Each year, over 200,000 people are diagnosed with breast cancer in the United States. Although the use of biomarkers has the potential to guide preventive interventions and improve survival and quality of life, there have been few successes and many disappointments. In November 2005, the National Breast Cancer Coalition Fund convened a conference aimed at developing a patient-centred, strategic approach to breast cancer biomarker research. The consumers, clinicians, researchers, industry representatives and US regulators who served on the consensus panel developed a set of principles and recommendations to guide the field and ensure that biomarker research results in clinically important applications.