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Clinical Trials in Ireland / NCT07425002
Recruiting Not applicable

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

NCT07425002 · tracked via the Priya Life Science Ireland tracker
Sponsor
Cancer Trials Ireland
Phase
Not applicable
Started
2025-11-11
Last updated
2026-02-20

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

TSO500 Assay

TSO500 Assay: 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. 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. 2. Patients receiving neoadjuvant treatment are also eligible (if applicable). 3. Patients must be ≥ 18 years of age. 4. Patients must be able to give informed consent. Exclusion Criteria: 1. Patients who do not have a confirmed diagnosis of primary breast cancer. 2. 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.

Primary outcome measure(s)

  • 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).

Trial sites (3)

FacilityCityRegionStatus
Beaumont RCSI Cancer Centre Dublin Leinster Recruiting
Cork University Hospital Cork Ireland Not Yet Recruiting
University Hospital Galway Galway Ireland Not Yet Recruiting

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Other trials for the same condition

Add-Aspirin: A Trial Assessing the Effects of Aspirin on Disease Recurrence and Survival After Primary Therapy in Common Non Metastatic Solid Tumours Active, not recruiting
SURVEY-CNS: A Feasibility Study of Randomising Women and Men With HER2-Positive Metastatic Breast Cancer to Central Nervous System Surveillance Versus No Surveillance Recruiting
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer Recruiting
First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors Recruiting
PALbociclib CoLlaborative Adjuvant Study Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07425002 on ClinicalTrials.gov ↗ ← All trials in Ireland