Neratinib for the Treatment of Early-Stage HER2-Positive Breast Cancer

The treatment of breast cancer has been revolutionized by the development of HER2-targeted treatments for patients who are HER2 positive. The HER2 protein is present at high levels in about 30% of breast cancer patients. These high levels are associated with a greater chance of metastasis, relapse, and decreased survival. The current standard of care for early-stage HER2-positive patients includes treatment with 1 year of trastuzumab therapy. Although trastuzumab has improved outcomes, there is still a 20% chance for tumor recurrence and a 16% chance of death. Neratinib was developed to give patients with early-stage HER2-positive breast cancer an option to increase the disease-free survival rate. The 5-year invasive disease-free survival rate was 90.2% (95% confidence interval = 88.3–91.8) in the neratinib group and 87.7% (95% confidence interval = 85.7–89.4) in the placebo group.