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Treatment

Brain Mets required

Brain: Leptomeningeal Mets required

BRCA1/2 (inherited)

Chemotherapy

Hormone Therapy

Radiation Oncology

Targeted Therapy: All

Targeted Therapy: Anti-HER2 Therapy

Targeted Therapy: CDK Inhibitors

Targeted Therapy: PARP Inhibitors

Targeted Therapy: Tumor Mutations

Targeted Therapy: Other Targeted Therapy

Vaccines and Immunotherapy

Other Treatment

Non-Treatment

Activities

Complementary and Alternative Medicine

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AKT

ALK

AR

BARD1

BRCA1/2 (tumor)

BRIP1

CD205

CD70

CHEK2 or CHEK1

ESR1

FGFR

HER2/ERBB2

HLA

MET or C-Met

NTRK

PALB2

PIK3CA or PI3K

PTEN

RAD51

RAF (including BRAF)

RAS (KRAS or NRAS)

RB

ROS1

TP53

No travel requiredTrials coming soon to MTSAdditional metastatic cancer trials

1

NEAREST SITE: 0 miles
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, PA

VISITS: Please contact the research site

PHASE: II

NCT ID: NCT03184038

Comparing Neurocognitive Changes Between Stereotactic Radiosurgery (SRS) and Stereotactic Body Radiation Therapy (SBRT) for Brain Metastases

Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery: A Phase II Study Scientific Title

Purpose
To determine if Stereotactic Radiosurgery (SRS) preserves neurological function better than Stereotactic Body Radiation Therapy (SBRT) in patients with multiple brain metastases.
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases) who are planning to undergo radiation therapy to the brain.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cognitive assessments at baseline and at 2, 4, 6, and 12 months after undergoing standard of care Stereotactic Radiosurgery (SRS) or Stereotactic Body Radiation Therapy (SBRT)</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic Radiosurgery (SRS) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy. </li> <li class="seamTextUnorderedListItem">Stereotactic Body Radiation Therapy (SBRT) treats the whole brain and the spine.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03184038' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mbcalliance.org/marina-kaplan-project' target='_blank'>The Marina Kaplan Project: Breast Cancer Brain Metastases Initiative</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.everydayhealth.com/cancer/stereotactic-therapy-is-best-for-brain-metastases-and-more-cancer-news-from-day-one-of-astro/' target='_blank'>Everyday Health: Stereotactic Therapy For Brain Metastases</a> </li></ul>
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2

NEAREST SITE: 0 miles
Indiana University Methodist Hospital
Indianapolis, IN

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT04047602

Reduced-Dose Radiation for Brain Metastases in Patients Receiving Immunotherapy

Radiosurgery Dose Reduction for Brain Metastases on Immunotherapy (RADREMI): A Prospective Pilot Study Scientific Title

Purpose
To study tissue damage from a reduced dose of radiosurgery to the brain in patients who are receiving immunotherapy.
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases) and who have not received whole-brain radiation. You must be receiving or planning to receive treatment with an immunotherapy drug.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Treatment with an immunotherapy drug </li> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery at a reduced dose, one time</li> <li class="seamTextUnorderedListItem">Brain MRI to study tissue damage, every 3 months for 1 year</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to damage cancer cell DNA. These x-rays stop cancer cells from dividing and growing, thus slowing or stopping tumor growth. </li> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy. </li> <li class="seamTextUnorderedListItem">Immunotherapies are drugs that trigger the immune system to go after and kill cancer cells.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04047602' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mbcalliance.org/marina-kaplan-project' target='_blank'>The Marina Kaplan Project: Breast Cancer Brain Metastases Initiative</a> </li></ul>
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3

NEAREST SITE: 0 miles
Penn State Milton S. Hershey Medical Center
Hershey, PA

VISITS: 2 visits over 2-3 weeks

PHASE: II

NCT ID: NCT04307186

A Study to Improve Detection of Brain Lesions Including Metastases

Multicenter, Single-blind, Adaptive Dose Finding Study of Single Intravenous Injections of BAY 1747846 With Corresponding Blinded Read in Adult Participants With Known or Highly Suspected CNS Lesions Referred for Contrast-enhanced MRI of the CNS Scientific Title

Purpose
To find the appropriate dose of a new contrast agent (BAY1747846) for viewing brain and spinal cord lesions during an MRI and compare it to gadobutrol, a contrast agent currently in use.
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases).    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following with a period of 3-14 days in between: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MRI with BAY1747846, by IV</li> <li class="seamTextUnorderedListItem">MRI with gadobutrol, by IV</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A Magnetic Resonance Imaging (MRI) produces body pictures created by using magnetic energy rather than x-ray energy.</li> <li class="seamTextUnorderedListItem">Gadobutrol is a drug used in MRIs to provide contrast and improve imaging performance.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04307186' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mbcalliance.org/marina-kaplan-project' target='_blank'>The Marina Kaplan Project: Breast Cancer Brain Metastases Initiative</a> </li></ul>
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4

