Study in Patients With Breast Cancer Leptomeningeal Metastasis

Recruiting now

Conditions studied: Leptomeningeal Metastasis of Breast Cancer

In brief

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.

Key facts

Study ID

NCT06638294

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

30

Starts

2024-11-25

Expected to finish

2028-12-01

Last updated by the study team

2025-11-28

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States (enrolling)
• Sibley Memorial Hospital — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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