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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: December 03, 2024)

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AKT

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ROS1

TP53

NEAREST SITE: 3 miles
UCSF Medical Center-Parnassus
San Francisco,CA

VISITS: 2 visits within 1 month including surgery; may require hospitalization

PHASE: III

NCT ID: NCT05438212

Radiation Before or After Surgery for Brain Metastasis

A Randomized Phase III Trial of Pre-Operative Compared to Post-Operative Stereotactic Radiosurgery in Patients With Resectable Brain Metastases Scientific Title

Purpose

To compare the safety, effects (good and bad), and anti-cancer activity of stereotactic radiosurgery (radiation) before and after surgery.

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. You must have at least 1 brain tumor that has not 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 to remove brain tumor</li> </ul> followed 10-30 days later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery, 1 time</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery, 1 time</li> </ul> followed up to 7 days later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain surgery to remove brain tumor</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery is a type of radiation therapy that delivers a high dose of radiation only to the small areas of cancer in the brain and avoids the surrounding normal brain tissue.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05438212' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>

NEAREST SITE: 8 miles
Bay Area Breast Surgeons Inc
Emeryville,CA

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

PHASE: II

NCT ID: NCT04647916

Sacituzumab Govitecan for HER2 Negative Breast Cancer Brain Metastases

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

Purpose

To study the anti-cancer activity, safety and side effects of giving the antibody-drug conjugate sacituzumab govitecan (Trodelvy®) to treat brain metastases (breast cancer that has spread to the brain).

Who is this for?

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

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

NEAREST SITE: 27 miles
Stanford Cancer Institute
Palo Alto,CA

VISITS: 1 visit per month

PHASE: II

NCT ID: NCT05305365

QBS72S Chemotherapy for Metastatic Triple Negative Breast Cancer with Brain or Leptomeningeal Metastasis

A Phase IIa Study Assessing QBS72S For Treating Brain Metastases of Triple Negative Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of QBS72S, an experimental chemotherapy.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases) or leptomeningeal metastasis visible on an MRI who have received chemotherapy. If you have brain metastasis, you must have at least 1 lesion that has not received treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">QBS72S, by IV, monthly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">QBS72S is an experimental chemotherapy that may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Leptomeningeal metastasis (LM) is when cancer has spread to the leptomeninges, also called leptomeningeal carcinomatosis, leptomeningeal disease (LMD), leptomeningeal cancer, neoplastic meningitis, meningeal metastasis, and meningeal carcinomatosis, among other names.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05305365' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.quadrigabiosciences.com/science/' target='_blank'>Quadriga Biosciences: QBS72S Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li></ul>

NEAREST SITE: 186 miles
Renown Regional Medical Center
Reno,NV

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: 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: 341 miles
Cedars-Sinai Medical Center
Los Angeles,CA

VISITS: May require hospitalization

PHASE: III

NCT ID: NCT04365374

Gamma Tile Surgically Targeted Radiation Therapy after Brain Surgery for Brain Metastasis

A Phase 3 Randomized Controlled Trial of Post-Surgical Stereotactic Radiotherapy (SRT) Versus Surgically Targeted Radiation Therapy (STaRT) With Gamma Tile for Treatment of Newly Diagnosed Metastatic Brain Tumors. Scientific Title

Purpose

To compare the safety, effects (good and bad), and anti-cancer activity of Gamma Tile Surgically Targeted Radiation Therapy (STaRT) and stereotactic radiation after brain surgery.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis). You must have 1-4 brain tumors that have not been treated with radiation. 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">Brain surgery to remove tumor and implant Gamma Tile device</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gamma Tile Surgically Targeted Radiation Therapy (STaRT)</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain surgery to remove tumor</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cognitive testing</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gamma Tile Surgically Targeted Radiation Therapy (STaRT) is a FDA-cleared radiation therapy.</li> <li class="seamTextUnorderedListItem">Gamma Tile is a device implanted during surgery that delivers radiation directly to the tumor, called Surgically Targeted Radiation Therapy (STaRT).</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">Additional brain tumors not removed during surgery will be treated with stereotactic radiation alone, which is standard of care.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04365374' 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: III-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: 353 miles
City of Hope Medical Center
Duarte,CA

VISITS: May require hospitalization

PHASE: I

NCT ID: NCT03696030

CAR T-Cell Immunotherapy in HER2+ Breast Cancer with Brain or Leptomeningeal Metastases

A Phase 1 Cellular Immunotherapy Study of Intraventricularly Administered Autologous HER2-Targeted Chimeric Antigen Receptor (HER2-CAR) T Cells in Patients With Brain and/or Leptomeningeal Metastases From HER2 Positive Cancers Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of a CAR T-cell immunotherapy that is delivered directly into the brain.

