William C. Wood, MD, FACS, FRCS Eng(Hon), FRCS Glasg.

1) On behalf of The Breast Cancer Intergroup and the Breast International Group
(made possible by generous support from Delta Air Lines, Inc.)

A prior grant from BCRF made possible meetings between the leadership of The Breast Cancer Intergroup of North America (TBCI) and The Breast International Group (BIG) of Europe and Australasia. The pace of clinical research in breast cancer and the commonality of scientific questions under study cry out for optimal collaboration between these two large groups of clinical trial groups. This facilitates the pace of translation of new agents and technologies into clinical use and avoids unnecessary duplication of effort. The major thrust over the next year is a continuation of infra-structure alignment, with focus on common terminology and common specimen collection. The major scientific issues that groups are beginning to address through this international collaboration involve biologic and genomic subtypes of breast cancer that will be best studied as separate entities. Over the coming year, teleconference and face-to-face meetings will continue.

Mid-Year Progress Report:
Following the progress in Data Harmonization using the STEEP system and the acceptance of common Guidelines for Biological Specimen Collection, Handling and Storage, each reported in separate articles in The Journal of Clinical Oncology, data from the international trials are being collected in The Breast Cancer DataMart, an NCI-supported infrastructure. This platform will allow co-operating groups to share data across many different studies to analyze and provoke hypotheses worthy of clinical trial testing. Common Data Elements have been developed across international studies to facilitate this sharing of data, and these elements have been applied prospectively to the Neo-ALTTO Trial now accruing the thousands of required participants. Objectives for the coming year arise from six primary working groups on immuno-vaccines, male breast cancer, metastatic breast cancer, "triple negative" breast cancer, neo-adjuvant treatment, and the harmonization of analytical methodology for important breast cancer biomarkers.

2) On behalf of Memorial Sloan-Kettering Cancer Center, The Breast International Group (BIG) and The Breast Cancer Intergroup of North America (TBCI)
Co-Investigators: Fatima Cardoso, MD, Jules Bordet Institute, Beldium; Julie Gralow, MD, University of Washington; Monica Morrow, MD, Memorial Sloan-Kettering Cancer Center; Martine J. Piccart-Gebhart, MD, PhD, Jules Bordet Institute, Beldium

In contrast to their female counterparts, men rarely develop breast cancer. In the US, less than 1% of all breast cancers are diagnosed in men. Doctors have a limited understanding of how to approach such an uncommon disease. Most decisions regarding treatment are based upon large clinical trials involving only women with this disease. However, there are important differences regarding the age at diagnosis, underlying risk factors, and biological characteristics which suggest that male breast cancer (Male BC) may be a distinct disease. In order to develop more appropriate treatment recommendations, a better understanding of the natural history and biology of Male BC is desperately needed. Due to the rarity of this disease, such insight can only be gained through co-operation between hospitals in different countries worldwide.

The Breast International Group, the Breast Cancer Intergroup of North America and Memorial Sloan-Kettering Cancer Center have joined forces to launch a three-part International Program on Male Breast Cancer (International Registration and Biologic Characterization Program). The first part of this Program consists of a retrospective joint analysis of a very large series of men previously diagnosed with breast cancer. This initiative will gather data regarding patient characteristics, tumor features, treatment and outcome for more than 1600 men diagnosed with breast cancer over the last 20 years. Tumor specimens (both paraffin-embedded and frozen) from a large proportion of these patients will be collected and centrally analyzed, to understand the biological characteristics of this disease and to identify important potential prognostic (indicative of the good or bad outcome of the disease) and predictive (indicative of probability of response to certain therapies) markers, which will then be validated in the third part of the Program.

This important study will provide invaluable information regarding the behavior of this rare disease and, combined with the information gathered during the second part of the Program (an international Male BC registry), will form the basis and rationale for the design of an international Male BC clinical trial.

During the past year, the preparatory work needed to launch this study has been done. The full protocol and the selection of centers have been accomplished. The database for collection and analysis of both clinical and pathological data is in advanced stages of development. The central labs have started developing common protocols for the construction of TMAs, for the analysis of the different biomarkers and for the reporting of the results. The researchers plan to have centers/groups active by July and to start the collection of data and material by the fall 2009 and they are aiming at finalizing the central pathology review by the end of 2009.

Mid-Year Progress Report:
During this period the preparatory work needed to launch this study has been done. The full protocol and database development for collection and analysis of both clinical and pathological data are finished. The central labs have developed common protocols for the construction of tissue microarrays (TMAs), for the analysis of the different biomarkers and for the reporting of the results. The participant centers/groups were selected and the activation process started. The researchers plan to start the actual collection of data and tumor samples in February and are aiming at finalizing the central pathology review by the mid of 2010. The objective is to analyze the first results of the retrospective male breast cancer (Male BC) study in 2010 as well as present it in an international conference and to prepare a manuscript for publication in a peer reviewed journal. In parallel, they are continuing their efforts to obtain the much needed funds for the associated correlative translational research projects. To this end, additional grant applications will be made by the study coordinators and two central pathologists.

Bio:
Dr. Wood has been the Joseph Brown Whitehead Professor of the Department of Surgery, Emory University School of Medicine, since 1991. He is an internationally recognized cancer surgeon and is known for his influence on the design and meta-analysis of conceptually driven national clinical trials.

Dr. Wood is past President of the Society of Surgical Oncology. An Editor-in-Chief of Oncology until recently, he served on the Board of Scientific Advisors of the National Cancer Institute for eight years, is co-chair of the Early Breast Cancer Trialists' Collaborative Group, and is also Chairman of the Intergroup Committee of the NIH Cooperative Group Breast Cancer Chairs. He has chaired the breast committees of both CALGB and ECOG. He is a Governor of the American College of Surgeons.

A native of Illinois, Dr. Wood graduated from Wheaton College with Honors in 1962 and received his Doctor of Medicine degree with Honors from Harvard Medical School. After internship and residency training in surgery at Massachusetts General Hospital, he completed a Fellowship in the Surgery Branch at the NCI.

He has been a member of ASCO since 1977 and has served on the Program and Education Committees, the Board of Directors from 1995-1998, and the Foundation Board of Directors from 1999-2002.