RecruitingNCT06638294

Study in Patients With Breast Cancer Leptomeningeal Metastasis

A Translational Observational Biorepository and Management Study in Patients With Breast Cancer Leptomeningeal Metastasis: The BioLept Study


Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

30 participants

Start Date

Nov 25, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

Traditional clinical trials in patients with breast cancer leptomeningeal disease (LMD) are challenging as patients often have a rapidly progressive course and prognosis is poor, making meeting standard eligibility difficult. Furthermore, there is limited information about the biology of LMD. The investigators thus propose a study that is as inclusive as possible, which will allow the investigators to collect biospecimens and clinical outcomes to learn more about LMD biology, but still potentially provide benefit for patients, by providing patients rapid diagnostics and multi-disciplinary treatment recommendations.


Eligibility

Min Age: 18 Weeks

Plain Language Summary

Simplified for easier understanding

This study collects data from breast cancer patients who have developed leptomeningeal metastasis — when cancer spreads to the fluid and membranes surrounding the brain and spinal cord. It aims to better understand this serious complication and improve how it is managed. **You may be eligible if...** - You are 18 or older with a history of breast cancer (any type) - You are suspected to have breast cancer that has spread to the leptomeninges (the membranes around the brain/spine), based on symptoms, imaging, or spinal fluid testing - You have an ECOG score of 3 or below, or a Karnofsky score of 60 or above (meaning you can perform at least some self-care) **You may NOT be eligible if...** - Your suspected brain/spine involvement is due to a blood cancer, lymphoma, or a different solid tumor - You are not eligible for leptomeningeal disease treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(2)

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

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NCT06638294


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