BIG 1-97 is a phase III randomised double blind study of letrozole versus placebo in women with primary breast cancer completing five or more years of adjuvant tamoxifen.
This study found that in postmenopausal women, letrozole after completion of standard TAM Rx significantly improves disease-free survival (New England Journal of Medicine 2003).
Coordinating group: NCIC CTG
Start date: August 1998
Closure date: September 2002
Target nr. of patients: 5184 (2380 in initial pilot phase)
Final accrual: 5187
ClinicalTrials.gov Identifier: NCT00003140