NEAREST SITE: 0 miles
M D Anderson Cancer Center
Houston, TX

VISITS: 1 visit 2 weeks before or 1 month after surgery

PHASE: III

NCT ID: NCT03741673

Stereotactic Radiosurgery (SRS) Before or After Surgery For Brain Metastases

A Phase III Trial of Pre-Operative Stereotactic Radiosurgery (SRS) Versus Post-Operative SRS for Brain Metastases Scientific Title

Purpose
To compare how well stereotactic radiosurgery (SRS) works before or after surgery in cancer that has spread to the brain.
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases) who have not received prior treatment (surgery or radiation) for brain mets.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic Radiosurgery (SRS), once, followed by surgery within 2 weeks</li> </ul> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery followed by Stereotactic Radiosurgery (SRS), once, within 1 month</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Participants may undergo additional SRS if disease returns after treatment.</i></p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic Radiosurgery (SRS) is the delivery of focused, high-dose radiation given in a single session to the tumors, with a minimal dose given to uninvolved areas of the brain.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03741673' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mbcalliance.org/marina-kaplan-project' target='_blank'>The Marina Kaplan Project: Breast Cancer Brain Metastases Initiative</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2018-0552.html' target='_blank'>MD Anderson Trial Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/symptoms/types/recur_metast/treat_metast/options/local/brain/radiosurgery' target='_blank'>Breastcancer.org: Stereotactic Radiosurgery for Brain Metastasis</a> </li></ul>
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5

NEAREST SITE: 0 miles
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, NY

VISITS: 2-8 visits per month

PHASE: I

NCT ID: NCT05184816

Deferoxamine For Leptomeningeal Metastasis

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

Purpose
To study the safety and best dose of deferoxamine to treat metastases in the leptomeninges (the lining of the brain and spinal cord).
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the leptomeninges.    Full eligibility criteria
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  • What's involved?
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  • <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>
  • <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 (leptomeninges).</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer that have spread to the leptomeninges.</li></ul>
  • <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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6

NEAREST SITE: 0 miles
M D Anderson Cancer Center
Houston, TX

VISITS: 1 visit

PHASE: NA

NCT ID: NCT03685539

DECT Imaging Before Stereotactic Radiosurgery to Detect Brain Metastases

Advanced CT Imaging Optimization for the Detection of Intracranial Metastasis Scientific Title

Purpose
To study how well DECT works for imaging breast cancer that has spread to the brain (brain metastases).
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases) and who have not received brain radiation. You must be planning to receive treatment with Gamma Knife radiosurgery.    Full eligibility criteria
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  • What's involved?
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DECT imaging up to 7 days before Gamma Knife radiosurgery</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dual-energy computed tomography (DECT) imaging is more specific than computed tomography (CT) imaging.</li> <li class="seamTextUnorderedListItem">DECT may help find and diagnose tumor cells and find out how far the tumor cells have spread in the brain.</li> <li class="seamTextUnorderedListItem">Gamma Knife radiosurgery is a type of stereotactic radiosurgery.</li> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03685539' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://radiology.ucsf.edu/blog/new-applications-dual-energy-ct-dect' target='_blank'>UCSF Department of Radiology and Biomedical Imaging: Dual-Energy Computed Tomography</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/brain-stereotactic-radiosurgery/about/pac-20384679' target='_blank'>Mayo Clinic: Gamma Knife Radiosurgery</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/types/metastatic/brain-metastasis' target='_blank'>Breastcancer.org: Stereotactic Radiosurgery</a> </li></ul>
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7

NEAREST SITE: 0 miles
M D Anderson Cancer Center
Houston, TX

VISITS: 1 visit

PHASE: NA

NCT ID: NCT04539574

An Imaging System for Detecting Untreated Brain Metastases

Validation of a Multi-Parametric Ultra-High Field MRI Protocol for Central Nervous System Malignancy Scientific Title

Purpose
To determine if a new MRI system (7-Tesla MRI) can find and diagnose brain metastases and other central nervous system tumors better than a standard MRI.
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases) that is newly diagnosed or recurrent, and untreated.    Full eligibility criteria
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  • What's involved?
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  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">7-Tesla MRI scan lasting over 60 minutes</li> <li class="seamTextUnorderedListItem">Questionnaire</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The 7-Tesla MRI has been shown to create high-quality images for the diagnosis of other neurological diseases.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04539574' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mbcalliance.org/marina-kaplan-project' target='_blank'>The Marina Kaplan Project: Breast Cancer Brain Metastases Initiative</a> </li></ul>
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8

NEAREST SITE: 0 miles
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, CA

VISITS: 1 visit every week (2 weeks on, 1 week off), ongoing

PHASE: II

NCT ID: NCT04647916

Sacituzumab Govitecan Therapy in Patients With HER2-Negative Breast Cancer and Brain Metastases

A Phase II Trial of Sacituzumab Govitecan (IMMU-132) (NSC #820016) for Patients With HER2-Negative Breast Cancer and Brain Metastases Scientific Title

Purpose
To study the anti-cancer activity, safety and side effects of giving the antibody-drug conjugate sacituzumab govitecan (Trodelvy®) to treat brain metastases (breast cancer that has spread to the brain).
Who is this for?
People with metastatic (stage IV) HER2 negative (HER2-) breast cancer that has spread to the brain.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®), by IV, every week (2 weeks on, 1 week off), ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) is an antibody-drug conjugate (ADC). This means it uses an antibody that targets cancer cells to deliver a chemotherapy directly to these cells.</li> <li class="seamTextUnorderedListItem">The antibody in this drug targets TROP2 proteins. It delivers the chemotherapy irinotecan. Irinotecan is approved for use in many other types of cancer.</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan is approved for use in people with metastatic triple negative breast cancer who have already received at least two other therapies for metastatic disease, but its use in this trial is considered experimental.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04647916' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2020/fda-sacituzumab-govitecan-triple-negative-breast-cancer' target='_blank'>NCI Cancer Currents Blog: Sacituzumab Govitecan Approved for Metastatic Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.targetedonc.com/view/sacituzumab-govitecan-shows-pfs-benefit-for-patients-with-mtnbc-and-brain-metastases' target='_blank'>Targeted Oncology: Sacituzumab Govitecan Shows PFS Benefit for Patients With mTNBC and Brain Metastases</a> </li></ul>
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9

NEAREST SITE: 0 miles
Memorial Sloan Kettering at Basking Ridge (Consent Only)
Basking Ridge, NJ

VISITS: Coincides with surgery

PHASE: II

NCT ID: NCT04690348

Radiation During Surgery for Recurrent Brain Metastases

Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II Study Scientific Title

Purpose
To compare the safety, anti-cancer activity, and side effects of brachytherapy (a type of radiation that occurs during brain surgery) with the usual approach of brain surgery without brachytherapy.
Who is this for?
People with metastatic (stage IV) breast cancer with brain metastases (cancer that has spread to the brain) that has already been treated with radiation.    Full eligibility criteria
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  • What's involved?
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  • <p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain surgery</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain surgery </li> <li class="seamTextUnorderedListItem">Cesium 131 (Cs131) brachytherapy (radiation), during surgery</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brachytherapy is a type of internal radiation therapy. It works by placing a radioactive material directly inside or next to the tumor. </li> <li class="seamTextUnorderedListItem">It takes less time than traditional radiation and uses a higher total radiation dose to treat a smaller area.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04690348' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mbcalliance.org/marina-kaplan-project' target='_blank'>The Marina Kaplan Project: Breast Cancer Brain Metastases Initiative</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/types/radiation-therapy/brachytherapy#:~:text=Brachytherapy%20is%20a%20type%20of%20internal%20radiation%20therapy%20in%20which,specific%20part%20of%20your%20body.' target='_blank'>Cancer.gov: Brachytherapy</a> </li></ul>
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10

NEAREST SITE: 0 miles
The SKCCC at Johns Hopkins
Baltimore, MD

VISITS: Please contact the research site

PHASE: NA

NCT ID: NCT03223922

Preserving Cognitive Function With Whole Brain Radiation Therapy for Brain Metastases

Preservation of Cognition and Neuropsychiatric Functioning With Corpus Callosum Genu-Sparing Whole Brain Radiation Therapy for Brain Metastases: A Pilot Study Scientific Title

Purpose
To evaluate how well genu-sparing whole brain radiation preserves cognitive function in patients with brain metastases.
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases) that has not been treated with whole brain radiation therapy.    Full eligibility criteria
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  • What's involved?
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Genu-sparing whole brain radiation therapy, once a day, 5 days a week</li> <li class="seamTextUnorderedListItem">Cognitive testing at baseline and at 4 , 6 and 12 months following completion of brain radiation</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Genu-sparing whole brain radiation limits the radiation dose to a specific area in the brain (the genu of the corpus callosum).</li> <li class="seamTextUnorderedListItem">The genu (front part) of the corpus callosum is associated with cognitive and neuropsychiatric functioning.</li> <li class="seamTextUnorderedListItem">Researchers believe that reducing damage to this area may prevent the decline of cognitive and neuropsychiatric functioning.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03223922' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mbcalliance.org/marina-kaplan-project' target='_blank'>The Marina Kaplan Project: Breast Cancer Brain Metastases Initiative</a> </li></ul>
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11

NEAREST SITE: 0 miles
University of Florida Health
Jacksonville, FL

VISITS: Surgery followed by 1 visit every 3 weeks for 2 years

PHASE: I

NCT ID: NCT04187872

Laser Thermotherapy and Pembrolizumab for Triple Negative Breast Cancer that has Spread to the Brain

Recurrent Brain Metastasis Immune Effects and RespOnse to Laser Interstitial ThermotHerapy (LITT) and Pembrolizumab in Combination (TORCH) Scientific Title

