Study in Patients With Breast Cancer Leptomeningeal Metastasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Leptomeningeal Metastasis of Breast Cancer. Basic parameters: from 18 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Translational Observational Biorepository and Management Study in Patients With Breast Cancer Leptomeningeal Metastasis: The BioLept Study
Overview
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.
Primary outcome measures
- Percentage of patients who achieve goal time to treatment recommendation [Time frame: 2 years]
Secondary outcome measures (2)
- Correlation of patient reported outcomes and biomarkers [Time frame: 2 years]
- Correlation of molecular features of cerebrospinal fluid and cerebrospinal fluid biomarkers [Time frame: 2 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Sibley Memorial Hospital — Washington D.C.
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore
Identifiers
NCT: NCT06638294 · J2323 · IRB00371039