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Find Breast Cancer Clinical Trials That Are Right For You

The clinical trials listed below are open in the U.S. for people with DCIS (stage 0), stage 1, stage 2, stage 3, or stage 4 (metastatic)
breast cancer. Clinical trials are available for people who are newly diagnosed with breast cancer, currently in treatment, experiencing
breast cancer recurrence, living with metastatic disease, as well as breast cancer survivors who have completed treatment.

Use the search box and filters to find a trial that’s right for you.

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(Last updated: April 22, 2026)

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Click here to view online studies and trials that do not require site visits

NEAREST SITE: 23 miles
John Muir Medical Center-Walnut Creek
Walnut Creek,CA

VISITS: At least 1-3 visits

PHASE: III

NCT ID: NCT06500455

Usual Radiation Therapy Compared to Longer Radiation Therapy for People with Brain Metastases

Phase III Trial of Single Fraction Stereotactic Radiosurgery (SRS) Versus Fractionated SRS (FSRS) for Intact Brain Metastases Scientific Title

Purpose

To compare the safety, effects (good and bad), and anti-cancer activity of standard of care stereotactic radiosurgery (SRS) to experimental fractionated stereotactic radiosurgery (FSRS).

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases) who have not yet received brain radiation. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Usual Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery (SRS), 1 session</li> <li class="seamTextUnorderedListItem">CT scan</li> <li class="seamTextUnorderedListItem">MRI scan</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fractionated stereotactic radiosurgery (FSRS), 3 sessions</li> <li class="seamTextUnorderedListItem">CT scan</li> <li class="seamTextUnorderedListItem">MRI scan</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. </li> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery (SRS) is a type of radiation that uses special equipment to precisely give a single large dose of radiation to a tumor. </li> <li class="seamTextUnorderedListItem">Fractionated stereotactic radiosurgery (FSRS) delivers a high dose of radiation to the tumor over 3 treatments.</li> <li class="seamTextUnorderedListItem">FSRS may be more effective compared to SRS in treating people with cancer that has spread to the brain.</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>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06500455' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 304 miles
FOMAT Medical Research (Network)
Oxnard,CA

VISITS: At least 5 visits every 3 weeks

PHASE: II

NCT ID: NCT06764940

Utidelone Chemotherapy for Metastatic HER2- or HER2 Low Breast Cancer with Brain Metastases

A Pivotal Phase II Clinical Trial of Utidelone Injection (UTD1) Plus Capecitabine (CAP) in HER2-negative Breast Cancer Patients with Brain Metastases Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of utidelone (UTD1), an experimental chemotherapy, with capecitabine (Xeloda®) chemotherapy.

Who is this for?

People with metastatic (stage IV) HER2 negative (HER2-) or HER2 low breast cancer that has spread to the brain (brain metastases) who have received no more than 3 lines of chemotherapy for metastatic disease. You must not have leptomeningeal metastasis (leptomeningeal disease). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Utidelone (UTD1), by injection, daily for 5 days, every 3 weeks</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Utidelone (UTD1) is an experimental chemotherapy drug that may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is an FDA approved chemotherapy drug.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2+/ISH-.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06764940' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/utd1-receives-fda-orphan-drug-designation-in-breast-cancer-brain-metastasis' target='_blank'>OncLive: UTD1 for Breast Cancer Brain Metastasis</a> </li></ul>

NEAREST SITE: 318 miles
City of Hope Antelope Valley
Lancaster,CA

VISITS: 1 to 10 visits over 1 month

PHASE: III

NCT ID: NCT03550391

Stereotactic Radiation or Memory Sparing Whole-Brain Radiation for Patients with 5-15 Brain Metastases

A Phase III Trial of Stereotactic Radiosurgery Compared With Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5-15 Brain Metastases Scientific Title

Purpose

To compare the anti-cancer activity and side effects of stereotaxic radiation with memory-sparing, whole-brain radiation, To preserve memory, radiation will avoid the hippocampus, an area of the brain associated with memory, and be given with Memantine, a drug used to treat memory loss caused by dementia.

Who is this for?

People with metastatic (stage IV) breast cancer and 5-15 brain metastases. You must not have received prior radiation or surgery for brain metastases (mets). Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Whole-brain radiation</li> <li class="seamTextUnorderedListItem">Memantine, by mouth, twice a day, for 4 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation to metastatic brain metastases</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to kill tumor cells that remain after surgery.</li> <li class="seamTextUnorderedListItem">Whole-brain radiation therapy (WBR) typically targets the entire brain, including the hippocampus. By avoiding the hippocampus, researchers hope to lessen the side effects of WBR.</li> <li class="seamTextUnorderedListItem">Stereotactic radiation (also called stereotactic radiosurgery) delivers focused radiation to each metastasis (met/tumor).</li> <li class="seamTextUnorderedListItem">Memantine is a medication approved for use in people with dementia, but its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer that have spread 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/NCT03550391' 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.webmd.com/drugs/2/drug-77932-377/memantine-oral/memantine-oral/details' target='_blank'>Memantine</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.verywellmind.com/what-is-the-hippocampus-2795231' target='_blank'>What is the Hippocampus?</a> </li></ul>

NEAREST SITE: 336 miles
UCLA
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05124912

Laser Interstitial Thermal Therapy for Brain Metastasis

REMASTer: REcurrent Brain Metastases After SRS Trial Scientific Title

Purpose

To study the effects (good and bad) and anti-cancer activity of NeuroBlate® Laser Interstitial Thermal Therapy alone or with stereotactic radiation.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases) who have received stereotactic radiation. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NeuroBlate® Laser Interstitial Thermal Therapy (LITT)</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NeuroBlate® Laser Interstitial Thermal Therapy (LITT)</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NeuroBlate® Laser Interstitial Thermal Therapy (LITT) is a minimally invasive surgical tool designed to remove brain metastases during surgery.</li> <li class="seamTextUnorderedListItem">Stereotactic radiation, also called stereotactic radiosurgery or hypofractionated radiation therapy, 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/NCT05124912' 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.monteris.com/patients-caregivers/what-is-neuroblate/' target='_blank'>Monteris Medical: NeuroBlate® Laser Interstitial Thermal Therapy (LITT)</a> </li></ul>

NEAREST SITE: 336 miles
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles,CA

VISITS: Up to 5 visits within 6 months

PHASE: NA

NCT ID: NCT07339085

MRI Scans to Tell the Difference Between Brain Tumors That Have Come Back and Tumor Destruction Due to Radiation for Metastatic Breast Cancer That Has Spread to the Brain

Advanced Dual-Nuclei MRI for Differentiation of Recurrent Brain Metastases and Radiation Necrosis Scientific Title

