DCIS (BIG 3-07 / TROG 07.01)
(Public name: Finely Tuned Radiotherapy)
A randomized phase III study of radiation doses and fractionation schedules for Ductal Carcinoma in Situ (DCIS) of the breast
ClinicalTrials.gov identifier: NCT00470236
|WHAT is DCIS ?||
Ductal Carcinoma in Situ (DCIS) is the earliest form of breast cancer (stage 0) and the most common type of non-invasive breast cancer. DCIS is a growing health problem since the introduction of mammographic screening has substantially increased its diagnoses. About 20% of screen-detected breast cancers are DCIS. There is currently no best practice and no standard of care worldwide in the management of DCIS.
• After surgery alone, up to 25-35% of DCIS will recur, of which approximately half would be in the form of invasive breast cancer with the potential to spread to other organs.
• If left untreated, 40-70% of DCIS may develop into invasive breast cancer.
• Radiotherapy and hormonal therapy reduce the risk of recurrence but may lead to significant over-treatment in some patients and unnecessary costs.
Finely Tuned Radiotherapy is an international study that aims to:
- investigate if a radiation “boost” to the part of the breast where the DCIS was, in addition to whole breast radiation after surgery would further improve tumour control
- investigate if a shorter course of radiotherapy (3 weeks) is as effective as the usual longer course (5 weeks) to improve patient convenience
- identify a molecular signature that predicts individual risk of recurrence to personalise treatment
Better patient outcomes:
- The study aims to improve the safety and the quality of DCIS treatment, and to tailor treatment intensity according to each patient’s individual risk of developing invasive breast cancer
- The goal is to minimise the risk of developing invasive breast cancer in patients with high-risk DCIS, and spare unnecessary treatment side-effects in low-risk patients.
Practice-changing potential and scientific advances:
- If biomarkers for recurrence can be identified, a molecular signature test for DCIS could be developed so that doctors can recommend the most appropriate therapy to patients, tailored to their individual risks of recurrence.
- The study will substantially advance knowledge about how DCIS progresses to invasive breast cancer.
Social benefits: The results of the study could lead to significant cost savings for healthcare systems by minimising over or under-treatment of patients with DCIS
1. The study of patients with DCIS treated with breast conserving surgery will examine:
2. Using the patient data and tumour blocks collected, researchers will work to identify biomarkers to predict which patients are at high risk of recurrence and may require more intensive treatment; and which patients are at low risk of recurrence and may require less treatment. Findings from this research can help tailor treatment to individual patients diagnosed with DCIS in the future.
Patients aged 18 and older, with a confirmed diagnosis of DCIS, without invasive breast cancer.
Coordinating group: Trans-Tasman Radiation Oncology Group (TROG) (sponsor)
The study was extended to European and non-European countries through the BIG network.
National Cancer Institute of Canada Clinical Trials Group (NCIC CTG)
European Organisation for Research and Treatment of Cancer (EORTC)
UK Breast Intergroup
International Breast Cancer Study Group (IBCSG)
All-Ireland Cooperative Oncology Research Group (ICORG)
• The 1.607 patients were recruited in June 2014, two years ahead of schedule
• Patients will be followed for at least 10 years after enrolment
• The identification of biomarkers of recurrence will take 5 years
135 centres worldwide in 11 countries from six BIG member groups participate in this study
|FUNDING||The total cost of the study: 5.730.000 EUR, of which 55% have already been raised, in grants and in-kind support: Susan G. Komen®, National Health & Medical Research Council (Australia), National Cancer Institute of Canada Clinical Trials Group, European Organization for the Research and Treatment of Cancer, Dutch Cancer Foundation, UK Breast Cancer Campaign, OncoSuisse, IBCSG Foundation Council
Still needed: 2.580.000 EUR, or 1.600 EUR per patient, for the study
To learn more about this study: http://www.trog.com.au/TROG-0701-DCIS
Last update: August 2015