569
Participants
Start Date
October 31, 2009
Primary Completion Date
June 30, 2015
Study Completion Date
June 30, 2015
everolimus
Oral everolimus was taken once 5 mg/day (2 × 2.5 mg tablets) and were packaged into blister packs.
Placebo
Oral everolimus placebo was taken once 5 mg/day (2 × 2.5 mg tablets) and were packaged into blister packs.
vinorelbine
intravenous vinorelbine (25 mg/m2 weekly)
trastuzumab
intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
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Novartis Pharmaceuticals
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