Study in Patients With Breast Cancer Leptomeningeal Metastasis

Phase

N/A

Condition

Neoplasm Metastasis

Treatment

N/A

Clinical Study ID

NCT06638294

J2323

IRB00371039

Ages > 18
All Genders

Study 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 Criteria

Inclusion

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 signsor symptoms (i.e., peri-oral dysesthesia, unexplained new neurological symptoms inthe 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 orbrain metastasis) is eligible.
Eastern Cooperative Oncology Group (ECOG) score of ≤3 or Karnofsky performancestatus ≥60.

Exclusion

Exclusion Criteria:

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

Study Design

November 25, 2024

December 31, 2028

Study Description

This is a prospective translational observational study for patients with breast cancer leptomeningeal disease (LMD). LMD is notoriously difficult to treat, and prognosis is generally very poor, with most patients typically succumbing to the disease within a few months of its diagnosis. Conducting clinical trials is challenging for these reasons, and there are limited data regarding biological processes of LMD. The overarching goal of this study is to be as inclusive as possible to optimize and learn from patients with LMD. The investigators propose a prospective observational study to establish (1) a translational collection protocol to comprehensively collect tissue, blood, and CNS samples, and (2) a therapeutic management program utilizing the Johns Hopkins Molecular Tumor Board, to provide multi-disciplinary treatment recommendations in a timely manner, and (3) collect outcome data that can be correlated with biomarkers.

Connect with a study center

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland 21287
United States
Active - Recruiting

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