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The MRC Supremo trial protocol was reviewed and approved by the Trial Steering Committee at its first meeting in June 2005. We are in the process of submitting to COREC for ethical approval and it is hoped this will be obtained by the end of November. As soon as confirmation is received from COREC that the application is valid, packs will be sent to interested centres to apply for Site Specific Assessment and local R&D approval. It is hoped that the trial will be open for recruitment early in 2006.
The trial launch was held in Edinburgh at the Royal College of Physicians on 17th June 2005 with around 100 delegates attending from the UK and abroad. All presentations and extracts from the DVD taken of the event, will be available on the Trial Launch section of the website.
The EORTC have approved an outline of the trial and it is intended to apply for ethical approval simultaneously with COREC submission in the UK. Funding has been secured for initiation and running costs and the EORTC will act as sponsor for all its centres. It has been agreed that randomisation will be via EORTC central office, which will contact the ISD Cancer Clinical Trials team in Edinburgh to receive randomisation allocation. This will ensure consistency in the randomisation process.
In Australia and New Zealand, ANZBCTG and TROG will jointly promote the trial. Initial funding will allow recruitment to begin in 2006 with further funding secured for 2007 onwards.
The Swedish Breast group have discussed the protocol and are keen to participate in the trial.
Discussions about participation in Supremo have been taking place with several centres in both France and India.
Notes of interest have also been received from several other countries and international breast groups, including
Borstkanker Onderzoeksgroep Nederland
Central East European Oncology Group
GECO Peru
Hellenic Breast Surgical Society;
International Breast Cancer Study Group
Irish Clinical Oncology Research Group
Japanese Breast Cancer Research Group
National Cancer Institute of Canada –Cancer Trials Group
Swiss Group for Clinical Cancer Research
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