This proposal seeks a renewal of funding for ttie United States-based International Breast Cancer Study Group (IBCSG) Statistical and Data Management Center, a resource that contributes to International-US collaboration in the following areas: ?Access to the IBCSG clinical database of over 29,300 breast cancer patients enrolled in large-scale, randomized clinical trials with up to 30 years'maximum follow-up. ?Access to the IBCSG translational database of tumor-specific markers, host factors, gene arrays, and pathways;and the bio-specimen bank for over 12,000 patients. ?Expertise of statistical and medical investigators and collaboration in the IBCSG research agenda. This proposal will continue the successful enrollment of U.S. patients to IBCSG trials (especially of endocrine therapy for young women), as well as enrollment of IBCSG patients to U.S.-led trials. Such global collaboration is essential to accrue the number of patients needed to evaluate treatments tailored for breast cancer subpopulations and tumor subtypes. The IBCSG is uniquely positioned to conduct translational research in large randomized clinical trials with extensive clinical databases and an established and expanding bio-specimen bank. The primary goal of the IBCSG is to determine the best possible treatments for individual patients with breast cancer.
The specific aims of this application comprise the major areas of research toward this goal. ?To provide US-based statistical and data management collaboration for the design, conduct, analysis, and reporting of IBCSG randomized clinical trials evaluating adjuvant therapies. ?To facilitate translational research by providing access to our bio-specimen bank, to our translational database from collected specimens, and to collaborate in the analysis of translational projects. ?To facilitate collaboration on database studies to identify and confirm the relationship between characteristics of breast cancer patients and response to adjuvant therapies.
This resource gives NCI a cost-effective opportunity to significantly improve the understanding of treatment and prognosis of women with operable breast cancer. Many women are successfully treated with current therapies, but many still relapse and die of their disease. The tailored therapy trials and translational research plans in this proposal will facilitate progress to identify the best treatments for the individual patient.
|Francis, Prudence A; Pagani, Olivia; Fleming, Gini F et al. (2018) Tailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer. N Engl J Med 379:122-137|
|Wapnir, Irene L; Price, Karen N; Anderson, Stewart J et al. (2018) Efficacy of Chemotherapy for ER-Negative and ER-Positive Isolated Locoregional Recurrence of Breast Cancer: Final Analysis of the CALOR Trial. J Clin Oncol 36:1073-1079|
|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|
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|Karlsson, Per; Cole, Bernard F; Price, Karen N et al. (2016) Timing of Radiation Therapy and Chemotherapy After Breast-Conserving Surgery for Node-Positive Breast Cancer: Long-Term Results From International Breast Cancer Study Group Trials VI and VII. Int J Radiat Oncol Biol Phys 96:273-279|
|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|
|Chirgwin, Jacquie H; Giobbie-Hurder, Anita; Coates, Alan S et al. (2016) Treatment Adherence and Its Impact on Disease-Free Survival in the Breast International Group 1-98 Trial of Tamoxifen and Letrozole, Alone and in Sequence. J Clin Oncol 34:2452-9|
|Pruneri, Giancarlo; Gray, Kathryn P; Vingiani, Andrea et al. (2016) Tumor-infiltrating lymphocytes (TILs) are a powerful prognostic marker in patients with triple-negative breast cancer enrolled in the IBCSG phase III randomized clinical trial 22-00. Breast Cancer Res Treat 158:323-31|
|Colleoni, Marco; Sun, Zhuoxin; Price, Karen N et al. (2016) Annual Hazard Rates of Recurrence for Breast Cancer During 24 Years of Follow-Up: Results From the International Breast Cancer Study Group Trials I to V. J Clin Oncol 34:927-35|
|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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