PIK3CA and breast cancer: In combination with fulvestrant, capivasertib is approved in the US for the treatment of adult patients with HR-positive/HER2-negative, locally advanced, or metastatic BC with ≥1 PIK3CA, AKT1, and/or PTEN alterations, following disease progression on ≥1 ET-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant ET11–14.