Mapping tumor DNA in spinal fluid from breast cancer that has spread to the brain
Official title: 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)
Run by Royal College of Surgeons, Ireland · NCT07503704 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 69 (estimated) |
| Sponsor | Royal College of Surgeons, Ireland Academic / other |
| Locations | 1 site (Dublin) |
| Status | Recruiting |
| Started | October 1, 2024 |
| Main results expected | October 1, 2028 |
| Study ends | October 1, 2035 |
| Registry record updated | March 31, 2026 |
| Trial ID | NCT07503704 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Beaumont RCSI Cancer Centre
Dublin, Ireland Recruiting
Study contacts
- Study coordinator: Leonie Young, PhD
- Email: breastcancerbank@rcsi.ie
- Phone: breastcancerbank@rcsi.ie
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Gyrotonic exercise for elders with breast cancer and Behcet disease
We’re testing whether a gyrotonic exercise program helps older people who have both Behcet disease and breast cancer.
-
PECS II vs SPSIP nerve blocks for pain after mastectomy
This study tests whether two ultrasound-guided nerve blocks (PECS II and SPSIP) differ in how much opioid patients need after mastectomy.
-
CG-7321: a first-in-human test in advanced solid tumors
We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.
-
Compare a new endoscopy-assisted breast-conserving surgery with the usual approach
This study tests whether a new endoscopy-assisted breast-conserving technique can provide similar or better cosmetic outcomes and safety compared with conventional breast-conserving surgery in women with early breast cancer who want to preserve their breast.
-
Different skin care approaches to prevent skin reactions after mastectomy radiation
This study tests three standard skin care methods to see which best prevents radiation dermatitis in people who had a mastectomy and are receiving post-mastectomy radiation therapy.
-
3D Heart Strain to Detect Early Cardiotoxicity in Cancer Therapy
This study tests whether 3D echocardiography can detect early heart damage from cancer treatments like anthracyclines or HER2-targeted therapy better than standard 2D methods.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.