This phase III trial studied neratinib in patients with early-stage HER2-positive breast cancer; while initially all patients with stages 1–3 were eligible, a protocol amendment 7 months into the study restricted eligibility to higher-risk patients with stage 2–3, and patients who completed neoadjuvant chemotherapy were only eligible if there was pathological residual invasive disease at the time of surgery. Here, ERBB2 is linked to breast carcinoma.