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

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Observational

Phase

Not applicable / not listed

Age range

18 years - 120 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

139 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

• INCLUSION CRITERIA:
• 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.

EXCLUSION CRITERIA:

• 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

Study population

Participants with metastatic triple negative breast cancer (TNBC) and HER2-positive breast cancer with no prior history nor active radiographically detectable brain metastases.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not reported

Masking

Not reported

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

National Cancer Institute (NCI)

Study start

Nov 15, 2026 Estimated

Primary completion

Jul 1, 2033 Estimated

Study completion

Jul 1, 2034 Estimated

First posted

Jun 2, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts