Interpreting Breast International Group (BIG) 1-98: a randomized, double-blind, phase III trial comparing letrozole and tamoxifen as adjuvant endocrine therapy for postmenopausal women with hormone receptor-positive, early breast cancer

被引:54
作者
Regan, Meredith M. [1 ,2 ,3 ]
Price, Karen N. [1 ,4 ]
Giobbie-Hurder, Anita [1 ]
Thuerlimann, Beat [5 ,6 ]
Gelber, Richard D. [1 ,2 ,3 ,4 ]
机构
[1] Dana Farber Canc Inst, Dept Biostat & Computat Biol, IBCSG, Ctr Stat, Boston, MA 02215 USA
[2] Harvard Univ, Sch Publ Hlth, Boston, MA 02115 USA
[3] Harvard Univ, Sch Med, Boston, MA 02115 USA
[4] Frontier Sci & Technol Res Fdn Inc, Boston, MA 02215 USA
[5] Kantonsspital, Breast Ctr, CH-9007 St Gallen, Switzerland
[6] Swiss Grp Clin Canc Res SAKK, CH-3008 Bern, Switzerland
关键词
PREDICTIVE-VALUE; ANASTROZOLE; SURVIVAL;
D O I
10.1186/bcr2837
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
The Breast International Group (BIG) 1-98 study is a four-arm trial comparing 5 years of monotherapy with tamoxifen or with letrozole or with sequences of 2 years of one followed by 3 years of the other for postmenopausal women with endocrine-responsive early invasive breast cancer. From 1998 to 2003, BIG 1-98 enrolled 8,010 women. The enhanced design of the trial enabled two complementary analyses of efficacy and safety. Collection of tumor specimens further enabled treatment comparisons based on tumor biology. Reports of BIG 1-98 should be interpreted in relation to each individual patient as she weighs the costs and benefits of available treatments. ClinicalTrials.gov ID: NCT00004205.
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页数:16
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