This research proposal U10-CA-12027, is seeking continuation of funding both for the NSABP Headquarters and for non-grant funded institutional members. It has provided support for NSABP breast and colorectal clinical trials since 1972 and 1977 respectively. The long-term goal of those studies continues to be the improvement of survival of patients with these cancers through the use of more effective treatment strategies.
Major specific aims for the next five years include: (1) complete accrual in on-going trials B-18, B- 20, B-21, B-23, B-24, R-02 and C-05; (2) continue follow-up in all trials initiated since 1971 that have completed accrual; (3) implement new studies upon completion of on-going trials; (4) maintain quality-control procedures to ensure the integrity of treatment data and validity of therapeutic results; (5) perform data analyses for monitoring accruing protocols and for determining treatment failure and survival of completed studies and; (6) to address treatment-related scientific issues that are adjunctive to the primary research objectives. The latter (number 6) includes: (a) correlating pathologic parameters with natural history and treatment outcome; (b) assessing tumor cell kinetics as discriminants of response and outcome following adjuvant therapy; (c) evaluating other biological markers of potential value for designating populations requiring therapy; and (d) conducting quality-of-life evaluations as they relate to treatment outcomes. To achieve these goals, the NSABP utilizes procedures in all studies which include: (1) eligibility check at randomization; (2) centralized review of pathology materials; (3) on-going toxicity monitoring to ensure identification and prevention of potential problems; (4) verification and editing of coded data with built-in quality assurance mechanisms; (5) employment of mechanisms that minimize delinquent data submission and ensure long-term follow-up reporting; (6) medical audits of active NSABP institutions at least once each three years; (7) reviews of institutional performance with respect to compliance with protocol and data requirements; (8) maintenance of appropriate administrative and fiscal records for institutions supported by subcontract; and (9) presentation of status of all studies at NSABP group meetings and publication of results.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Cooperative Clinical Research--Cooperative Agreements (U10)
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Cancer Clinical Investigation Review Committee (CCI)
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University of Pittsburgh
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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
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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