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

{ "Observational Study for Metastatic HER2+ or Triple Negative Breast Cancer", "This study aims to understand why breast cancer spreads to the brain. Researchers want to collect samples of spinal fluid (CSF), blood, tumor tissue, and saliva from people with metastatic HER2-positive (HER2+) or triple negative breast cancer (TNBC). You can join if your cancer has spread to other parts of your body, but not to your brain. The goal is to see if tumor DNA in these samples can help predict when the cancer might spread to the brain. This information could help doctors identify people at high risk and potentially prevent brain metastases in the future. You will need to be able to have a lumbar puncture (spinal tap) and a brain MRI.", "design": "This is an observational study that plans to enroll 139 participants. It is a single-site study focused on collecting samples for analysis.", "commitments": "You will be screened, have blood tests to check kidney function, and undergo a lumbar puncture and brain MRI. Samples of CSF, blood, tumor tissue, and saliva or buccal mucosa will be collected at the start of the study and possibly later.", "compensation": "Not stated in the trial record.", "follow_up": "The primary goal is the collection of CSF samples, measured for up to 3 years.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT07619534

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

Not Yet Recruiting
Not specifiedAges 18+Observational
National Cancer Institute (NCI)
~139 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Arm 1

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Collection of CSF samples
Measured over Up to 3 years
Breast Cancer
Breast Carcinoma
Cancer of the Breast
Malignant Neoplasm of Breast
1 sites across 1 states
Maryland1
  • Takeo Fujii, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

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Eligibility criteria

Inclusion

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)
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)

Exclusion

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
  • Collection of CSF samplesUp to 3 years

    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.