Purpose

To study the ability of advanced MRI methods to tell the difference between a brain tumor that has come back and destruction of the tumor due to radiation.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) who are planning to receive surgery or radiation to remove the tumor. Full eligibility criteria

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You will be assigned to 1 of 2 groups depending on your treatment plan: Group 1: Surgery <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MRI scan, before surgery</li> <li class="seamTextUnorderedListItem">Brain surgery to remove the tumor or biopsy</li> </ul> Group 2: Radiation <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation</li> <li class="seamTextUnorderedListItem">MRI scans, before radiation and 2 weeks, 3 months, and 6 months after radiation</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Current imaging methods have a limited ability to tell the difference between a brain tumor that has come back and destruction of the tumor due to radiation.</li> <li class="seamTextUnorderedListItem">This trial is studying advanced MRI methods that may be able to tell the difference.</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>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07339085' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>

NEAREST SITE: 342 miles
California Research Institute
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05386108

Elacestrant Hormone Therapy and Abemaciclib CDK 4/6 Inhibitor for ER+, HER2- Breast Cancer with Brain Metastasis

An Open-label Multicenter Phase 1b-2 Study of Elacestrant as Monotherapy and in Combination With Abemaciclib in Women and Men With Brain Metastasis From Estrogen Receptor Positive, HER-2 Negative Breast Cancer Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of elacestrant, an experimental hormone therapy, alone or with abemaciclib (Verzenio®) CDK 4/6 inhibitor.

Who is this for?

People with metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) or HER2 low breast cancer that has spread to the brain (brain metastasis) who have received at least 1 hormone therapy, up to 2 chemotherapies, and up to 2 CDK 4/6 inhibitors for metastatic disease. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant, daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®)</li> <li class="seamTextUnorderedListItem">Elacestrant, daily</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant is an experimental hormone therapy called a selective estrogen receptor degrader (SERD). SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK 4/6 inhibitors block two proteins, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women and men will also be given a drug that will put women in temporary menopause.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05386108' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/benefit-of-elacestrant-improves-with-longer-duration-of-cdk4-6-inhibition-in-patients-with-er-her2-metastatic-breast-cancer' target='_blank'>OncLive: Benefit of Elacestrant Improves With Longer Duration of CDK4/6 Inhibition in People With ER+/HER2- Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.targetedonc.com/view/the-emerald-trial-elacestrant-mechanism-of-action-study-design-and-outcomes' target='_blank'>Targeted Oncology: Elacestrant for ER+, HER2- MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/oral-serds/' target='_blank'>Metastatic Trial Talk: Update on Oral SERDs for Estrogen Receptor-Positive MBC</a> </li></ul>

NEAREST SITE: 353 miles
City of Hope Medical Center
Duarte,CA

VISITS: 1 visit every 1-2 months

PHASE: IV

NCT ID: NCT05376878

PET/MRI Scan to Determine Response to Treatment for People with Metastatic HER2+ Breast Cancer with Brain or Leptomeninges Metastasis

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

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 leptomeninges (brain or leptomeningeal metastasis) who are planning to receive treatment with trastuzumab deruxtecan (Enhertu®). Full eligibility criteria

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

NEAREST SITE: 447 miles
Moores Cancer Center
San Diego,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT04343157

Cognitive-Sparing Stereotactic Radiosurgery for Brain Metastasis

UCSD Image-Guided Cognitive-Sparing Radiosurgery for Brain Metastases: Avoidance of Eloquent White Matter and Hippocampal Regions Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of cognitive-sparing stereotactic radiosurgery.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis). You must have at least 1 brain tumor that has not been treated with radiation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cognitive-sparing stereotactic radiosurgery</li> <li class="seamTextUnorderedListItem">MRI scans, 4 scans within 6 months</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cognitive tests</li> </ul> Please contact research site for treatment schedule.
<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">Cognitive-sparing stereotactic radiosurgery is a targeted radiation therapy that avoids the white matter and hippocampus (parts of the brain that control memory, language, attention, and cognition).</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>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04343157' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>

NEAREST SITE: 660 miles
Mayo Clinic in Arizona
Scottsdale,AZ

VISITS: 1-5 radiation sessions, then 1 visit every 3-6 months for 5 years

PHASE: II

NCT ID: NCT05222620

2 Types of Stereotactic Radiosurgery for Brain Metastasis

Phase IIR Trial of Single Fraction Stereotactic Radiosurgery (SRS) Compared With Fractionated SRS (FSRS) for Intact Metastatic Brain Disease (FRACTIONATE) Scientific Title

Purpose

To compare the safety, effects (good and bad), and anti-cancer activity of two different types of stereotactic radiosurgery.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) that has not been treated with whole brain radiation. You are eligible if you have at least one brain lesion that has not been yet been treated with radiation. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Single Fraction Stereotactic Radiosurgery, 1 session</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fractionated Stereotactic Radiosurgery, 2-5 sessions</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> </ul> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery or stereotactic radiotherapy) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> </ul> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Single Fraction Stereotactic Radiosurgery (SFSR) is stereotactic radiation received in one higher dose of radiation given on one day of treatment.</li> </ul> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fractionated Stereotactic Radiation Therapy (FSRT) is stereotactic radiation is divided into several smaller doses (typically 2-5 sessions) of radiation given on separate days of treatment.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05222620' target='_blank'>ClinicalTrials.gov</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><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/stereotactic-radiosurgery/about/pac-20384526' target='_blank'>Mayo Clinic: Stereotactic Radiosurgery</a> </li></ul>

NEAREST SITE: 660 miles
Mayo Clinic in Arizona
Scottsdale,AZ

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). Full eligibility criteria

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You will be randomly assigned to one of two groups: Group 1 (Experimental group) <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">You will receive stereotactic radiosurgery followed by brain surgery within 4 weeks</li> </ul> Group 2 (Control Group) <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://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>

NEAREST SITE: 1418 miles
University of Nebraska Medical Center
Omaha,NE

VISITS: May require hospitalization

PHASE: NA

NCT ID: NCT01535430

Studying Speech, Movement, and Senses During Brain Surgery for Brain Metastasis

Assessment of Reorganization and Plasticity of Eloquent Function in Patients With Brain Tumors Scientific Title