Who is this for?

People with metastatic (stage IV) HER2 positive (HER2+) breast cancer with brain or leptomeningeal metastases. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw to collect white blood cells to make your HER2 CAR T-cell therapy (leukapheresis)</li> <li class="seamTextUnorderedListItem">Surgery to place a device (similar to a chemotherapy port) under your scalp</li> <li class="seamTextUnorderedListItem">HER2 CAR T-cells, by injection, weekly, 3 times</li> </ul> Please contact research site for treatment schedule. Hospital stay may be required. Follow up <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Every 2 months for 1 year, then every year for 15 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leptomeningeal metastases are when cancer spreads to the membranes surrounding the brain and/or the spinal cord (leptomeninges) or to the cerebrospinal fluid.</li> <li class="seamTextUnorderedListItem">CAR-T or CAR T cell therapy is a personalized immunotherapy made from your white blood cells.</li> <li class="seamTextUnorderedListItem">Your blood cells are removed and modified in a lab with chimeric antigen receptors (CARs) so that they can attack a specific protein.</li> <li class="seamTextUnorderedListItem">The CAR T-cells are then infused back into you while you are hospitalized. </li> <li class="seamTextUnorderedListItem">The CAR T-cell therapy being used in this study trains the immune system to attack HER2+ cancer cells.</li> <li class="seamTextUnorderedListItem">You will have surgery to insert a device under your scalp so that the CAR T-cell therapy can be infused directly into your brain.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03696030' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cityofhope.org/physician-news/breast-cancer-car-t-cell-therapy' target='_blank'>City of Hope Trial Information</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/car-t-cell-therapy' target='_blank'>NCI Dictionary of Cancer Terms: CAR T-cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/immunotherapy/car-t-cell1.html' target='_blank'>American Cancer Society: CAR T-cell Therapy and Its Side Effects</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/what-is-car-t-therapy/' target='_blank'>Metastatic Trial Talk: What is CAR-T Therapy?</a> </li><li class='seamTextUnorderedListItem'><a href='http://mbcn.org/brain-mets/' target='_blank'>Metastatic Breast Cancer Network: Brain Metastases</a> </li></ul>

NEAREST SITE: 362 miles
Innovative Clinical Research Institute
Whittier,CA

VISITS: 1 visit every 3 weeks

PHASE: I

NCT ID: NCT05593094

ZN-A-1041 Targeted Therapy for Advanced HER2 Positive or HER2 Low Breast Cancer

A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ZN-A-1041 Enteric Capsules as a Single Agent or in Combination in Patients With HER2-Positive Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of ZN-A-1041, an experimental anti-HER2 targeted therapy, with other anti-HER2 targeted therapies.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) or HER2 low (IHC 2+) breast cancer who have no standard treatment options available. You must have received treatment with trastuzumab (Herceptin®) and chemotherapy. Full eligibility criteria

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You will be assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZN-A-1041, by mouth, daily</li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine (T-DM1, Kadcyla®), by IV, every 3 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZN-A-1041, by mouth, daily</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-Dxd), by IV, every 3 weeks</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZN-A-1041, by mouth, daily</li> <li class="seamTextUnorderedListItem">Pertuzumab/trastuzumab (PHESGO®), by injection, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZN-A-1041 is an experimental anti-HER2 targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps cancer cells grow.</li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine (T-DM1, Kadcyla®) and trastuzumab deruxtecan (T-Dxd, Enhertu®) are antibody drug conjugates (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">Trastuzumab emtansine and trastuzumab deruxtecan target HER2 and deliver anti-cancer drugs.</li> <li class="seamTextUnorderedListItem">Pertuzumab/trastuzumab (PHESGO®) is a combination of two anti-HER2 targeted therapies, pertuzumab (Perjeta®) and trastuzumab (Herceptin®). You may also receive the two drugs separately.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 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/NCT05593094' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.businesswire.com/news/home/20200907005109/en/Zion-Pharma-Announces-Initiation-of-Phase-1-Study' target='_blank'>Zion Pharma Press Release: ZN-A-1041</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/kadcyla' target='_blank'>Breastcancer.org: Trastuzumab emtansine (T-DM1, Kadcyla®)</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><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/phesgo' target='_blank'>Breastcancer.org: Pertuzumab/trastuzumab (PHESGO®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/what-are-anti-her2-therapies' target='_blank'>Breastcancer.org: Anti-HER2 Targeted Therapy</a> </li></ul>

