamTextUnorderedListItem'><a href='https://moffitt.org/cancers/brain-tumor/leptomeningeal-disease/' target='_blank'>Moffitt Cancer Center: Leptomeningeal Disease</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mskcc.org/cancer-care/patient-education/faq-about-ommaya-reservoirs-and-ommaya-taps' target='_blank'>Memorial Sloan Kettering Cancer Center: Frequently Asked Questions About Ommaya Reservoirs and Ommaya Taps</a> </li></ul>
8

Radiation Therapy and HER2-Targeted Therapies Infused Directly into the Brain for HER2+ Breast Cancer with Leptomeningeal Metastases

Phase I/II Study of Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in the Management of HER2+ Breast Leptomeningeal Disease
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Nearest Location:
1851 miles
Northwestern University
Evanston, IL

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Visits:
Approximately 22 visits over the first 2.5 months; then 1 visit every 2 weeks, ongoing

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ClinicalTrials.gov: NCT04588545

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Phase I-II

9

Methotrexate in Metastatic Breast Cancer With Leptomeningeal Metastasis

Traditional Incision and Drainage of Cutaneous Abscess Vs. Minimally Invasive Incision and Drainage With Vessel Loop: A Randomized Controlled Trail

Purpose: To study the effects (good and bad) of using high-dose methotrexate to treat metastases in the cerebrospinal fluid surrounding the brain and spinal cord and/or in the <span class="highlight">leptomeninges</span> (the lining of the brain and spinal cord).

Who is this for?: People with metastatic (stage IV) breast cancer with leptomeningeal metastases (defined below). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">High-dose Methotrexate (HD-MTX), by IV, once every 2 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leptomeningeal metastases are when cancer spreads to the membranes surrounding the brain and/or the spinal cord <span class="highlight">(leptomeninges)</span> or to the cerebrospinal fluid.</li> <li class="seamTextUnorderedListItem">Methotrexate is a chemotherapy approved to treat advanced breast cancer.</li> <li class="seamTextUnorderedListItem">Researchers believe methotrexate can cross the blood-brain barrier, which will allow the drug to reach the leptomeningeal metastases.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02422641' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/publications/cancerwise/2017/04/new-hope-for-leptomeningeal-disease-care.html' target='_blank'>MDAnderson: New Hope for Leptomeningeal Disease Care</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/secondary-cancer/leptomeningeal-metastases/what-are#:~:text=Leptomeningeal%20metastases%20mean%20cancer%20cells,leptomeningeal%20disease' target='_blank'>Cancer Research UK: What are Leptomeningeal Metastases?</a> </li></ul>
9

Methotrexate in Metastatic Breast Cancer With Leptomeningeal Metastasis

Traditional Incision and Drainage of Cutaneous Abscess Vs. Minimally Invasive Incision and Drainage With Vessel Loop: A Randomized Controlled Trail
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Nearest Location:
2314 miles
Comprehensive Cancer Center at Wake Forest University (CCCWFU)
Winston-Salem, NC

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Visits:
1 visit every 2 weeks, ongoing

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ClinicalTrials.gov: NCT02422641

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Phase II

10

Wearable Device for Metastatic Breast Cancer that has Spread to the <span class="highlight">Leptomeninges</span>

Pilot Feasibility Study of Tumor Treating Fields in Treatment of Leptomeningeal Metastases From Breast Carcinoma Involving the Spine

Purpose: This trial will study the safety and effects (good and bad) of the Novo TTF-200T device.

Who is this for?: People with stage IV (metastatic) breast cancer that has spread to the <span class="highlight">leptomeninges</span> (the lining of the brain and spinal cord). You must not be receiving high-dose methotrexate, thiotepa, or cytarabine. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The portable Novo TTF-200T device to wear</li> <li class="seamTextUnorderedListItem">MRI scan</li> <li class="seamTextUnorderedListItem">Possible lumbar puncture (also called a spinal tap), 2 times</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The Novo TTF-200T device is a wearable device that produces electric fields to target areas on the body to stop the growth of tumor cells. </li> <li class="seamTextUnorderedListItem">The device has breakthrough designation from the FDA for advanced liver cancer and is being tested in other advanced cancers including MBC.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05746325' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancernetwork.com/view/novottf-200t-delivery-system-given-a-breakthrough-designation-by-the-fda-for-advanced-liver-cancer' target='_blank'>Cancer Network: The Novo TTF-200T Device</a> </li></ul>
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Wearable Device for Metastatic Breast Cancer that has Spread to the <span class="highlight">Leptomeninges</span>

