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

NCT05130840 | Active Not Recruiting

• 1 other identifier: 21-440
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Keywords

Central Nervous System; HER2+ Breast; 21-140

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Stage IV HER2+ breast cancer

EXPERIMENTAL

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; Diagnostic Test: Lumbar puncture

Stage II-III HER2+ breast cancer

EXPERIMENTAL

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; Diagnostic Test: Lumbar puncture

Interventions

MRI 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).

Stage II-III HER2+ breast cancer; Stage IV HER2+ breast cancer

Lumbar puncture 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; Stage IV HER2+ breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Spinal Puncture

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jessica Wilcox, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: November 23, 2021
• Study Start: July 13, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)