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In response to COVID-19, some breast cancer trials have temporarily stopped enrolling new patients. Use the contact information in our trial listings to call or email the research site for information about a trial's status.
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(Last updated: February 27, 2021)
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Targeted Therapy: Anti-HER2 Therapy
Targeted Therapy: CDK Inhibitors
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AKT
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HLA
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RAD51
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1
NEAREST SITE: 3 miles
University of California, San Francisco Medical Center
San Francisco,CA
VISITS: 1 visit every 4 weeks, ongoing
PHASE: II
NCT ID: NCT01494662
Neratinib for HER2-Positive Brain Metastases
A Phase II Trial of HKI-272 (Neratinib) for Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer and Brain Metastases Scientific Title
Purpose
To determine how well neratinib works in treating breast cancer that has spread to the brain, as well as the effect that it has on cognitive functioning.
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the brain.
Full eligibility criteria
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<p class="seamTextPara"> All participants will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib by mouth daily</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Brain</span> metastases are difficult to treat because many drugs are unable to cross the blood-<span class="highlight">brain</span> barrier, which means they cannot enter the <span class="highlight">brain</span> from the bloodstream. </li> <li class="seamTextUnorderedListItem">The experimental drug Neratinib (HKI-272) is a tyrosine kinase inhibitor. </li> <li class="seamTextUnorderedListItem">It works by blocking the HER2 and EGFR receptors, both of which are involved in cancer cell growth. </li> <li class="seamTextUnorderedListItem">Neratinib is a much smaller molecule than Herceptin® (the drug widely used to treat HER2+ tumors), and it is able to cross the blood-<span class="highlight">brain</span> barrier. </li> <li class="seamTextUnorderedListItem">The goal of this trial is to determine how well neratinib works in treating breast cancer that has spread to the <span class="highlight">brain</span>, as well as the effect that it has on cognitive functioning.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01494662' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.sciencedaily.com/releases/2009/05/090528203821.htm' target='_blank'>Science Daily Article</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.curetoday.com/index.cfm/fuseaction/news.showNewsArticle/id/5/news_id/2357' target='_blank'>Cure Magazine Article</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/search.jsp?terms=neratinib' target='_blank'>BreastCancer.org: Neratinib</a> </li><li class='seamTextUnorderedListItem'><a href='https://externalmediasite.partners.org/Mediasite/Play/dbc4bfbf0f6a46208443613881b188e41d' target='_blank'>Dana-Farber Cancer Institute: Patient-friendly informational video about this trial</a> </li></ul>
2
NEAREST SITE: 8 miles
Bay Area Breast Surgeons Inc
Emeryville,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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<p class="seamTextPara"> You will be assigned to 1 of 3 groups depending on which genetic mutations are found in your tumors: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: CDK-mutation</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, twice a day, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: PI3K-mutation</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GDC-0084, by mouth, daily, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: NTRK or ROS1-mutation</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Entrectinib (Rozlytrek®), by mouth, daily, ongoing</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor samples from your <span class="highlight">brain</span> 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>
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<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>
3
NEAREST SITE: 336 miles
UCLA Department of Medicine - Hematology & Oncology
Los Angeles,CA
VISITS: 1 visit every 3 weeks, ongoing
PHASE: II
NCT ID: NCT04539938
Tucatinib and Fam-Trastuzumab Deruxtican-nxki for Advanced HER2 Positive Breast Cancer
