Precision Oncology Clinical Diagnostic Study In Primary and Metastatic Breast Cancer (PRISM)

NCT07425002 | Recruiting DMC

• 1 other identifier: CTRIAL-IE 25-15
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 3

Brief Summary

This study aims to provide information about the genomics of your breast cancer which your oncologist can use to enhance the treatment of your disease possibly enabling more targeted and personalised therapy.This study will carry out TruSight Oncology Comprehensive (TSOComprehensive) testing on breast cancer tumour tissue that was collected at the time of your breast cancer diagnosis or during your breast surgery or if you have brain metastasis and you have had a biopsy for this. The TruSight Oncology Comprehensive assay is a next-generation sequencing (NGS) test used to analyse cancer-related genomic changes in patients, offering a comprehensive view of potential mutations and other alterations that can impact treatment decisions. The TruSight Oncology Comprehensive assay is CE-IVD marked for use in Europe, meaning that it complies with the relevant EU regulation, for comprehensive genomic profiling for different types of cancer. It analyses 523 cancer-relevant genes from both DNA and RNA to identify variations. It will also look for changes and mutations which may affect cell growth and stability. By identifying relevant mutations and biomarkers, the assay can help oncologists select the most appropriate treatment strategies with the aim of improving patient outcomes.

Conditions

Breast Cancer

Keywords

Breast cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of enrolled patients with at least one clinically actionable mutation identified by PRISM diagnostics compared with standard-of-care diagnostics.

  At the time of therapeutic decision following diagnostic assessment (up to 6 weeks from enrollment).

Study Arms (1)

Experimental: Intervention: TSO 500

EXPERIMENTAL

Utilisation of TSO500 assay to identify somatic, clinically actionable somatic in the primary breast tumour and, where relevant, brain metastatic tumour to the treating physician to inform clinical management of participating patients

Diagnostic Test: TSO500 Assay

Interventions

TSO500 Assay DIAGNOSTIC_TEST

Utilisation of TSO500 assay to identify somatic, clinically actionable somatic in the primary breast tumour and, where relevant, brain metastatic tumour to the treating physician to inform clinical management of participating patients.

Experimental: Intervention: TSO 500

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with primary breast cancer attending hospital for the resection of their tumour tissue. Or Patients with suspected or confirmed brain metastatic breast cancer (Patient has a history of a biopsy or surgically (i.e. pathologically) confirmed primary breast cancer) attending hospital for the resection/biopsy and/or treatment of their tumour tissue. Or Patients with suspected (but not necessarily biopsy confirmed) newly diagnosed brain metastatic breast cancer attending hospital for the resection/biopsy and/or treatment of their tumour tissue.
• Patients receiving neoadjuvant treatment are also eligible (if applicable).
• Patients must be ≥ 18 years of age.
• Patients must be able to give informed consent.

You may not qualify if:

• Patients who do not have a confirmed diagnosis of primary breast cancer.
• Patients whose participation, in the opinion of the PI, would not be in their best interest, or those whom in the opinion of the PI would be unsuitable for study for reasons of infirmity or poor health.

Sponsors & Collaborators

• Cancer Trials Ireland: lead
• Royal College of Surgeons, Ireland: collaborator

Study Sites (3)

Beaumont RCSI Cancer Centre

Dublin, Leinster, D09V2N0, Ireland

RECRUITING

Cork University Hospital

Cork, Ireland

NOT YET RECRUITING

University Hospital Galway

Galway, Ireland

NOT YET RECRUITING

Related Links

• Cancer Trials Ireland

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Cancer Trials Ireland

CONTACT

00353 1 6677211; info@cancertrials.ie

Leonie Young

CONTACT

00 353 1 797 7800; lyoung@rcsi.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 20, 2026
• Study Start: November 11, 2025
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): December 30, 2030
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

IE (3)