The main project launched by TRANSBIG is the MINDACT trial, which compares a genomic prognostic test (Mammaprint®) developed with micro-array technology to traditional clinical-pathological methods for assessing the risk of breast cancer recurring in women with lymph node negative or 1 to 3 node positive disease. It is hypothesised that using the genomic test in addition to traditional methods will result in more accurate risk assessment and ultimately help physicians and patients make better decisions about who can safely avoid chemotherapy and its potential side effects.
With 63 centres participating in 9 countries and recruiting about 120 patients per month, accrual reached the first milestone of 800 patients (end of the pilot phase) in November 2008. The preliminary results of this pilot phase demonstrate that the trial is both feasible from the logistical point of view and scientifically relevant. These outcomes also demonstrate that multidisciplinary team collaboration on a large-scale is feasible.
In parallel to this, the TRANSBIG network implemented the first amendment to the study protocol. This amendment was primarily made to allow patients with 1-3 positive lymph nodes to participate in MINDACT and to allow the collection of the whole blood.
Main 2009 achievements are:
- Central pathology review work including that of the first 800 MINDACT patients
- Storage of MINDACT biological samples in the TRANSBIG biobank MINDACT quality assurance programme
- Evaluation of the first project proposals using the MINDACT Access to Samples and Data Policy
- Second amendment to the TRANSBIG Access to Samples and Data Policy
- Results of the validation of the 70-gene signature in the aged 65 and older patient population
- Results of the validation of the 70-gene signature in patients’ population with 4-9 lymph nodes
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