NCT06638294Recruiting
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
Source: ClinicalTrials.gov · Last updated 28 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 9 Oct 2024
- Start date
- 25 Nov 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Diseases
- Childhood cancers
- NCT number
- NCT06638294
What you commit to
- Study type: Observational
- Planned participants: 30
- From 25 Nov 2024 to the primary completion date, Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Suspected central nervous system recurrence of hematologic malignancy, lymphoma or other solid tumor
- Not eligible for treatment of leptomeningeal disease.
Who the study is looking for
- 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.
Age in the registry: 18 weeks to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Sibley Memorial Hospital Coordinator of this site? Confirm its status | Washington D.C. | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.