Alpelisib is a new drug registered in Russia in 2020 for patients with luminal HER2- metastatic breast cancer with a confirmed mutation in the PIK3CA gene, who have developed resistance against the background of previous endocrine therapy. The results of the SOLAR-1 and BYLieve trials demonstrated not only the effectiveness of the drug, but also new types of toxicity inherent in this therapy. To date, recommendations for the prevention and treatment of the most common adverse events, which make it possible to use the drug as safely as possible, have been developed. This article presents our own clinical experience with the use of Alpelisib with an emphasis on dermatological toxicity, as well as an overview of current recommendations devoted to this problem.

Keywords: dermatological toxicity, PIK3CA mutation, alpelisib, PI3K/Akt/mTOR signaling pathway, resistance