A Single Arm, Open Label Phase 2 Study of Tucatinib in Combination With Trastuzumab Deruxtecan in Subjects With Previously Treated Unresectable Locally-Advanced or Metastatic HER2+ Breast Cancer Scientific Title
Purpose
To study the anti-cancer activity and side-effects of giving tucatinib (Tukysa) in combination with fam-trastuzumab deruxtican-nxki (Enhertu®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer. You must have already received at least two anti-HER2 targeted therapies for metastatic disease.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa), by mouth, twice daily, ongoing</li> <li class="seamTextUnorderedListItem">Fam-Trastuzumab Deruxtican-nxki (Enhertu®), by IV, every 3 weeks, ongoing</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa) is a type of HER2 targeting therapy called a kinase inhibitor. </li> <li class="seamTextUnorderedListItem">It is able to cross the blood-<span class="highlight">brain</span> barrier. This means it works against cancer cells that have spread to the <span class="highlight">brain</span>. </li> <li class="seamTextUnorderedListItem">Tucatinib is approved for use in people with metastatic, HER2+ breast cancer when it is taken with for use trastuzumab and capecitabine. Its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">Fam-trastuzumab deruxtican-nxki (Enhertu®) is an antibody-drug conjugate (ADC). It targets HER2 to deliver a chemotherapy drug directly to the cancer cells. </li> <li class="seamTextUnorderedListItem">It is approved for use to treat people with metastatic HER2+ breast cancer who have already received two anti-HER2 therapies but its use in this trial is considered experimental.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04539938' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/tukysa' target='_blank'>Breastcancer.org: Tukysa</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.curetoday.com/view/what-you-need-to-know-about-the-fdas-approval-of-tukysa-for-her2positive-breast-cancer' target='_blank'>Cure Today: What You Need to Know About the FDA's Approval of Tukysa for HER2 Positive Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.enhertuhcp.com/en/?utm_source=google&utm_medium=cpc&utm_campaign=branded+general_2020&utm_content=branded+general_2020_exact&utm_term=enhertu&gclid=cj0kcqjw8fr7brdsarisak0qqr5x8-k8j8h3d3_wahp-jhjvjjtjaqr3dnefidhs2onmte7b9gbmcfmaaoteealw_wcb&gc' target='_blank'>Daiichi-Sankyo AstraZeneca Drug Information Page: Enhertu®</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/brufsky-spotlights-data-with-trastuzumab-deruxtecan-in-her2-metastatic-breast-cancer' target='_blank'>OncLive: Trastuzumab Deruxtecan in HER2+ Metastatic Breast Cancer</a> </li></ul>
4
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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<p class="seamTextPara"> You will receive the following: </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule. Hospital stay may be required.</i> </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Follow up</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Every 2 months for 1 year, then every year for 15 years</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leptomeningeal metastases are when cancer spreads to the membranes surrounding the <span class="highlight">brain</span> and/or the spinal cord (leptomeninges) or to the cerebrospinal fluid.</li> <li class="seamTextUnorderedListItem">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 <span class="highlight">brain</span>.</li></ul>
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<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://en.wikipedia.org/wiki/Leukapheresis' target='_blank'>Wikipedia: Leukapheresis</a> </li><li class='seamTextUnorderedListItem'><a href='http://mbcn.org/brain-mets/' target='_blank'>Metastatic Breast Cancer Network: Brain Metastases</a> </li></ul>
5
NEAREST SITE: 1382 miles
Mercy Hospital Oklahoma City
Oklahoma City,OK
VISITS: 1 visit every week (2 weeks on, 1 week off), ongoing
PHASE: II
NCT ID: NCT04647916
Sacituzumab Govitecan Therapy in Patients With HER2-Negative Breast Cancer and Brain Metastases
A Phase II Trial of Sacituzumab Govitecan (IMMU-132) (NSC #820016) for Patients With HER2-Negative Breast Cancer and Brain Metastases Scientific Title
Purpose
To study the anti-cancer activity, safety and side effects of giving the antibody-drug conjugate sacituzumab govitecan (Trodelvy®) to treat brain metastases (breast cancer that has spread to the brain).
Who is this for?
People with metastatic (stage IV) HER2 negative (HER2-) breast cancer that has spread to the brain.
