Precision genomic testing for primary and metastatic breast cancer

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

This project will test a comprehensive genetic sequencing assay on tumour tissue to help your oncologist find targeted treatment options for adults with primary or brain-metastatic breast cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1600 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cancer Trials Ireland (Research network)
• Locations: 3 sites (Dublin, Leinster and 2 other locations)
• Trial ID: NCT07425002 on ClinicalTrials.gov

What this trial studies

This pragmatic single-arm diagnostic project uses Illumina TruSight Oncology 500 next-generation sequencing on paraffin-embedded tumour tissue to profile 523 cancer-relevant genes and measure microsatellite instability, tumour mutational burden, and homologous recombination deficiency. Testing is performed centrally at the ISO 15189–accredited molecular diagnostics laboratory at Beaumont RCSI Cancer Centre using a NextSeq 550Dx, with bioinformatic analysis to identify somatic variants. Results and treatment recommendations are reviewed at a multi-disciplinary Molecular Tumour Board and provided to the treating oncology team. Eligible adults include those undergoing resection or biopsy of primary breast tumours or suspected/confirmed brain metastases, including patients receiving neoadjuvant therapy.

Who should consider this trial

Good fit: Adults (≥18) with primary breast cancer or suspected/confirmed brain metastatic breast cancer who can provide informed consent and have available tumour tissue for resection or biopsy.

Not a fit: Patients without available tumour tissue, without a confirmed breast cancer diagnosis, or whose tumours lack actionable genomic changes are unlikely to gain direct treatment benefit from the testing.

Why it matters

Potential benefit: If successful, the results could help match patients to targeted therapies or clinical trials based on their tumour's genomic alterations.

How similar studies have performed: Other comprehensive genomic profiling programs have identified actionable mutations and helped match patients to targeted drugs or trials, although improvements in survival have been inconsistent across studies.

Eligibility criteria

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.

Where this trial is running

Dublin, Leinster and 2 other locations

• Beaumont RCSI Cancer Centre — Dublin, Leinster, Ireland (Recruiting)
• Cork University Hospital — Cork, Ireland (Not_yet_recruiting)
• University Hospital Galway — Galway, Ireland (Not_yet_recruiting)

Study contacts

• Study coordinator: Cancer Trials Ireland

Conditions Breast Cancer; Breast cancer