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) (PRIMROSE)

March 26, 2026 updated by: Royal College of Surgeons, Ireland

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)

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

69

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Ireland
      • Dublin, Ireland
        • Recruiting
        • Beaumont RCSI Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

  1. Male or female.
  2. >18 years of age
  3. Any ER, PgR or HER2 status
  4. Newly diagnosed with BCBM OR Progressive BCBM following either local or systemic treatment OR Leptomeningeal disease

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Outcome
Time Frame: Up to 2 years post randomisation
The proportion of patients agreeing to undergo screening and randomisation to surveillance versus no surveillance.
Up to 2 years post randomisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal College of Surgeons, Ireland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2035

Study Registration Dates

First Submitted

February 16, 2026

First Submitted That Met QC Criteria

March 26, 2026

First Posted (Actual)

March 31, 2026

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23/46

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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