Purpose

To study how brain tumors affect your speech, movement, and senses and to develop new methods of diagnosing brain tumors.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cognitive testing</li> <li class="seamTextUnorderedListItem">MRI and fMRI scans</li> <li class="seamTextUnorderedListItem">DTI tractograms</li> <li class="seamTextUnorderedListItem">MEG studies</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Awake brain mapping and surgery to remove brain tumor</li></ul>
<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 to monitor how the surgery is affecting your speech, movement, and senses. Your scalp will be anesthetized, so you will not feel the operation or any pain.</li> <li class="seamTextUnorderedListItem">You will receive cognitive testing, MRI and fMRI scans, DTI tractograms, and MEG studies before and after surgery.</li> <li class="seamTextUnorderedListItem">Cognitive tests study your cognition, which is your ability to think.</li> <li class="seamTextUnorderedListItem">Magnetic resonance imaging (MRI) and functional magnetic resonance imaging (fMRI) scans produce brain images created by magnetic energy rather than x-ray energy.</li> <li class="seamTextUnorderedListItem">A DTI tractogram is a type of MRI scan that produces brain images created by radio waves and magnetic fields.</li> <li class="seamTextUnorderedListItem">MEG studies measure the magnetic fields produced by your brain.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01535430' 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://braintumorcenter.ucsf.edu/treatments/surgery/awake-brain-mapping-faq' target='_blank'>UCSF Brain Tumor Center: Awake Craniotomy</a> </li></ul>

NEAREST SITE: 1418 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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You will be assigned to 1 of 2 groups: Group 1: Gliadel <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> Group 2: Standard care <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://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</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>

NEAREST SITE: 1509 miles
University of Texas Southwestern
Dallas,TX

VISITS: At least 4 visits over 3 weeks including surgery; may require hospitalization

PHASE: NA

NCT ID: NCT01668082

Tissue Collection During Surgery for Brain Metastasis

An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection Scientific Title

Purpose

To collect brain tumor tissue during surgery and study brain metastasis activity with U-13C-glucose and/or 1,2-13C-acetate.

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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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MRI and PET scans, 1-2 weeks before surgery</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">U-13C-glucose, by IV and/or 1,2-13C-acetate, by IV</li> <li class="seamTextUnorderedListItem">Brain surgery to remove brain tumor tissue</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">On the day of surgery, you will receive U-13C-glucose and/or 1,2-13C-acetate naturally occurring chemicals to study brain metastasis activity.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01668082' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>

NEAREST SITE: 1615 miles
Mayo Clinic in Rochester
Rochester,MN

VISITS: May require hospitalization

PHASE: NA

NCT ID: NCT04047264

Microdialysis During Surgery for Metastatic Breast Cancer that has Spread to the Brain

Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies Scientific Title

Purpose

To study the safety and effects (good and bad) of the use of microdialysis catheters during surgery to collect biomarkers, which may help doctors to develop new strategies to better diagnose, monitor, and treat 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 metastasis) who are planning to receive surgery to remove the tumor at Mayo Clinic (Rochester, MN). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Microdialysis during a biopsy or surgery</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A biomarker is a gene, protein, or molecule produced by the body or tumor in a person with cancer that tells a doctor something about the cancer cells. </li> <li class="seamTextUnorderedListItem">Microdialysis is a procedure used for collecting a small volume of liquid during surgery. This liquid contains substances that may provide valuable information to doctors about the nearby cancer.</li> <li class="seamTextUnorderedListItem">Microdialysis will be performed during surgery while your brain tumor is being removed.</li> <li class="seamTextUnorderedListItem">Information collected in this study may help doctors to develop new strategies to better diagnose, monitor, and treat brain tumors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04047264' 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.news-medical.net/life-sciences/What-is-Microdialysis.aspx' target='_blank'>News Medical: What is Microdialysis?</a> </li></ul>

NEAREST SITE: 1615 miles
Mayo Clinic in Rochester
Rochester,MN

VISITS: At least 3 visits including surgery; may require hospitalization

PHASE: NA

NCT ID: NCT04692337

Ommaya Reservoir Placement to Collect CSF Samples for Brain Metastasis

Ommaya Reservoir Placement for Brain Tumor Biomarker Access Scientific Title

Purpose

To study the safety and effects (good and bad) of Ommaya reservoir placement that will be used to collect and study CSF samples.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) who are planning to undergo brain surgery. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain surgery to place Ommaya reservoir</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Collection of CSF from Ommaya reservoir, 2 or more times</li> </ul> Please contact research site for schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">An Ommaya reservoir will be placed during brain surgery.</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">CSF samples will be used to study brain cancer activity and develop new brain cancer treatments.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04692337' 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.mskcc.org/cancer-care/patient-education/faq-about-ommaya-reservoirs-and-ommaya-taps' target='_blank'>Memorial Sloan Kettering Cancer Center: Ommaya Reservoir</a> </li></ul>

NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT05673928

Tucatinib and T-DM1 for HER2-Positive Breast Cancer with Brain Metastasis

A Phase II Study of Tucatinib and Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2-positive Metastatic Solid Tumors and Metastases to Brain (TUCATEMEB) Scientific Title

Purpose

To study the anti-cancer activity, safety and side effects of tucatinib and adotrastuzumab emtansine (T-DM1) for controlling brain metastases (breast cancer that has spread to the brain).

Who is this for?

People with metastatic (stage IV) HER2 positive (HER2+) breast cancer that has spread to the brain. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily for 1 year</li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine (T-DM1; Kadcyla®), by injection, every 3 weeks for 1 year</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®) is a type of anti-HER2 targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps HER2+ cancer cells grow.</li> <li class="seamTextUnorderedListItem">T-DM1 is an antibody-drug conjugate (ADC). It uses the HER2-targeted therapy trastuzumab to deliver the chemotherapy DM1 directly to cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05673928' 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.breastcancer.org/treatment/targeted-therapy/tukysa' target='_blank'>breastcancer.org: Tucatinib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/kadcyla' target='_blank'>Breastcancer.org: T-DM1</a> </li></ul>

NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT05700721

Niraparib and Dostarlimab for Metastatic Triple Negative or Mutated Breast Cancer with Brain Metastasis

Phase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of niraparib (Zejula®) PARP inhibitor with dostarlimab (Jemperli®) PD-1 inhibitor.

Who is this for?

People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer or breast cancer with a BRCA1, BRCA2, ATM, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51, RAD51B, RAD51C, RAD51D, RAD52, or RAD54L mutation that has spread to the brain (brain metastasis). You must have received at least one line of therapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®), by mouth</li> <li class="seamTextUnorderedListItem">Dostarlimab (Jemperli®), by IV</li> <li class="seamTextUnorderedListItem">Lumbar puncture (optional)</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®) is a type of targeted therapy called a PARP inhibitor. It works by blocking poly (ADP-ribose) polymerase, an enzyme that helps cancer cells grow by repairing their DNA.</li> <li class="seamTextUnorderedListItem">Dostarlimab (Jemperli®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</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">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/NCT05700721' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>

NEAREST SITE: 1643 miles
The University of Texas MD Anderson Cancer Center
Houston,TX

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT06649058

Stereotactic Radiosurgery for People with Metastatic Breast Cancer with Brain Metastases

