Daniel F. Hayes, MD

On behalf of The Breast Cancer Intergroup of North America
The Breast Cancer Intergroup (TBCI) of North America conducts fundamentally important prospective randomized clinical trials that have changed practice patterns for patients with breast cancer, especially in the adjuvant setting. Therapy for patients with breast cancer can be individualized by judicious use of tumor markers, such as using ER to decide if a patient should get anti-estrogen therapy and HER-2 to decide if a patient should get trastuzumab (Herceptin™).

Since the early 1990s, TBCI has prospectively collected and stored breast cancer tissue from patients who participated in its clinical trials. These samples are available for studies of new or promising tumor markers. A Correlative Science Committee (CSC), established by TBCI, rigorously reviews submitted concepts to decide which should go forward using these precious samples. However, no funding mechanism has been linked to TBCI CSC reviews. Therefore investigators with approved projects must then fund the studies themselves, or be subjected to a second set of peer review from outside funding sources (such as the NIH or DOD). This cumbersome and redundant process results in delays of efficient conduct of these studies.

For the second year, The Breast Cancer Research Foundation is providing support so that investigators who receive permission to use TBCI specimens for tumor marker studies can also apply for funding to proceed with the approved study immediately. Such a system should decrease the time and effort required to determine if the tumor marker should be used to make clinical decisions, thus improving patient care.

Mid-Year Progress Report:
BCRF has supplied grant support for ongoing activities of the Correlative Science Committee. To date, these include: 1. Research grants to individual laboratory investigators to conduct correlative science studies; 2. Infrastructure grants to the Pathology Coordinating Offices of the individual cooperative groups to support conduct of routine but important tasks, such as construction of tissue microarrays, harvesting of DNA and RNA, and staining of tissue sections for standard markers, such as estrogen receptor and HER2; and 3. Support of a "Summit" meeting between investigators in TBCI and investigators in the NIH-funded Pharmacogenetics Research Network to facilitate research in the relatively new field of pharmacogenomics. Planning for this meeting has been ongoing for nine months and it will occur in March 2008 in Bethesda.

Dr. Hayes notes that publications are forthcoming, and progress is being reported via posters at ASCO's annual meeting and the San Antonio Symposium. The availability of BCRF funding to support TBCI CSC has now substantially enhanced efforts to conduct high-quality and important studies using Intergroup resources, thus leveraging an already-existing and functioning system.

Bio:
Daniel Fleming Hayes, MD, is the Director of the Breast Oncology Program at the University of Michigan Cancer Center, where he is also a Professor of Medicine. The University of Michigan is a federally designated Comprehensive Cancer Center that has placed a particular emphasis on cancer research that translates exciting findings from the laboratory to the clinic.

Over nearly twenty years, Dr. Hayes professional training and career have been directed toward bridging the gap between laboratory and clinical research. He received a bachelor's degree (1974) in biology and a master's degree (1977) in biochemistry at Indiana University. He received his MD from the Indiana University School of Medicine in 1979, followed by a residency in internal medicine at the University of Texas Health Science Center at Dallas, Texas (Parkland Memorial and affiliated hospitals). He served a fellowship in medical oncology from 1982-1985 at Harvard’s Dana Farber Cancer Institute in Boston, where he subsequently distinguished himself on the faculty in regards to breast cancer research and care. In 1992, he assumed the role as the Medical Director of the Breast Evaluation Center at DFCI. He held that title until 1996, when he moved to Georgetown University and spent the succeeding five years establishing an enormously successful collaboration with Dr. Marc E. Lippman. In 2001, both Drs. Lippman and Hayes joined the already prestigious University of Michigan Cancer Center to continue their fruitful relationship in the context of the existing translational science.

Dr. Hayes has been influential in both clinical and laboratory studies of the diagnosis and treatment of breast cancer. With his long-time colleague, Dr. Donald Kufe, Dr. Hayes published the first reports concerning the development of the CA15-3 blood test, which is currently used world-wide to evaluate patients with breast cancer. He has become an internationally recognized leader in the use of this and other tumor markers, such as HER-2. More recently, he and his colleagues have reported ground breaking results regarding circulating tumor cells in metastatic breast cancer and regarding the pharmacogenomics of tamoxifen. He is widely considered to be an expert in the field of clinical research of breast cancer, especially in regards to new hormonal and chemotherapeutic treatments. He also lectures and publishes extensively regarding the management of patients with breast cancer.

Reflecting his expertise, Dr. Hayes has been Chair of the Solid Tumor Correlative Sciences Committee of the Cancer and Leukemia Group B (CALGB), one of the leading federally-funded multi-institutional cooperative groups that perform definitive clinical research in cancer care and he now hold similar positions in the Southwest Oncology Group and the U.S. Breast Cancer Intergroup. He co-chairs the Expert Panel for Tumor Marker Practice Guidelines for the American Society of Clinical Oncology, and he is on the editorial boards of several leading cancer journals.

Dr. Hayes lives in Ann Arbor with his wife, Jane.