Pilot Feasibility Study of Tumor Treating Fields in Treatment of Leptomeningeal Metastases From Breast Carcinoma Involving the Spine
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Nearest Location:
2383 miles
Mayo Clinic in Florida
Jacksonville, FL

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05746325

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Phase NA

11

Datopotamab Deruxtecan ADC for HER2- Breast Cancer That Spread to the Brain or <span class="highlight">Leptomeninges</span>

DATO-BASE: A Phase 2 Trial of DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of datopotamab deruxtecan, an experimental antibody drug conjugate (ADC).

Who is this for?: People with metastatic (stage IV) HER2 negative (HER2-) breast cancer that has spread to the brain (brain metastasis) or <span class="highlight">leptomeninges</span> (leptomeningeal disease). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (Dato-DXd), by IV, daily</li> <li class="seamTextUnorderedListItem">CT or MRI scans, every 1-2 months</li> <li class="seamTextUnorderedListItem">Lumbar puncture to collect CSF (optional), 1 time</li> <li class="seamTextUnorderedListItem">Heart scans</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (Dato-DXd) is an experimental antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan's antibody targets TROP2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called deruxtecan.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06176261' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/issues/october-10-2022-supplement-breast-cancer-almanac/datopotamab-deruxtecan-shows-activity-in-advanced-triple-negative-breast-cancer/' target='_blank'>ASCO: Dato-DXd</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/?_gl=1*msj5sm*_ga*NDI3ODYxOTY5LjE2NzE2MzcwODA.*_ga_Y9F235S3X2*MTcxMDc3NDgwNy40MTEuMS4xNzEwNzc2MTM5LjQ2LjAuMA..' target='_blank'>Metastastic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li></ul>
11

Datopotamab Deruxtecan ADC for HER2- Breast Cancer That Spread to the Brain or <span class="highlight">Leptomeninges</span>

DATO-BASE: A Phase 2 Trial of DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs
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Nearest Location:
2385 miles
Duke University Medical Center
Durham, NC

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Visits:
At least 1 visit every 1-2 months

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ClinicalTrials.gov: NCT06176261

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Phase II

12

Dendritic Cell Vaccine for Metastatic Triple Negative or HER2+ Breast Cancer With Leptomeningeal Disease

A First in Human Dose Escalation of Dendritic Cell Vaccine (DCV) Administered Intrathecally (IT) Primed Against HER2/HER3 in Patients With Leptomeningeal Disease (LMD) From Triple-Negative Breast Cancer (TNBC) or HER2+ Breast Cancer (HER2+BC)

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of a dendritic cell vaccine.

Who is this for?: People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or HER2 positive (HER2+) breast cancer with leptomeningeal disease (LMD). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Procedure to place Ommaya reservoir</li> <li class="seamTextUnorderedListItem">Dendritic cell vaccine, by Ommaya reservoir, weekly for 1.5-3 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that has spread to the <span class="highlight">leptomeninges</span> is called leptomeningeal disease (LMD).</li> <li class="seamTextUnorderedListItem">The dendritic cell vaccine is a type of immunotherapy that boosts the immune system to recognize and destroy cancer cells.</li> <li class="seamTextUnorderedListItem">Ommaya reservoirs are very small plastic devices put under the scalp to give access to cerebrospinal fluid (CSF), the fluid or liquid surrounding your brain and spinal cord.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05809752' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy#section-cancer-vaccines' target='_blank'>Breastcancer.org: Cancer Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/secondary-cancer/leptomeningeal-metastases/what-are' target='_blank'>Cancer Research UK: Leptomeningeal Metastasis</a> </li></ul>
12

Dendritic Cell Vaccine for Metastatic Triple Negative or HER2+ Breast Cancer With Leptomeningeal Disease

