To determine if treatment with paclitaxel plus AMG 706 is superior to paclitaxel plus AMG 706 placebo in subjects with HER2 negative locally recurrent or metastatic breast cancer. Also to estimate differences between treatment with paclitaxel plus AMG 706 and paclitaxel plus bevacizumab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
282
Blinded placebo
Bevacizumab is a recombinant, humanized anti-VEGF monoclonal antibody.
AMG 706 is a small organic molecule that has been shown in preclinical pharmacology and PK studies to be a potent, oral, multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively targeting all known VEGF, PDGF and Kit receptors.
Objective response rate, measured radiologically and assessed by an independent review committee.
Time frame: Last patient enrolled + 16 weeks of treatment
Progression free survival, duration of response, clinical benefit rate (percentage of subjects with complete response, partial response or stable disease lasting >24 weeks), overall survival and incidence of adverse events.
Time frame: >24 weeks
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Paclitaxel is an antineoplastic agent that acts by promoting and stabilizing the polymerization of microtubules.