Director, Medical Affairs
National Surgical Adjuvant Breast and Bowel Project
University of Pittsburgh Cancer Institute
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.
NSABP has activated Discovery Protocol 1 ("DP-1"), and the researchers report that each of the five participating NSABP Member sites, of which all are major universities and health systems, have activated the study at their institutions. To date, Washington University has enrolled one patient. Study Marketing - DP-1 was presented at two meetings of NSABP investigators in Chicago (October) and San Antonio (December). Also, in keeping with plans to build awareness of this novel study at the site level, NSABP has worked closely with each site during its local activation to identify a surgeon and a nurse coordinator, whose responsibility it is to work as a team to identify DP-1 eligible patients at the sites, explain the protocol and consent the patient. In addition, the local study activation process on the NSABP Foundation website contains educational information geared to key study personnel at participating sites. The major focus for the remainder of BCRF support Year 2 is to enroll and collect specimens from as many of the 50 patient sample size as possible. The projection for Year 2 was to accrue between 3 and 7 patients, and this remains achievable. While the research team has made substantial progress in bringing this novel Discovery Protocol to its current state, each step along the way has presented special challenges in the timing of its completion. Currently, a meeting of PIs from participating sites is scheduled for late January to address patient enrollment. Further discussion is planned at the NRG Oncology meeting in February. The plan is now to focus on patient enrollment and to reassess project progress in the spring.