EXPERT

About this trial

The purpose of this study is to see whether a genomic test (looking at specific genes) of breast cancer tissue can be used to select women who can safely avoid radiation therapy because they have a low risk of the cancer coming back. The researchers will request a sample of patient’s breast cancer tissue, which was removed at the time of the breast surgery, to do a genomic test called “Prosigna (PAM50) Assay”. Patients whose cancer is tested as having a high risk of coming back according to the Prosigna (PAM50) Assay will not be eligible to participate. However, it is expected that more than 80% of women we test (more than 8 in 10) will have breast cancer that is considered low risk and will be suitable to participate in this study. Eligible patients will be randomly put into one of two treatment groups in this study:
• Arm A: Standard care – radiation therapy and hormone (endocrine) therapy after surgery; OR
• Arm B: Investigational group – no radiation therapy after surgery (hormone (endocrine) therapy only).
Study patients will be followed-up for 10 years from the time of randomisation.

Patient Profile

Female patients aged ≥50 years of any menopausal status diagnosed with hormone receptor-positive and HER2 negative early stage breast cancer (characterised by PAM50-based luminal A subtype and ROR score ≤60) with tumour size ≤2 cm, who are planned to receive adjuvant endocrine therapy.

Where’s this trial being run?

Cork University Hospital, St Luke’s Radiation Oncology Network @ Beaumont Hospital, St Luke’s Radiation Oncology Network @ St James’s Hospital, St Luke’s Radiation Oncology Network @ St Luke’s Hospital, University Hospital Limerick, and University Hospital Galway

Can I join this study / trial?

The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.

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For more detailed information

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Questions?

Here’s a list of questions you may have for your doctor or local cancer research team.

Questions

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Summary Data

Name:	EXPERT
Number:	19-03
Full Title:	A Randomised Phase III Trial of Adjuvant Radiation Therapy Versus Observation Following Breast Conserving Surgery and Endocrine Therapy in Patients With Molecularly Characterised Luminal A Early Breast Cancer

Principal Investigator:	Prof Sinead Brennan (St Luke’s Radiation Oncology Network)
Type:	Collaborative
Sponsor:	Breast Cancer Trials, Australia and New Zealand
Recruitment Started:	Global: August 2017 Ireland: March 2024

Global Recruitment Target:	1170
Ireland Recruitment Target:	22