At a glance
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A Single Arm Open-label, Phase II Study of Bevacizumab in Combination With Trastuzumab and Capecitabine as First-line Treatment of Patients With HER2-positive Locally Recurrent or Metastatic Breast Cancer
In Brief
A Phase 2 clinical trial evaluating bevacizumab [Avastin], capecitabine [Xeloda], and 1 other intervention for Breast Cancer. Completed, enrolled 88 participants across 35 sites in 6 countries.
Detailed Summary
This single arm study will assess the efficacy and safety of Avastin in combination with Herceptin and Xeloda as first-line treatment of patients with HER2-positive locally recurrent or metastatic breast cancer. Patients will receive 3-weekly treatment cycles of Herceptin (8mg/kg iv on day 1 of first cycle, followed by 6mg/kg iv maintenance dose on day 1 of subsequent cycles), Xeloda (1000mg/m2 bid po on days 1-14 of each treatment cycle) and Avastin (15mg/kg on day 2 of first treatment cycle,and on day 1 of each subsequent cycle).The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.
Study Details
Timeline
Interventions
15mg/kg iv on day 2 of first 3-week cycle,and on day 1 of subsequent cycles
1000mg/m2 bid po on days 1-14 of each 3-week cycle
8mg/kg iv loading dose on day 1 of first 3-week cycle, followed by 6mg/kg iv maintenance dose on day 1 of subsequent cycles