Study in Patients With Breast Cancer Leptomeningeal Metastasis

NCT06638294 | Recruiting

• 2 other identifiers: J2323IRB00371039
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Leptomeningeal Metastasis of Breast Cancer

Keywords

breast cancer

Outcome Measures

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)..

  2 years

Secondary Outcomes (2)

• Correlation of patient reported outcomes and biomarkers

  2 years

• Correlation of molecular features of cerebrospinal fluid and cerebrospinal fluid biomarkers

  2 years

Study Arms (1)

Patients with breast cancer leptomeningeal disease (LMD)

Participation involves allowing access to participant medical records including the genetic information of the tumor, undergoing standard-of-care work up as indicated (this may include MRI of brain or spine, spinal tap, etc.), providing a cerebrospinal (CSF) sample (less than 2 tablespoons), blood sample (about 4 tablespoons) at baseline and possibly again after month, and answering online questionnaires monthly. Johns Hopkins Molecular Tumor Board will review clinical and genetic information and provide treatment recommendations. CSF and blood will be collected at baseline no matter what treatment is recommended. If possible, collect CSF and blood again after one month. Additional blood and CSF sampling may also be obtained if/when therapy changes. The oncologist will ultimately decide if participant will proceed with the recommend treatment or not. Health information and questionnaires are obtained to assess how participants are doing on therapy.

Eligibility Criteria

• Age: 18 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective translational observational study for patients with breast cancer leptomeningeal disease (LMD).

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Avon Foundation: collaborator

Study Sites (2)

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

NOT YET RECRUITING

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Cerebrospinal fluid (CSF) collections and blood samples

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Cesar Santa-Maria, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hopkins Breast Trials

CONTACT

410-614-1361; HopkinsBreastTrials@jhmi.edu

Sidney Kimmel Cancer Center Clinical Research Office

CONTACT

410-955-8866; jhcccro@jhmi.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: November 25, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

US (2)