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

Official record

Identifier

NCT07619534

Recruiting locations

country

United States

Interventions studied

Arm 1

Lead sponsor

National Cancer Institute (NCI)

Target enrolment

139 participants

Study type

OBSERVATIONAL

Phase

Not provided in the official record

Status

Not yet recruiting

First posted

Jun 2, 2026

Last updated on the registry

Jul 31, 2026

Age

18 Years – 120 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

* 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