Journal article
Radiation doses and fractionation schedules in non-low-risk ductal carcinoma in situ in the breast (BIG 3–07/TROG 07.01): a randomised, factorial, multicentre, open-label, phase 3 study
BH Chua, EK Link, IH Kunkler, TJ Whelan, AH Westenberg, G Gruber, G Bryant, V Ahern, K Purohit, PH Graham, M Akra, O McArdle, P O'Brien, JA Harvey, C Kirkove, JH Maduro, ID Campbell, GP Delaney, JD Martin, TTT Vu Show all
Lancet | ELSEVIER SCIENCE INC | Published : 2022
Abstract
Background: Whole breast irradiation (WBI) after conservative surgery for ductal carcinoma in situ (DCIS) reduces local recurrence. We investigated whether a tumour bed boost after WBI improved outcomes, and examined radiation dose fractionation sensitivity for non-low-risk DCIS. Methods: The study was an international, randomised, unmasked, phase 3 trial involving 136 participating centres of six clinical trials organisations in 11 countries (Australia, New Zealand, Singapore, Canada, the Netherlands, Belgium, France, Switzerland, Italy, Ireland, and the UK). Eligible patients were women aged 18 years or older with unilateral, histologically proven, non-low-risk DCIS treated by breast-conse..
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Grants
Awarded by Susan G. Komen for the Cure
Funding Acknowledgements
We thank the patients, investigators, and support staff of all participating centres. The list of contributors from participating centres is provided in the appendix (pp 2-5). We acknowledge the support of the trial management staff of the Trans-Tasman Oncology Group, and participating cooperative trials groups including the Canadian Cancer Trials Group, the European Organisation for Research and Treatment of Cancer, the International Breast Cancer Trials Group, Cancer Trials Ireland, and the Scottish Cancer Trials Breast Group. We thank the Breast International Group in enabling international collaboration. We acknowledge the support of the Centre for Biostatistics and Clinical Trials of the Peter MacCallum Cancer Centre (Melbourne, VIC, Australia), and the Data and Safety Monitoring Committee (Richard Gelber, Boston, MA, USA; Lori Pierce, Ann Arbor, MI, USA; and Mary Gospodarowicz, Toronto, ON, Canada). We thank the National Health and Medical Research Council (grant numbers 454390 and 1099860), Susan G Komen for the Cure (grant number OG12-BIG), Breast Cancer Now (grant number PR55), OncoSuisse Swiss Federation Against Cancer (grant number KLS/KFS 02527-02-2010), and the Dutch Cancer Society (grant number 2009-4467) for directly funding the study, and the Canadian Cancer Society for indirectly funding the study through the Canadian Cancer Trials Group.