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NCT07619534 · ClinicalTrials.gov registry record
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
A clinical trial, sponsored by National Cancer Institute (NCI).
- Not yet
- Registry status
- 139
- Enrollment target
NCT07619534: Clinical Trial study, sponsored by National Cancer Institute (NCI).
NCT07619534 is a clinical trial that has not yet begun recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 139 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07619534 has not yet begun recruiting, sponsored by National Cancer Institute (NCI).
- NOT YET RECRUITING
- Registry status
- 139 participants
- Enrollment target
Study 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....
Primary Outcome
CSF samples from participants with metastatic triple negative breast cancer (TNBC) and HER2+ breast cancer (BC) with no prior history nor active radiographically detectable brain metastases will be collected to perform downstream analyses will be collected and summarized/described descriptively.
Interventions
- OTHER Arm 1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2026-07-15 |
| Est. Completion | 2034-07-01 |
What is known before NCT07619534 opens enrollment
NCT07619534 is an observational study that tracks outcomes without assigning an intervention. The registered 139 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Arm 1 is the first listed.
NCT07619534 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07619534 about?
NCT07619534 is a clinical study titled "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". 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 wil...
What is the current status of trial NCT07619534?
This trial is currently not yet recruiting. The enrollment target is 139 participants. The study started on 2026-07-15. Estimated completion is 2034-07-01.
What interventions are being tested in trial NCT07619534?
The interventions under investigation include: Arm 1 (OTHER).
Who is sponsoring clinical trial NCT07619534?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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