At a glance
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A Phase II Study Evaluating The Efficacy And Tolerability Of Everolimus (RAD001) In Combination With Trastuzumab And Vinorelbine In The Treatment Of Progressive HER2-Positive Breast Cancer Brain Metastases
In Brief
A Phase 2 clinical trial evaluating Everolimus, Vinorelbine, and 1 other intervention for HER-2 Positive Breast Cancer. Completed, enrolled 32 participants across 4 sites.
Detailed Summary
Purpose: This study is a single-arm, open-label phase II clinical trial testing the hypothesis that daily everolimus plus weekly vinorelbine and trastuzumab will be effective, safe, and tolerable among patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer brain metastases. Once enrolled, patients will receive everolimus PO daily in combination with weekly intravenous (IV) vinorelbine and trastuzumab. Cycles will be repeated every 3 weeks (21 days). At the time of progression, patients will come off study. Participants: Up to 35 adults over 21 with HER-2 positive breast cancer that has metastasized to the brain.
Study Details
Timeline
Interventions
everolimus 5 mg PO daily as two 2.5-mg tablets
vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.
2 mg/kg IV administered over 30 minutes weekly