Fatima Cardoso, MD and John Bartlett, PhD and Sharon Giordano, MD, MPH and Peggy Porter, MD

Breast cancer rarely occurs in men but its incidence is rising. In the United States, around 2,100 men are diagnosed with breast cancer and 450 men die from this disease each year. In contrast to female breast cancer, the understanding of the biology of this rare disease is very limited. There are no large trials conducted for male breast cancer patients. Additionally, male breast cancer patients are frequently excluded from the majority of breast cancer clinical trials exploring the role of new anti-cancer drugs. Therefore, the treatment of male breast cancer is based upon extrapolation from existing clinical trial data for female breast cancer. However, there are important differences regarding the age at diagnosis, underlying risk factors, and biological characteristics which suggest that male breast cancer may be a distinct disease. Survival rates among male breast cancer patients are lower than their female counterparts, mainly due to late diagnosis and lack of individualized treatment.Due to the rarity of the disease, international cooperation is necessary to undertake relevant projects with potential clinical impact. With the support of BCRF, the Male Breast Cancer International Registration and Biologic Characterization Program has been launched, as a joint effort between the Breast International Group (BIG) and the North American Breast Cancer Groups (NABCG) and coordinated by the European Organization for the Research and Treatment of Cancer (EORTC).In 2010-2011, the analysis of the largest series of male breast cancer samples started in Europe. To get the study up and running in the US, this team, led by Dr. Cardoso, had to address some unexpected regulatory issues which have now been solved and hence opening of the first part of the project in the US is imminent. Each US center is now going through the process of submitting the protocol to the respective Independent Review Boards. Researchers in Europe started collecting and shipping tumor samples for testing in the first half of 2011. The study is fully running in Belgium and sites are in the process of being opened in Poland, The Netherlands, and the UK. This project has generated much interest among the scientific community with several other centers/groups wishing to join. Their acceptance is highly dependent on the feasibility of increasing the sample size in view of the limited budget. An additional grant to help coordinate the study has been obtained in The Netherlands, one of the largest contributors to this part of the study. The two central pathologists in the US and Europe are planning additional grant applications to obtain funding for testing of new biomarkers of disease progression.