This is 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.
The purpose of this study is to see whether a specialised laboratory test (Prosigna (PAM50) Assay) of breast cancer tissue can be used to choose women who can safely avoid radiation therapy because there is a low risk of the cancer coming back.
It is an investigator-led trial funded by an NHMRC (Australia) grant via Breast Cancer Trials (ANZ). Participants who agree to take part will have a genomic test called “Prosigna (PAM50) Assay” performed on a sample of their tumour tissue from surgery. With patient consent a tumour block will be obtained for this assay. In addition to clinical pathological features the PAM50 assay will be used to determine those breast cancers that are low risk for recurrence.
The two treatment arms in this trial are either:
• Arm A: Standard Care - radiation therapy and hormonal treatment after surgery; OR
• Arm B: Investigational Group - no radiation therapy after surgery (hormonal treatment only).
All radiation therapy and endocrine therapy for this study will be usual standard care. The investigational arm omits radiation therapy for patients at very low risk of recurrence, thereby avoiding the time, side effects and cost of this treatment.
This trial commenced in 2018 at Waikato, Palmerston North, Wellington and Christchurch Hospitals. If you would like to be considered for this trial please speak to your medical team about it. More information about the trial is available here. For full details, view this link.
15 May 2023
