CSF sample collection from people with metastatic breast cancer to see brain metastasis risk

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot, single-site study collects CSF, blood, tumor tissue, and saliva or buccal mucosa from adults with metastatic HER2-positive or triple-negative breast cancer who have no current brain metastases. Participants undergo baseline lumbar puncture and brain MRI, with follow-up for brain metastasis every six months for up to three years. The goal is to identify molecular and other biomarkers in CSF and other samples that could predict future brain involvement. The study is observational and aims to improve understanding of brain metastasis risk in these breast cancer subtypes. Enrollment requires consent and adequate organ function, and participants must be able to undergo LP and MRI.

Why it matters

Who can join: the full rules

* 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

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Takeo Fujii, M.D. — National Cancer Institute (NCI)
• Study coordinator: Ann C McCoy, R.N.
• Email: ann.mccoy@nih.gov
• Phone: (240) 760-6021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.