Purpose
To study the immune effect of Laser Interstitial Thermotherapy (LITT), a type of surgery, given with pembrolizumab (Keytruda®).
Who is this for?
People with triple negative (ER-, PR-, HER2-) metastatic (stage IV) breast cancer that has spread to the brain (brain metastases). Your brain mets must have been treated with stereotactic radiosurgery and must test positive for PD-L1.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain biopsy and laser interstitial thermotherapy (LITT)</li> <li class="seamTextUnorderedListItem">Pembrolizumab, by IV, every 3 weeks for up to 2 years</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Laser Interstitial Thermotherapy (LITT) is a minimally-invasive surgical technique to treat primary and metastatic brain tumors that can be hard to reach with conventional surgery. </li> <li class="seamTextUnorderedListItem">LITT is done by implanting a laser catheter into the tumor and heating it to temperatures high enough to kill the tumor.</li> <li class="seamTextUnorderedListItem">Keytruda® is a type of immunotherapy called a PD-L1 inhibitor. It is approved to metastatic treat triple negative, PD-L1-positive breast cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04187872' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mbcalliance.org/marina-kaplan-project' target='_blank'>The Marina Kaplan Project: Breast Cancer Brain Metastases Initiative</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/drugs/pembrolizumab' target='_blank'>NCI: Pembrolizumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/treatment-options/laser-interstitial-thermal-therapy.html' target='_blank'>MD Anderson: Laser Interstitial Thermal Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.monteris.com/healthcare-professionals/neuroblate-system/' target='_blank'>Monteris Medical: NeuroBlate System (LITT)</a> </li></ul>
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12

NEAREST SITE: 0 miles
Hoag Memorial Hospital Presbyterian
Newport Beach, CA

VISITS: 3 visits per month for 6 months

PHASE: I

NCT ID: NCT04396717

Pritumumab for Brain Metastases

A Phase 1, Sequential Cohort, Open-Label, Dose-Escalation Study of the Safety and CNS Exposure of Pritumumab in Patients With Brain Cancer Scientific Title

Purpose
To determine the safety, side effects, and recommended dose of pritumumab, a targeted therapy.
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the brain and have no standard treatment options available.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pritumumab, by IV, weekly for 3 weeks on, 1 week off, for up to 6 months.</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pritumumab is a monoclonal antibody, a type of anti-cancer therapy that targets only the cancer cells without damaging healthy cells.</li> <li class="seamTextUnorderedListItem">It targets a certain protein on the outside of cells called ectodomain vimentin, or EDV.</li> <li class="seamTextUnorderedListItem">Researchers believe that pritumumab may be effective in treating brain cancer and brain metastases.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04396717' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.biospace.com/article/releases/nascent-biotech-opens-phase-1-human-trial-to-evaluate-pritumumab-as-treatment-option-for-primary-and-metastatic-brain-cancer/' target='_blank'>Press Release: Nascent Biotech Opens Phase 1 Human Trial to Evaluate Pritumumab as Treatment Option for Primary and Metastatic Brain Cancer</a> </li></ul>
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13

NEAREST SITE: 0 miles
University of Nebraska Medical Center
Omaha, NE

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT04222062

Local Chemotherapy to Prevent a Recurrence of Brain Metastases After Surgery

A Randomized Trial Evaluating GLIADEL Compared to Stereotactic Radiosurgery in Subjects With Metastatic Brain Disease Scientific Title

Purpose
To compare local chemotherapy (Gliadel Wafer®) with stereotactic radiosurgery (SRS), after surgery, to prevent brain metastases from recurring.
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases) with at least one tumor requiring surgery.    Full eligibility criteria
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  • <p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Gliadel</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery to remove the metastatic brain tumor</li> <li class="seamTextUnorderedListItem">Placement of Gliadel Wafers (chemotherapy) in the surgical site after the tumor is removed</li> <li class="seamTextUnorderedListItem">MRIs, before and after surgery</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery to remove the metastatic brain tumor</li> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery (SRS) to the tumor site, within 6 weeks after surgery</li> <li class="seamTextUnorderedListItem">MRIs, before and after surgery</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy. </li> <li class="seamTextUnorderedListItem">Gliadel Wafer® is an implant that dissolves slowly and releases chemotherapy directly into the area where the brain tumor has been removed. It has been approved for certain types of brain tumors.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04222062' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mbcalliance.org/marina-kaplan-project' target='_blank'>The Marina Kaplan Project: Breast Cancer Brain Metastases Initiative</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.webmd.com/drugs/2/drug-20903/gliadel-wafer-implant/details' target='_blank'>WebMD: Gliadel Wafer</a> </li></ul>
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14

NEAREST SITE: 0 miles
Priscilla Brastianos
Boston, MA

VISITS: 1 visit every 3 weeks

PHASE: II

NCT ID: NCT02886585

Pembrolizumab For Brain and Spinal Cord Metastases

Phase II Trial of Pembrolizumab in Central Nervous System Metastases From Multiple Histologies Scientific Title

Purpose
To study pembrolizumab (Keytruda®) as a possible treatment for central nervous system (CNS) metastases (cancer that spread to the brain or spinal cord).
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the brain or spinal cord.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain MRI and PET CT</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) by IV, every 3 weeks</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02886585' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mbcalliance.org/marina-kaplan-project' target='_blank'>The Marina Kaplan Project: Breast Cancer Brain Metastases Initiative</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/drugs/pembrolizumab' target='_blank'>Cancer.gov: Pembrolizumab</a> </li></ul>
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15