EXCLAIM: Exploring Combined Local and Systemic Approaches In Brain Metastasis: a Multi-cohort Randomized Phase II Study Evaluating Initial Response to Systemic Therapy and Subsequent Integration of Stereotactic Radiosurgery in Patients With Low-risk Brain Metastases and Central Nervous System-active Systemic Therapy Options Scientific Title

Purpose

To learn if using SRS to treat all brain metastases that do not respond to systemic therapy versus treating only metastases that are getting worse can help to control CNS disease in patients whose disease gets worse after systemic therapy.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) who have at least 1 brain lesion that has not received radiation. You must be planning to receive chemotherapy or targeted therapy as the first treatment for brain mets. Full eligibility criteria

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You will receive the following after receiving chemotherapy or targeted therapy: Group 1: Tumors Completely Disappear (Complete Response) <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">No radiation</li> <li class="seamTextUnorderedListItem">Brain MRIs</li> </ul> Group 2: Tumors Shrink (Partial Response) or Stay the Same (Stable Disease) You will be randomly assigned to 1 of the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery</li> </ul> or <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">No radiation</li> <li class="seamTextUnorderedListItem">Brain MRIs</li> </ul> Group 3: Tumors Grow (Progressive Disease) You will be randomly assigned to 1 of the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery only to brain tumors that have grown (progressed)</li> </ul> or <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery to all brain tumors</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">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></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06649058' 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.mayoclinic.org/tests-procedures/stereotactic-radiosurgery/about/pac-20384526#:~:text=Stereotactic%20radiosurgery%20(SRS)%20uses%20many,sense%20because%20there's%20no%20incision.' target='_blank'>Mayo Clinic: Stereotactic Radiosurgery</a> </li></ul>

NEAREST SITE: 1643 miles
The University of Texas M. D. Anderson Cancer Center
Houston,TX

VISITS: n/a

PHASE: II

NCT ID: NCT07053033

Laser Interstitial Thermal Therapy (LITT) or Surgery and Radiation for Recurrent Brain Metastases

Laser Interstitial Thermal Therapy (LITT) or Surgery and Adjuvant Reirradiation for Recurrent Brain Metastases (LaSAR BeaM) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of stereotactic radiosurgery (SRS) following surgery or LITT.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) and has recurred (come back). You must have received prior stereotactic radiosurgery (SRS). Full eligibility criteria

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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) (SRS) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">Laser interstitial thermal therapy (LITT) is a technique that is done by implanting a laser catheter into the tumor and heating it to temperatures high enough to kill the tumor.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07053033' 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.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.mdanderson.org/treatment-options/stereotactic-radiosurgery.html' target='_blank'>MD Anderson: Stereotactic Radiosurgery</a> </li></ul>

NEAREST SITE: 1643 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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You will be randomly assigned to 1 of 2 groups: <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> Participants may undergo additional SRS if disease returns after treatment.
<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>

NEAREST SITE: 1643 miles
MD Anderson Cancer Center
Houston,TX

VISITS: 1 visit every 3 weeks

PHASE: I

NCT ID: NCT06545682

Alpelisib Targeted Therapy with Pembrolizumab Immunotherapy for Metastatic Triple Negative Breast Cancer with Active Brain Metastases

Phase Ib Study of AlpeliSib with PEmbroLizumab in Patients with MEtastatic Breast CaNcer or MelanomA (SELENA) Scientific Title

Purpose

To find a dose of the combination of alpelisib (Piqray®) targeted therapy and pembrolizumab (Keytruda®) immunotherapy that can be given to people with metastatic breast cancer.

Who is this for?

People with metastatic (stage IV) triple negative (ER-, PR-, HER2- or HER2 low) breast cancer who have active and untreated brain metastases. You must have no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2+/FISH-.</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/NCT06545682' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX

VISITS: 1 visit every 3 weeks

PHASE: II

NCT ID: NCT05064280

Pembrolizumab and Lenvatinib for People with Breast Cancer Brain Metastases

Phase II Study of Pembrolizumab in Combination With Lenvatinib in Patients With TNBC, NSCLC, and Other Tumor Types and Brain Metastases Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of lenvatinib (Lenvima®) tyrosine kinase inhibitor and pembrolizumab (Keytruda®) PD-1 inhibitor.

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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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Lenvatinib (Lenvima®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lenvatinib (Lenvima®) is a type of targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps cancer cells grow.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</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/NCT05064280' target='_blank'>ClinicalTrials.gov</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://medlineplus.gov/druginfo/meds/a615015.html' target='_blank'>MedlinePlus: Lenvatinib (Lenvima®)</a> </li></ul>

NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX

VISITS: May require hospitalization

PHASE: NA

NCT ID: NCT02754544

Brain Surgery and Electrocorticography for Brain Metastasis

Pilot Investigation of Using Electrocorticogram (ECoG) in Predicting Eloquent Cortex and Post-Operative Functional Outcomes in Patients With Brain Tumors Scientific Title

Purpose

To identify which areas of the brain are active during brain surgery and to improve the safety of brain surgery.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) that are planning to receive brain surgery at the University of Texas M. D. Anderson Cancer Center. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain surgery to remove brain tumor</li> <li class="seamTextUnorderedListItem">Electrocorticography</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">During brain surgery, you will complete various tasks to allow doctors to identify which areas of the brain are active during brain surgery, which is called electrocorticography.</li> <li class="seamTextUnorderedListItem">Tasks include speaking and moving parts of your body.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02754544' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>

NEAREST SITE: 1832 miles
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee,WI

VISITS: Daily for 10 days

PHASE: II

NCT ID: NCT05045950

Memantine for Cognition with Whole Brain Radiation Therapy for Brain Metastasis

Optimizing Neurocognition With Whole Brain Radiation Therapy (WBRT) Using Upfront Pulsed Reduced Dose-Rate (PRDR) Technique (ONCO-RT) - A Phase II Trial of Upfront Pulsed Reduced Dose Rate Whole-Brain Radiation Therapy for Brain Metastases Scientific Title

Purpose

To study the effects (good and bad) of memantine and whole brain radiation therapy (WBRT) on your cognition (ability to think).

