The American Cancer Society estimated that in 2004, breast or colorectal cancer would strike over 350,000 Americans and close to 100,000 people would die from these diseases. The National Surgical Adjuvant Breast and Bowel Project(NSABP) is a multi-center clinical cooperative trials group with nearly 200 member institutions located throughout the US, Canada and Puerto Rico. The primary research objective of the NSABP is to conduct therapeutic research designed to improve the survival and the quality of life for persons with breast or colorectal cancer. This goal is achieved through the conduct of definitive phase III trials and the developmental efforts that lead to them. In calendar years 2002 and 2003, the NSABP entered 10,270 breast cancer patients and 962 colorectal cancer patients into adjuvant therapy trials. According to NCI data, this represents 64% of the breast cancer patients and 78% of the colorectal cancer patients entering NCI sponsored phase III cooperative group adjuvant breast or colorectal adjuvant trials. The NSABP integrates key behavior and health outcomes into its phase III trials to provide added value to the traditional endpoints of disease-free and overall survival. The NSABP also conducts correlative laboratory research in conjunction with its clinical trials designed to improve methods of assessing prognosis and predicting response to treatment with the aim of optimizing therapy for individual patients. In the proposed project period our aim will be to continue to improve breast and colorectal cancer therapies through the development and conduct of well-designed Phase III adjuvant therapy trials which will be carried out at our extensive network of affiliated members throughout North America.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
3U10CA012027-39S1
Application #
7931029
Study Section
Subcommittee G - Education (NCI)
Program Officer
Mooney, Margaret M
Project Start
2009-09-30
Project End
2011-09-29
Budget Start
2009-09-30
Budget End
2011-09-29
Support Year
39
Fiscal Year
2009
Total Cost
$69,847
Indirect Cost
Name
Nsabp Foundation, Inc.
Department
Type
DUNS #
107186988
City
Pittsburgh
State
PA
Country
United States
Zip Code
15212
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
Cheung, Winson Y; Renfro, Lindsay A; Kerr, David et al. (2016) Determinants of Early Mortality Among 37,568 Patients With Colon Cancer Who Participated in 25 Clinical Trials From the Adjuvant Colon Cancer Endpoints Database. J Clin Oncol 34:1182-9
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
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
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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