The approval was based on the results of the ExteNET randomized study evaluating neratinib when compared with placebo as an extended adjuvant tharapy in patients with early-stage HER2-positive breast cancer who had completed treatment with trastuzumab: patients that were treated with neratinib had significantly fewer iDFS (invasive disease-free survival) events than those did in the placebo group [105]. This evidence concerns the gene ERBB2 and breast cancer.