NEAREST SITE: 0 miles
M D Anderson Cancer Center
Houston, TX

VISITS: 1 visit every 2 weeks, ongoing

PHASE: I-II

NCT ID: NCT04789668

Immunotherapy and Targeted Therapy for Breast Cancer that has Spread to the Brain

Phase I/II Trial of BINTRAFUSP ALFA (M7824) and Pimasertib for Treatment of Intracranial Metastases Scientific Title

Purpose
To study the safety, dose, and anti-cancer activity of giving the immunotherapy bintrafusp alfa in combination with the targeted therapy pimasertib.
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases).    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bintrafusp alfa (M7824), by IV, every 2 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Pimasertib, by mouth, twice a day, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bintrafusp alfa (M7824) is an investigational immunotherapy. It is designed to get the immune system to go after cancer cells by blocking the proteins PD-L1 and TGF-beta.</li> <li class="seamTextUnorderedListItem">Pimasertib is an experimental targeted therapy that inhibits the proteins MEK1/2 proteins. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04789668' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medical.emdserono.com/en_US/home/immuno-oncology/m7824--anti-pd-l1-tgf-beta-trap-.html' target='_blank'>EMD Serono: Bintrafusp Alfa</a> </li><li class='seamTextUnorderedListItem'><a href='https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=NCI_Thesaurus&code=C84864' target='_blank'>NCI Thesaurus: Pimasertib</a> </li></ul>
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16

NEAREST SITE: 0 miles
Wake Forest University Health Sciences
Winston-Salem, NC

VISITS: Coincides with standard surgery

PHASE: NA

NCT ID: NCT03796273

Ketoconazole Before Surgery For Breast Cancer Brain Metastases

tGLI1 as a Therapeutic Target in Brain Metastases: A Window of Opportunity Study Scientific Title

Purpose
To study the anti-cancer activity, safety, and effects (good and bad) of the anti-fungal drug ketoconazole when it is given before surgery.
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the brain.    Full eligibility criteria
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  • <p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ketoconazole, by mouth, once daily, for 4 days before surgery</li> <li class="seamTextUnorderedListItem">Surgery</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ketoconazole is an antifungal drug that may be able to block a protein called tGLI1. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of brain tumors.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03796273' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/ketoconazole' target='_blank'>NCI Drug Dictionary: Ketoconazole</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/symptoms/types/recur_metast/treat_metast/options/local/brain' target='_blank'>Breastcancer.org: Brain Metastasis Local Treatments</a> </li></ul>
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17

NEAREST SITE: 0 miles
Memoral Sloan Kettering Basking Ridge (Consent only)
Basking Ridge, NJ

VISITS: At least 10 visits

PHASE: I

NCT ID: NCT04192981

GDC-0084 With Radiation Therapy For Brain Metastases or Leptomeningeal Metastases With a PIK3CA Mutation

A Phase I Study With Expansion Cohort of Concurrent GDC-0084 With Radiation Therapy for Patients With Solid Tumor Brain Metastases or Leptomeningeal Metastases Harboring PI3K Pathway Mutations Scientific Title

Purpose
To determine the effectiveness and best dose for giving GDC-0084, a PI3K inhibitor, in combination with radiation therapy.
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases) or leptomeninges, with a PIK3CA mutation.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GDC-0084, by mouth, daily</li> <li class="seamTextUnorderedListItem">Whole brain radiation therapy, over 10 sessions</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GDC-0084 is an investigational targeted therapy called a PI3K inhibitor.</li> <li class="seamTextUnorderedListItem">This study will test increasing doses of GDC-0084 to find the highest dose that causes few or mild side effects. </li> <li class="seamTextUnorderedListItem">The study will also determine if the combination of GDC-0084 with radiation is effective against cancer that spread to the brain or leptomeninges.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PIK3CA, PIK3CB, PIK3CD, PIK3CG, PIK3R1, PIK3R2, PIK3R3, PIK3C2G, PIK3C3, INPP4A, INPP4B, INPPL1, INPP5D, PTEN, AKT1, AKT2, AKT3, and MTOR.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04192981' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mbcalliance.org/marina-kaplan-project' target='_blank'>The Marina Kaplan Project: Breast Cancer Brain Metastases Initiative</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.targetedonc.com/view/gdc0084-shows-efficacy-for-treatment-of-glioblastoma' target='_blank'>Targeted Oncology: GDC-0084 Shows Efficacy for Treatment of Glioblastoma</a> </li></ul>
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18

NEAREST SITE: 0 miles
Mayo Clinic
Jacksonville, FL

VISITS: Coincides with surgery

PHASE: NA

NCT ID: NCT04742231

Measuring Hand Strength During Brain Surgery to Predict How the Craniotomy Will Affect Motor Skills

Use of Handheld Dynamometer as a Novel Tool to Assess Motor Function During Awake Craniotomy for Brain Lesions Located Within or Adjacent to the Motor Cortex: A Single-Center Pilot Study Scientific Title

