Monitoring for Cancer Spread to the Central Nervous System (CNS) in People With Breast Cancer

Feasibility of Multi-modality Central Nervous System Evaluation in HER2+ Breast Cancer Patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05130840

Enrollment

Registered

2021-11-23

Start date

2022-07-13

Completion date

2026-07-01

Last updated

2026-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Central Nervous System, HER2+ Breast, 21-140

Brief summary

The researchers doing this study think that performing scans of the brain and testing cerebrospinal fluid (CSF) in people with HER2-positive breast cancer may be an effective way of identifying the early onset of CNS metastases (such as brain cancer). If the researchers can identify the early onset of CNS metastases, they can immediately treat that cancer and possibly prevent it from worsening. Currently, people with breast cancer don't usually have scans of the brain or CSF testing unless they are experiencing symptoms of CNS metastases.

Interventions

DIAGNOSTIC_TESTMRI

MRI Brain (unless already done as standard of care within 2 months on enrollment to evaluate for CNS disease) MRI Brain at 2 timepoints 6 months apart (+/- 8 weeks).

DIAGNOSTIC_TESTLumbar puncture

LP at 2 timepoints 6 months apart (+/- 8 weeks). LP will be performed to analyze cerebrospinal fluid for: cytology, circulating tumor cells and cell-free DNA.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

This represents a two-cohort feasibility study to establish the feasibility of a multi-modality central nervous system (CNS) disease detection platform in patients with HER2+ breast cancer with no known CNS metastatic disease. Patients will enroll into one of 2 cohorts. Cohort A will be open to patients with Stage IV HER2+ breast cancer and Cohort B will include patients with Stage II-III HER2+ breast cancer.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with Stage IV metastatic HER2+ breast cancer without CNS disease s/p 1 or more lines of HER2 directed therapy (Cohort A Only) * Patients with Stage II-III HER2+ breast cancer without CNS disease (Cohort B Only) * Male and Female participants Age ≥18 years * HER2+ as defined by ASCO/CAP guidelines\* * Ability to undergo bedside Lumbar puncture to obtain cerebrospinal fluid; if beside LP is not successful due to patient discomfort or inability to obtain spinal fluid then patients will be offered LP through interventional radiology and patients will continue to be monitored on study * Patients with breast implants and/or tissue expanders are eligible if they are able to safely undergo an MRI * Able to provide written informed consent \*ASCO/CAP guidelines: HER2+ defined as IHC 3+ positive and/or by ISH average copy number ≥ 6 signals/cell

Exclusion criteria

* Patients who are unable to undergo MRI with gadolinium * Patients with CNS Metastases on Screening MRI * Patients with Positive Cytology on Screening Bedside lumbar puncture

Design outcomes

Primary

Measure	Time frame	Description
Number of eligible patients completing initial MRI	2 years	will require 8 out of 10 eligible patients to successfully complete the initial MRI
Percentage of eligible patients completing cerebrospinal fluid (CSF) evaluation	2 years	will require 8 out of 10 eligible patients to successfully complete the CSF evaluation

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJessica Wilcox, MD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026