Utilization of Genomic Signatures to Direct Use of Primary Chemotherapy in Early Stage Breast Cancer.

摘要

The project 'Utilization of Genomic Signatures to Direct Use of Primary Chemotherapy in Early Stage Breast Cancer' was an attempt to conduct an integral biomarker validation study of chemosensitivity signatures derived from cell lines for doxorubicin and docetaxel in the context of a standard of care preoperative breast cancer treatment trial using pathologic complete response as a primary endpoint. To execute this trial, a clinical trial support infrastructure was created to be able to obtain full genome expression data in a clinical assay laboratory on breast cancer biopsies, and then interpret that data for relevant predictors. The underlying scientific, preclinical, and clinical work justifying a prospective trial employing these signatures was found to be corrupted, and most of the publications retracted. The clinical trial was therefore terminated. Analyses of available samples using the developed clinical trial infrastructure allowed generation of biologic data from available samples, salvaging potentially useful datasets for investigating breast cancer biology and preliminary validation of signatures from other investigators.