The “BIG Radio Tuning” study is known in the scientific community as EXPERT, which stands for EXamining PErsonalised Radiation Therapy for low-risk early breast cancer.
The BIG Radio Tuning study aims to improve personalised use of radiation therapy in early breast cancer patients, according to individual risk of recurrence. Like adjusting your radio to find the right frequency, the study aims to personalise radiation therapy to each individual patient, even going as far as to avoid it altogether.
The societal impact could be substantial
The results of this study could influence how 2 in 5 women with breast cancer are treated in the future. If the study proves that certain patients do not need radiation therapy, many women affected by this disease may be spared its potential side effects; health care systems could also make significant savings.
De primary aim of the trial is to see whether a multi-gene expression test called Prosigna (PAM50) can be used to identify women with early stage, hormone receptor positive breast cancer who can safely avoid radiation therapy after surgery. The need for radiation therapy after breast cancer surgery depends on the risk of the cancer coming back. If the risk is very small, there may be no need for radiation therapy and standard endocrine therapy may be enough. This means that patients can potentially be spared from overtreatment and radiation side effects like skin changes, swelling and, rarely, heart and lung problems.
This clinical trial has already included more than 430 patients from hospitals across Australia, New Zealand and Taiwan. Breast Cancer Trials Australia and New Zealand (BCT-ANZ) leads the study in Australia and New Zealand, with the Taiwan Breast Cancer Consortium (TBCC) leading the study in Taiwan. The Breast International Group (BIG) network leads the study in Italy, Spain, Switzerland, Ireland, Argentina, and Chile through the following study groups:
- Cancer Trials Ireland (CT-IRE)
- Groupo Oncologico Cooperativo Chileno de Investigacin (GOCCHI)
- Grupo Argentino de Investigacion Clinica en Oncologia (GAICO)
- Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC)
- International Breast Cancer Study Group (IBCSG)
- SOLTI-Innovative Breast Cancer Research (SOLTI, Spain)
Hospital Clinic de Barcelona (Spain) is the first BIG site to be activated and ready to include patients to EXPERT. It is also the location of the central laboratory for the European sites. Several other countries have also received ethics committee approvals namely: Ireland, Chile, and Switzerland. Site activations and patient recruitment will hopefully follow very soon across all BIG sites. Our aim is to include 1170 patients globally.
The study is funded by Breast Cancer Trials Australia and New Zealand (BCT-ANZ) (sponsor) and the National Health and Medical Research Council of Australia, Belgian National Lottery, and generous donations.