NEAREST SITE: 374 miles
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03994796

Genetic Testing for Choosing a Targeted Therapy for Brain Metastases that Test Positive for Certain Mutations

Genomically-Guided Treatment Trial in Brain Metastases Scientific Title

Purpose

To study the anti-cancer activity of choosing a targeted therapy for brain metastases based on the genetic mutations found in your tumors.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread (metastasized) to your brain with a gene mutation or alteration in: NTRK, ROS1, CDK or PI3K. You must have already received at least one treatment for metastatic disease. Full eligibility criteria

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You will be assigned to 1 of 3 groups depending on which genetic mutations are found in your tumors: Group 1: CDK-mutation <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, twice a day, ongoing</li> </ul> Group 2: PI3K-mutation <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GDC-0084, by mouth, daily, ongoing</li> </ul> Group 3: NTRK or ROS1-mutation <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Entrectinib (Rozlytrek®), by mouth, daily, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor samples from your brain and other parts of your body will be tested for mutations. This is called genomic testing.</li> <li class="seamTextUnorderedListItem">You will be assigned a targeted therapy based on which genetic mutations are found in your tumors.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer. </li> <li class="seamTextUnorderedListItem">Targets or mutations: NTRK, ROS1, CDK, PI3K</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03994796' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://mbcn.org/brain-mets/' target='_blank'>Metastatic Breast Cancer Network: Brain Mets</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.verzenio.com/hcp/patient-profiles' target='_blank'>Eli Lilly & Company Drug Information Page: Verzenio® (Abemaciclib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.rozlytrek.com' target='_blank'>Genentech USA Drug Information Page: Rozlytrek (Entrectinib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/pi3k-inhibitor-gdc-0084' target='_blank'>NCI Drug Dictionary: GDC-0084</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancernetwork.com/view/targeting-sanctuary-site-options-when-breast-cancer-metastasizes-brain' target='_blank'>Journal Article: Targeting the Sanctuary Site, Options when Breast Cancer Metastasizes to the Brain</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: 538 miles
Providence Portland Medical Center
Portland,OR

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT05323955

Adding Tucatinib Targeted Therapy to Standard of Care Therapy for Metastatic HER2+ Breast Cancer with Brain Metastases

Secondary BRain Metastases Prevention After Isolated Intracranial Progression on Trastuzumab/Pertuzumab or T-DM1 in Patients With aDvanced Human Epidermal Growth Factor Receptor 2+ brEast Cancer With the Addition of Tucatinib (BRIDGET) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of adding tucatinib (Tukysa®) tyrosine kinase inhibitor to standard of care trastuzumab (Herceptin®) or pertuzumab (Perjeta®) anti-HER2 targeted therapy or trastuzumab emtansine (Kadcyla®, T-DM1) antibody drug conjugate.

Who is this for?

People with metastatic (stage IV) HER2 positive (HER2+) breast cancer that has spread to the brain (brain metastasis) who are receiving their first line of metastatic treatment with trastuzumab (Herceptin®) or pertuzumab (Perjeta®) or second line of metastatic treatment with trastuzumab emtansine (Kadcyla®, T-DM1). You must not have received whole brain radiation therapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Continue standard of care trastuzumab (Herceptin®), pertuzumab (Perjeta®), or trastuzumab emtansine (Kadcyla®, T-DM1)</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine (Kadcyla®, T-DM1) is an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An 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">Trastuzumab emtansine (Kadcyla®, T-DM1)'s antibody targets HER2 and delivers an anti-cancer drug called emtansine.</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®) and trastuzumab (Herceptin®) are anti-HER2 targeted therapies used to treat HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®) is a type of targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme that helps cancer cells grow.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05323955' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/featured-clinical-trials/#toggle-id-1' target='_blank'>MBCBrainMets.org: BRIDGET Trial Video with Dr. Sarah Sammons</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/kadcyla' target='_blank'>Breastcancer.org: Trastuzumab Emtansine (Kadcyla®, T-DM1)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/perjeta' target='_blank'>Breastcancer.org: Pertuzumab (Perjeta®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/tukysa' target='_blank'>Breastcancer.org: Tucatinib (Tukysa®)</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: 733 miles
Cancer Care Northwest
Spokane Valley,WA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04791384

