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Study in Patients With Breast Cancer Leptomeningeal Metastasis

A Translational Observational Biorepository and Management Study in Patients With Breast Cancer Leptomeningeal Metastasis: The BioLept Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Weeks and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study aims to learn more about breast cancer that may have spread to the lining around the brain and spinal cord, called leptomeningeal disease (LMD). It is for adults with breast cancer and suspected LMD. Researchers will collect body samples and track health outcomes, while offering quick testing and treatment advice from a team of specialists.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older, of any sex.
  • Have a history of breast cancer of any type.
  • Have suspected LMD from breast cancer based on symptoms, scans, or tests of fluid around the brain and spinal cord, with plans to treat it as LMD.
  • Past cancer spread to the brain or its surrounding lining is allowed.
  • Have an ECOG score of 3 or less, or a Karnofsky score of 60 or more. These scores measure how well you can do daily tasks and care for yourself.

Who can't join

  • Doctors suspect that a blood cancer, lymphoma, or another solid tumor has returned in the brain or spinal cord.
  • Cannot receive treatment for LMD.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (2)

DC

MD