Purpose
To study the safety and reliability of measuring hand strength during an awake craniotomy to monitor how the surgery will affect your motor skills.
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases) and who will have an awake craniotomy at the Mayo Clinic in Jacksonville, Florida.    Full eligibility criteria
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  • <p class="seamTextPara"> Your hand strength will be measured during surgery with a handheld device called a K-FORCE Grip dynamometer®.</p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A craniotomy is a type of brain surgery. The surgeon will remove part of your skull (cranium) to access your brain to remove the tumors. </li> <li class="seamTextUnorderedListItem">You will be awake during the craniotomy so that you can use a handheld device to monitor how the surgery is affecting your motor skills. </li> <li class="seamTextUnorderedListItem">Motor skills are body movements and include walking, hand movements (like writing), and other types of movement. </li> <li class="seamTextUnorderedListItem">K-FORCE Grip® is a handheld dynamometer. A dynamometer is a machine that is held in the hand and can measure the strength of your grip. </li> <li class="seamTextUnorderedListItem">Researchers believe measuring grip strength may predict how removing tumors will affect motor skills.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04742231' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mbcalliance.org/marina-kaplan-project' target='_blank'>The Marina Kaplan Project: Breast Cancer Brain Metastases Initiative</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/craniotomy' target='_blank'>Johns Hopkins Medicine: Craniotomy?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/awake-brain-surgery/about/pac-20384913' target='_blank'>Mayo Clinic: Awake Brain Surgery</a> </li><li class='seamTextUnorderedListItem'><a href='https://k-invent.com/produit/k-force-grip/' target='_blank'>Kinvent Device Information Page: KForce Grip</a> </li></ul>
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19

NEAREST SITE: 0 miles
Duke University Health System
Durham, NC

VISITS: At least 1 visit

PHASE: NA

NCT ID: NCT04246879

MRI Following Stereotactic Radiosurgery (SRS) for Brain Metastases

Diagnostic Accuracy of Delayed MRI Contrast Enhancement Characteristics and Radiation Necrosis Following Stereotactic Radiosurgery (SRS) for Brain Metastases Scientific Title

Purpose
To test whether additional magnetic resonance image (MRI) sequences (runs) can better distinguish between damage from prior radiation and recurrent brain metastases.
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the brain and at least 1 brain metastasis previously treated with stereotactic radiosurgery (SRS).    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MRI with additional sequences (runs), following stereotactic radiosurgery</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Magnetic resonance image (MRI) exams generally include multiple runs (sequences), some of which may last several minutes. Each run will create a different set of noises.</li> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04246879' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mbcalliance.org/marina-kaplan-project' target='_blank'>The Marina Kaplan Project: Breast Cancer Brain Metastases Initiative</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/stereotactic-radiosurgery' target='_blank'>Stereotactic Radiosurgery</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.radiologyinfo.org/en/info/bodymr' target='_blank'>RadiaologyInfo.org: Magnetic Resonance Imaging (MRI)</a> </li></ul>
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20

NEAREST SITE: 0 miles
Dana Farber Cancer Institute
Boston, MA

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT04033497

MRI-Based Imaging Technique to Distinguish Recurrent Brain Metastases from Radiation Damage

Treatment Response Assessment Maps (TRAMs) in the Delineation of Radiation Necrosis From Tumor Progression After Stereotactic Radiation in Patients With Brain Metastases: A Prospective Study Scientific Title

Purpose
To study whether Treatment Response Assessment Maps, a brain imaging technique, can help distinguish between a metastatic recurrence and tissue damage from prior radiation.
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases). Participants must have had a metastatic recurrence at least 4 months after radiation to the same site in the brain and planning to undergo surgery.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain imaging by MRI and Treatment Assessment Maps <i class="seamTextEmphasis">followed by</i></li> <li class="seamTextUnorderedListItem">Brain surgery to remove suspected recurrence of brain metastasis</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Treatment Response Assessment Maps is an MRI-based imaging technique that may be able to distinguish recurrent brain metastases from radiation-damaged, but non-cancerous brain tissue.</li> <li class="seamTextUnorderedListItem">This technique may allow future patients to avoid unnecessary surgery.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04033497' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mbcalliance.org/marina-kaplan-project' target='_blank'>The Marina Kaplan Project: Breast Cancer Brain Metastases Initiative</a> </li></ul>
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21

NEAREST SITE: 0 miles
Massachusetts General Hospital
Boston, MA

VISITS: Please contact the research site

PHASE: II

NCT ID: NCT02896335

Targeted Therapy Palbociclib for Brain Metastases

A Phase 2 Study of Palbociclib in Progressive Brain Metastases Harboring Alterations in the CDK Pathway Scientific Title

Purpose
To study the safety, anti-cancer activity, and side effects of giving the CDK 4/6 inhibitor palbociclib (Ibrance®).
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases). You may not enroll if you have already received a CDK 4/6 inhibitor.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily (3 weeks on, 1 week off), ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is commonly used with anti-estrogen therapy for metastatic, hormone-positive (ER+ and/or PR+), HER2-negative (HER2-) breast cancer, but its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer that metastasized to the brain.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02896335' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mbcalliance.org/marina-kaplan-project' target='_blank'>The Marina Kaplan Project: Breast Cancer Brain Metastases Initiative</a> </li></ul>
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22