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

Multicenter Open Label Phase Ib/II Trial of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/Her2- 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, with abemaciclib (Verzenio®) CDK 4/6 inhibitor.

Who is this for?

Postmenopausal women with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) or HER2 low breast cancer that has spread to the brain or leptomeninges (brain or leptomeningeal metastasis) who have received up to 2 chemotherapies for advanced/metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Elacestrant, by mouth, daily</li></ul>
<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 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/NCT04791384' 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/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: 895 miles
Lovelace Medical Center-Saint Joseph Square
Albuquerque,NM

VISITS: 1-5 visits within 1-2 weeks

PHASE: NA

NCT ID: NCT05703269

Single vs. Multiple Doses of Radiation with Immunotherapy for Breast Cancer with Brain Metastasis

Hypofractionated Radiotherapy vs Single Fraction Radiosurgery for Brain Metastasis Patients on Immunotherapy (HYPOGRYPHE) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of single fraction stereotactic radiosurgery (SSRS) compared to fractionated stereotactic radiosurgery (FSRS).

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) who have received or are receiving treatment with a PD-1/PD-L1 inhibitor. You must have at least 1 brain tumor that has not been treated with radiation. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Single Radiation Dose <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Single fraction stereotactic radiosurgery (SSRS), 1 time</li> </ul> Group 2: Multiple Radiation Doses <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fractionated stereotactic radiosurgery (FSRS), 3-5 times within 3-10 days</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">Single fraction stereotactic radiosurgery (SSRS) uses a higher dose of radiation in a single dose.</li> <li class="seamTextUnorderedListItem">SSRS has recently become a standard of care treatment for people with 1-4 brain metastases and is also commonly used for people with up to 15 metastases.</li> <li class="seamTextUnorderedListItem">Fractionated stereotactic radiosurgery (FSRS) uses a lower dose of radiation over 3 to 5 treatments given daily or every other day.</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/NCT05703269' 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' target='_blank'>Mayo Clinic: Stereotactic Radiation</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: 1481 miles
UT Health Science Center San Antonio / Mays Cancer Center
San Antonio,TX

VISITS: May require surgery

PHASE: I

NCT ID: NCT05034497

186RNL Radioactive Drug for People with Leptomeningeal Metastases

A Multicenter Phase 1 Clinical Study to Determine the Maximum Tolerated Dose/Maximum Feasible Dose, Safety,& Efficacy of Single Dose Rhenium-186 NanoLiposome (186RNL) (ReSPECT-LM) Administered Via Intraventricular Catheter for Leptomeningeal Metastases Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of rhenium-186 nanoliposome (186RNL), an experimental radionuclide.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the leptomeninges (leptomeningeal metastasis or leptomeningeal disease). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Procedure to place Ommaya reservoir under the scalp</li> <li class="seamTextUnorderedListItem">MRI scan</li> </ul> followed up to 1 week later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Rhenium-186 nanoliposome (186RNL), via Ommaya reservoir, 1 time</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Rhenium-186 nanoliposome (186RNL) is an experimental radionuclide (also called radiopharmaceutical or radioactive drug).</li> <li class="seamTextUnorderedListItem">186RNL may slow or stop cancer cells from growing.</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">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy.</li> <li class="seamTextUnorderedListItem">In this trial, the MRI scans will study the flow of CSF in your body.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05034497' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.respect-trials.com/lm/' target='_blank'>Plus Therapeutics: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://plustherapeutics.com/186rnl/' target='_blank'>Plus Therapeutics: 186RNL Drug Information Page</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT03508752

Increasing Doses of Stereotactic Radiation Therapy for People with Six or More Brain Metastases

Phase I/II Trial to Determine the Neurocognitive Decline in Patients With Multiple (>6) Brain Metastases Treated With Distributed Stereotactic Radiosurgery Scientific Title

Purpose

To study the safety, anti-cancer activity, and side effects of giving increasing doses of stereotactic radiation therapy to multiple brain metastases.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases) and with six or more brain metastases. You must not have already received whole-brain radiation therapy or stereotactic radiation therapy for the brain metastases being treated in this trial. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotacitc radiation therapy for your brain metastases</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">Whole-brain radiation therapy (WBRT) treats the entire brain, even tumors that may be too small to see with an MRI.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03508752' 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: 1509 miles
University of Texas Southwestern Medical Center
Dallas,TX

VISITS: 1-2 visits

PHASE: NA

NCT ID: NCT02645487

Stereotactic Radiosurgery (SRS) for Brain Metastasis

A Phase I Dose-Escalation Study of Stereotactic Radiosurgery (SRS) for Brain Metastasis Without Whole Brain Radiation (WBRT) Scientific Title

Purpose

To identify the highest dose of stereotactic radiosurgery that can be safely tolerated.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases) and who have not received prior brain radiation. Participants can have up to 10 sites of metastases. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A single dose of stereotactic radiosurgery in one session.</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/NCT02645487' 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' target='_blank'>Stereotactic Radiosurgery (Mayo Clinic)</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: 1615 miles
Mayo Clinic in Rochester
Rochester,MN

VISITS: May require hospitalization

PHASE: NA

NCT ID: NCT04810871

Brain Surgery Before Recurrence for Brain Metastasis

Surgical Resection of Latent Brain Tumors Prior to Recurrence Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of brain surgery before brain tumor recurrence.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases) who have received treatment with chemotherapy and/or radiation. 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>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">You will receive brain surgery to remove your brain tumor before the tumor comes back (recurrence).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04810871' 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
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 BRCA1/2 Mutant Breast Cancer that has Spread to the Brain

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 the combination of niraparib (Zejula®), a PARP inhibitor, and dostarlimab (Jemperli®), an immunotherapy, to control breast cancer that has spread to the brain.

Who is this for?

People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or BRCA1/2 mutated breast cancer that has spread to the brain (brain metastasis). You must have received at least one standard treatment. 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></ul>
<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
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
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: 1643 miles
University of Texas MD Anderson Cancer Center
Houston,TX

VISITS: 1-3 days, then every 3-6 months for 2 years

PHASE: II

NCT ID: NCT03028337

2 Dosing Schedules of Stereotactic Radiosurgery for Spine Metastasis

Single Versus Multifraction Salvage Spine Stereotactic Radiosurgery for Previously Irradiated Spinal Metastases: a Randomized Phase II Clinical Trial Scientific Title

Purpose

To compare the safety, effects (good and bad), and anti-cancer activity of 2 dosing schedules of stereotactic radiosurgery.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the spine (spine metastasis) and has progressed after treatment with radiation therapy. 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">Stereotactic radiosurgery, 1 dose within 1 day</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery, 3 doses within 3 days</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MRI scans</li> <li class="seamTextUnorderedListItem">Neurological exams</li> <li class="seamTextUnorderedListItem">Physical exams</li> <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">In this trial, experimental stereotactic radiosurgery is received in 1 larger dose.</li> <li class="seamTextUnorderedListItem">Standard of care stereotactic radiosurgery is received over 3 smaller doses.</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">Neurological exams will check the functioning of your nerves, including your strength and sensation.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03028337' 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/cancer-types/spinal-tumors/spinal-tumor-treatment.html' target='_blank'>MD Anderson Cancer Center: Spinal Tumor Treatment</a> </li></ul>

NEAREST SITE: 1827 miles
Northwestern Memorial HealthCare, Central DuPage Hospital, Warrenville Cancer Center
Winfield,IL

VISITS: 10 visits within 2 weeks

PHASE: I

NCT ID: NCT05417282

MW151 and Hippocampal-Avoidant Whole Brain Radiation Therapy for Brain Metastasis

Safety and Tolerability of MW151 Administered With Hippocampal Avoidant Whole Brain Radiation Therapy (HA-WBRT) in Patients With Brain Metastases Scientific Title

