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Study in Patients With Breast Cancer Leptomeningeal Metastasis
A Translational Observational Biorepository and Management Study in Patients With Breast Cancer Leptomeningeal Metastasis: The BioLept Study
Who can join
18 Weeks · All sexes
Full 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.
About the study
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.
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Participants: 30 · Started: Nov 25, 2024
Contact the study team
- Hopkins Breast Trials · Phone: 410-614-1361
- Sidney Kimmel Cancer Center Clinical Research Office · Phone: 410-955-8866
Official record on ClinicalTrials.gov — NCT06638294
Locations in the U.S.
| District of Columbia | Sibley Memorial Hospital, Washington D.C. (Not yet recruiting) |
| Maryland | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.