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Neratinib is a new small molecule aimed at HER2 receptor. It has recently been approved in the United States of America and Europe for adjuvant treatment of patients with early, HER2-positive breast cancer, who underwent surgical resection followed by at least one year of adjuvant trastuzumab treatment. Despite initial enthusiasm, several factors limit the implementation of neratinib in clinical practice. These include: modest reduction of recurrence rate; limited data regarding the effect on overall survival; and a significant rate of adverse events. Thus, neratinib should be considered mainly in patients with high-risk HER2-positive breast cancer, because its clinical benefit might outweigh the side effects in this population. In the following article, we discuss the controversies regarding the pivotal phase III trial that eventually led to neratinib approval.

Neratinib in adjuvant treatment of patients with HER2-positive breast cancer — less is more?