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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
Sponsor: National Cancer Institute (NCI)
Summary
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 collected: * Spinal fluid. A thin needle will be inserted into the lower back to draw out a sample of fluid from the space around the spinal cord. A physical exam and blood tests will be done to make sure it is safe for participants to have this procedure. * Blood. * Saliva or cheek swabs. They will rub a cotton swab inside of their mouth. * Tumor samples. If participants have had samples of tumor tissue (biopsies) collected in the past, leftover tissue may be used for this study. Participants will be contacted for follow-up every 6 months for 3 years. They may return once a year to provide further samples. ...
Official title: Sample Collection Study to Analyze Cerebral Spinal Fluid as a Biomarker for Brain Metastasis in Metastatic Breast Cancer
Key Details
Gender
All
Age Range
18 Years - 120 Years
Study Type
OBSERVATIONAL
Enrollment
139
Start Date
2026-07-01
Completion Date
2034-07-01
Last Updated
2026-06-02
Healthy Volunteers
No
Interventions
Arm 1
Collection of CSF, blood, tumor tissue, and saliva or buccal mucosa
Locations (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, United States