Full eligibility criteria
Contact research site
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®), by IV, every week (2 weeks on, 1 week off), ongoing</li></ul>
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<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 drug 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>
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<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>
6
NEAREST SITE: 1478 miles
USA04
Dallas,TX
VISITS: Number of visits unavailable
PHASE: I-II
NCT ID: NCT04444427
GLR2007 for Metastatic Breast Cancer that has Spread to the Brain
An Open-Label, Multicenter, Phase 1b/2 Study to Establish Safety, Tolerability, and Optimal Dosing Strategy of GLR2007 in Subjects With Advanced Solid Tumors Scientific Title
Purpose
To study the safety, side effects, and best dose of the experimental targeted therapy GLR2007.
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the brain and who have already received a CDK 4/6 inhibitor.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GLR2007, by mouth, daily (3 weeks on, 1 week off), ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Brain</span> MRI</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GLR2007 is a type targeted therapy called a cyclin-dependent kinase 4/6 inhibitor (CDK 4/6 inhibitor). </li> <li class="seamTextUnorderedListItem">Experimental therapies are only available in clinical trials.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04444427' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.biospace.com/article/releases/gan-and-amp-lee-pharmaceuticals-initiates-first-in-human-phase-1-clinical-trial-for-new-anti-tumor-drug-glr2007/' target='_blank'>BioSpace Press Release: GLR2007</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nature.com/articles/s41523-019-0121-y' target='_blank'>Journal Article: Are all cyclin-dependent kinases 4/6 inhibitors created equal?</a> </li></ul>
7
NEAREST SITE: 1479 miles
Mary Crowley Cancer Research Centers
Dallas,TX
VISITS: Number of visits unavailable
PHASE: I-II
NCT ID: NCT03150810
BGB-290 with Temozolomide for Advanced Breast Cancer
A Phase 1b Study to Assess the Safety, Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide (TMZ) in Subjects With Locally Advanced or Metastatic Solid Tumors Scientific Title
Purpose
To investigate the safety and effects (good and bad) of using an oral chemotherapy along with a new targeted drug to treat advanced breast cancer.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer who have not already received a PARP inhibitor. If you have triple negative (ER-, PR-, HER2-) breast cancer, you must have received less than three prior therapies for advanced disease.
Full eligibility criteria
Contact research site
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BGB-290, by mouth</li> <li class="seamTextUnorderedListItem">Temolozomide, by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The two drugs being used in this study are temozolomide (Temodar) and BGB-290. </li> <li class="seamTextUnorderedListItem">Temodar is used to treat <span class="highlight">brain</span> cancer. </li> <li class="seamTextUnorderedListItem">BGB-290 is a type of targeted therapy called a PARP inhibitor.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03150810' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a601250.html' target='_blank'>NIH MedlinePlus: Temozolomide</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.beigene.com/pipeline/clinical-candidates/bgb-290/' target='_blank'>Drug Company Information Page: BGB-290</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/cancer-drugs/drugs/temozolomide' target='_blank'>Cancer Research UK: Temozolomide</a> </li></ul>
8
NEAREST SITE: 1481 miles
Mays Cancer Center, UT Health San Antonio
San Antonio,TX
VISITS: 2 visits every 3 weeks, ongoing
PHASE: NA
NCT ID: NCT03995706
Sacituzumab Govitecan for Breast Cancer That Has Spread to the Brain
A Phase 0, Investigator Initiated Study to Determine the Bioavailability of Sacituzumab Govitecan in Breast Brain Metastasis and Glioblastoma Scientific Title
Purpose
To look at the safety of sacituzumab govitecan (Trodelvy), an antibody-drug conjugate.
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the brain and are scheduled to have surgery to remove the tumors in your brain.
Full eligibility criteria
Contact research site
Share with my doctor
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- What's involved?
- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy), by IV, 1 day before surgery, then 2 times every 3 weeks, ongoing</li></ul>
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<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 drug directly to these cells. </li> <li class="seamTextUnorderedListItem">The antibody in this drug targets TROP2 proteins. </li> <li class="seamTextUnorderedListItem">It delivers the chemotherapy irinotecan. Irinotecan is approved for use in many other types of cancer. </li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy) 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>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03995706' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Sacituzumab_govitecan' target='_blank'>Wikipedia: Sacituzumab Govitecan</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.trodelvy.com/' target='_blank'>Immunomedics Drug Information Page: Trodelvy (Sacituzumab Govitecan-Hziy)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancertodaymag.org/pages/Fall2015/Advances-Treating-Brain-Metastases.aspx' target='_blank'>Cancer Today: Breaking the Blood-Brain Barrier</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/2019/05/01/mbc-news-11/' target='_blank'>MetastaticTrialTalk: Getting to the Target, Antibody Drug Conjugates in Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nejm.org/doi/full/10.1056/NEJMoa1814213' target='_blank'>The New England Journal of Medicine: Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer</a> </li></ul>
9
NEAREST SITE: 1643 miles
University of Texas MD Anderson Cancer Center
Houston,TX
VISITS: 1 visit every 3 weeks, ongoing
PHASE: II
NCT ID: NCT03501979
Tucatinib, Trastuzumab, and Capecitabine for HER2+ Breast Cancer with Leptomeningeal Metastases
A Phase II Non-randomized Study to Assess the Safety and Efficacy of the Combination of Tucatinib and Trastuzumab and Capecitabine for Treatment of Leptomeningeal Metastases in HER2 Positive Breast Cancer Scientific Title
Purpose
To look at the safety and effects (good and bad) of using tucatinib (Tukysa) along with trastuzumab (Herceptin®) and capecitabine (Xeloda®).
Who is this for?
People with metastatic (stage IV) HER2 positive (HER2+) breast cancer with leptomeningeal metastases (defined below).
Full eligibility criteria
Contact research site
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa), by mouth, twice daily</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks </li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, twice daily, 2 weeks on and 1 week off</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa) is a HER2-targeted therapy approved to treat some advanced HER2+ breast cancer in combination with certain other therapies. </li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is a commonly used HER2-targeted therapy. </li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a type of chemotherapy.</li> <li class="seamTextUnorderedListItem">Leptomeningeal metastases are when cancer spreads to the membranes surrounding the <span class="highlight">brain</span> and/or the spinal cord (leptomeninges) or to the cerebrospinal fluid.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03501979' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/cancer-drugs/drugs/capecitabine' target='_blank'>CancerResearchUK: Capecitabine (Xeloda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tukysahcp.com' target='_blank'>Seattle Genetics Information Page: Tukysa (Tucatinib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/publications/oncology-live/2018/vol-19-no-24/tucatinib-shows-promise-in-patients-with-breast-cancer-and-brain-metastases' target='_blank'>OncLive: Tucatinib Shows Promise in Patients With Breast Cancer and Brain Metastases</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/secondary-cancer/leptomeningeal-metastases/what-are#:~:text=Leptomeningeal%20metastases%20mean%20cancer%20cells,leptomeningeal%20disease' target='_blank'>Cancer Research UK: Leptomeningeal Metastases</a> </li></ul>
10
NEAREST SITE: 1735 miles
Siteman Cancer Center- Washington University School of Medicine in St. Louis
Saint Louis,MO
VISITS: 1 visit every 2 weeks, ongoing
PHASE: II
NCT ID: NCT02422641
Methotrexate in Metastatic Breast Cancer With Leptomeningeal Metastasis
Traditional Incision and Drainage of Cutaneous Abscess Vs. Minimally Invasive Incision and Drainage With Vessel Loop: A Randomized Controlled Trail Scientific Title
Purpose
To study the effects (good and bad) of using high-dose methotrexate to treat metastases in the cerebrospinal fluid surrounding the brain and spinal cord and/or in the leptomeninges (the lining of the brain and spinal cord).
Who is this for?
People with metastatic (stage IV) breast cancer with leptomeningeal metastases (defined below).
