Monitoring for Cancer Spread to the Central Nervous System (CNS) in People With Breast Cancer
Breast Cancer
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring Central Nervous System, HER2+ Breast, 21-140
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
Sites / Locations
- Memorial Sloan Kettering Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Stage IV HER2+ breast cancer
Stage II-III HER2+ breast cancer
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.
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.