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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05130840
• Other study ID #: 21-440
• Status: Recruiting
• Phase: N/A
• Start date: July 13, 2022
• Est. completion date: July 2026

Study information

• Verified date: July 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Jessica Wilcox, MD
• Phone: 212-639-6767
• Email: wilcoxj[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Diagnostic Test:
• 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).
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of eligible patients completing initial MRI	will require 8 out of 10 eligible patients to successfully complete the initial MRI	2 years
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center