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NCT05130840 | RECRUITING | Breast Cancer

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

Memorial Sloan Kettering Cancer Center

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.

Condition or disease

Breast Cancer

Intervention/treatment

MRI

Lumbar puncture

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : Feasibility of Multi-modality Central Nervous System Evaluation in HER2+ Breast Cancer Patients
Actual Study Start Date : 2022-07-13
Estimated Primary Completion Date : 2026-07
Estimated Study Completion Date : 2026-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Monitoring for Cancer Spread to the Central Nervous System (CNS) in People With Breast Cancer

Location Details

NCT05130840

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065