Study in Patients With Breast Cancer Leptomeningeal Metastasis

Conditions

• Leptomeningeal Metastasis of Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Weeks - N/A

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

Start date

Nov 25, 2024

Status verified

Nov 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2028

Study Design

Enrollment

30 participants (estimated)

Arms

• Arm: 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

• Hopkins Breast Trials
  410-614-1361
  [email protected]
• Sidney Kimmel Cancer Center Clinical Research Office
  410-955-8866
  [email protected]

Locations (2)

Find similar trials in Washington D.C., DC