Data from CAPItello-291 have led to the regulatory approval of capivasertib–fulvestrant in patients with HR-positive/HER2-negative advanced breast cancer and one or more tumor biomarker alterations (PIK3CA, AKT1 or PTEN) in several countries, including in Japan and the US [19, 20]. The gene discussed is ERBB2; the disease is breast carcinoma.