Capivasertib (TRUQAP®), developed by AstraZeneca, is FDA-approved in combination with fulvestrant for adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer harboring PIK3CA, AKT1, or PTEN alterations.
Diarrhea, rash, and hyperglycemia are the most frequent clinically significant adverse events. Proactive assessment before treatment initiation-and structured monitoring during therapy-is critical to maintain dose intensity and adherence.
Fasting glucose and HbA1c must be tracked regularly. Diabetic ketoacidosis and fatal outcomes have occurred. Capivasertib is contraindicated in patients with severe hypersensitivity to the drug.
Among 355 patients in the CAPItello-291 trial, diarrhea occurred in 72%, cutaneous reactions in 58%, and elevated glucose in 57%.
Treatment interruption or discontinuation depends on severity and reversibility of events. Escalation protocols guide when to withhold, resume, or stop therapy permanently.