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

Description

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.

Conditions

Breast Cancer

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patients with Stage IV metastatic HER2+ breast cancer without CNS disease s/p 1 or more lines of HER2 directed therapy
  • * Patients with Stage II-III HER2+ breast cancer without CNS disease
  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Memorial Sloan Kettering Cancer Center,

Jessica Wilcox, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

2026-07