The American Cancer Society estimates that annually there are 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 50 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. Since 1984, when NSABP became a CCOP Research Base, the CCOP investigators have accounted for approximately 30,000 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 have substantially enhanced the base of scientific information regarding the treatment and prevention of cancer. In 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.

Public Health Relevance

Breast and Colorectal cancer is a substantial public health problem that is the focus of the National Surgical Adjuvant Breast and Bowel Project (NSABP). The focus of the NSABP is the conduct of large-scale, clinical trials designed to improve the standard of care, quality of life and survival of persons who develop these diseases as well as the conduct of breast and colorectal cancer prevention studies. Our current and planned studies are designed to improve the prevention and treatment of these diseases.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
3U10CA069974-18S1
Application #
8681584
Study Section
Special Emphasis Panel (ZCA1-SRLB-B (J1))
Program Officer
Mooney, Margaret M
Project Start
1995-09-01
Project End
2015-05-31
Budget Start
2013-06-01
Budget End
2014-05-31
Support Year
18
Fiscal Year
2013
Total Cost
$2,902,319
Indirect Cost
$999,159
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
Regan, M M; Walley, B A; Francis, P A et al. (2017) Concurrent and sequential initiation of ovarian function suppression with chemotherapy in premenopausal women with endocrine-responsive early breast cancer: an exploratory analysis of TEXT and SOFT. Ann Oncol 28:2225-2232
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
Christian, Nicholas J; Ha, Il Do; Jeong, Jong-Hyeon (2016) Hierarchical likelihood inference on clustered competing risks data. Stat Med 35:251-67
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
Ha, Il Do; Christian, Nicholas J; Jeong, Jong-Hyeon et al. (2016) Analysis of clustered competing risks data using subdistribution hazard models with multivariate frailties. Stat Methods Med Res 25:2488-2505
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
Wolmark, Norman; Mamounas, Eleftherios P; Baehner, Frederick L et al. (2016) Prognostic Impact of the Combination of Recurrence Score and Quantitative Estrogen Receptor Expression (ESR1) on Predicting Late Distant Recurrence Risk in Estrogen Receptor-Positive Breast Cancer After 5 Years of Tamoxifen: Results From NRG Oncology/Nati J Clin Oncol 34:2350-8
Ribi, Karin; Bernhard, Jürg; Luo, Weixiu et al. (2016) Reply to F. Tomao et al. J Clin Oncol 34:4189-4190
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

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