Table 7.
Trials of mTOR inhibitors in metastatic breast cancer
| Reference | Phase | Number of patients | Treatment | Response (%) | PFS (months) |
|---|---|---|---|---|---|
| mTOR inhibitor monotherapy | |||||
| Chan et al. [78] | II (randomised) | 109 | Temsirolimus (two dose levels) | ORR 9 | NR |
| Ellard et al. [79] | II (randomised) | 49 (33: daily schedule) | Everolimus (two different schedules) | ORR 12 (daily schedule) | NR |
| ORR 0 (weekly schedule) | NR | NR | |||
| mTOR inhibitor plus chemotherapy | |||||
| Moulder et al. [81]* | I | 15 | Everolimus + docetaxel | RR 0 | NR |
| Mayer et al. [82] | Ib | 16 | Everolimus + cisplatin + paclitaxel | RR 23 | NR |
| mTOR inhibitor plus endocrine therapy | |||||
| Carpenter et al. [83] | II (randomised) | 33: daily | Temsirolimus (two schedules) + letrozole | PR 27 | Not reached |
| 30: intermittent | CR 3, PR 27 | Not reached | |||
| 29 | Letrozole | CR 7 + PR 34 | 9.2 | ||
| Chow et al. [84]* | III | 556 | Temsirolimus + letrozole | ORR 27 | 8.8 |
| 556 | Letrozole | ORR 27 | 8.9 | ||
*Study terminated due to toxicity. CR, complete response; mTOR, mammalian target of rapamycin; NR, not reported; ORR, overall response rate; PFS, progression free survival; PR, partial response; RR, response rate.