Study in Patients With Breast Cancer Leptomeningeal Metastasis

Recruiting

• Conditions: Leptomeningeal Metastasis of Breast Cancer

• Registration Number: NCT06638294
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Study Timeline

• Study First Submitted: 2024-10-09
• Study First Submitted QC: 2024-10-09
• Study First Posted: 2024-10-15
• Status Verified: 2024-11
• Study Start: 2024-11-25
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-27
• Primary Completion: 2026-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients who achieve goal time to treatment recommendation	2 years	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)..

Secondary Outcome Measures

Name	Time	Method
Correlation of patient reported outcomes and biomarkers	2 years	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.
Correlation of molecular features of cerebrospinal fluid and cerebrospinal fluid biomarkers	2 years	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.

Trial Locations

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States