The Breast European Adjuvant Study Team

The Breast European Adjuvant Studies Team (BrEAST) is a specialized clinical trials unit (data centre) created in 1997 by Dr Martine Piccart in order to conduct large, international Phase III studies in breast cancer aiming to register new drugs. The unit is responsible for setting-up, coordinating and managing the data collected in these trials, which are run in collaboration with pharmaceutical companies and the Breast International Group (BIG).

The team at BrEAST team consists of over 40 professionals, including physicians, project managers, data managers, computer scientists, clinical monitors, quality assurance managers, safety specialists, data entry staff, and administrative assistants. The BrEAST data centre has hosted many young oncologists (fellows) from numerous continents and countries around the world, including Europe, Canada, Australia, Brazil, Argentina, India, and Peru. A strength of this unit is that all BrEAST personnel receive continuous extensive training in breast cancer as well as in Good Clinical Practice. Data managers, monitors and investigators participating in any of the trials run by BrEAST can count on the availability of 5 full- time medical oncologists, including its medical director, to help in solve problems and answer questions. On a daily basis, BrEAST personnel deal with more 1,300 hospitals distributed in approximately 40 countries. This impressive network of investigators, most of whom are affiliated with collaborative research groups under the BIG umbrella, is able to speed up the process of drug development by rapidly accruing patients to its trials and representing global diversity.

To date BrEAST has been responsible for the conduct and management of three large phase III trials: The first, BIG 02-98, is a 4-arm trial that included 2,887 patients with lymph node-positive breast cancer testing the hypothesis that docetaxel would improve the outcome of breast cancer patients when given either in sequence or in combination to anthracycline chemotherapy. The first results of this study were presented at prestigious annual meeting of the American Society of Clinical Oncology (ASCO) in 2006 and subsequently published in the Journal of National Cancer Institute. Translational research,, conducted in close collaboration with the European Institute of Oncology in Milan, is ongoing.

The second, and one the most important breast cancer trials in recent years, has been the HERceptin Adjuvant trial (HERA; BIG 01-01), which randomised 5,102 HER-2 positive breast cancer patients. HERA is an international, multicentre, randomized, controlled trial comparing 1-year or 2-years of trastuzumab given every 3 weeks with observation. The first study results were presented at ASCO in 2005, together with two similar studies run by North American investigators. These trials demonstrated that adjuvant trastuzumab reduced the risk of breast cancer recurrence for patients receiving 1 year of the drug. These results were both astonishing and practice changing, with adjuvant trastuzumab becoming the new standard of care for HER-2 positive breast cancer. The data from HERA comparing 1 year versus 2 years of adjuvant trastuzumab treatment are expected to be published in 2011.

The third major trial being managed by BrEAST is the Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation (ALTTO; BIG 02-06) trial, which is a global collaboration between the Breast International Group (BIG) and the North America Breast Cancer Group (NABCG). ALTTO is a 4-arm phase III trial evaluating the efficacy of lapatinib either given alone, sequentially or in combination with trastuzumab in 8,000 patients with HER-2 positive early breast cancer. The first patient was recruited in Europe in June 2007 and accrual, which has exceeded all expectations, will finish in 2010. ALTTO incorporates important features such as central pathology review of all patients, biological specimen banking, and translational research. Beyond these trials, BrEAST is actively involved in other ambitious programmes developed under BIG, including international collaborations related to ensuring that data collection across different trials are harmonized in a manner to allow better comparison across trials and pooling of study results. These efforts are essential to advance the research process and more rapidly provide benefit to patients.