Clinical trial NCT06638294: Study in Patients With Breast Cancer Leptomeningeal Metastasis
Official title: A Translational Observational Biorepository and Management Study in Patients With Breast Cancer Leptomeningeal Metastasis: The BioLept Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Leptomeningeal Metastasis of Breast Cancer
Keywords: breast cancer
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Avon Foundation
First posted: 2024-10-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a prospective translational observational study for patients with breast cancer leptomeningeal disease (LMD).

Brief 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.

Detailed description: This is a prospective translational observational study for patients with breast cancer leptomeningeal disease (LMD). LMD is notoriously difficult to treat, and prognosis is generally very poor, with most patients typically succumbing to the disease within a few months of its diagnosis. Conducting clinical trials is challenging for these reasons, and there are limited data regarding biological processes of LMD. The overarching goal of this study is to be as inclusive as possible to optimize and learn from patients with LMD. The investigators propose a prospective observational study to establish (1) a translational collection protocol to comprehensively collect tissue, blood, and CNS samples, and (2) a therapeutic management program utilizing the Johns Hopkins Molecular Tumor Board, to provide multi-disciplinary treatment recommendations in a timely manner, and (3) collect outcome data that can be correlated with biomarkers.

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.

Primary outcomes:
measure: Percentage of patients who achieve goal time to treatment recommendation
timeFrame: 2 years
Secondary outcomes:
measure: Correlation of patient reported outcomes and biomarkers
timeFrame: 2 years
measure: Correlation of molecular features of cerebrospinal fluid and cerebrospinal fluid biomarkers
timeFrame: 2 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Cesar Santa-Maria, MD
role: PRINCIPAL_INVESTIGATOR
References: