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Observational Study for Breast Cancer Leptomeningeal Metastasis

This study is for people with breast cancer that has spread to the leptomeninges (the membranes covering the brain and spinal cord), a condition called leptomeningeal metastasis (LMD). It's an observational study, meaning researchers will collect information and samples from you to learn more about LMD. There are no specific interventions (treatments) being tested in this study. The goal is to understand the biology of LMD better and to provide quick diagnoses and treatment recommendations from a team of specialists. To join, you must be 18 or older, have a history of breast cancer, and be suspected of having breast cancer-related LMD. The study aims to see what percentage of patients receive timely treatment recommendations within two years. The current recruitment status is unclear.

Study design
This is an observational study with a planned enrollment of 30 participants. It is designed to collect information and samples to learn more about leptomeningeal metastasis.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is measured at 2 years, which suggests a follow-up period of at least that long.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06638294

Study in Patients With Breast Cancer Leptomeningeal Metastasis

Recruiting
Not specifiedAges 18+Observational
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
~30 participants
Updated 2025-11-28 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of patients who achieve goal time to treatment recommendation
Measured over 2 years

Conditions

Leptomeningeal Metastasis of Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

2 sites across 2 states
District of Columbia1
Maryland1

Study leadership

  • Cesar Santa-Maria, MD · PRINCIPAL_INVESTIGATOR · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Who to contact

Hopkins Breast Trials
[email protected]
410-614-1361
Email the study team

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Eligibility criteria

Inclusion

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

Suspected central nervous system recurrence of hematologic malignancy, lymphoma or other solid tumor
Not eligible for treatment of leptomeningeal disease.

What this trial measures

  • Percentage of patients who achieve goal time to treatment recommendation2 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)..