(Applicant's narrative) This application requests funding to enable the Operations center of the National Surgical Adjuvant Breast and Bowel Project (NSABP), in conjunction with the NSABP Biostatistical Center, to continue as a CCOP research base. The NSABP has been a research base since the inception of the CCOP program in 1983. Since that time, the CCOP members have been successfully incorporated into the overall functioning of the NSABP, including the development, design, conduct, and publication of protocols and concomitant scientific and biological studies. Over the past five years, the proportion of NSABP patients entered into treatment trials by CCOP institutions has ranged from 21% to 32%. A comparison of the CCOP institutions to other NSABP centers demonstrates that data quality and overall performance of the CCOPs is as good, or better than, other NSABP centers. During the proposed period, the NSABP will: 1) complete accrual and continue follow-up on participants in the Breast Cancer Prevention Trial (BCPT) and its ancillary studies, 2) provide clinical treatment protocols focusing on the adjuvant treatment of breast and bowel cancer, 3) institute new cancer control research protocols, 4) implement recruitment mechanisms and procedures to achieve adequate accrual and foster the participation of women and minorities in NSABP clinical trials, 5) monitor CCOP performance through ongoing quality assurance programs managed by the Biostatistical Center, 6) promote improved institutional performance, 7) establish quality control procedures that are in compliance with federal guidelines, and 8) continue the integration of CCOP investigators into the overall functioning of the NSABP.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
3U10CA037377-14S3
Application #
2875879
Study Section
Special Emphasis Panel (SRC (15))
Program Officer
Dunn, Barbara K
Project Start
1983-09-15
Project End
2001-05-31
Budget Start
1998-06-01
Budget End
1999-05-31
Support Year
14
Fiscal Year
1998
Total Cost
Indirect Cost
Name
Allegheny-Singer Research Institute
Department
Type
DUNS #
033098401
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
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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