Table 4.
Phase II/III trials of PI3K/AKT/mTOR inhibitors in advanced breast cancer.
| Study | Phase | Population | Arms | mPFS, Months |
|---|---|---|---|---|
| SOLAR-1 | III | HR+/ HER2− |
Alpelisib + FLV vs. placebo + FLV |
PIK3CA not mut: mPFS 7.4 alpelisb vs. 5.6 placebo HR 0.85 PIK3CA mut: mPFS 11.0 alpelisib vs. 5.7 placebo, p < 0.001 |
| BELLE-2 | III | HR+/ HER2− |
Buparlisib + FLV vs. placebo + FLV | mPFS 6.9 buparlisib vs. 5.0 placebo p < 0.001 PIK3CA-mut: mPFS 7 buparlisib vs. 3.2 placebo, p < 0.001 |
| BELLE-3 | III | HR+/ HER2− |
Buparlisib + FLV vs. placebo + FLV | mPFS 3.9 buparlisib vs. 1.8 placebo, p = 0.00030 |
| BELLE-4 | II/III | HR+/ HER2− |
Txl + buparlisib vs. Txl + placebo | mPFS 9.2 Buparlisib vs. 8.0 placebo + paclitaxel, HR 1.18 |
| FERGI | II | HR+/ HER2− |
Pictilisib + FLV vs. placebo + FLV | mPFS Part 1: 6.6 Pictilisib vs. 5.1 placebo, p = 0.096 mPFS Part 2: 5.4 Pictilisib: vs. 10, p = 0.84 |
| SANDPIPER | III | HR+/ HER2− |
taselisib + FLV vs. placebo + FLV | mPFS 7.4 taselisib vs. 5.4, p = 0.0037 |
| TAMRAD | II | HR+/ HER2− |
TAM + everolimus vs. TAM alone | mPFS 8.6 everolimus vs. 4.5 placebo, p = 0.002 |
| BOLERO-2 | III | HR+/ HER2− |
EXE + everolimus vs. Exe + placebo | mPFS 6.9 everolimus vs. 2.8 placebo, p < 0.001 |
| FAKTION | II | HR+/ HER2− |
Capivasertib + FLV vs. FLV + placebo | mPFS 10.3 capivasertib vs. 4.8 placebo, p = 0.0018 |
| PEGGY | II | HR+/ HER2− |
Txl + pictilisib or Txl + placebo | mPFS 8.2 Pictilisib vs. 7.8 placebo, p = 0.83 |
| HORIZON | III | HR+/ HER2− |
LET + temsirolimus vs. LET + placebo | mPFS 8.9 temsirolimus vs. 9 placebo, p = 0.5 |
| LOTUS | II | TNBC | Txl + ipatasertib vs. Txl + placebo | mPFS 6.2 ipatasertib vs. 4.9, p = 0.037 PTEN-low: mPFS 6.2 months ipatasertib vs. 3.7, p = 0.18 |
| PAKT | II | TNBC | Txl + capivasertib vs. txl + placebo | mPFS 5.9 capivasertib vs. 4.2 placebo, p = 0.06 PIK3CA/AKT1/PTEN-altered: mPFS 9.3 capivasertib vs. 3.7 placebo, p = 0.01 |
Abbreviations: advanced breast cancer (ABC), pathological complete response (pCR), Overall response rate (ORR), Median progression free survival (mPFS), human epidermal growth factor receptor-2 positive (HER2+), hormone receptor positive (HR+), triple-negative breast cancer (TNBC), Fulvestrant (FLV), Exemestane (EXE), Tamoxifen (TAM), Taxol (Txl).