At a glance
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A Pilot, Phase II, Multicenter, Open-Label, Prospective Evaluation of Docetaxel and Bevacizumab ± Trastuzumab in the First-Line Treatment of Patients With Metastatic Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Bevacizumab, Docetaxel, and 1 other intervention for Breast Cancer. Completed, enrolled 73 participants across 1 site.
Detailed Summary
Pilot, phase II, parallel-group, open-label, noncomparative, prospective, multicenter study designed to evaluate the progression-free survival of docetaxel and bevacizumab ± trastuzumab for the first-line treatment of participants with metastatic breast cancer. Participants were stratified according to human epidermal growth factor receptor-2 (HER2) status at the time of enrollment. HER2 negative participants were assigned to receive docetaxel and bevacizumab (DB). HER2 positive participants were assigned to receive docetaxel, bevacizumab, and trastuzumab (DBT). All participants (except one) were off study treatment on 30 June 2011. All efficacy analysis and safety analysis was performed using the cut-off date of June 2011. One participant continued treatment till 11 March 2012. For this participant, adverse events were collected upto 19 April 2012 and included in the safety analysis.
Study Details
Timeline
Interventions
Bevacizumab (Avastin) 15 mg/kg will be administered prior to chemotherapy on * On Day 1 of the 1st cycle over 120 minutes * On Day 1 of the 2nd cycle over 90 minutes, if no reaction on the first dose * On Day 1 of 3rd cycle over 60 minutes, if no reaction on previous doses * On Day 1 of subsequent cycles over 30 minutes, if no reaction on previous doses
Docetaxel 75 mg/m\^2 IV infused over 60 minutes after completion of Bevacizumab infusion q3w
* A loading dose of 8 mg/kg Trastuzumab (Herceptin) IV will be infused over 90 minutes on Day 2 of Cycle 1. * For all subsequent cycles 6 mg/kg trastuzumab will be administered on Day 1 one hour following completion of docetaxel infusion