Although progress has definitely been made towards improving the prognosis of breast cancer, relatively little progress has been made in biomarker discovery in order to match the right therapeutic strategies to the right patients. Furthermore, despite increasing knowledge of different molecular pathways underlying tumorigenesis and more anti-cancer drugs entering development, the rate of marketing approval for these new drugs is disappointingly low. Also, the length of development of successful targeted agents easily exceeds 10 years, with too many years spent on trials in advanced disease where progress in “tailoring” treatment is difficult to achieve.
To address these issues, BIG aims to build on its already well established research collaborations to introduce a new model for the conduct of early breast cancer trials in the era of molecular oncology. A new research programme, NeoBIG, was launched in late 2009, with the aim to:
- set up a series of neoadjuvant trials that select the most promising targeted therapies for specific molecular breast cancer subpopulations
- utilise the pre-operative setting, where valuable opportunities for correlative translational research exist
- use short-term surrogate endpoints to help detect early signals of drug activity or inactivity
- integrate and accelerate drug development and predictive biomarker research
- develop a data-sharing platform that will serve NeoBIG but also maximize the potential for research collaborations within the wider BIG community and beyond, such as with the NCI / NABCG and others
In 2009, the programme has received grants from the charities NIF Trust and the Fonds Jean-Claude Heuson. It has also received an unrestricted educational grant from Amgen (Europe).
Data sharing
The concept of data sharing embedded in the NeoBIG research programme is an innovative principle whereby raw data from the “standard of care” arms from each NeoBIG study will be shared by NeoBIG partners. In order to set up the needed structure, contacts have been established with European informatics networks offering the technological infrastructure for biomedical data management.