Mapping tumor DNA in spinal fluid from breast cancer that has spread to the brain
PRIMROSE - 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)
This project will test whether analyzing tumor DNA in cerebrospinal fluid can reveal genetic changes in people whose breast cancer has spread to the brain or its lining.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 69 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Royal College of Surgeons, Ireland Academic / other |
| Locations | 1 site (Dublin) |
| Trial ID | NCT07503704 on ClinicalTrials.gov |
What this trial studies
The PRIMROSE CSF project collects cerebrospinal fluid (CSF) from adults with breast cancer that has spread to the brain or leptomeninges and extracts cell-free tumor DNA from those samples. Samples will be compared with blood and any available tumor tissue to map genetic changes specific to central nervous system disease. CSF is obtained by lumbar puncture or from an existing Ommaya reservoir when it is considered safe and with consent. The aim is to build a clearer genomic picture of CNS breast cancer to inform future targeted treatments and monitoring strategies.
Who should consider this trial
Good fit: Adults over 18 with newly diagnosed or progressive breast cancer brain metastases or leptomeningeal disease, any receptor status, who can give informed consent and are safe to undergo a lumbar puncture or Ommaya aspiration.
Not a fit: Patients who cannot safely undergo lumbar puncture or Ommaya aspiration, those without CNS involvement, or those unlikely to shed detectable tumor DNA into CSF may not receive benefit from this approach.
Why it matters
Potential benefit: If successful, the approach could provide a less invasive way to genetically profile brain metastases, helping clinicians choose targeted treatments and monitor disease.
How similar studies have performed: Prior research has shown that CSF cell-free DNA can detect tumor-specific mutations in CNS metastases, although comprehensive genomic data for breast cancer CNS disease are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female. 2. \>18 years of age 3. Any ER, PgR or HER2 status 4. Newly diagnosed with Breast Cancer Brain Metastasis (BCBM) OR Progressive BCBM following either local or systemic treatment OR Leptomeningeal disease 5. Informed Consent Exclusion Criteria: 1. Where the investigator considers it unsafe to undertake a lumbar puncture or perform an aspiration from the Ommaya reservoir. 2. Unable to comply with study procedures or give informed consent. 3. Where the investigator considers it not in the best interest of the patient to participate.
Where this trial is running
Dublin
- Beaumont RCSI Cancer Centre — Dublin, Ireland (Recruiting)
Study contacts
- Study coordinator: Leonie Young, PhD
- Email: breastcancerbank@rcsi.ie
- Phone: breastcancerbank@rcsi.ie
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.