Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) … (NCT07619534) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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
United States139 participantsStarted 2026-07-02
Plain-language 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....
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
-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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is focused on collecting cerebrospinal fluid samples from people with metastatic triple negative or HER2+ breast cancer who don't currently have brain metastases — can you explain why researchers would want CSF from patients without active brain metastases, and what they might be hoping to learn from it?
2Since this trial is listed as 'not yet recruiting,' do you know when it might open, and would it make sense for me to revisit this option once enrollment begins rather than waiting on it now?
3The study involves collecting CSF, which typically requires a lumbar puncture — can you walk me through what that procedure involves, how often it would need to happen, and what the risks are for someone in my situation?
4Given that this trial is categorized as 'Phase NA' and focuses purely on sample collection rather than testing a treatment, does participating in it affect my ability to enroll in any treatment-focused trials at the same time?
5For someone with my specific diagnosis — whether TNBC or HER2+ metastatic breast cancer — do you think contributing to this kind of research is something worth prioritizing alongside my treatment plan, or are there other studies that might offer more direct benefit to me right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.