Clinical evidence of the efficacy of everolimus and its potential in the treatment of breast cancer

Figures & data

Table 1 Ongoing studies with everolimus

Study	Phase	Treatment
BOLERO-1 : everolimus in combination with trastuzumab and paclitaxel, as first line therapy in women with HER2+ locally advanced or metastatic breast cancer	III	Experimental arm: everolimus 10 mg daily + paclitaxel 80 mg/m^2 weekly on days 1,8, and 15 + trastuzumab 2 mg/kg weekly on days 1, 8, 15, and 22 Control arm: placebo + paclitaxel 80 mg/m^2 weekly on days 1, 8, and 15 + trastuzumab 2 mg/kg weekly on days 1, 8, 15, and 22
BOLERO-3: daily everolimus in combination with trastuzumab and vinorelbine, in pretreated women with HER2+ locally advanced or metastatic breast cancer	III	Experimental arm: everolimus + vinorelbine + trastuzumab Control arm: placebo + vinorelbine + trastuzumab
Randomized, placebo-controlled clinical trial evaluating the use of adjuvant endocrine therapy ± 1 year of everolimus in patients with high-risk, hormone receptor–positive and HER2/neu negative breast cancer	III	Experimental arm: adjuvant endocrine therapy × 2–5 years + everolimus daily × 1 year Control arm: adjuvant endocrine therapy × 2–5 years + placebo × 1 year
GeparQuinto – integration of bevacizumab, everolimus, and lapatinib into current neoadjuvant chemotherapy regimens for primary breast cancer	III	Arm 1: epirubicin − cyclophosphamide/docetaxel Arm 2: epirubicin − cyclophosphamide/docetaxel + bevacizumab Arm 3: paclitaxel Arm 4: paclitaxel + everolimus Arm 5: epirubicin − cyclophosphamide/docetaxel + trastuzumab Arm 6: epirubicin − cyclophosphamide/docetaxel + lapatinib
Lapatinib in combination with everolimus in triple negative metastatic or locally advanced breast cancer	II	Lapatinib 1250 mg daily + everolimus 5 mg daily
Randomized study to compare vinorelbine in combination with everolimus vs vinorelbine monotherapy for second-line treatment in advanced breast cancer (VicTORia)	II	Experimental arm: vinorelbine 25 mg/m^2 days 1, 8, and 15 + everolimus 5 mg daily Control arm: vinorelbine 25 mg/m^2 days 1, 8, and 15
Trastuzumab or everolimus in hormone-refractory metastatic breast cancer	II	Arm A: trastuzumab every 3 weeks + endocrine therapy (everolimus added at progression) Arm B: everolimus 10 mg daily + endocrine therapy (trastuzumab added at progression)
Combined fulvestrant (Faslodex) and RAD001 in advanced/metastatic breast cancer after aromatase inhibitor failure	II	Everolimus 10 mg daily + fulvestrant 500 mg day 1, then 250 mg days 14 and 28, then 250 mg every 4 weeks
Value of adding RAD001 to trastuzumab as preoperative therapy of HER2+ primary breast cancer amenable to surgery	II	Experimental arm: weekly trastuzumab + everolimus daily × 6 weeks Control arm: weekly trastuzumab × 6 weeks
Weekly abraxane and RAD001 in women with locally advanced or metastatic breast cancer	I/II	Everolimus daily + paclitaxel albumin-stabilized nanoparticle formulation days 1, 8, and 15
Neo-adjuvant study of cisplatin, paclitaxel with or without RAD001 in patients with triple-negative locally advanced breast cancer	II	Experimental arm: cisplatin 25 mg/m^2 weekly + everolimus 5 mg daily × 1 week followed by cisplatin 25 mg/m^2 + paclitaxel 80 mg/m^2 weekly + everolimus 5 mg daily × 11 weeks Control arm: cisplatin 25 mg/m^2 IV weekly + placebo daily × 1 week followed by cisplatin 25 mg/m^2 + paclitaxel 80 mg/m^2 IV weekly + placebo daily × 11 weeks
The efficacy and tolerability of everolimus in combination with trastuzumab and vinorelbine in the treatment of progressive HER2+ breast cancer brain metastases	II	Everolimus 5 mg daily + plus vinorelbine 25 mg/m^2 days 1, 8, and 15 + weekly trastuzumab
Lapatinib and RAD001 for HER2+ metastatic breast cancer	II	Lapatinib 1250 mg daily + everolimus 5 mg daily
GCC 0901 – letrozole in combination with lapatinib followed by an addition of everolimus in postmenopausal women with advanced endocrine resistant breast cancer	II	Letrozole 2.5 mg daily + lapatinib 1500 mg daily Everolimus 5 mg daily added upon progression (with reduction of lapatinib to 1250 mg daily)
Everolimus in invasive breast cancer patients after preoperative use of anthracycline and/or taxane-based chemotherapy	II	Experimental arm: everolimus 10 mg daily × 3 weeks 1 week after completion of neoadjuvant treatment and before surgery Control arm: no intervention

Abbreviations: HER2, human epidermal growth factor receptor-2; IV, intravenously.