In the extended adjuvant setting, following one year of trastuzumab therapy, endocrine therapy is standard treatment for HRc+ disease. There is no standard treatment for HRc- disease. The annual hazard of recurrence peaks in the second year after diagnosis but remains at 2%–5% in years 5–20. 25% of HER2+ early breast cancer patients suffer a recurrence or die within 10 years of initiation of adjuvant therapy. Mortality from breast cancer is 23.1/100 000 in Europe. There is an unmet need for additional therapies to further reduce the risk of recurrence and prolong survival.