Precision genomic testing for primary and metastatic breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: info@cancertrials.ie
• Phone: 00353 1 6677211

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.