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">High-dose Methotrexate (HD-MTX), by IV, once every 2 weeks</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leptomeningeal metastases are when cancer spreads to the membranes surrounding the <span class="highlight">brain</span> and/or the spinal cord (leptomeninges) or to the cerebrospinal fluid.</li> <li class="seamTextUnorderedListItem">Methotrexate is a chemotherapy drug approved to treat advanced breast cancer.</li> <li class="seamTextUnorderedListItem">Researchers believe methotrexate can cross the blood-<span class="highlight">brain</span> barrier, which will allow the drug to reach the leptomeningeal metastases.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02422641' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/publications/cancerwise/2017/04/new-hope-for-leptomeningeal-disease-care.html' target='_blank'>MDAnderson: New Hope for Leptomeningeal Disease Care</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/secondary-cancer/leptomeningeal-metastases/what-are#:~:text=Leptomeningeal%20metastases%20mean%20cancer%20cells,leptomeningeal%20disease' target='_blank'>Cancer Research UK: What are Leptomeningeal Metastases?</a> </li></ul>
11
NEAREST SITE: 2314 miles
Wake Forest University Health Sciences
Winston-Salem,NC
VISITS: Coincides with standard surgery
PHASE: NA
NCT ID: NCT03796273
Ketoconazole Before Surgery For Breast Cancer Brain Metastases
tGLI1 as a Therapeutic Target in Brain Metastases: A Window of Opportunity Study Scientific Title
Purpose
To study the anti-cancer activity, safety, and effects (good and bad) of the anti-fungal drug ketoconazole when it is given before surgery.
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the brain.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ketoconazole, by mouth, once daily, for 4 days before surgery</li> <li class="seamTextUnorderedListItem">Surgery</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ketoconazole is an antifungal drug that may be able to block a protein called tGLI1. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of <span class="highlight">brain</span> tumors.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03796273' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/ketoconazole' target='_blank'>NCI Drug Dictionary: Ketoconazole</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/symptoms/types/recur_metast/treat_metast/options/local/brain' target='_blank'>Breastcancer.org: Brain Metastasis Local Treatments</a> </li></ul>
12
NEAREST SITE: 2376 miles
University of Virginia
Charlottesville,VA
VISITS: At least 11 visits over 3-4 months; may require hospitalization
PHASE: I
NCT ID: NCT03661424
T-Cell Immunotherapy for Women with Breast Cancer-Related Leptomeningeal Metastases
A Phase I Study of Anti-CD3 x Anti-Her2/Neu (Her2Bi) Armed Activated T Cells (ATC) in Patients With Breast Cancer Leptomeningeal Metastases Scientific Title
Purpose
To study the safety and effects (good and bad) of an immunotherapy made from T-cells taken from your body that have been treated to go after cancer cells.
Who is this for?
Women with metastatic (stage IV) HER2 positive (HER2+) breast cancer with leptomeningeal metastases (defined below).
