Table 1.

Phase II and III trials of everolimus in patients with hormone receptor-positive, HER2-negative breast cancer

Trial	Phase	Patients (n)	Study treatment	Primary endpoint	Outcomes
BOLERO-2 Baselga et al76	III	724	Exemestane 25 mg/day + everolimus 10 mg/day versus exemestane 25 mg/day + placebo	Progression-free survival	Median PFS 10.6 months versus 4.1 months, P < 0.001
TAMRAD Bachelot et al77	II	111	Tamoxifen 20 mg/day + everolimus 10 mg/day versus tamoxifen 20 mg/day	Clinical benefit rate	CBR 61% versus 42%, P = 0.046
Neoadjuvant Baselga et al78	II	270	Everolimus 10 mg/day + letrozole 2.5 mg/day versus placebo + letrozole 2.5 mg/day	Clinical response by palpation	CR 68.1% versus 59.1%, P = 0.062

Abbreviations: CR, complete response; CBR, clinical benefit rate; BOLERO-2, Breast Cancer Trials of Oral Everolimus; TAMRAD, tamoxifen and RAD001; PFS, progression-free survival.