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Sample Collection Study to Analyze Cerebral Spinal Fluid as a Biomarker for Brain Metastasis in Metastatic Breast Cancer

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 120
Healthy Volunteers: f
View:

⁃ 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.

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Ann C McCoy, R.N.
ann.mccoy@nih.gov
(240) 760-6021
Backup
Takeo Fujii, M.D.
takeo.fujii@nih.gov
(240) 858-3558
Time Frame
Start Date: 2026-11-02
Estimated Completion Date: 2034-07-01
Participants
Target number of participants: 139
Treatments
Cohort 1
Participants with metastatic triple negative breast cancer (mTNBC) without a history or active radiographically detectable CNS disease who underwent at least one systemic therapy
Cohort 2
Participants with metastatic HER2+ BC without a history or active radiographically detectable CNS disease who underwent at least one systemic therapy
Cohort 3
Participants with newly diagnosed mTNBC without a history or active radiographically detectable CNS disease and without prior systemic therapies
Cohort 4
Participants with newly diagnosed metastatic HER2+ BC without a history or active radiographically detectable CNS disease and without prior systemic therapies
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov