Table 2.
Trials targeting PI3K/AKT/mTOR in breast cancer.
| Study | Target | Treatment schedule | n | Results |
|---|---|---|---|---|
| BOLERO-220 | mTOR | Everolimus plus exemestane vs. placebo plus exemestane | 485 vs. 239 | PFS: 11.0 vs. 4.1 months, HR = 0.38, P < 0.0001 |
| BOLERO-321 | mTOR | Everolimus plus trastuzumab and vinorelbine vs. placebo plus trastuzumab and vinorelbine | 284 vs. 285 | PFS: 7.00 vs. 5.78 months, HR = 0.78, P = 0.0067 |
| BELLE-322 | PI3K | Buparlisib plus fulvestrant vs. placebo plus fulvestrant | 289 vs. 143 | PFS: 3.9 vs. 1.8 months, HR = 0.67, P = 0.0003 |
| BELLE-223 | PI3K | Buparlisib plus fulvestrant vs. placebo plus fulvestrant | 576 vs. 571 | PFS: 6.9 vs. 5.0 months, HR = 0.78, P = 0.00021 |
| LOTUS24 | AKT | Ipatasertib plus paclitaxel vs. placebo plus paclitaxel | 62 vs. 62 | PFS: 6.2 vs. 4.9 months, HR = 0.60, P = 0.037 |
PI3K: phosphoinositide-3-kinase; AKT: v-akt murine thymoma viral oncogene homolog; mTOR: mechanistic target of rapamycin; PFS: progression-free survival; HR: hazard ratio; BOLERO-2: Initial Breast Cancer Trials of Oral Everolimus 2; BOLERO-3: Initial Breast Cancer Trials of Oral Everolimus 3.