NEAREST SITE: 0 miles
UT Southwestern Medical Center
Dallas, TX

VISITS: 1-2 visits

PHASE: NA

NCT ID: NCT03067467

Metabolic Differences Between Brain Metastases and Normal Brain Tissue

Investigating Metabolic Characteristics of Intracranial Malignancy In Vivo Using Hyperpolarized Carbon-13 Magnetic Resonance Spectroscopic Imaging (MRSI) Scientific Title

Purpose
To look at how the metabolism of brain metastases differs from normal tissue.
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases) and who have not received prior chemotherapy or radiation for these metastases.    Full eligibility criteria
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  • <p class="seamTextPara"> You will undergo the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain MRSI (a type of MRI), with contrast, by IV</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MRSI (Magnetic Resonance Spectroscopic Imaging) is a technique used to visualize tumor metabolism in real-time.</li> <li class="seamTextUnorderedListItem">Learning how the metabolism of brain metastases differs from normal tissue may lead to the development of new targeted therapies.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03067467' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mbcalliance.org/marina-kaplan-project' target='_blank'>The Marina Kaplan Project: Breast Cancer Brain Metastases Initiative</a> </li></ul>
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23

NEAREST SITE: 0 miles
Roswell Park Cancer Institute
Buffalo, NY

VISITS: 1 visit every 3 weeks

PHASE: II

NCT ID: NCT04348747

Dendritic Cell Vaccine and Pembrolizumab for Metastatic Triple Negative and HER2+ Breast Cancer With Brain Metastasis

A Phase IIa Study of Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab in Patients With Asymptomatic Brain Metastasis From Triple Negative Breast Cancer (TNBC) or HER2+ Breast Cancer (HER2+BC) Scientific Title

Purpose
To study the safety, effects (good and bad), and anti-cancer activity of a dendritic cell vaccine, an experimental type of immunotherapy, with pembrolizumab (Keytruda®), a type of immunotherapy.
Who is this for?
Women with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or HER2 positive (HER2+) breast cancer that has spread to the brain (brain metastasis) and progressed on standard treatment.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dendritic cell vaccine, by injection, every 3 weeks for 3 sessions (potential additional sessions every 3 months)</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">May require 1 brain MRI</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that has spread to the brain is called brain metastasis.</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">Pembrolizumab (Keytruda®) is an experimental type of immunotherapy called a PD-1 inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04348747' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org: About Breast Cancer Brain Mets</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.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.roswellpark.org/newsroom/202107-roswell-park-team-shows-dendritic-cell-vaccines-can-be-paired-standard-therapy' target='_blank'>Roswell Park Comprehensive Cancer Center Press Release: Dendritic-Cell Vaccines Can Be Paired With Standard Therapy for Breast Cancer</a> </li></ul>
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24

NEAREST SITE: 0 miles
M D Anderson Cancer Center
Houston, TX

VISITS: 8 visits over 8 months

PHASE: NA

NCT ID: NCT04870645

Advanced MRI Scan Before and After Radiation Therapy to Detect Brain Metastases

Advanced MRI for Intracranial Metastasis Treated With Stereotactic Radiosurgery Scientific Title

Purpose
To compare a new type of imaging technique with standard MRI to see if it provides better images.
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the brain who are planning to receive radiation therapy for brain mets.    Full eligibility criteria
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  • What's involved?
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  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard MRI and advanced MRI, over 60 minutes, within 2 weeks before the start of brain radiation</li> <li class="seamTextUnorderedListItem">7 additional MRIs, over 60 minutes each, between 1-4 months apart</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sequences during magnetic resonance imaging (MRI) is a new, advanced type of imaging technique.</li> <li class="seamTextUnorderedListItem">Researchers believe this technique might provide better images compared to standard MRI imaging.</li> <li class="seamTextUnorderedListItem">Diagnostic procedures, such as MRI, may help find and diagnose cancer and find out how far the disease has spread.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04870645' target='_blank'>ClinicalTrials.gov</a> </li></ul>
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25

NEAREST SITE: 0 miles
University of Chicago
Chicago, IL

VISITS: At least 1 visit

PHASE: II

NCT ID: NCT02747303

Comparing Two Doses of Stereotactic Radiosurgery for the Treatment of Brain Metastases

The Clinical Relevance of Margins in Frameless Stereotactic Radiosurgery for Intact Brain Metastases: a Randomized Trial of 0 vs 2 mm Margins Scientific Title

