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Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases

Recruitingn/aAges 18 Years - 120 YearsAllNational Cancer Institute (NCI)
NCT07619534 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Background: Breast cancer is the most common cancer among women. It can often spread to the liver, lungs, bones, or brain. Breast cancer that spreads to the brain is often fatal. Researchers want to know if tumor DNA found in spinal fluid, blood, or tumor tissue can help predict when the cancer will spread to the brain. They want to collect these fluid and tissue samples for research. Objective: To collect spinal fluid and other samples from people with breast cancer that has spread to other parts of the body. Eligibility: People aged 18 years and older with HER2-positive or triple negative breast cancer. The cancer must have spread to other parts of the body but not to the brain. Design: Participants will be screened. They will have blood tests to assess kidney function. They will have an imaging scan of the brain. Participants will come to the NIH clinic to have their samples c

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📋 Eligibility rules (as published)
* INCLUSION CRITERIA: * Pathology documentation of histologically confirmed HER2+ BC or TNBC with a history of metastatic disease. * Participants must be able to undergo lumbar puncture (LP) and brain MRI. * Women age \>= 18 years * Adequate organ function as defined below: * Creatinine \<=1.5 x institutional upper limit of normal (ULN) OR --Calculated Creatinine clearance \>=40 mL/min/1.73 m2 for individuals with creatinine levels above institutional ULN (using either Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] equation) \- Participants must be able to understand and willing to sign a written informed consent document. EXCLUSION CRITERIA: * Prior history or current MRI-detected brain metastasis or leptomeningeal disease * Previous history of any invasive malignancies, except for surgically resected local cutaneous malignancies. * Pregnancy
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What it tests

  • Arm 1
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Where

1 site
National Institutes of Health Clinical Center
Bethesda, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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