Observational study for patients with breast cancer leptomeningeal metastasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to gather comprehensive data on patients with breast cancer-related leptomeningeal metastasis (LMD), a condition with a poor prognosis and limited treatment options. The study will collect biospecimens, including tissue, blood, and cerebrospinal fluid, to better understand the biology of LMD. Additionally, it will provide rapid diagnostics and multi-disciplinary treatment recommendations through the Johns Hopkins Molecular Tumor Board. By being as inclusive as possible, the study seeks to optimize patient management and correlate clinical outcomes with biological markers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female, aged 18 or older
* History of breast cancer (any subtype)
* Suspected breast cancer-related leptomeningeal metastasis (i.e., by clinical signs or symptoms (i.e., peri-oral dysesthesia, unexplained new neurological symptoms in the absence of brain metastasis), radiographic, or by cerebrospinal fluid analysis), whereby patient will be treated along an leptomeningeal disease paradigm.
* Previous central nervous system metastasis (including leptomeningeal disease or brain metastasis) is eligible.
* Eastern Cooperative Oncology Group (ECOG) score of ≤3 or Karnofsky performance status ≥60.

Exclusion Criteria:

* Suspected central nervous system recurrence of hematologic malignancy, lymphoma or other solid tumor
* Not eligible for treatment of leptomeningeal disease.

Where it's running

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  Baltimore, Maryland, United States Recruiting
• Sibley Memorial Hospital
  Washington D.C., District of Columbia, United States Not yet recruiting

Study contacts

• Principal investigator: Cesar Santa-Maria, MD — Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Study coordinator: Hopkins Breast Trials
• Email: HopkinsBreastTrials@jhmi.edu
• Phone: 410-614-1361

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.