Conditions: HER2/Neu Over-expressing Locally Advanced Breast Cancer Metastatic Breast Cancer
Keywords: Metastatic breast cancer locally advanced breast cancer HER2/neu positive breast cancer HER2/neu over-expressing progressive-free survival (PFS) over survival (OS) bolero bolero 3 Breast cancer everolimus HER+ vinorelbine herceptin trastuzumab RAD001
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 569
Healthy volunteers: no

Brief summary:
This phase III, double-blind, placebo-controlled multinational study will assess the combination everolimus, vinorelbine, and trastuzumab compared to the combination vinorelbine and trastuzumab with respect to progressive-free survival and over survival in HER2/neu positive women with locally advanced or metastatic breast cancer who are resistant to trastuzumab and have been pre-treated with a taxane.

Detailed description:

Arms:
arm 1: Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only) arm 2: Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only

Interventions: intervention 1: everolimus intervention 2: Placebo intervention 3: vinorelbine intervention 4: trastuzumab
Intervention descriptions: intervention 1: Oral everolimus was taken once 5 mg/day (2 × 2.5 mg tablets) and were packaged into blister packs. intervention 2: Oral everolimus placebo was taken once 5 mg/day (2 × 2.5 mg tablets) and were packaged into blister packs. intervention 3: intravenous vinorelbine (25 mg/m2 weekly) intervention 4: intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)

Protocol document: