Conditions: Breast Cancer
Keywords: Breast Cancer HER2+ mTOR everolimus RAD001 first line metastatic locally advanced Trastuzumab Paclitaxel First Line Therapy HER2 Positive Metastatic Breast Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 719
Healthy volunteers: no

Brief summary:
The purpose of this Phase III study was to confirm the value of adding everolimus to weekly paclitaxel and trastuzumab as treatment of HER2-overexpressing metastatic breast cancer.

Detailed description:

Arms:
arm 1: Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22 arm 2: Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22

Interventions: intervention 1: Everolimus intervention 2: Placebo intervention 3: Trastuzumab intervention 4: Paclitaxel
Intervention descriptions: intervention 1: Everolimus was administered in a continuous oral daily dosing of 10 mg (two 5-mg tablets). intervention 2: Everolimus placebo was administered in a continuous oral daily dosing of 10 mg (two 5-mg tablets). intervention 3: Trastuzumab, 2 mg/kg weekly was used intravenously. intervention 4: Paclitaxel, 80 mg/m2 weekly was used intravenously.

Protocol document: