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OpenTrials
Active, Not Recruiting

NCT Number: NCT05130840

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Diagnostic Test

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).

Lumbar puncture

Diagnostic Test

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.

Primary outcomes

  1. Number of eligible patients completing initial MRI

    Time frame: 2 years

    will require 8 out of 10 eligible patients to successfully complete the initial MRI

  2. Percentage of eligible patients completing cerebrospinal fluid (CSF) evaluation

    Time frame: 2 years

    will require 8 out of 10 eligible patients to successfully complete the CSF evaluation

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Nov 23, 2021
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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