Study in Patients With Breast Cancer Leptomeningeal Metastasis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About this trial
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
Qualifiers
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.
Disqualifiers
Suspected central nervous system recurrence of hematologic malignancy, lymphoma or other solid tumor
Not eligible for treatment of leptomeningeal disease.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
30 Participants
are grouped into 1 trial groupSponsors and collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead sponsor
Avon Foundation
Collaborator
Source ClinicalTrials.gov