BIG 1-98
A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer
Phase 3N = 8,010NCT00004205
- Population
- Postmenopausal women with hormone-receptor-positive early breast cancer; 8010 women with assessable data
- Design
- Randomized, double-blind trial of five years of adjuvant letrozole, letrozole followed by tamoxifen, tamoxifen, or tamoxifen followed by letrozole. This analysis compares the two letrozole-first groups with the two tamoxifen-first groups, counting events in the sequential groups up to the time of the switch.
- Arms
- Letrozole first (experimental, n = 4,003): Letrozole (alone, or followed by tamoxifen; events counted until the switch)
- Tamoxifen first (control, n = 4,007): Tamoxifen (alone, or followed by letrozole; events counted until the switch)
- People
- Breast International Group (BIG) 1-98 Collaborative Group, Breast International Group (BIG) 1-98 Collaborative Group
DFSHR 0.81 (95% CI 0.70–0.93)Δ 60-month DFS+2.6 points
Show the numbers
| Endpoint | Analysis | Letrozole first | Tamoxifen first | Effect |
|---|---|---|---|---|
| DFS | primarymedian follow-up 25.8 monthsBreast 2005 | 84% at 5 y | 81.4% at 5 y | HR 0.81 (95% CI 0.70–0.93)P=0.003First (primary) report of the trial; the abstract does not label the analysis. Median follow-up only 25.8 months; five-year figures are Kaplan-Meier estimates. 351 vs 428 events. Distant recurrence HR 0.73 (95% CI 0.60 to 0.88; P=0.001) in the same abstract. |
| Endpoint | Analysis | Letrozole first | Tamoxifen first | Effect |
|---|---|---|---|---|
| DFS | primarymedian follow-up 25.8 monthsBreast 2005 | 84% at 5 y | 81.4% at 5 y | HR 0.81 (95% CI 0.70–0.93)P=0.003First (primary) report of the trial; the abstract does not label the analysis. Median follow-up only 25.8 months; five-year figures are Kaplan-Meier estimates. 351 vs 428 events. Distant recurrence HR 0.73 (95% CI 0.60 to 0.88; P=0.001) in the same abstract. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| DFS | 0.81 | 0.7–0.93 |