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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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Memantine (Namenda®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Whole brain radiation therapy (WBRT) with pulsed reduced dose rate (PRDR), daily for 10 days</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cognitive testing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Whole brain radiation therapy (WBRT) is radiation therapy that treats the entire brain.</li> <li class="seamTextUnorderedListItem">WBRT with pulsed reduced dose rate (PRDR) uses a slower rate of radiation to improve safety and anti-cancer activity.</li> <li class="seamTextUnorderedListItem">Memantine (Namenda®) is a medication that treats cognition (ability to think).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05045950' 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.webmd.com/drugs/2/drug-77932-377/memantine-oral/memantine-oral/details' target='_blank'>WebMD: Memantine</a> </li></ul>

NEAREST SITE: 1857 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. Full eligibility criteria

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You will be assigned to one of two groups: Group 1 Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic Radiosurgery using a reduced dose of radiation delivered to the tumor sites.</li> </ul> Group 2: Control <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://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</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>

NEAREST SITE: 1946 miles
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis,IN

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04711824

Targeted Therapy, Radiation, Chemotherapy, and Immunotherapy for Metastatic Triple Negative or HER2-, BRCA Mutated Breast Cancer with Brain Metastases

Phase I/II Study of Stereotactic Radiosurgery With Concurrent Administration of DNA Damage Response (DDR) Inhibitor (Olaparib) Followed by Adjuvant Combination of Durvalumab (MEDI4736) and Physician's Choice Systemic Therapy in Subjects With Breast Cancer Brain Metastases Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of olaparib (Lynparza®) PARP inhibitor, stereotactic radiosurgery, chemotherapy, and durvalumab (Imfinzi®) PD-L1 inhibitor.

Who is this for?

Postmenopausal women or men with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer or HER2 negative (HER2-) breast cancer that has spread to the brain (brain metastasis). If you have HER2- breast cancer, you must also have a germline (inherited) or somatic (tumor) BRCA mutation. You must have at least 1 brain tumor that has not been treated with radiation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, daily for 1 month</li> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery (SRS), 1-5 times</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of chemotherapy: Paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), eribulin (Halaven®), carboplatin (Paraplatin®), cisplatin (Platinol®), capecitabine (Xeloda®), or gemcitabine (Gemzar®)</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</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">Paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), eribulin (Halaven®), carboplatin (Paraplatin®), cisplatin (Platinol®), capecitabine (Xeloda®), or gemcitabine (Gemzar®) are chemotherapy drugs that slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) is a type of immunotherapy called a PD-L1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-L1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04711824' 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.breastcancer.org/treatment/targeted-therapy/lynparza' target='_blank'>Breastcancer.org: Olaparib (Lynparza®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/stereotactic-radiosurgery/about/pac-20384526' target='_blank'>Mayo Clinic: Stereotactic Radiosurgery</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a617030.html' target='_blank'>MedlinePlus: Durvalumab (Imfinzi®)</a> </li></ul>

NEAREST SITE: 1984 miles
University of Louisville Hospital
Louisville,KY

VISITS: Coincides with surgery

PHASE: NA

NCT ID: NCT07044557

Surgery for Breast Cancer that has Spread to the Brain Without Dexamethasone

MeDex: No Perioperative Dexamethasone in Brain Metastases Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of surgery for brain metastasis without dexamethasone before, during, or up to 3 weeks after surgery.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis). The cancer in your brain must have been recently diagnosed, and you must be planning to receive brain surgery to remove the cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain surgery to remove the tumor</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dexamethasone is a steroid used during brain surgery to prevent brain swelling. Because it is an anti-inflammatory drug, it may also reduce the effect of immunotherapies used to treat cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07044557' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>

NEAREST SITE: 2011 miles
University of Michigan Health Sparrow
Lansing,MI

VISITS: Coincides with surgery

PHASE: IV

NCT ID: NCT07225101

STRATAFIX Absorbable Sutures for Closure of Surgical Wounds for Surgery to Remove Brain Metastases

Evaluation of the Efficacy of STRATAFIX for Neurosurgical Cranial and Spine Procedures Scientific Title

Purpose

To study the safety and effects (good and bad) of STRATAFIX sutures to close a surgical wound.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) who are planning to receive surgery to remove the tumor. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">STRATAFIX sutures to close the surgical wound.</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">STRATAFIX sutures are FDA-approved absorbable sutures for closing surgical wounds.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with other types of cancer and people with non-cancerous conditions.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07225101' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>

NEAREST SITE: 2013 miles
University of Alabama at Birmingham (UAB) Hazelrig-Salter Radiation Oncology Center
Birmingham,AL

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT06857006

Comparing Radiosurgery Margins for People with Breast Cancer Brain Metastases

UAB 2507 - Randomized Phase II Study of Differential Margins in Single Isocenter Radiosurgery of Brain Metastases Scientific Title

Purpose

To compare the anti-cancer activity of giving radiosurgery (radiation) with no margin vs. a 2 millimeter margin.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis). You must have at least 1 lesion that has not received stereotactic radiosurgery (SRS) or stereotactic body radiotherapy (SBRT) (targeted radiation). You are still eligible if you received prior whole brain radiation alone. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: No Margin <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiosurgery with 0 millimeter (mm) margin</li> </ul> Group 2: 2 mm Margin <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiosurgery with 2 millimeter (mm) margin</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiosurgery (also called stereotactic radiation) uses a high dose of radiation to destroy or kill a tumor.</li> <li class="seamTextUnorderedListItem">In this study, margins refer to the area around the brain tumor where radiation is given.</li> <li class="seamTextUnorderedListItem">This trial will compare giving radiation with no margin (0 millimeters) vs. a 2 millimeter margin.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06857006' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>

NEAREST SITE: 2108 miles
Ohio State University Comprehensive Cancer Center
Columbus,OH

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04923542

Stereotactic Radiation, Abemaciclib, and Hormone Therapy for HR+, HER2- Breast Cancer Brain Metastases

Phase I/II Study of Stereotactic Radiation and Abemaciclib in the Management of Hormone Receptor Positive HER2 Negative Breast Cancer Brain Metastases Scientific Title

Purpose

To study the anti-cancer activity and side effects of giving the CDK 4/6 inhibitor abemaciclib (Verzenio®), hormone therapy, and stereotactic radiation therapy together to treat brain metastases.

Who is this for?

People with metastatic (stage IV) hormone receptor-positive, HER2 negative (HER2-) breast cancer that has spread to the brain. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Doctor's choice of anti-estrogen therapy, ongoing</li> <li class="seamTextUnorderedListItem">Stereotactic Radiation Therapy to each brain met</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor -- it blocks two enzymes, CDK4 and CDK6, that help cancer grow. It is already approved to treat some metastatic breast cancer, but its use in this trial is experimental.</li> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to damage cancer cell DNA. This stops 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">Anti-estrogen therapies are commonly used to treat hormone receptor-positive breast cancer. These drugs are also called endocrine or hormone therapy and include tamoxifen, aromatase inhibitors, fulvestrant, and others. </li> <li class="seamTextUnorderedListItem">The hormone therapies used in this trial are fulvestrant and aromatase inhibitors.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04923542' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/?s=brain+mets' target='_blank'>Metastatic Trial Talk: Topics for Breast Cancer Brain Mets</a> </li></ul>

NEAREST SITE: 2139 miles
Emory University Hospital/Winship Cancer Institute
Atlanta,GA

