The American Cancer Society estimates that in 2005 there were more than 350,000 new cases of breast or colorectal cancers and almost 100,000 deaths related to these cancers, This is a substantial public health problem that remains the focus the National Surgical Adjuvant Breast and Bowel Project (NSABP). For more than 40 years, the NSABP has successfully conducted large-scale, randomized clinical trials in breast and colorectal cancer designed to improve the standard of care, quality of life and survival of persons who develop these diseases. In 1992, the NSABP began a breast cancer prevention program. In 2002-2003, the NSABP accounted for 64% of the breast cancer patients and 78% of the colorectal cancer patients who entered the NCI Phase III trials that were available for these patients. More than one-third of these patients were enrolled by CCOP investigators. Since 1984, when NSABP became a CCOP Research Base, the CCOP investigators have accounted for more than 21,600 treatment trial patients and more than 33,100 participants have been enrolled in the BCPT and STAR breast cancer prevention trials. The timeliness and quality of data obtained through these programs have been exceptional and have contributed positively to overall NSABP data integrity and substantially enhanced the base of scientific information regarding the treatment and prevention of cancer.ln the proposed project period, funding will be used to sustain our efforts as a data and statistical center in support of the NSABP CCOP treatment, cancer control and prevention scientific agenda. In that capacity, we will continue to enhance the utilization of newer technologies for data collection, data management and the communication and training of clinical site collaborators with the goal of developing more efficient methodologies to design, conduct and analyze clinical trials. This research proposal requests funding to enable the continued functioning of the CCOP, MB-CCOP and Prevention components of the NSABP Biostatistical Center which provide: 1) data management support for the collection and processing of data from NSABP trials;2) quality assurance programs which ensure that the collected data is of the highest integrity;3) scientific collaboration in the development of the NSABP research agenda and logistical support for the conduct of the research;and 4) statistical leadership and support for the design, monitoring and analysis of trials and correlative studies.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10CA069974-16
Application #
8117136
Study Section
Special Emphasis Panel (ZCA1-SRRB-3 (J1))
Program Officer
Mccaskill-Stevens, Worta J
Project Start
1995-09-01
Project End
2012-05-31
Budget Start
2011-06-01
Budget End
2012-05-31
Support Year
16
Fiscal Year
2011
Total Cost
$4,131,155
Indirect Cost
Name
University of Pittsburgh
Department
Biostatistics & Other Math Sci
Type
Schools of Public Health
DUNS #
004514360
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
Saha, Poornima; Regan, Meredith M; Pagani, Olivia et al. (2017) Treatment Efficacy, Adherence, and Quality of Life Among Women Younger Than 35 Years in the International Breast Cancer Study Group TEXT and SOFT Adjuvant Endocrine Therapy Trials. J Clin Oncol 35:3113-3122
Ternès, Nils; Rotolo, Federico; Michiels, Stefan (2017) Robust estimation of the expected survival probabilities from high-dimensional Cox models with biomarker-by-treatment interactions in randomized clinical trials. BMC Med Res Methodol 17:83
Ribi, Karin; Luo, Weixiu; Bernhard, Jürg et al. (2016) Adjuvant Tamoxifen Plus Ovarian Function Suppression Versus Tamoxifen Alone in Premenopausal Women With Early Breast Cancer: Patient-Reported Outcomes in the Suppression of Ovarian Function Trial. J Clin Oncol 34:1601-10
Phillips, Kelly-Anne; Regan, Meredith M; Ribi, Karin et al. (2016) Adjuvant ovarian function suppression and cognitive function in women with breast cancer. Br J Cancer 114:956-64
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Ribi, Karin; Bernhard, Jürg; Luo, Weixiu et al. (2016) Reply to F. Tomao et al. J Clin Oncol 34:4189-4190
Land, Stephanie R; Walcott, Farzana L; Liu, Qing et al. (2016) Symptoms and QOL as Predictors of Chemoprevention Adherence in NRG Oncology/NSABP Trial P-1. J Natl Cancer Inst 108:
Christian, Nicholas J; Ha, Il Do; Jeong, Jong-Hyeon (2016) Hierarchical likelihood inference on clustered competing risks data. Stat Med 35:251-67
Regan, Meredith M; Francis, Prudence A; Pagani, Olivia et al. (2016) Absolute Benefit of Adjuvant Endocrine Therapies for Premenopausal Women With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer: TEXT and SOFT Trials. J Clin Oncol 34:2221-31
Johansson, Harriet; Gray, Kathryn P; Pagani, Olivia et al. (2016) Impact of CYP19A1 and ESR1 variants on early-onset side effects during combined endocrine therapy in the TEXT trial. Breast Cancer Res 18:110

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