| Sumario: | Simple Summary: Capivasertib is a selective AKT kinase inhibitor recently approved for the treatment of estrogen receptor-positive/HER2-negative advanced BC with alterations of the PIK3CA/AKT1/PTEN pathway, in combination with fulvestrant after progression on endocrine therapy. In this review we summarize preclinical evidence, pharmacology, clinically relevant problems, practical management and future options related to capivasertib. Most patients with advanced/metastatic hormone receptor-positive, HER2-negative breast cancer receive first-line therapy with cycline-dependent kinase 4/6 inhibitors plus endocrine therapy. Almost universally, these patients eventually progress due to the emergence of resistant cancer clones. Targeting the PIK3CA/AKT1/PTEN pathway is a way of overcoming resistance. Recently, the oral, selective AKT kinase inhibitor capivasertib has been approved for the treatment of estrogen receptor-positive/human HER2-growth factor receptor-2 advanced BC with alterations in PIK3CA/AKT1/PTEN, in combination with fulvestrant after progression on endocrine therapy. We performed a narrative review to recapitulate the available evidence about capivasertib in the management of advanced hormone receptor-positive, HER2-negative breast cancer, focusing on studies that address preclinical rationale, pharmacology, and clinically relevant problems.
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