VISITS: Coincides with surgery

PHASE: II

NCT ID: NCT06132685

Decreasing Doses of Dexamethasone to Reduce Side Effects After Brain Surgery for People with Breast Cancer Brain Metastases

Post-Operative Dosing of Steroids Post Craniotomy for Brain Tumor (PODS) Scientific Title

Purpose

To study the effects (good and bad) of decreasing doses of dexamethasone on side effects after surgery to remove a brain tumor.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) who are planning to receive brain surgery. Full eligibility criteria

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You will receive the following after surgery: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dexamethasone, decreasing doses every day for up to 2 weeks</li> <li class="seamTextUnorderedListItem">Blood tests</li> <li class="seamTextUnorderedListItem">MRI scan</li> <li class="seamTextUnorderedListItem">CT scan</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Craniotomy is surgery to remove a brain tumor.</li> <li class="seamTextUnorderedListItem">Steroids are the standard of care treatment to reduce swelling (edema) and reduce symptoms after surgery.</li> <li class="seamTextUnorderedListItem">However, some steroids have side effects including high blood sugar, high blood pressure, and worsened wound healing.</li> <li class="seamTextUnorderedListItem">Dexamethasone is a type of steroid called a corticosteroid. It is used to reduce inflammation, reduce swelling, and lower the body's immune response.</li> <li class="seamTextUnorderedListItem">Reducing the dose of dexamethasone may decrease steroid side effects without increasing the risk of swelling after brain surgery.</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">A computed tomography (CT) scan produces body pictures created by x-ray energy.</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/NCT06132685' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>

NEAREST SITE: 2139 miles
Emory University Hospital/Winship Cancer Institute
Atlanta,GA

VISITS: 11 visits within 2 weeks

PHASE: I

NCT ID: NCT06328686

Arginine and Whole Brain Radiation Therapy for People with Brain Metastases

Arginine With Whole Brain Radiation Therapy for the Treatment of Brain Metastases Scientific Title

Purpose

To compare the safety and effects (good and bad) of 2 ways to give L-arginine with whole brain radiation therapy.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) who are planning to receive whole brain radiation therapy. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: L-arginine By IV <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">L-arginine, by IV, 10 times within 2 weeks</li> <li class="seamTextUnorderedListItem">Whole brain radiation therapy, 10 times within 2 weeks</li> <li class="seamTextUnorderedListItem">CT scan, 1 time</li> <li class="seamTextUnorderedListItem">MRI scan 2 times</li> </ul> Group 2: L-arginine By Mouth <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">L-arginine, by mouth, 10 times within 2 weeks</li> <li class="seamTextUnorderedListItem">Whole brain radiation therapy, 10 times within 2 weeks</li> <li class="seamTextUnorderedListItem">CT scan, 1 time</li> <li class="seamTextUnorderedListItem">MRI scan 2 times</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Arginine is an essential amino acid.</li> <li class="seamTextUnorderedListItem">Amino acids are the molecules that join together to form proteins in the body.</li> <li class="seamTextUnorderedListItem">Giving arginine has been shown to improve how brain metastases respond to radiation therapy.</li> <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">Whole brain radiation therapy (WBRT) is radiation therapy that treats the entire brain.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06328686' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>

NEAREST SITE: 2193 miles
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland,OH

VISITS: May require hospitalization

PHASE: I-II

NCT ID: NCT01891318

Stereotactic Radiosurgery Before Brain Surgery for Brain Metastasis

Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study Scientific Title

Purpose

To study the safety, effects (good and bad), best dose, and anti-cancer activity of stereotactic radiosurgery given before brain surgery.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) and 1-4 brain tumors. You must have at least 1 brain tumor that has not been treated with radiation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain surgery to remove brain tumor</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Questionnaires</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">Stereotactic radiosurgery focuses the x-rays directly to the tumor and cause less damage to the normal tissue 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/NCT01891318' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>

NEAREST SITE: 2299 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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You will receive the following: <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> Additional procedures <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>

NEAREST SITE: 2352 miles
University of Rochester
Rochester,NY

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT04965064

Neratinib Targeted Therapy with Capecitabine Chemotherapy for Metastatic HER2 Negative Breast Cancer with Abnormally Active HER2 Signaling and Brain Metastases

An Open-Label Phase II Trial of Neratinib Plus Capecitabine in Subjects With HER2-Negative Metastatic Breast Cancer With Brain Metastases and Abnormally Active HER2 Signaling Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of neratinib (Nerlynx®) anti-HER2 targeted therapy with capecitabine (Xeloda®) chemotherapy.

Who is this for?

People with metastatic (stage IV) HER2 negative (HER2-) breast cancer with abnormally active HER2 signaling that has spread to the brain (brain metastasis). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 day off</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®) is an anti-HER2 targeted therapy that stops cancer cells from growing by targeting and blocking the HER2 proteins that help cancer cells grow.</li> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®) is an oral drug approved by the U.S. Food and Drug Administration (FDA) to treat HER2 positive breast cancer. It is considered investigational in this study because your breast cancer was determined to be HER2 negative by the standard method of testing. However, the CELsignia test showed that your breast cancer cells have HER2 pathway activity that might respond to HER2-targeted treatment.</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy drug that may slow or stop breast cancer cells from growing.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04965064' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/nerlynx' target='_blank'>Breastcancer.org: Neratinib (Nerlynx®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/xeloda' target='_blank'>Breastcancer.org: Capecitabine (Xeloda®)</a> </li></ul>

NEAREST SITE: 2377 miles
Medical University of South Carolina Hollings Cancer Center
Charleston,SC

VISITS: 2-3 radiation sessions within 2 months

PHASE: II

NCT ID: NCT07227610

Comparing Two Types of Radiation Therapy for People with Brain Metastases

Brain Metastases in Greater Size - Hypofractionated Options Trial (BIGSHOT) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of two types of radiation therapy used to treat large brain metastases: staged stereotactic radiosurgery (SSRS) and fractionated stereotactic radiotherapy (FSRT).

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases). The metastases must be larger tumors (2 to 5 cm). Full eligibility criteria

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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07227610' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>Metastatic Trial Talk: MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/side-effects-of-brain-mets-radiation/' target='_blank'>Metastatic Trial Talk: Side Effects of Radiation Therapy for Brain Mets</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/tag/brain-metastases/' target='_blank'>Metastatic Trial Talk: The Latest in Treatments for MBC With Brain Metastases</a> </li></ul>

NEAREST SITE: 2385 miles
Duke University Medical Center
Durham,NC

VISITS: At least 1 visit every 1-2 months

PHASE: II

NCT ID: NCT06176261

Datopotamab Deruxtecan ADC for HER2- Breast Cancer That Spread to the Brain or Leptomeninges

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

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 leptomeninges (leptomeningeal disease). Full eligibility criteria

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You will receive the following: <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>
<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>
<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>

NEAREST SITE: 2395 miles
Moffitt Cancer Center
Tampa,FL

VISITS: At least 1 visit every 1-2 weeks

PHASE: I-II

NCT ID: NCT06238921

ADC, Targeted Therapy, and Stereotactic Radiation for Metastatic Triple Negative Breast Cancer with Brain Metastases

Phase I/II Study of Stereotactic Radiation and Sacituzumab Govitecan With Zimberelimab in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of stereotactic radiation, sacituzumab govitecan (Trodelvy®) antibody drug conjugate, and zimberelimab experimental targeted therapy.

