Site Editor

William J. Gradishar, MD, FACP, FASCO


Adding Capivasertib to Fulvestrant for Advanced Hormone Receptor–Positive Breast Cancer

By: Julia Fiederlein Cipriano
Posted: Wednesday, January 25, 2023

Nicholas Turner, MD, PhD, of The Royal Marsden Hospital, London, and colleagues conducted the phase III CAPItello-291 trial to determine whether patients with advanced aromatase inhibitor–resistant, hormone receptor–positive, HER2-negative breast cancer may benefit from treatment with the pan-AKT inhibitor capivasertib in combination with fulvestrant. Their findings were presented during the 2022 San Antonio Breast Cancer Symposium (SABCS; Abstract GS3-04).

“The improvement in progression-free survival with relatively well-tolerated side effects is extremely encouraging,” commented Dr. Turner in a press release from the American Association for Cancer Research. “We are hopeful that capivasertib will become a new treatment option for patients whose cancer has progressed on a regimen containing an endocrine therapy.”

Eligible patients were randomly assigned to receive fulvestrant in combination with either capivasertib (n = 355) or a placebo (n = 353). Of the study population, 41% harbored an AKT pathway mutation.

A total of 551 and 236 progression-free survival events had occurred in the overall and pathway-altered populations, respectively, at primary analysis. In the overall population, the median duration of progression-free survival was prolonged with capivasertib compared with the placebo (7.2 vs. 3.6 months; hazard ratio [HR] = 0.60). The median duration of progression-free survival in the AKT pathway–altered population was 7.3 months with capivasertib and 3.1 months with the placebo (HR = 0.50). The objective response rates in the overall and AKT pathway–altered populations were 22.9% and 28.8% with capivasertib and 12.2% and 9.7% with the placebo, respectively.

Diarrhea, rash, and nausea were the most frequently reported all-grade adverse events with capivasertib. The most common adverse events of grade 3 or higher were rash, diarrhea, and hyperglycemia. Adverse events leading to treatment discontinuation occurred in 13.0% and 2.3% of the capivasertib and placebo arms, respectively.

Disclosure: For full disclosures of the study authors, visit

By continuing to browse this site you permit us and our partners to place identification cookies on your browser and agree to our use of cookies to identify you for marketing. Read our Privacy Policy to learn more.