AVADO was a
randomized, double-blind, placebo-controlled phase III study.
locally recurrent or metastatic breast cancer were randomized to one of three
treatment arms; patients were stratified by: region, presence or absence of
measurable disease, hormone receptor status, disease-free interval and prior
randomized to receive docetaxel 100mg/m2 every 3 weeks, for a
maximum of nine cycles, with either placebo or bevacizumab. Dose reduction of
docetaxel to 75mg/m2 and/or 60mg/m2 was permitted in
the event of toxicity.
given at either 7.5 or 15mg/kg every
3 weeks. Patients continued to receive placebo or bevacizumab until disease
All patients were
given the option to receive bevacizumab in combination with their second-line
The primary endpoint
of the trial was progression-free survival. Secondary endpoints were overall
response rate, duration of response, time to treatment failure, overall
survival, safety and quality of life.