Observational study for patients with breast cancer leptomeningeal metastasis
A Translational Observational Biorepository and Management Study in Patients With Breast Cancer Leptomeningeal Metastasis: The BioLept Study
This study is trying to learn more about breast cancer patients with leptomeningeal metastasis by collecting samples and providing better treatment options to improve their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Weeks and up |
| Sex | All |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Academic / other |
| Locations | 2 sites (Washington D.C., District of Columbia and 1 other locations) |
| Trial ID | NCT06638294 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older with a history of breast cancer and suspected leptomeningeal metastasis.
Not a fit: Patients with central nervous system recurrence of hematologic malignancies or those not eligible for treatment of leptomeningeal disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of breast cancer leptomeningeal metastasis, potentially enhancing patient outcomes.
How similar studies have performed: While studies on leptomeningeal metastasis are limited, the approach of collecting biospecimens and providing multi-disciplinary treatment recommendations is innovative and has not been widely tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Washington D.C., District of Columbia and 1 other locations
- Sibley Memorial Hospital — Washington D.C., District of Columbia, United States (Not_yet_recruiting)
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.