Table 4.
Seminal trials of PI3Ki and mTORi + endocrine therapy in advanced breast cancer.
| First-/Second-Line | Second-Line | First-/Second-Line | Second-Line | |
|---|---|---|---|---|
| Trial | TamRad | Bolero | Solar 1 | Sandpiper |
| Drug | Everolimus | Everolimus | Alpelisib | Taselisib |
| Population (pre- or post-menopausal) | Post-M | Post-M | Post-M | Post-M |
| Endocrine therapy | Tam | NSAI | Ful | Ful |
| Phase | III | III | III | III |
| N | 111 | 724 | 572 | 516 |
| Randomisation | 1:1 | 2:1 | 1:1 | 2:1 |
| PFS/TTP (mth) | 8.6 vs. 4.5 | 10.6 vs. 4.1 | 11.0 vs. 5.7 | 7.4 vs. 5.4 |
| HR | 0.54; p = 0.002 | 0.36; p < 0.001 | 0.65; p < 0.001 | 0.70; p = 0.004 |
| OS (mth) | Not reached vs. 32.9 | 31 vs. 26.6 | NR | NR |
| HR | 0.45; p = 0.007 | 0.89; p = 0.14 | - | - |
| Reference | [23] | [21,22] | [20] | [151] |
AI: aromatase inhibitor; NSAI: non-steroidal aromatase inhibitor; Tam: tamoxifen; Ful: fulvestrant; NR: not reported; PFS: progression-free survival; TTP: time to progression; HR: hazard ratio; OS: overall survival; mth: months.