Neoplasms

Skin and Connective Tissue Diseases

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Breast Neoplasms

Breast Diseases

Skin Diseases

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.

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).

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.

Lumbar puncture

Jessica Wilcox, MD

Chau Dang, MD

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.

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.

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

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

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Monitoring for Cancer Spread to the Central Nervous System (CNS) in People With Breast Cancer	NCT05130840	Breast Cancer	MRI Lumbar puncture	18 Years -	Memorial Sloan Kettering Cancer Center
Monitoring for Cancer Spread to the Central Nervous System (CNS) in People With Breast Cancer	NCT05130840	Breast Cancer	MRI Lumbar puncture	18 Years -	Memorial Sloan Kettering Cancer Center
Monitoring for Cancer Spread to the Central Nervous System (CNS) in People With Breast Cancer	NCT05130840	Breast Cancer	MRI Lumbar puncture	18 Years -	Memorial Sloan Kettering Cancer Center

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