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw for the collection of your white blood cells (leukapheresis)</li> <li class="seamTextUnorderedListItem">Surgery to place a device (similar to a chemotherapy port) under your scalp, 2 weeks after the blood draw</li> <li class="seamTextUnorderedListItem">Methotrexate, by IV, at least once</li> <li class="seamTextUnorderedListItem">T-cell immunotherapy (HER2 BATs), by IV, weekly, for 2 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional procedures:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">2 <span class="highlight">brain</span> MRIs (before the first and after the eighth infusion)</li> <li class="seamTextUnorderedListItem">Blood draws, before, during and after treatment</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leptomeningeal metastases are when cancer spreads to the membranes surrounding the <span class="highlight">brain</span> and/or the spinal cord (leptomeninges) or to the cerebrospinal fluid.</li> <li class="seamTextUnorderedListItem">HER2 BATs is the name for the T-cell immunotherapy you will receive. </li> <li class="seamTextUnorderedListItem">BATs is short for bi-specific antibody armed T-cells. </li> <li class="seamTextUnorderedListItem">Although trastuzumab (Herceptin®) is used to make the BATs, women do not need to have HER2+ breast cancer to take part in the study.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03661424' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.drsusanloveresearch.org/impatient-science/understanding-immunology' target='_blank'>Dr. Susan Love Foundation: Cancer Immunology</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tandfonline.com/doi/full/10.1080/2162402X.2018.1500672' target='_blank'>OncoImmunology Journal: BATs</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/her2bi-armed-activated-t-cells' target='_blank'>NCI Drug Dictionary: HER2Bi-armed ATCs</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/secondary-cancer/leptomeningeal-metastases/what-are#:~:text=Leptomeningeal%20metastases%20mean%20cancer%20cells,leptomeningeal%20disease' target='_blank'>Cancer Research UK: What are Leptomeningeal Metastases</a> </li></ul>
13
NEAREST SITE: 2385 miles
Duke University Medical Center
Durham,NC
VISITS: 1 visit
PHASE: II
NCT ID: NCT04434560
Immunotherapy Before Surgery for Triple Negative Brain Metastases that are PD-L1 Positive
A Randomized Phase II Trial of Surgery and Stereotactic Radiosurgery With and Without Neoadjuvant Nivolumab and Ipilimumab in Patients With Surgically-resectable, Solid Tumor Brain Metastases Scientific Title
Purpose
To study the safety and anti-cancer activity of giving a combination of two immunotherapies before surgery and radiation therapy.
Who is this for?
People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that is PD-L1 positive and has metastasized (spread) to the brain. You must have no more than 3 untreated brain metastases and be planning to have surgery and radiation therapy.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups and receive the following before surgery for <span class="highlight">brain</span> metastases: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, once, about 1 week before surgery</li> <li class="seamTextUnorderedListItem">Ipilimumab (Yervoy®), by IV, once, about 1 week before surgery</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">No therapies before surgery for <span class="highlight">brain</span> metastases</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Opdivo is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking a protein called PD-1 (programmed cell death 1). </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">Ipilimumab (Yerovy®) is a type of immunotherapy called a CTLA-4 inhibitor. It is approved for use in other cancers but its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancers that have spread (metastasized) to the <span class="highlight">brain</span>. </li> <li class="seamTextUnorderedListItem">Targets or mutations: PD-L1</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04434560' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancernetwork.com/view/targeting-sanctuary-site-options-when-breast-cancer-metastasizes-brain' target='_blank'>CancerNetwork: Targeting the Sanctuary Site</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2018/melanoma-brain-metastases-nivolumab-ipilimumab' target='_blank'>NCI, Cancer Currents Blog: Nivolumab and Ipilimumab Effective against Melanoma That Has Spread to the Brain</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.oncnursingnews.com/web-exclusives/more-immunotherapy-may-enter-tnbc-space' target='_blank'>Oncology Nursing News: More Immunotherapy May Enter TNBC Space</a> </li></ul>
14
NEAREST SITE: 2432 miles
National Institutes of Health Clinical Center
Bethesda,MD
VISITS: 1 visit every 3 weeks, ongoing
PHASE: I-II
NCT ID: NCT03190967
Kadcyla and Temodar for Metastatic HER2+ Breast Cancer That Has Spread to the Brain
Phase I/II Study of T-DM1 Alone Versus T-DM1 and Metronomic Temozolomide in Secondary Prevention of HER2-Positive Breast Cancer Brain Metastases Following Stereotactic Radiosurgery Scientific Title
Purpose
To investigate the safety and effects (good and bad) of using a targeted therapy along with chemotherapy to treat HER2-positive breast cancer that has spread to the brain.
Who is this for?
