First-line therapy with lapatinib in the advanced/metastatic breast cancer setting was assessed in two phase III trials. Progression-free survival was improved by about 5 months in HER2 and hormone receptor positive women but similar data for gains in overall survival are still missing. Hence, it seems that the primary benefit of orally administered lapatinib is the potential of delaying more aggressive therapies with considerable toxicities in a well-defined hormone receptor/HER2 positive population.