Table 2.
Phase III clinical trials of hormone treatment and anti-HER2 agents.
| STUDY | TREATMENT ARMS | N | RR (CBR) | PFS (MONTHS) | OS (MONTHS) | COMMENTATION |
|---|---|---|---|---|---|---|
| TanDEM68 | Anastrozole Anastrozole + trastuzumab |
104 103 |
6,8% 20,3% P = 0.018 (27,9% vs 42,7%; P = 0.026) |
2,4 4,8 P = 0.016 |
23,9 28,5 P = 0.325 |
23–29, 8% negative hormone receptors in central review. Cross over between arms. 15% patients without progression after 2 years. |
| EGF3000869 | Letrozole + placebo Letrozole + lapatinib |
108 111 |
15% 28% P = 0.021 (29% vs 48%; P = 0.003) |
3 8,2 P = 0.019 |
33,3 32,3 |
10–15% patients without progression after 2 years. |
| eLEcTRA70 | Letrozole Letrozole + trastuzumab |
31 26 |
13% 27% P = 0.3124 (39% vs 65%; P = 0.0636) |
3,3 14,1 P = 0.23 |
Early closure because of slow recruitment. Differences in basal characteristics between arms. |