Key exclusion criteria included prior palliative cytotoxic chemotherapy, prior treatment with mTOR (mammalian target of rapamycin)-inhibitors (prior treatment with exemestane was permitted), symptomatic visceral metastases, unstable skeletal metastases, medically uncontrolled cardiovascular diseases or diabetes mellitus, and known dihydropyrimidine dehydrogenase deficiency. The gene discussed is MTOR; the disease is cardiovascular disorder.