Who is this for?

People with metastatic (stage IV) triple negative (ER- or ER low, PR- or PR low, HER2-) breast cancer that has spread to the brain (brain metastasis) and who have at least 1 brain lesion that has not been treated with radiation. You must have received chemotherapy with doxorubicin (Adriamycin®) and at least 1 of the following: paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), or docetaxel (Taxotere®). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation</li> </ul> followed 1 week later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®), by IV, weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Zimberelimab, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Imaging scans, every 2 months</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">Sacituzumab govitecan (Trodelvy®) is a type of targeted therapy called an 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">The antibody in sacituzumab govitecan (Trodelvy®) targets TROP2 proteins. It delivers the chemotherapy irinotecan.</li> <li class="seamTextUnorderedListItem">Zimberelimab is an experimental targeted therapy called a PD-1 inhibitor, which is a type of immune checkpoint 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/NCT06238921' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/zimberelimab' target='_blank'>National Cancer Institute: Zimberelimab</a> </li></ul>

NEAREST SITE: 2432 miles
National Institutes of Health Clinical Center
Bethesda,MD

VISITS: Requires hospitalization

PHASE: NA

NCT ID: NCT02639325

Brain Surgery for Brain Metastasis and Tumor Related Epilepsy

Tumor Related Epilepsy Scientific Title

Purpose

To study if brain surgery reduces the number of seizures and to see how surgery affects seizures.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis). You must have no more than one brain tumor and have experienced at least one seizure associated with the tumor. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain surgery to remove brain tumor</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Requires hospitalization for at least one week</li> <li class="seamTextUnorderedListItem">Questionnaires, cognitive assessments, and seizure diary</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Some people with brain tumors have seizures related to the tumor. This is called tumor-related epilepsy. </li> <li class="seamTextUnorderedListItem">Researchers think surgery may improve outcomes for people with tumor-related epilepsy by stopping seizures or reducing the number of seizures.</li> <li class="seamTextUnorderedListItem">Cognitive assessments study your cognition, which is your ability to think.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02639325' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/brain-metastasis/' target='_blank'>MBCBrainMets.org: About Brain Metastasis</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/treatments-brain-metastasis/#toggle-id-7' target='_blank'>MBCBrainMets.org: Brain Metastasis Treatments</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/brain-mets/' target='_blank'>Metastastic Trial Talk: Treating Breast Cancer Brain Mets</a> </li></ul>

NEAREST SITE: 2433 miles
Sibley Memorial Hospital
Washington D.C.,DC

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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You will receive the following: <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://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>

NEAREST SITE: 2436 miles
Georgetown University Medical Center
Washington D.C.,DC

VISITS: 4 visits within 2 weeks

PHASE: NA

NCT ID: NCT07105358

Brain Stimulation and Training to Improve Vision for Metastatic Breast Cancer that has Spread to the Brain

Vision Improvement Through Behavioral Rehabilitation And Neuroplasticity Training Scientific Title

Purpose

To study whether transcranial random noise stimulation (tRNS) plus learning-based training can improve vision.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) and who are experiencing vision loss due to brain metastases. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Transcranial random noise stimulation (tRNS), three 18-minute sessions per day for 2 days</li> <li class="seamTextUnorderedListItem">Perceptual learning-based training</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sham stimulation, three 18-minute sessions per day for 2 days</li> <li class="seamTextUnorderedListItem">Perceptual learning-based training</li> </ul> Group 2: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sham stimulation, three 18-minute sessions per day for 2 days</li> <li class="seamTextUnorderedListItem">Perceptual learning-based training</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Transcranial random noise stimulation (tRNS), three 18-minute sessions per day for 2 days</li> <li class="seamTextUnorderedListItem">Perceptual learning-based training</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Transcranial random noise stimulation (tRNS) is a noninvasive brain stimulation technique for improving vision by targeting the regions of the brain responsible for vision.</li> <li class="seamTextUnorderedListItem">Perceptual learning-based training is a task in which the person judges the direction of moving dots.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling healthy people as controls.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07105358' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>

NEAREST SITE: 2539 miles
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge,NJ

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT06807619

Sotorasib Targeted Therapy for Metastatic Breast Cancer with KRAS G12C+ Brain Metastases

BrainMet ADePPT (Anticancer Drug Penetration Platform Trial) Scientific Title

Purpose

To find out how safe and effective sotorasib, an experimental targeted therapy, is at treating KRAS G12C+ brain tumors.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) who are planning to receive brain surgery. Brain metastases must be KRAS G12C positive (KRAS G12C+). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sotorasib</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sotorasib is an experimental targeted therapy called a KRAS G12C inhibitor. Blocking KRAS G12C may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Sotorasib has been approved for other types of cancer. 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/NCT06807619' 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.onclive.com/view/dr-fakih-on-the-fda-approval-of-sotorasib-plus-panitumumab-for-kras-g12c-mutated-mcrc' target='_blank'>OncLive: Sotorasib for KRAS G12C+ Colorectal Cancer</a> </li></ul>

NEAREST SITE: 2539 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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You will be randomly assigned to 1 of 2 groups: Group 1: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain surgery</li> </ul> Group 2: <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://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</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>

NEAREST SITE: 2567 miles
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York,NY

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT06058988

Trastuzumab Deruxtecan Antibody Drug Conjugate for Metastatic HER2 Positive, Low, or Mutated Breast Cancer with Brain Metastases

Window of Opportunity Assessment of [Fam-]Trastuzumab DERuxtecan-nxki (T-DXd) Brain Tumor Penetration and Efficacy (WOnDER-BT) Scientific Title

Purpose

To study the safety, effects, and anti-cancer activity of trastuzumab deruxtecan (T-DXd, Enhertu®) antibody-drug conjugate (ADC) for people with brain metastases.

Who is this for?

