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.

Public Health Relevance

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.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Resource-Related Research Projects--Cooperative Agreements (U24)
Project #
5U24CA075362-17
Application #
8598458
Study Section
Subcommittee G - Education (NCI)
Program Officer
Zujewski, Jo Anne
Project Start
1997-09-30
Project End
2015-12-31
Budget Start
2014-01-01
Budget End
2014-12-31
Support Year
17
Fiscal Year
2014
Total Cost
$433,127
Indirect Cost
$88,604
Name
Dana-Farber Cancer Institute
Department
Type
DUNS #
076580745
City
Boston
State
MA
Country
United States
Zip Code
02215
Aebi, Stefan; Gelber, Shari; Anderson, Stewart J et al. (2014) Chemotherapy for isolated locoregional recurrence of breast cancer (CALOR): a randomised trial. Lancet Oncol 15:156-63
Pagani, Olivia; Regan, Meredith M; Walley, Barbara A et al. (2014) Adjuvant exemestane with ovarian suppression in premenopausal breast cancer. N Engl J Med 371:107-18
Decensi, Andrea; Sun, Zhuoxin; Guerrieri-Gonzaga, Aliana et al. (2014) Bone mineral density and circulating biomarkers in the BIG 1-98 trial comparing adjuvant letrozole, tamoxifen and their sequences. Breast Cancer Res Treat 144:321-9
Huober, J; Cole, B F; Rabaglio, M et al. (2014) Symptoms of endocrine treatment and outcome in the BIG 1-98 study. Breast Cancer Res Treat 143:159-69
Regan, Meredith M; Pagani, Olivia; Fleming, Gini F et al. (2013) Adjuvant treatment of premenopausal women with endocrine-responsive early breast cancer: design of the TEXT and SOFT trials. Breast 22:1094-100
Crivellari, Diana; Gray, Kathryn P; Dellapasqua, Silvia et al. (2013) Adjuvant pegylated liposomal doxorubicin for older women with endocrine nonresponsive breast cancer who are NOT suitable for a "standard chemotherapy regimen": the CASA randomized trial. Breast 22:130-7
Rae, James M; Regan, Meredith M; Thibert, Jacklyn N et al. (2013) Concordance between CYP2D6 genotypes obtained from tumor-derived and germline DNA. J Natl Cancer Inst 105:1332-4
Goldhirsch, A; Winer, E P; Coates, A S et al. (2013) Personalizing the treatment of women with early breast cancer: highlights of the St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2013. Ann Oncol 24:2206-23
Metzger-Filho, Otto; Sun, Zhuoxin; Viale, Giuseppe et al. (2013) Patterns of Recurrence and outcome according to breast cancer subtypes in lymph node-negative disease: results from international breast cancer study group trials VIII and IX. J Clin Oncol 31:3083-90
Giobbie-Hurder, Anita; Gelber, Richard D; Regan, Meredith M (2013) Challenges of guarantee-time bias. J Clin Oncol 31:2963-9

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