Impact of randomized clinical trials on therapy of primary breast cancer: the NSABP overview.

The history of treatment for early breast cancer, particularly as it relates to the most recent calendar decade, exemplifies the contribution that can be made to resolving therapeutic controversies by well-designed prospective randomized clinical trials (RCTs). In this article we provide an overview of the breast cancer clinical trials that have been conducted by the National Surgical Adjuvant Project for Breast and Bowel Cancers (NSABP) since 1971. These trials have had a strong impact in changing the clinical management of breast cancer over the past decade. Emphasis will be given to those aspects of the studies that demonstrate the advantages and/or necessity for RCTs to evaluate alternative therapeutic approaches to the management of breast cancer.