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

N/AActive Not RecruitingNCT05130840

Memorial Sloan Kettering Cancer Center9 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

MRI

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of eligible patients completing initial MRI

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

Time frame: 2 years

Percentage of eligible patients completing cerebrospinal fluid (CSF) evaluation

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