Recruiting

Observational Study

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Code:

NCT06638294

Conditions

Leptomeningeal Metastasis of Breast Cancer

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT06638294

Start date

Nov 25, 2024

Status verified date

Nov, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Percentage of patients who achieve goal time to treatment recommendation [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Hopkins Breast Trials

410-614-1361HopkinsBreastTrials@jhmi.edu

Sidney Kimmel Cancer Center Clinical Research Office

410-955-8866jhcccro@jhmi.edu

Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Hopkins Breast Trials

410-614-1361HopkinsBreastTrials@jhmi.edu

Principal Investigator:

Cesar A Santa-Maria, M.D.

More Information

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Last update posted

Nov 28, 2025

Last verified

Nov, 2025

Keywords

  • breast cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins on 2025-11-28.