Malignant Neoplasm of Breast / Breast Carcinoma / Breast Cancer · Observational Study

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

ClinicalTrials.gov · July 27, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registry record for an observational study designed to collect cerebrospinal fluid, blood, saliva, and archival tumor tissue from patients with metastatic HER2-positive or triple negative breast cancer without brain metastases. The study aims to explore whether tumor DNA in these samples can predict future brain metastasis over a 3-year follow-up period.

What was studied

Prospective observational biospecimen collection with 3-year follow-up. Adults aged 18 years and older with HER2-positive or triple negative breast cancer metastatic to sites other than the brain, with no prior history or active radiographically detectable brain metastases. Intervention: Cohort 1; Cohort 2; Cohort 3; Cohort 4. n = 139. 1 site: United States.

Key findings

Estimated enrollment is 139 participants with metastatic TNBC or HER2+ breast cancer Study involves collection of CSF, blood, saliva, and archival tumor tissue samples Follow-up will occur every 6 months for up to 3 years

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

This registry record describes a planned biomarker discovery study; it does not provide outcome data. If completed, findings may inform future development of predictive tests for brain metastasis risk stratification in metastatic breast cancer patients.

Plain-language summary

Observational study collecting CSF and biospecimens from metastatic breast cancer patients to explore predictive markers; no results yet available.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measure: Collection of CSF samples (assessed at Up to 3 years)

DesignProspective observational biospecimen collection with 3-year follow-up

PopulationAdults aged 18 years and older with HER2-positive or triple negative breast cancer metastatic to sites other than the brain, with no prior history or active radiographically detectable brain metastases

Sample size139

InterventionCohort 1; Cohort 2; Cohort 3; Cohort 4

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Estimated enrollment139

Primary outcome measureCollection of CSF samples

Study durationUp to 3 years

Clinical bottom line

Caveats

This is a registry record only; no results are yet reported.
Study recruitment has not yet begun (status: NOT_YET_RECRUITING).
No information provided on biomarker assay methods, detection thresholds, or statistical analysis plan.
Clinical validity and utility of any identified biomarkers will require subsequent validation studies.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Prospective observational biospecimen collection with 3-year follow-up

Directness

limited

Exploratory biomarker discovery; clinical predictive utility not yet established

Consistency

not graded

The material analysed did not support a judgement on this dimension.

Risk of bias

insufficient

Registry record provides insufficient methodological detail for assessment

Sample adequacy

moderate

Estimated enrollment 139 participants, not yet recruiting

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Malignant Neoplasm of BreastNational Cancer Institute (NCI)Breast CarcinomaNCT07619534Breast Cancer