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
This trial does not accept healthy volunteersQualifiers
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 population
This is a prospective translational observational study for patients with breast cancer leptomeningeal disease (LMD).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
30 Participants
are grouped into 1 trial groupGroup A: Patients with breast cancer leptomeningeal disease (LMD)
Trial outcomes
Primary outcomes
1
Percentage of patients who achieve goal time to treatment recommendation
Rapid molecular tumor board (MTB) evaluation. The investigators will measure the percentage of patients who achieve the following the goal time to treatment recommendation. The investigators goal time to treatment recommendation will be ≤7 days from enrollment, and the investigators goal time to treatment initiation ≤14 days from enrollment. There is no set goal in terms of percentage of patients achieving set timeframes as there will be a significant variability. The investigators hope to continuously refine this process to meet these ideal timeframes. The investigators will report the investigators' ability to achieve these timeframes in order to evaluate the feasibility of rapid molecular tumor board (MTB) evaluation and time to treatment in patients with breast cancer leptomeningeal disease (LMD)..
Time frame
2 yearsSecondary outcomes
1
Correlation of patient reported outcomes and biomarkers
The investigators will assess patient reported outcomes (PROs) using the Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS Global-10) and select questions from the Functional Assessment of Cancer Therapy - Central nervous System (FACT-CNS) and Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire. The investigators will describe development of central nervous systems and clinical deterioration, and correlate with patient reported outcomes and biomarkers including Germline testing and Tumor Next Generation Sequencing.
Time frame
2 years2
Correlation of molecular features of cerebrospinal fluid and cerebrospinal fluid biomarkers
Molecular features of cerebrospinal fluid (CSF) including circulating tumor cell (CTCs) and cell-free tumor DNA (ctDNA). Cerebrospinal fluid biomarkers will be described and correlated with standard CSF assessments including cytology and cell count, radiographic assessments, and clinical outcomes, and correlate these with standard CSF and radiographic assessments, and patient outcomes.
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead sponsor
Avon Foundation
Collaborator
Source ClinicalTrials.gov