Breast Cancer Clinical Trial
Monitoring for Cancer Spread to the Central Nervous System (CNS) in People With Breast Cancer
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.
Eligibility Criteria
Inclusion 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
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
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