Purpose

To study the safety, effects (good and bad), anti-cancer activity, and cognitive effects of MW151, an experimental drug, with hippocampal-avoidant whole brain radiation therapy.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) who have not received whole brain radiation therapy. 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">MW151, by mouth, daily for 1 month</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hippocampal-avoidant whole brain radiation therapy, 10 days within 2 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for MW151, by mouth, daily for 1 month</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hippocampal-avoidant whole brain radiation therapy, 10 days within 2 weeks</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cognitive tests</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MW151 is an experimental drug that may reduce brain inflammation and improve cognitive function.</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) treats the entire brain, even tumors that may be too small to see with an MRI.</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">Cognitive tests 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/NCT05417282' 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: 2108 miles
Ohio State University Comprehensive Cancer Center
Columbus,OH

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05428852

Ketogenic Diet for Brain Metastasis

Keto-Brain: Investigating the Use of Ketogenic Diets in Brain Metastases Scientific Title

Purpose

To compare the effects (good and bad) of the ketogenic diet and the American Institute for Cancer Research diet on your response to stereotactic radiosurgery.

Who is this for?

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

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You will be randomly assigned to 1 of 2 groups: Group 1: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">American Institute for Cancer Research diet, 4 months</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ketogenic diet, 4 months</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fitbit physical activity tracking</li> <li class="seamTextUnorderedListItem">Cognitive tests</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A ketogenic diet is a low-carbohydrate, high-fat diet.</li> <li class="seamTextUnorderedListItem">The American Institute for Cancer Research diet is two thirds (2/3) plant foods, such as whole grains, vegetables, fruit, and beans. The remaining third (1/3) is animal-based, protein-rich foods, such as seafood, poultry, dairy foods, and occasionally lean red meat.</li> <li class="seamTextUnorderedListItem">The American Institute for Cancer Research diet is standard of care.</li> <li class="seamTextUnorderedListItem">A Fitbit is device you wear on your wrist that tracks your physical activity.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05428852' 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: NA

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

VISITS: May require hospitalization

PHASE: NA

NCT ID: NCT04895592

Stereotactic Radiosurgery and Dexamethasone Before Surgery for Brain Metastasis

Preoperative Radiosurgery for Brain Metastases Planned for Surgical Resection: A Two Arm Pilot Study Scientific Title

Purpose

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery, 1-3 sessions within 1-5 days</li> <li class="seamTextUnorderedListItem">Dexamethasone, by mouth or IV, up to 3 weeks</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain surgery to remove brain tumor</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">Dexamethasone is an anti-inflammation medication used to prevent and treat side effects of some cancer treatments.</li> <li class="seamTextUnorderedListItem">You will receive either a low or high dose of dexamethasone.</li> <li class="seamTextUnorderedListItem">Giving stereotactic radiosurgery before surgery may reduce the risk of cancer coming back after surgery.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04895592' 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: 2260 miles
Allegheny General Hospital
Pittsburgh,PA

VISITS: May require hospitalization

PHASE: NA

NCT ID: NCT05341739

Stereotactic Radiosurgery and Brain Surgery for Brain Metastasis

A Phase II Study of Pre-Operative Stereotactic Radiosurgery Followed by Surgical Resection for Brain Metastases Scientific Title

Purpose

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CT and MRI scan</li> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery, 3 sessions within 3-6 days</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">Questionnaire</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">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 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/NCT05341739' 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: 2383 miles
Mayo Clinic
Jacksonville,FL

VISITS: Coincides with surgery

PHASE: NA

NCT ID: NCT04742231

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

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

Purpose

To study the safety and reliability of measuring hand strength during an awake craniotomy to monitor how the surgery will affect your motor skills.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases) and who will have an awake craniotomy at the Mayo Clinic in Jacksonville, Florida. Full eligibility criteria

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Your hand strength will be measured during surgery with a handheld device called a K-FORCE Grip dynamometer®.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A craniotomy is a type of brain surgery. The surgeon will remove part of your skull (cranium) to access your brain to remove the tumors. </li> <li class="seamTextUnorderedListItem">You will be awake during the craniotomy so that you can use a handheld device to monitor how the surgery is affecting your motor skills. </li> <li class="seamTextUnorderedListItem">Motor skills are body movements and include walking, hand movements (like writing), and other types of movement. </li> <li class="seamTextUnorderedListItem">K-FORCE Grip® is a handheld dynamometer. A dynamometer is a machine that is held in the hand and can measure the strength of your grip. </li> <li class="seamTextUnorderedListItem">Researchers believe measuring grip strength may predict how removing tumors will affect motor skills.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04742231' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/craniotomy' target='_blank'>Johns Hopkins Medicine: Craniotomy?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/awake-brain-surgery/about/pac-20384913' target='_blank'>Mayo Clinic: Awake Brain Surgery</a> </li><li class='seamTextUnorderedListItem'><a href='https://k-invent.com/produit/k-force-grip/' target='_blank'>Kinvent Device Information Page: KForce Grip</a> </li></ul>