A First in Human Dose Escalation of Dendritic Cell Vaccine (DCV) Administered Intrathecally (IT) Primed Against HER2/HER3 in Patients With Leptomeningeal Disease (LMD) From Triple-Negative Breast Cancer (TNBC) or HER2+ Breast Cancer (HER2+BC)
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Nearest Location:
2395 miles
Moffitt Cancer Center
Tampa, FL

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Visits:
1 visit every week for 1.5-3 months

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ClinicalTrials.gov: NCT05809752

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Phase I

13

Registry to Identify Biomarkers and Improve Treatment for Breast Cancer Leptomeningeal Metastasis

A Translational Observational Biorepository and Management Study in Patients With Breast Cancer Leptomeningeal Metastasis: The BioLept Study

Purpose: To identify biomarkers for leptomeningeal metastases and improve treatment options for people with leptomeningeal metastases.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the <span class="highlight">leptomeninges</span> (leptomeningeal metastasis or leptomeningeal disease). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood and/or CSF samples, at least 1-2 times in 1 month</li> <li class="seamTextUnorderedListItem">Questionnaires, monthly</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leptomeningeal metastasis or leptomeningeal disease (LMD) is difficult to treat.</li> <li class="seamTextUnorderedListItem">This trial will collect information and samples that will be used to study LMD.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06638294' target='_blank'>ClinicalTrials.gov</a> </li></ul>
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Registry to Identify Biomarkers and Improve Treatment for Breast Cancer Leptomeningeal Metastasis

A Translational Observational Biorepository and Management Study in Patients With Breast Cancer Leptomeningeal Metastasis: The BioLept Study
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Nearest Location:
2453 miles
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, MD

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Visits:
At least 1-2 visits in 1 month

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ClinicalTrials.gov: NCT06638294

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Phase NA

14

Deferoxamine For Leptomeningeal Metastasis

A Phase 1a/1b Trial of Intrathecal Deferoxamine for Leptomeningeal Metastases

Purpose: To study the safety and best dose of deferoxamine to treat metastases in the <span class="highlight">leptomeninges</span> (the lining of the brain and spinal cord).

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the <span class="highlight">leptomeninges.</span> View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery to place a device (Ommaya reservoir) similar to a chemotherapy port under your scalp</li> <li class="seamTextUnorderedListItem">Deferoxamine, via the Ommaya reservoir, 2-8 sessions per month</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Deferoxamine is an experimental therapy and will be administered through an Ommaya reservoir.</li> <li class="seamTextUnorderedListItem">Ommaya reservoirs are very small plastic devices put under the scalp to give access to cerebrospinal fluid (CSF), the fluid or liquid surrounding your brain and spinal cord.</li> <li class="seamTextUnorderedListItem">Leptomeningeal metastasis occurs when cancer spreads to the membranes surrounding the brain and/or the spinal cord <span class="highlight">(leptomeninges).</li></span> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer that have spread to the <span class="highlight">leptomeninges.</li></ul></span>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05184816' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/secondary-cancer/leptomeningeal-metastases/what-are#:~:text=Leptomeningeal%20metastases%20mean%20cancer%20cells,leptomeningeal%20disease' target='_blank'>Cancer Research UK: What are Leptomeningeal Metastases?</a> </li><li class='seamTextUnorderedListItem'><a href='https://moffitt.org/cancers/brain-tumor/leptomeningeal-disease/' target='_blank'>Moffitt Cancer Center: Leptomeningeal Disease</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mskcc.org/cancer-care/patient-education/deferoxamine-01' target='_blank'>Memorial Sloan Kettering Cancer Center: Deferoxamine</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mskcc.org/cancer-care/patient-education/faq-about-ommaya-reservoirs-and-ommaya-taps' target='_blank'>Memorial Sloan Kettering Cancer Center: Frequently Asked Questions About Ommaya Reservoirs and Ommaya Taps</a> </li></ul>
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Deferoxamine For Leptomeningeal Metastasis

A Phase 1a/1b Trial of Intrathecal Deferoxamine for Leptomeningeal Metastases
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Nearest Location:
2539 miles
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, NJ

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Visits:
2-8 visits per month

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ClinicalTrials.gov: NCT05184816

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Phase I

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