[Rich66]

Discussion: High clinical responses were observed in patients with Her2+ breast cancer, including the first-line subset and patient subsets with prior Her2-directed, endocrine, and taxane therapies. The combination of neratinib 240 mg and paclitaxel 80 mg/m² was tolerable, with a toxicity profile similar to each drug given as monotherapy. A phase 3 trial is ongoing to study this combination in the first-line setting compared with trastuzumab plus paclitaxel.