A Prospective Study of the Genomic Landscape of Central Nervous System Disease Secondary to Breast Cancer Utilising Cell-free DNA Derived From Cerebrospinal Fluid (CSF)

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorRoyal College of Surgeons, Ireland

About this trial

The PRIMROSE CSF Study aims to study cerebrospinal fluid (CSF) in patients with breast cancer that has spread to the brain (brain metastasis) or the lining surrounding the brain (leptomeningeal disease). Research into breast cancer that has spread to the brain or the lining of the brain is limited due to difficulty in obtaining brain tissue containing cancer cells. Such tissue is typically only available when tumours are removed, which does not occur in all patients. Evidence indicates an increasing number of patients with breast cancer are developing disease that spreads to the brain or the lining of the brain as treatments improve. The PRIMROSE CSF Study aims to improve understanding of breast cancers that spread to the brain or brain lining by collecting and analysing the fluid that circulates around the brain and comparing these samples with other cancer and blood samples. Cancer cells that have spread to the brain or its lining shed genetic material into the surrounding fluid. Collection of this fluid enables purification of genetic material released by breast cancer cells. This approach allows examination of the genetic profile of breast cancer cells affecting the brain or its lining without the need for surgery. Differences between the original cancer and metastatic disease in the brain can then be analysed. This research will support improved understanding of why certain breast cancers spread to the brain and contribute to the development of new treatments for breast cancer that has spread to the brain or the lining of the brain.

Eligibility criteria

Qualifiers

Male or female.

>18 years of age

Any ER, PgR or HER2 status

Newly diagnosed with Breast Cancer Brain Metastasis (BCBM) OR Progressive BCBM following either local or systemic treatment OR Leptomeningeal disease

Disqualifiers

Where the investigator considers it unsafe to undertake a lumbar puncture or perform an aspiration from the Ommaya reservoir.

Unable to comply with study procedures or give informed consent.

Where the investigator considers it not in the best interest of the patient to participate.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed