Table 1.

Phase 2 and 3 clinical trials with everolimus and temsirolimus in HR-positive breast cancer

Study	Study design	Patients	Treatment	Response rate	PFS
Everolimus
Baselga et al. [45]	phase 2 randomized	postmenopausal, neoadjuvant (n = 272)	letrozole + everolimus vs. letrozole + placebo	68% vs. 59%	not evaluated
TAMRAD, Bachelot et al. [46]	phase 2 randomized	metastatic breast cancer (n = 111)	tamoxifen + everolimus vs. tamoxifen	61% vs. 42% (p = 0.045)	8.6 months vs. 4.5 months (p = 0.002)
BOLERO-II, Baselga et al. [48]	phase 3 randomized	postmenopausal advanced breast cancer, failure of non-steroidal aromatase inhibitors (n = 724)	exemestane + everolimus vs. exemestane + placebo	9.5% vs. 0.4% (p < 0.0001)	6.9 months vs. 2.8 months (p < 0.001)
Temsirolimus
Carpenter et al. [51]	phase 2 randomized	advanced breast cancer (n = 92)	letrozole + temsirolimus (10 mg/day) vs. letrozole + temsirolimus (30 mg/day for 5 days q2w) vs. letrozole	n = 9, 9, and 12, respectively	PFS at 1 year: 69% vs. 62% vs. 48%
HORIZON, Wolff et al. [52]	phase 3 randomized	postmenopausal advanced breast cancer (n = 1,112)	letrozole + temsirolimus (30 mg/day for 5 days q2w) vs. letrozole	27% vs. 27%	8.8 vs. 8.9 months