TABLE I.
Endpoints used in clinical trials for adjuvant hormone treatments for early breast cancer
| Reference | Investigators or study group |
Pts
(n) |
Study description | Primary endpoints |
|---|---|---|---|---|
| Fisher et al., 19896 | NSABP B14 | 2,644 | Tamoxifen vs. placebo | OS, DFS |
| EBCTCG 19927 | EBCTCG | 29,892
(40 trials) |
Tamoxifen vs. no treatment meta-analysis | OS, DFS
(CLBC not included within DFS definition) |
| EBCTCG 19988 | EBCTCG | 36,689
(55 trials) |
Tamoxifen vs. no treatment meta-analysis | OS, DFS |
| Baum et al., 20029 | ATAC | 9,366 | Tamoxifen vs. anastrozole | DFS |
| Goss et al., 200310 | MA. 17 | 5,187 | Tamoxifen followed by letrozole (extended) | DFS |
| Coombes et al., 200411 | IES | 4,742 | Tamoxifen followed by exemestane (switch) | DFS |
| Boccardo et al., 200512 | ITA | 448 | Tamoxifen followed by anastrozole (switch) | DFS |
| EBCTCG 20051 | EBCTCG | 66,000
(71 trials) |
Tamoxifen vs. no treatment meta-analysis | OS, DFS |
| Thurlimann et al., 200513 | BIG 1–98 | 8,010 | Tamoxifen vs. letrozole | DFS |
EBCTCG = Early Breast Cancer Trialists’ Collaborative Group; OS = overall survival; DFS = disease-free survival; CLBC = contralateral breast cancer; NSABP = National Surgical Adjuvant Breast and Bowel Project; ATAC = Arimidex, Tamoxifen, Alone or in Combination; BIG = Breast International Group; IES = Intergroup Exemestane Study; ITA = Italian Tamoxifen Anastrozole trial.