The National Surgical Adjuvant Breast and Bowel Project (NSABP) is an NCI-funded clinical trials cooperative group for cancer treatment and prevention and control research. The group has a more than 40-year history of conducting large-scale controlled treatment trials that have improved the outcome for patients with breast or colorectal cancer and have provided a better understanding of tumor biology. In 1992, the NSABP extended its research agenda to include cancer prevention trials. The NSABP has been a CCOP Research Base since the inception of the CCOP Program and 45 CCOPs and 8 MBCCOPs currently list the NSABP among their research bases. CCOP participation in NSABP treatment and prevention trials is substantial;approximately 30% of NSABP accrual is attributable to CCOP investigators. This application requests continued funding for the NSABP to continue as a CCOP Research Base for the period of June 1, 2012, through May 31, 2017. During the proposed grant period, the NSABP will 1) continue to design and implement multi-institutional cancer treatment and prevention and control clinical trials;2) analyze, report, and publish the results of current NSABP studies;3) implement recruitment mechanisms and procedures to achieve adequate accrual and foster the participation of women and minorities in NSABP clinical trials;4) maintain data collection, data monitoring, and quality control procedures that are in compliance with federal guidelines;5) monitor CCOP performance through ongoing quality assurance programs;and, 6) continue the integration of CCOP investigators into the overall functioning of the NSABP.

Public Health Relevance

Breast and bowel represents a major public health issue with a combined incidence of 361,530 cases in the United States in 2010 and more than 96,140 deaths attributed to the cancers. The NSABP has a 50+ year history of conducting high quality cancer, treatment, prevention, and control clinical trials that have substantially improved the survival and the quality of life of individuals with these diseases. This application will allow th NSABP to continue this important research that has the potential to impact the care of women and men in the United States and around the world.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Cooperative Clinical Research--Cooperative Agreements (U10)
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Special Emphasis Panel (ZCA1-SRLB-B (J1))
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Mccaskill-Stevens, Worta J
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Nsabp Foundation, Inc.
United States
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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
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
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
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:
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
Dalerba, Piero; Sahoo, Debashis; Paik, Soonmyung et al. (2016) CDX2 as a Prognostic Biomarker in Stage II and Stage III Colon Cancer. N Engl J Med 374:211-22
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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