NEAREST SITE: 2385 miles
Duke University Health System
Durham,NC

VISITS: At least 1 visit

PHASE: NA

NCT ID: NCT04246879

MRI Following Stereotactic Radiosurgery (SRS) for Brain Metastases

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

Purpose

To test whether additional magnetic resonance image (MRI) sequences (runs) can better distinguish between damage from prior radiation and recurrent brain metastases.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain and at least 1 brain metastasis previously treated with stereotactic radiosurgery (SRS). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MRI with additional sequences (runs), following stereotactic radiosurgery</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Magnetic resonance image (MRI) exams generally include multiple runs (sequences), some of which may last several minutes. Each run will create a different set of noises.</li> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04246879' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mbcalliance.org/marina-kaplan-project' target='_blank'>The Marina Kaplan Project: Breast Cancer Brain Metastases Initiative</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/stereotactic-radiosurgery' target='_blank'>Stereotactic Radiosurgery</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.radiologyinfo.org/en/info/bodymr' target='_blank'>RadiaologyInfo.org: Magnetic Resonance Imaging (MRI)</a> </li></ul>

NEAREST SITE: 2395 miles
Moffitt Cancer Center
Tampa,FL

VISITS: 4 visits over 1 week including surgery; may require hospitalization

PHASE: II

NCT ID: NCT05267587

Stereotactic Radiosurgery and Craniotomy for Brain Metastasis

Pre-operative Hypofractionated Stereotactic Radiosurgery for Resectable Brain Metastases Scientific Title

Purpose

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery, 3 days</li> </ul> followed 5 days later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Craniotomy to remove tumor</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">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">If there are additional brain metastases, they will also be treated with stereotactic radiosurgery.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05267587' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>

NEAREST SITE: 2395 miles
Moffitt Cancer Center
Tampa,FL

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: 2406 miles
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill,NC

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT04073966

MRI Biomarkers for Radiation-Induced Neurocognitive Decline Following SRS of Newly Diagnosed Brain Mets

Magnetic Resonance Imaging Biomarkers for Radiation-Induced Neurocognitive Decline Following Stereotactic Radiosurgery of Newly Diagnosed Brain Metastases: An Observational Pilot Study Scientific Title

Purpose

To study why radiation causes brain function changes to help doctors predict and prevent brain function changes.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) who are receiving stereotactic radiosurgery (SRS). You must not have received surgery to the lesion receiving SRS or any radiation to the brain or head. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MRI scans</li> <li class="seamTextUnorderedListItem">Neurocognitive function tests</li> </ul> Please contact research site for trial schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery (SRS) is a type of radiation therapy that delivers a high dose of radiation only to the areas of cancer in the brain and avoids the surrounding normal brain tissue.</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/NCT04073966' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</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,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
Brain Tumor Institute, Children's National Medical Center
Washington,DC

VISITS: May require hospitalization

PHASE: I

NCT ID: NCT03652545

TAA-T T-Cell Immunotherapy for Brain Metastasis

Phase I REsearch on Multi-antigen T Cell Infusion Against Neuro-oncologic Disease Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of TAA-T T-cell therapy, an experimental immunotherapy.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases) and have received standard treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TAA-T T-cell therapy, by IV, 1-9 sessions every 4-6 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor multi-antigen associated specific cytotoxic T lymphocytes (TAA-T) T-cell therapy is an experimental immunotherapy.</li> <li class="seamTextUnorderedListItem">TAA-T T-cell therapy are tumor-specific immune cells generated from your blood cells.</li> <li class="seamTextUnorderedListItem">TAA-T T-cell therapy may initiate an immune response against brain tumors and prevent tumor progression.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03652545' 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 (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: 2539 miles
Memorial Sloan Kettering Cancer Center (Limited Protocol Activities)
Basking Ridge,NJ

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT05892068

Tucatinib Before Surgery for Metastatic HER2+ Breast Cancer That Has Spread to the Brain

Window of Opportunity Analysis of Pre-Operative Tucatinib for Surgically Resected HER2+ Brain Metastases: Understanding Mechanisms of Resistance Scientific Title

Purpose

To study how the brain absorbs, distributes, and gets rid of tucatinib (Tukysa®) in people who have HER2+ breast cancer that has spread to the brain, and to learn more about how cancer cells develop resistance to treatment.