Women with HER2 positive breast cancer with brain metastases that were recently treated with stereotactic radiation and/or surgery.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">T-DM1 (Kadcyla®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Temozolomide (Temodar®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">2 lumbar punctures (spinal taps)</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">T-DM1 (Kadcyla®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">2 lumbar punctures (spinal taps)</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The targeted therapy used in this study is T-DM1 (Kadcyla®). It is used to treat HER2-positive metastatic breast cancer.</li> <li class="seamTextUnorderedListItem">It combines the chemotherapy drug DM1 with the HER2-targeted drug trastuzumab (Herceptin®). </li> <li class="seamTextUnorderedListItem">The chemotherapy drug used in this study is temozolomide (Temodar®). It is used to treat <span class="highlight">brain</span> cancer. </li> <li class="seamTextUnorderedListItem">Participants will have at least two lumbar punctures (spinal taps) under local anesthesia.</li> <li class="seamTextUnorderedListItem">During lumbar puncture, imaging will guide the insertion of a needle into the spinal canal in the lower back to collect cerebrospinal fluid.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03190967' 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.kadcyla.com' target='_blank'>Genentech Information Page: Kadcyla</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3920177/' target='_blank'>Journal Article: Temozolomide for Treatment of Brain Mets</a> </li></ul>
15
NEAREST SITE: 2567 miles
Lenox Hill Brain Tumor Center
New York,NY
VISITS: Number of visits unavailable
PHASE: I
NCT ID: NCT02571530
Herceptin for HER2 Positive Breast Cancer That Has Spread to the Brain
Phase 1 Trial of Super-selective Intra-arterial Cerebral Infusion of Trastuzumab After Blood-Brain Barrier Disruption for the Treatment of Cerebral Metastases of HER2/Neu Positive Breast Cancer Scientific Title
Purpose
To determine the safety of administering a single dose of trastuzumab directly into an artery in 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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<p class="seamTextPara"> You will receive a single infusion of trastuzumab (Herceptin®) into arteries in the <span class="highlight">brain</span> (Intra-arterial Cerebral Infusion).</p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is used to treat HER2 positive breast cancer. </li> <li class="seamTextUnorderedListItem">It is delivered intravenously. However, the blood-<span class="highlight">brain</span> barrier might prevent the drug from getting to cancer cells that have spread to the <span class="highlight">brain</span>.</li> <li class="seamTextUnorderedListItem">This study is evaluating the safety of administering a single dose of trastuzumab into an artery in the <span class="highlight">brain</span> to treat HER2+ <span class="highlight">brain</span> metastases.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02571530' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://jco.ascopubs.org/content/early/2014/12/29/JCO.2012.44.8894.full' target='_blank'>ASCO: Intrathecal Trastuzumab Halts Progression of CNS Metastases in Breast Cancer</a> </li></ul>
16
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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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, once every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Stereotactic Radiosurgery (SRS), once after the first treatment of pembrolizumab</li></ul>
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<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 <span class="highlight">brain</span>.</li></ul>
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<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>
17
NEAREST SITE: 2693 miles
Brigham and Women's Hospital
Boston,MA
VISITS: 1-10 visits over 1-2 weeks
PHASE: III
NCT ID: NCT03075072
How Different Radiation Therapy Techniques for People With 5 to 15 Brain Metastases Affect Their Quality of Life
Whole Brain Radiation Versus Stereotactic Radiation (SRS) in Patients With 5-15 Brain Metastases: A Phase III, Randomized Clinical Trial Scientific Title
Purpose
To compare the side effects and quality of life in people who receive stereotactic radiation to those who receive whole brain radiation (the current standard of care).
Who is this for?
