Chairman and Principal Investigator, National Surgical Adjuvant Breast and Bowel Project (NSABP)
Professor and Chairman of Human Oncology
Drexel University School of Medicine
The National Surgical Adjuvant Breast and Bowel Project (NSABP) is a clinical trials cooperative group chaired by Dr. Wolmark and supported through the National Cancer Institute (NCI). The NSABP has conducted over 50 years of clinical trials and enrolled over 110,000 women and men. BCRF supports two clinical trial projects conducted through the NSABP with Dr.Wolmark and BCRF colleagues, Matthew Ellis and Patricia Ganz.
In collaboration with several NCI Clinical Proteomic Tumor Analysis Consortium Centers, Drs. Wolmark and Ellis are conducting a deep proteo-genomic analysis of samples from a phase II randomized clinical trial evaluating neoadjuvant chemotherapy regimens in women with advanced HER2 negative breast cancer. Technologies that allow for unbiased discovery of the events underlying cancer are improving at a rapid pace. This field, referred to as cancer “omics” encompasses the collective characterization of the genetic, biologic and metabolic makeup of a cancer, including DNA, RNA and protein components. As the field advances, it is critically important that clinical investigation evolves to match the demands and opportunities that integrated cancer “omics” present. Neoadjuvant clinical trials in which patients receive systemic treatment before surgery for breast cancer provide a valuable tissue resource to the “omics” field, as serial samples can be obtained before and after the initiation of therapy. The long-term objective of this study, called NSABP Discovery Protocol 1 (DP-1), is to develop standard procedures for the incorporation of integrated cancer “omics” into the design of all neoadjuvant breast cancer trials conducted by the NSABP and other cooperative groups. This trial has resulted in the award of an NCI Translational Science Center grant to Dr. Ellis, which will expand the research to include five cancer disease sites.
Dr. Wolmark and his BCRF colleague, Dr. Patricia Ganz, are working together on a cost of care/quality of life data collection study that is part of a SWOG/NSABP Phase III clinical treatment trial testing the combination of endocrine therapy with everolimus, a new targeted breast cancer treatment. With funding from BCRF, Drs. Wolmark and Ganz are collecting data on quality of life measures as well as assessing the costs that are likely to occur with the everolimus treatment. This will facilitate an examination of both the extended survival benefits, quality of life impact, and value (costs) of this targeted treatment at the end of the trial. Without the real time collection of data concerning side effects that may require additional tests and medical treatments, it would not be possible to estimate the additional cost of this new treatment. The increased cost of care includes the drug itself, which is considerable, along with additional costs that can be incurred due to increased toxicities resulting in additional office visits, prescribed medications to manage toxicities, as well as increased hospitalizations.
The NSABP has a 50-year-plus history of conducting large randomized clinical trials designed to improve the treatment and prevention of breast and colorectal cancers and quality of life for cancer patients. The Group has produced practice-changing clinical research in the surgical management of breast cancer, in the use of adjuvant therapies for breast and colorectal cancer, and in the prevention of these diseases. The NSABP Study of Tamoxifen and Raloxifene (STAR) trial, which compared the effects of these two drugs in reducing the incidence of breast cancer in more than 19,000 women, was conducted with CCOP affiliates. As chair of the NSABP, Dr. Wolmark has overseen the design and implementation of the group’s breast and colorectal cancer trials since 1994. In the coming five years the group plans to continue its work in these areas, with increased focus on molecularly-driven research using the resources of its biospecimen bank and in concert with the Radiation Therapy Oncology (RTOG) and the Gynecologic Oncology Group (GOG) legacy Groups as part of the new NRG Oncology Foundation, Inc.