Trial of Paclitaxel/Bevacizumab +/- Everolimus for Patients With HER2-Negative Metastatic Breast Cancer

This randomized, double blind, placebo controlled trial will evaluate the impact of adding
everolimus to the combination of weekly paclitaxel plus bevacizumab in the first-line
treatment of women with HER2-negative metastatic breast cancer. Patients will be randomized
(1:1) to receive either paclitaxel/bevacizumab/everolimus (Treatment Arm 1) or paclitaxel/
bevacizumab/placebo (Treatment Arm 2). Patients will be evaluated for response to treatment
every 8 weeks; responding and/or stable patients will continue treatment, with
re-evaluations every 8 weeks, until tumor progression or intolerable toxicity occurs.
Outcomes will be assessed for each treatment arm separately. This trial is not intended to
compare treatment arms primarily. Any such analyses are exploratory and will be conducted
without adjustment for multiple hypothesis testing.