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

NCT ID: NCT05130840

Last Updated: 2026-01-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-13
• Study Completion Date: 2026-07-31

Brief 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Stage IV 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.

Group Type: EXPERIMENTAL

MRI

Intervention Type: DIAGNOSTIC_TEST

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).

Lumbar puncture

Intervention Type: DIAGNOSTIC_TEST

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.

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.

Group Type: EXPERIMENTAL

MRI

Intervention Type: DIAGNOSTIC_TEST

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).

Lumbar puncture

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

MRI

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).

Intervention Type: DIAGNOSTIC_TEST

Lumbar puncture

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.

Intervention Type: DIAGNOSTIC_TEST

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 (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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Wilcox, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Related Links

http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

21-440

Identifier Type: -

Identifier Source: org_study_id