Investigation of the effectiveness and safety of treatment with neratinib

This study investigated the effectiveness and safety of neratinib treatment in patients with early-stage HER2+ breast cancer.  The study concluded that neratinib significantly improved 2-year invasive disease-free survival in women with HER2+ breast cancer.

HER2 positive (HER2+) breast cancer is dependent on the human epidermal growth factor receptor 2 (HER2) for growth. Since the approval of the drug trastuzumab (Herceptin), the survival of patients with HER2+ breast cancers has improved dramatically. Trastuzumab locks onto HER2 and inhibits its actions. Neratinib is a new oral drug that is also designed to inhibit HER2. The effectiveness and safety of neratinib in patients with early-stage HER2+ breast cancer already treated with trastuzumab is not known. 

2840 women were included in this trial. All women had stage 1-3 HER2+ breast cancer and had received trastuzumab therapy and chemotherapy. Patients were randomized to receive either neratinib or a placebo (substance with no effect on the body) for 12 months. There was a 2-year follow-up period. Invasive disease-free survival was examined. This is the length of time following treatment before the disease spreads.

The 2-year invasive disease-free survival rate was 93.9% in the neratinib group and 91.6% in the placebo group. Patients in the neratinib group were 33% less likely to experience invasive disease during the follow-up.

40% of patients in the neratinib group experienced diarrhea versus 2% in the placebo group. 3% of those in the neratinib group experienced vomiting and 2% experienced nausea. Serious adverse events were reported in 7% of patients in the neratinib group and 6% of patients in the placebo group.

The current study concluded that neratinib significantly improved 2-year invasive disease-free survival in women with HER2+ breast cancer.

A longer follow-up time is required to ensure that the improvement is maintained.