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Study in Patients With Breast Cancer Leptomeningeal Metastasis

NCT06638294 · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
In plain English

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Official title
A Translational Observational Biorepository and Management Study in Patients With Breast Cancer Leptomeningeal Metastasis: The BioLept Study
About this study
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.
Eligibility criteria
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.
Study design
Enrollment target: 30 participants
Age groups: child, adult, older_adult
Timeline
Starts: 2024-11-25
Estimated completion: 2028-12
Last updated: 2025-11-28
Primary outcomes
  • Percentage of patients who achieve goal time to treatment recommendation (2 years)
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · other
With: Avon Foundation
Contacts & investigators
ContactHopkins Breast Trials · contact · HopkinsBreastTrials@jhmi.edu · 410-614-1361
ContactSidney Kimmel Cancer Center Clinical Research Office · contact · jhcccro@jhmi.edu · 410-955-8866
InvestigatorCesar Santa-Maria, MD · principal_investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
All locations (2)
Sibley Memorial HospitalNot Yet Recruiting
Washington D.C., District of Columbia, United States
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsRecruiting
Baltimore, Maryland, United States
Study in Patients With Breast Cancer Leptomeningeal Metastasis · TrialPath