THE ROLE of clinical trials is to answer important questions related to human health. The emergence of randomized clinical trials as an alternative to guidelines established by empiricism and tradition has been important in the development of many modern treatments. The best clinical trials, by asking important therapeutic questions, may challenge conventional therapeutic paradigms. Challenges to conventional paradigms are by their very nature controversial. Perhaps because of the cultural and psychological significance of the breast and our society's attitude toward cancer, breast cancer trials in particular tend to evoke emotionally charged controversy.
Randomized clinical trials in breast cancer detection and treatment have advanced our understanding of breast cancer biology and have made major contributions toward treatments that provide equal or better survival with less deformity. The first randomized breast cancer trials began nearly 50 years ago. The lessons learned about methods of conducting the breast cancer trials have