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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Diagnostic Test: MRI
* Diagnostic Test: Lumbar puncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stage IV HER2+ breast cancer<br>Once enrolled on study, patients will undergo screening MRI Brain (unless already done as standard of care within 2 months on enrollment to evaluate for CNS disease) as well as lumbar puncture to evaluate for CNS disease. Once on study, patients will undergo LP and MRI Brain 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. 6-month intervals for investigations have been based on feedback from patient advocates as well as clinical determination. | Diagnostic Test: MRI<br>* 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).<br>Diagnostic Test: Lumbar puncture<br>* 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.<br>|
| Experimental: Stage II-III HER2+ breast cancer<br>Once enrolled on study, patients will undergo screening MRI Brain (unless already done as standard of care within 2 months on enrollment to evaluate for CNS disease) as well as lumbar puncture to evaluate for CNS disease. Once on study, patients will undergo LP and MRI Brain 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. 6-month intervals for investigations have been based on feedback from patient advocates as well as clinical determination. | Diagnostic Test: MRI<br>* 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).<br>Diagnostic Test: Lumbar puncture<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of eligible patients completing initial MRI | will require 8 out of 10 eligible patients to successfully complete the initial MRI | 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 | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Central Nervous System, HER2+ Breast, 21-140