According to the results of a phase II, randomized study published in the New England Journal of Medicine, neratinib may effectively treat women with HER2-positive, hormone receptor-negative breast cancer. 

Researchers enrolled 211 women with clinical stage II or III breast cancer. Of them, 127 were randomly assigned to receive neratinib and 84 were randomly assigned to standard chemotherapy. The neratinib group had almost twice as many patients with HER2-positive cancer (57% versus 28%). 

Fifty-six percent of patients in the neratinib group had complete responses, compared to 33% in the control group, which met the study’s prespecified efficacy threshold. The most common adverse event was diarrhea, and all adverse events were similar to those in other studies of advanced breast cancer

The researchers concluded that neratinib is likely to be successful in phase III testing, particularly in patients with HER2-positive, hormone receptor-negative breast cancer.