Samuel A. Jacobs, MD
Director, Medical Affairs
National Surgical Adjuvant Breast and Bowel Project
2013-2014 BCRF Project:
On behalf of National Surgical Adjuvant for Breast and Bowel Project
Co-Investigators: Matthew J. Ellis, MD, PhD Washington University School of Medicine, St. Louis, MO; and Norman Wolmark, MD, Drexel University School of Medicine, Philadelphia, PA
Technologies for unbiased discovery of the events underlying cancer are improving at a rapid pace. It is, therefore, critically important that scientists evolve their approaches to clinical investigation to match the demands and opportunities that the integrated studies of cancer DNA, RNA, and proteins—collectively referred to as ""cancer 'omics"" present.
The ready availability of tissue from patients receiving systemic treatment before surgery (neoadjuvant therapy) for breast cancer is of central importance to the 'omics field as serial sample acquisition can be reliably attempted before and after the initiation of therapy. Several National Cancer Institute Clinical Proteomic Tumor Analysis Consortium centers have, therefore, developed a collaboration with the National Surgical Adjuvant Breast and Bowel Project (NSABP) to determine the feasibility of conducting a deep proteogenomic analysis of samples from the phase II randomized clinical trial evaluating neoadjuvant chemotherapy regimens with weekly paclitaxel or eribulin followed by doxorubicin and cyclophosphamide in women with locally advanced HER2 negative breast cancer. The long-term objective of this study is to develop standard operating procedures that will allow integrated cancer 'omics from all neoadjuvant breast cancer protocols conducted by the NSABP, and indeed, by all cooperative groups.
NSABP has completed all pre-activation activities for Discovery Protocol 1 (""DP-1"") including developing the database needed for operation of the protocol. Currently, seven NSABP member sites, which are major universities and health systems, are taking the protocol through their local activation processes. Study activation has taken longer than originally anticipated but NSABP and Washington University are focusing on the development of a two-pronged marketing plan to heighten awareness for this novel discovery protocol. In its second year of support, BCRF funds will allow patient accrual and collection of specimens to proceed.