BIG to date has been mainly focused on large adjuvant trials looking at questions related to optimal chemo-, hormono- and biological therapies, or to special groups of patients, such as the young or the elderly. BIG trials incorporate a substantial translational research component and emphasise the collection and banking of biological specimens for future research. However, BIG also provides a discussion forum for prevention trials and studies in advanced breast cancer, and it has launched a biomarkers and drug development programme centred around neo-adjuvant studies, NeoBIG.
While nearing the end (in 2011) of its formal support by the European Commission under the Framework Programme VII, the TRANSBIG consortium will leave a lasting legacy in the form of a biological materials bank (“biobank”). Extremely valued for translational research, this will allow researchers from around the world to access genomic data and biospecimens. Moreover, many of the TRANSBIG committees and structures are being adapted to expand their expertise across BIG, benefitting the association in the longer term.
Among the many studies conducted under the BIG umbrella, several may be considered landmark trials, introducing particularly innovative designs, contributing to significant breakthroughs, or paving the way towards more personalised treatment of the disease:
- BIG 1-01 HERA (HERceptin Adjuvant) – A new standard of treatment
- BIG 1-98 – Answers to important questions for hormone receptor positive breast cancer
- BIG 3-04 MINDACT (Microarray In Node-negative and 1 to 3 positive lymph node Disease may Avoid ChemoTherapy) – Testing new technology to reduce overtreatment with adjuvant chemotherapy
- BIG 2-06 ALTTO (Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization) / BIG 1-06 Neo-ALTTO (Neo-Adjuvant Lapatinib and/or Trastuzumab Treatment Organisation study) – The integration of translational research and strength of international collaboration