Who is this for?

Women with metastatic (stage IV) HER2+ breast cancer that has spread to the brain (brain metastases) and who are planning to receive surgery to remove the cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily for 5 days</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain surgery</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa) is a type of HER2 targeting therapy called a kinase inhibitor. It is able to cross the blood-brain barrier. This means it works against cancer cells that have spread to the brain. Tucatinib is approved for use in people with metastatic, HER2+ breast cancer when it is taken with trastuzumab and capecitabine. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05892068' 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></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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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

NCT ID: NCT05553522

Targeted Therapy, Chemotherapy, and Stereotactic Radiosurgery for Metastatic HER2+ Breast Cancer with Brain Metastases

Phase 1 Trial of Tucatinib, Trastuzumab, and Capecitabine With Stereotactic Radiosurgery (SRS) in Patients With Brain Metastases From HER-2 Positive Breast Cancer Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of stereotactic radiosurgery (SRS) with tucatinib (Tukysa®) tyrosine kinase inhibitor, capecitabine (Xeloda®) chemotherapy, and trastuzumab (Herceptin®) anti-HER2 targeted therapy.

Who is this for?

People with metastatic (stage IV) HER2 positive (HER2+) breast cancer that has spread to the brain (brain metastasis). Your brain metastases must be newly diagnosed. 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">Stereotactic radiosurgery (SRS)</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily for 2 weeks</li> </ul> followed 2 weeks later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks</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">Capecitabine (Xeloda®) is a chemotherapy commonly used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy commonly used to treat HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery (SRS, stereotactic radiation) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">The combined use of SRS with the three drugs is considered investigational.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05553522' 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 (Tukysa®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/xeloda' target='_blank'>Breastcancer.org: Capecitabine (Xeloda®)</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.mayoclinic.org/tests-procedures/stereotactic-radiosurgery/about/pac-20384526' target='_blank'>Mayo Clinic: Stereotactic Radiosurgery</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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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
Dana Farber Cancer Institute
Boston,MA

VISITS: 7 visits

PHASE: II

NCT ID: NCT04899908

Stereotactic Radiation with AGuIX® for Brain Metastases

A Double-blind, Phase II Randomized Study of Brain-directed Stereotactic Radiation With or Without AGuIX Gadolinium-based Nanoparticles in the Management of Brain Metastases at Higher Risk of Local Recurrence With Radiation Alone Scientific Title

Purpose

To determine if AGuIX® (Activation and Guidance of Irradiation by X-ray) can make stereotactic radiation work more effectively.

Who is this for?

People with metastatic (stage IV) breast cancer whose cancer has spread to their brain (brain metastases). Full eligibility criteria

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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">AGuIX®, by IV, 3-5 days before radiation and up to 2 additional sessions during radiation sessions</li> <li class="seamTextUnorderedListItem">Stereotactic radiation, up to 6 sessions</li> </ul> Group 2: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for AGuIX®, by IV, 3-5 days before radiation and up to 2 additional sessions during radiation sessions</li> <li class="seamTextUnorderedListItem">Stereotactic radiation, up to 6 sessions</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AGuIX® is short for Activation and Guidance of Irradiation by X-ray.</li> <li class="seamTextUnorderedListItem">AGuIX® consists of two parts: a drug that helps improve visualization of MRI scans and a drug that may make stereotactic radiation work more effectively.</li> <li class="seamTextUnorderedListItem">Stereotactic radiation delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</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/NCT04899908' 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/radiation-therapy' target='_blank'>Breastcancer.org: Radiation Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://nhtheraguix.com/aguix/' target='_blank'>NH TherAguix Information Page: AGuIX®</a> </li></ul>

NEAREST SITE: 2693 miles
Massachusetts General Hospital
Boston,MA

VISITS: 5 visits every 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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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: 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: 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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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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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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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>