Landmark adjuvant randomized clinical trials of systemic therapy in early breast cancer

Abstract

In this era of evidence-based medicine, it is generally recognized that level 1 evidence is important before a new drug or strategy can be universally accepted and consequently change the standard of care. This level of evidence requires the existence of either several well-designed randomized phase III trials or a meta-analysis of multiple well-designed controlled studies. Some of these randomized phase III trials can be considered milestones in the history of adjuvant systemic breast cancer therapy, playing a crucial role in changing clinical practice and establishing new standards of care. In this article, the authors analyze in detail some of these landmark studies of adjuvant endocrine and cytotoxic therapy, emphasizing their strengths and weaknesses.