Monitoring for Cancer Spread to the Central Nervous System (CNS) in People With Breast Cancer
Running, not enrolling · Not applicable
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT05130840
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 9
- Starts
- 2022-07-13
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2026-01-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
Full record on ClinicalTrials.gov
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