Purpose
To study the safety, anti-cancer activity, and side effects of giving a reduced dose of stereotactic radiation to metastatic tumor sites in the brain.
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases). The metastases must be located in the cerebrum of the brain and be no larger than 3.0 centimeters in diameter. Patients whose cancer has spread to the coverings of the brain (leptomeninges) are not eligible.    Full eligibility criteria
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  • What's involved?
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  • <p class="seamTextPara"> You will be assigned to one of two groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1 Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic Radiosurgery using a reduced dose of radiation delivered to the tumor sites.</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Control</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"> Stereotactic radiosurgery using the standard dose of radiation delivered to tumor sites.</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02747303' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mbcalliance.org/marina-kaplan-project' target='_blank'>The Marina Kaplan Project: Breast Cancer Brain Metastases Initiative</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.radiologyinfo.org/en/info/stereotactic' target='_blank'>Stereotactic Radiosurgery</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.hopkinsmedicine.org/health/conditions-and-diseases/anatomy-of-the-brain' target='_blank'>Anatomy of the Brain</a> </li></ul>
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26

NEAREST SITE: 0 miles
Montefiore Medical Center
Bronx, NY

VISITS: Visits every other day for 1.5-2 weeks

PHASE: I

NCT ID: NCT03726359

Determining Best Dose of Fractionated Stereotactic Radiation Therapy for Brain Metastases

Phase I TITE-CREM Dose Escalation Study of Fractionated Stereotactic Radiation Therapy (FSRT) in Unresected Brain Metastases Scientific Title

Purpose
To determine the maximum tolerated dose (MTD) for treating brain metastases with Fractionated Stereotactic Radiation Therapy (FSRT).
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases). You must have at least one brain lesion that has not been treated with radiation.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiotherapy, every other day, for 1.5-2 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">The dose given will vary depending upon when you enroll.</i></p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic Radiation is non-surgical radiation therapy that delivers radiation directly to a tumor.</li> <li class="seamTextUnorderedListItem">Fractionated Stereotactic Radiation Therapy (FSRT) is stereotactic radiation is divided into several smaller doses of radiation, given on separate days of treatment.</li> <li class="seamTextUnorderedListItem">This is done to minimize damage to healthy tissue.</li> <li class="seamTextUnorderedListItem">In this study, the dose of radiation will increase with each patient enrolled.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03726359' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mbcalliance.org/marina-kaplan-project' target='_blank'>The Marina Kaplan Project: Breast Cancer Brain Metastases Initiative</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/radiotherapy/external/types/stereotactic-body-radiotherapy-sbrt' target='_blank'>CancerResearchUK: Stereotactic radiotherapy (SRT)</a> </li></ul>
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27

NEAREST SITE: 0 miles
Mayo Clinic in Florida
Jacksonville, FL

VISITS: Please contact the research site

PHASE: III

NCT ID: NCT03750227

Delivery of Stereotactic Radiation Before or After Brain Surgery for Metastatic Brain Tumors

Pre-Operative vs. Post-Operative Stereotactic Radiosurgery for Operative Metastatic Brain Tumors Scientific Title

Purpose
To study whether delivering stereotactic radiation before surgery is more effective for treating brain metastases than delivering stereotactic radiation after surgery.
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases). Those whose cancer has spread to the leptomeninges of the brain (membranes covering the brain) are not eligible.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be randomly assigned to one of two groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1 (Experimental group)</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">You will receive stereotactic radiosurgery followed by brain surgery within 4 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2 (Control Group)</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">You will undergo brain surgery followed by stereotactic radiosurgery within 2 weeks</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation, also known as stereotactic radiosurgery, delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation.</li> <li class="seamTextUnorderedListItem">Brain surgery to remove metastases.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03750227' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mbcalliance.org/marina-kaplan-project' target='_blank'>The Marina Kaplan Project: Breast Cancer Brain Metastases Initiative</a> </li></ul>
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28

NEAREST SITE: 0 miles
Weill Cornell Medicine
New York, NY

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I-II

NCT ID: NCT03449238

Pembrolizumab (Immunotherapy) And Radiosurgery (Radiation) to Treat Brain Metastases

Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients Scientific Title

Purpose
To study the safety and effects (good and bad) of using pembrolizumab (Keytruda®) along with stereotactic radiosurgery (SRS) to treat breast cancer that has spread to the brain.
Who is this for?
Women with metastatic (stage IV) breast cancer and at least two brain metastases.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, once every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Stereotactic Radiosurgery (SRS), once after the first treatment of pembrolizumab</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Keytruda is a type of immunotherapy called a PD-1 inhibitor.</li> <li class="seamTextUnorderedListItem">It stimulates the body's immune system to go after cancer cells. </li> <li class="seamTextUnorderedListItem">It has been approved to treat certain types of cancer, but its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery is not surgery. It is a type of radiation therapy that precisely targets metastases in the brain.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03449238' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://mbcn.org/brain-mets/' target='_blank'>Metastatic Breast Cancer Network: Brain Metastases</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/symptoms/types/recur_metast/treat_metast/options/local/brain/radiosurgery' target='_blank'>Breastcancer.org: Stereotactic Radiosurgery for Brain Metastasis</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com' target='_blank'>Merck Oncology Information Page: Keytruda</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/what' target='_blank'>Breastcancer.org: What is Immunotherapy?</a> </li></ul>
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