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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.

Abstract
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 -98 enrolled 8,010 women. The enhanced design f 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.
AuthorsMeredith M Regan, Karen N Price, Anita Giobbie-Hurder, Beat Thürlimann, Richard D Gelber, International Breast Cancer Study Group and BIG 1-98 Collaborative Group
JournalBreast cancer research : BCR (Breast Cancer Res) Vol. 13 Issue 3 Pg. 209 (May 26 2011) ISSN: 1465-542X [Electronic] England
PMID21635709 (Publication Type: Comparative Study, Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't, Review)
Chemical References
  • Nitriles
  • Receptors, Estrogen
  • Receptors, Progesterone
  • Triazoles
  • Tamoxifen
  • Letrozole
  • ERBB2 protein, human
  • Receptor, ErbB-2
Topics
  • Breast Neoplasms (drug therapy)
  • Chemotherapy, Adjuvant
  • Clinical Trials, Phase III as Topic
  • Double-Blind Method
  • Female
  • Humans
  • Letrozole
  • Nitriles (administration & dosage, adverse effects, therapeutic use)
  • Randomized Controlled Trials as Topic
  • Receptor, ErbB-2 (metabolism)
  • Receptors, Estrogen (metabolism)
  • Receptors, Progesterone (metabolism)
  • Tamoxifen (administration & dosage, adverse effects, therapeutic use)
  • Triazoles (administration & dosage, adverse effects, therapeutic use)

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