Breast cancer gene expression profiling: clinical trial and practice implications

The advent of high-throughput array-based technology and the sequencing of the human genome has provided the opportunity to begin comprehensive molecular and genetic profiling of cancers. Such efforts have, in a limited time, given us new insights into breast cancer biology and confirmed that the disease is considerably more heterogeneous than can be predicted by traditional histopathological methods. The estrogen receptor has been found to be the most dominant factor influencing the molecular composition of breast cancer and, in addition, novel subgroups of breast cancer with differing clinical outcomes have been observed. These may have substantial management implications for breast cancer patients and facilitate individualized rather than empirical oncological prescription. Furthermore, new methods of prognostic classification have been developed using array technology. The challenges ahead lie in refining the use of the technology, proper validation of discoveries, and the large-scale collaborative efforts necessary for the incorporation of genomic knowledge into the design and conduct of clinical trials. This will lead, ultimately, to the application of user-friendly tools derived from this technology to everyday patient care.