This case study outlines a Phase III trial comparing drug treatments in patients with advanced breast cancer that were previously treated with or resistant to an anthracycline and are taxane resistant.

A mid-size, top five European pharmaceutical company was conducting a global Phase III study in 770 patients with advanced breast cancer.

The study was to be conducted in more than 20 countries, and the sponsor proactively included emerging markets in the global study plans to avoid the need for a rescue phase later.