People with metastatic (stage IV) HER2 positive (HER2+), HER2 low, or HER2 mutated breast cancer that has spread to the brain (brain metastasis) and are planning to receive brain surgery. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-DXd, Enhertu®), by IV</li></ul>
<ul class="seamTextUnorderedList"> <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> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC1+ or 2+.</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/NCT06058988' 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.breastcancer.org/treatment/targeted-therapy/enhertu' target='_blank'>Breastcancer.org: Trastuzumab Deruxtecan (T-DXd, Enhertu®)</a> </li></ul>

NEAREST SITE: 2567 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 being studied?
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You will receive the following: <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>

NEAREST SITE: 2587 miles
Miami Cancer Institute at Baptist Health, Inc.
Miami,FL

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05789589

Azeliragon and Stereotactic Radiation for Breast Cancer with Brain Metastases

A Phase I/II Study to Assess Safety and Preliminary Evidence of a Therapeutic Effect of Azeliragon Combined With Stereotactic Radiation Therapy in Patients With Brain Metastases (ADORATION) Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of azeliragon, an experimental anti-cancer therapy, with stereotactic radiosurgery.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis). You must have at least 1 lesion that has not received radiation. Full eligibility criteria

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What's involved?
What's being studied?
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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azeliragon, by mouth, daily, up to 2 years</li> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery</li> <li class="seamTextUnorderedListItem">Cognitive tests</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azeliragon is an experimental anti-cancer drug. It is also being studied for treating Alzheimer's and glioblastoma, a type of brain cancer.</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/NCT05789589' 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.onclive.com/view/fda-grants-orphan-drug-designation-to-azeliragon-for-gbm' target='_blank'>OncLive: Azeliragon for Glioblastoma</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/stereotactic-radiosurgery#:~:text=What%20is%20stereotactic%20radiosurgery%3F,trigeminal%20neuralgia%20and%20arteriovenous%20malformations.' target='_blank'>Johns Hopkins Medicine: Stereotactic Radiosurgery</a> </li></ul>

NEAREST SITE: 2693 miles
Massachusetts General Hospital
Boston,MA

VISITS: 5 visits per week

PHASE: NA

NCT ID: NCT03286335

Proton Radiation Therapy for Brain Metastasis

Local Control, Quality of Life and Toxicities in Adults With Benign or Indolent Brain Tumors Undergoing Proton Radiation Therapy Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of proton radiation therapy.

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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What's involved?
What's being studied?
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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Proton radiation therapy, 5 visits per week</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surveys</li> <li class="seamTextUnorderedListItem">Vision and hearing assessments</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Proton radiation therapy is a type of radiation therapy that uses protons instead of x-rays.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03286335' 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.texascenterforprotontherapy.com/cancers-treated/brain-cancer#:~:text=Proton%20therapy%20can%20be%20used,healthy%20tissue%20surrounding%20the%20brain.' target='_blank'>Texas Center for Proton Therapy</a> </li></ul>

NEAREST SITE: 2693 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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What's involved?
What's being studied?
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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain imaging by MRI and Treatment Assessment Maps followed by</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://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>

NEAREST SITE: 2693 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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What's involved?
What's being studied?
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You will receive the following: <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>

NEAREST SITE: 2694 miles
Massachusetts General Hospital Cancer Center
Boston,MA

VISITS: 5 visits per week for 2-3 weeks

PHASE: II

NCT ID: NCT05013892

2 Types of Whole Brain Radiation Therapy for Brain Metastasis

Randomized Phase II Trial of Normal Tissue Sparing Whole Brain Radiation Therapy (NTS-WBRT) Versus Hippocampal Avoidance Whole Brain Radiation Therapy (HA-WBRT) in Patients With Brain Metastases Scientific Title

Purpose

To compare the safety, effects (good and bad), and anti-cancer activity of 2 types of whole brain radiation therapy (WBRT).

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) that have not received treatment with memantine (Namenda®). Full eligibility criteria

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What's involved?
What's being studied?
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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Normal tissue sparing whole brain radiation therapy (NTS-WBRT), 5 sessions per week for 2-3 weeks</li> <li class="seamTextUnorderedListItem">Memantine (Namenda®), by mouth, daily for 6 months</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hippocampal avoidance whole brain radiation therapy (HA-WBRT), 5 sessions per week for 2-3 weeks</li> <li class="seamTextUnorderedListItem">Memantine (Namenda®), by mouth, daily for 6 months</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Questionnaires</li> <li class="seamTextUnorderedListItem">Cognitive testing</li> <li class="seamTextUnorderedListItem">Hearing assessments</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Whole brain radiation therapy (WBRT) is radiation therapy that treats the entire brain.</li> <li class="seamTextUnorderedListItem">Normal tissue sparing whole brain radiation therapy (NTS-WBRT) is a targeted radiation therapy that reduces radiation to tissue that does not need radiation therapy.</li> <li class="seamTextUnorderedListItem">Hippocampal avoidance whole brain radiation therapy (HA-WBRT) is a targeted radiation therapy that avoids the hippocampus (part of the brain that controls learning and memory) during radiation therapy.</li> <li class="seamTextUnorderedListItem">Memantine (Namenda®) is a standard of care medication that treats cognition (ability to think).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05013892' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>

No Travel Required

VISITS: No visits required

PHASE: II

NCT ID: NCT06377696

Care and Monitoring at Home for People with Brain Metastasis

Neuro-Oncology Anywhere: Deploying Mayo Clinic's Remote Cognitive Assessment Battery and Wearable Device Monitoring Platform While Assessing the Impact of Metformin on Cognition and Quality of Life in Patients With History of Cranial Radiation Scientific Title

Purpose

To study if giving metformin and monitoring can be done at home for people receiving brain radiation or who have previously had brain radiation.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis). You must be planning to receive brain radiation or completed brain radiation within the last 3 years. Full eligibility criteria

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What's involved?
What's being studied?
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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Metformin, by mouth, daily, 1 year</li> <li class="seamTextUnorderedListItem">FitBit wearable device</li> <li class="seamTextUnorderedListItem">Cognitive tests</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> Group 2: Usual Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care treatment, 1 year</li> <li class="seamTextUnorderedListItem">FitBit wearable device</li> <li class="seamTextUnorderedListItem">Cognitive tests</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain radiation can result in significant negative effects on cognition (the ability to clearly think, learn, and remember).</li> <li class="seamTextUnorderedListItem">Cognitive tests study your cognition, which is your ability to think.</li> <li class="seamTextUnorderedListItem">Metformin is a drug approved to treat type 2 diabetes (a condition in which the body cannot control the level of sugar in the blood).</li> <li class="seamTextUnorderedListItem">Metformin may also be used to treat cancer and improve your cognition (ability to think) and quality of life.</li> <li class="seamTextUnorderedListItem">In this study, a FitBit wearable device will be used to monitor and detect seizures.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06377696' 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.mayo.edu/research/clinical-trials/cls-20567690' target='_blank'>Mayo Clinic: Trial Information Page</a> </li></ul>