People with metastatic (stage IV) breast cancer who have 5 to 15 brain metastases.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Whole <span class="highlight">brain</span> radiation treatments, 10 times</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation treatments, 1-5 times</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation delivers focused radiation to each site of <span class="highlight">brain</span> metastasis. </li> <li class="seamTextUnorderedListItem">Whole <span class="highlight">brain</span> radiation treats the entire <span class="highlight">brain</span>.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03075072' 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='http://www.dana-farber.org/Adult-Care/Treatment-and-Support/Treatment-Centers-and-Clinical-Services/Center-for-Neuro-Oncology/Brain-Metastases-Program.aspx' target='_blank'>Dana-Farber Cancer Institute: Radiation Treatments</a> </li></ul>
18
NEAREST SITE: 2693 miles
Dana-Farber Cancer Institute
Boston,MA
VISITS: Visits every 3 weeks
PHASE: II
NCT ID: NCT03765983
GDC-0084 with Trastuzumab for HER2 Positive Breast Cancer with Brain Metastases
Phase II Trial of GDC-0084 in Combination With Trastuzumab for Patients With HER2-Positive Breast Cancer Brain Metastases Scientific Title
Purpose
To study the safety and effects (good and bad) of using the experimental PI3K inhibitor GDC-0084 in combination with trastuzumab (Herceptin®).
Who is this for?
People with metastatic (stage IV) breast cancer that has spread (metastasized) to the brain.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GDC-0084, by mouth, daily</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GDC-0084 is an investigational drug that blocks a protein called PI3-kinase that helps cancer cells grow. </li> <li class="seamTextUnorderedListItem">Herceptin is a HER2 targeted therapy. It is routinely used to for HER2 positive (HER2+) breast cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03765983' target='_blank'>ClinicalTrials.gov</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></ul>
19
NEAREST SITE: 2693 miles
Brigham and Women's Hospital
Boston,MA
VISITS: 1 visit every 6 months, for 2 years
PHASE: NA
NCT ID: NCT04030507
Using MRIs to Screen for Brain Metastases in Advanced Breast Cancer
Screening Magnetic Resonance Imaging of the Brain in Patients With Metastatic Breast Cancer Managed With First/Second Line Chemotherapy or Inflammatory Breast Cancer Managed With Definitive Intent: A Prospective Study Scientific Title
Purpose
To study if using MRIs to screen for brain metastases (breast cancer that has spread to the brain) is safe and finds brain metastases earlier than the standard of care (no screening).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer who will be starting their first or second chemotherapy for advanced disease.
Full eligibility criteria
Contact research site
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Share with my patient
- What's involved?
- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will be assigned to 1 of 3 groups depending upon your cancer subtype: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Triple negative</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Brain</span> MRI, every 6 months for 2 years</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Inflammatory</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Brain</span> MRI, every 6 months for 2 years</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Hormone positive or HER2 positive</i> </p> <p class="seamTextPara"> People in Group 3 will be randomly assigned to receiving screening or no screening </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Screening group</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Brain</span> MRI, every 6 months for 2 years</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">No screening group</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">No <span class="highlight">brain</span> MRIs</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Brain</span> metastases (<span class="highlight">brain</span> mets) is when breast cancer has spread to the <span class="highlight">brain</span>. </li> <li class="seamTextUnorderedListItem">The standard of care for metastatic breast cancer does not include ongoing screening for <span class="highlight">brain</span> metastases.</li> <li class="seamTextUnorderedListItem">This imaging trial will use regularly scheduled MRIs (magnetic resonance imaging) to look for <span class="highlight">brain</span> mets.</li> <li class="seamTextUnorderedListItem">Researchers believe adding <span class="highlight">brain</span> metastases screening to the standard of care will help doctors find <span class="highlight">brain</span> mets earlier--when they are smaller and potentially easier to manage.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04030507' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/mri/about/pac-20384768' target='_blank'>Mayo Clinic: Brain MRI</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.radiologybusiness.com/topics/policy/brain-mri-could-id-metastases-breast-cancer-patients-guidelines-dont-recommend-it' target='_blank'>Radiology Business: Brain MRI Could ID Metastases in Breast Cancer Patients</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancertodaymag.org/Pages/Spring2019/Looking-for-Brain-Metastases.aspx' target='_blank'>Cancer Today: Looking for Brain Metastases</a> </li></ul>
