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Daniel F. Hayes, MD

Clinical Director, Breast Oncology Program
Stuart B. Padnos Professor of Breast Cancer Research
University of Michigan
Ann Arbor, Michigan

Current Research

  • Seeking to identify and validate clinical biomarkers to inform patient care and the design of future clinical trials.

  • Ongoing efforts include the collection and analysis of clinical samples for translational and correlative studies to identify clinical biomarkers.

  • These efforts are leading to new and promising biomarkers that can inform patient care, including predicting side effects from treatment or whether a patient will or will not benefit from a particular drug.

The North American Breast Cancer Group (NABCG) and the Breast International Group (BIG) have prospectively collected and stored breast cancer tissues, blood, serum, and DNA from patients who participated in clinical trials for correlative science studies of new or promising tumor biomarkers.

Since 2006, BCRF has supplied support for ongoing correlative science activities of the NABCG and BIG, including support for approved studies, for infrastructure projects related to archived specimens, and collaborations between the two groups.

These collaborations have resulted in more than 30 papers and reports at major scientific meetings. Inventories of the archived tissues are now publically available, and these specimens have been centrally evaluated for the major breast cancer biomarkers: ER, PgR, and HER2.

Major workshops have led to initiatives within the NABCG for pharmacogenomics studies, standardization of assays for an important biomarker, Ki67, and planning of correlative studies for one of the NABCG major trials, TAILORx. The International Ki67 working group will initiate phase III trials to standardize this marker.

In the coming year, the NABCG will continue to provide support for important correlative and translational studies, as well as ongoing efforts by the various cooperative groups to build new tissue microarrays (for analysis of tumor specimens), perform routine marker analyses, and harvest nucleic acids.

These studies are validating biomarkers that may change prognosis or predict whether a patient will or will not benefit from a particular therapy, or even predict side effects. The information resulting from these efforts can inform clinical care for patients with breast cancer or the design future trials in which the respective marker is used to make the clinical investigations more efficient and clinically relevant.


Daniel Hayes, MD, is the Clinical Director of the Breast Oncology Program at the University of Michigan Comprehensive Cancer Center (UMCCC) and the Stuart B. Padnos Professor of Breast Cancer Research. He received AB (1974) and MS (1977) degrees at Indiana University, his MD from the Indiana University School of Medicine (1979), a residency in Internal Medicine at the UTHSC, Dallas, Texas (Parkland Memorial Hospital, 1979-1982), and a fellowship in Medical Oncology at Harvard’s Dana Farber Cancer Institute (DFCI, 1982–1985). From 1992–1996, he was Medical Director of the Breast Evaluation Center at DFCI. In 1996, he moved to the Georgetown University Lombardi Cancer Center, and he joined the UMCCC in 2001. Dr. Hayes has a national and international reputation in the field of experimental therapeutics targeted to breast cancer, working on serum and tissue markers such as HER-2, circulating tumor cells and pharmacogenomics which have prognostic and/or predictive value in the treatment of breast cancer.  In June 2015 he became president-elect of the American Society of Clinical Oncology.

BCRF Investigator Since


Donor Recognition

The Genentech Award
The Macy's Award

Area(s) of Focus