A Translational Observational Biorepository and Management Study in Patients With Breast Cancer Leptomeningeal Metastasis: The BioLept Study
Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 4 months
Healthy Volunteers: f
View:
• 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.
Locations
United States
Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
RECRUITING
Baltimore
Contact Information
Primary
Hopkins Breast Trials
HopkinsBreastTrials@jhmi.edu
410-614-1361
Backup
Sidney Kimmel Cancer Center Clinical Research Office
jhcccro@jhmi.edu
410-955-8866
Time Frame
Start Date:2024-11-25
Estimated Completion Date:2028-12
Participants
Target number of participants:30
Treatments
Patients with breast cancer leptomeningeal disease (LMD)
Participation involves allowing access to participant medical records including the genetic information of the tumor, undergoing standard-of-care work up as indicated (this may include MRI of brain or spine, spinal tap, etc.), providing a cerebrospinal (CSF) sample (less than 2 tablespoons), blood sample (about 4 tablespoons) at baseline and possibly again after month, and answering online questionnaires monthly.~Johns Hopkins Molecular Tumor Board will review clinical and genetic information and provide treatment recommendations. CSF and blood will be collected at baseline no matter what treatment is recommended. If possible, collect CSF and blood again after one month. Additional blood and CSF sampling may also be obtained if/when therapy changes.~The oncologist will ultimately decide if participant will proceed with the recommend treatment or not. Health information and questionnaires are obtained to assess how participants are doing on therapy.