The Breast International Group (BIG), founded in 1999, is today the largest academic network in the world dedicated to conducting research designed to accelerate and refine the use of anticancer treatments and diagnostic tools for the benefit of women and men with breast cancer (BC).

BIG’s collaborative research model provides academic leadership in industry-sponsored randomized clinical trials. Some of these trials have successfully led to the rapid registration of new anticancer drugs with a significant impact on breast cancer mortality, such as the HERA trial.

BIG also supports clinical trials sponsored by its academic member groups and facilitates collaboration between international researchers and the US cooperative groups: the SOFT and TEXT trials evaluating adjuvant endocrine therapies for 5,738 premenopausal women are an example of such a collaboration.

Despite its success, BIG and its affiliated cooperative groups must battle constantly to remain vigorously involved in clinical trial design and conduct and in translational research. Without academic leadership in the research process, critical issues important for patient care will remain unaddressed. Moreover, healthcare costs will continue to rise substantially as a consequence of the worrisome “add on” approach in registration trials.

This talk will try to formulate important messages for the next generation of oncology leaders.