ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-07-13
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05130840

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with Stage IV metastatic HER2+ breast cancer without CNS disease s/p 1 or more lines of HER2 directed therapy (Cohort A Only)
  2. * Patients with Stage II-III HER2+ breast cancer without CNS disease (Cohort B Only)
  3. * Male and Female participants Age ≥18 years
  4. * HER2+ as defined by ASCO/CAP guidelines\*
  5. * 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
  6. * Patients with breast implants and/or tissue expanders are eligible if they are able to safely undergo an MRI
  7. * 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
  1. * Patients who are unable to undergo MRI with gadolinium
  2. * Patients with CNS Metastases on Screening MRI
  3. * Patients with Positive Cytology on Screening Bedside lumbar puncture

Contacts and Locations

Principal Investigator

Jessica Wilcox, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Jessica Wilcox, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-13
Study Completion Date2026-07

Study Record Updates

Study Start Date2022-07-13
Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

  • Central Nervous System
  • HER2+ Breast
  • 21-140

Additional Relevant MeSH Terms

  • Breast Cancer