Table 2.
Clinical trials targeting mTOR in HER2-positive breast cancer.
| Treatment | Trial Name | Patients | ORR | Median PFS | OS (Months) |
REF | |
|---|---|---|---|---|---|---|---|
| Everolimus | EV, V, T | NCT0046556 Phase Ib/II | 33 | 44.00% | 34 weeks | n/a | [164] |
| EV, EX | NCT00426530 Phase Ib | 50 | 19.10% | 30.7 weeks | n/a | [176] | |
| EV, P, T | BOLERO-1 (NCT00876395) Phase III | 719 | 67.00% | 14.95 months | 63% survival at 41.3 | [165] | |
| 303 (Asian subset) | 69.20% | 18.40 months, 25.46 months (HR-) | n/a | [166] | |||
| EV, P, T | BOLERO-3 (NCT01007942) Phase III | 569 | 41.00% | 7 months | n/a | [167] | |
| EV, P, T | LCCC 1025 (NCT01305941) Phase II | 32 | CBR: 20% (>6 months), IRR: 4% | 3.93 months (TTP) | 12.2 | [169] | |
| Ridaforolimus | R, T | NCT00736970 Phase IIb | 34 | CBR: 34.3% | 5.4 months | 17.7 | [168] |
| Dactolisib (BEZ235) | B | NCT00620594 PhaseI/Ib | 153 | 0% | SD: 31.1–42.4% | n/a | [173] |
| B, T | 30 | 13.30% | SD: 40% | n/a | |||
CBR = clinical benefit rate, TTP = time to intercranial progression, IRR = intracranial response rate, SD = stable disease, EV = everolimus, EX = exemestane, P = pacitataxel, T = trastuzumab, V = vinorelbine, B = BEZ235, HR = hormone receptor.