Capivasertib plus fulvestrant in patients with HR-positive/HER2-negative advanced breast cancer: phase 3 CAPItello-291 study extended Chinese cohort

Xichun Hu (), Qingyuan Zhang, Tao Sun, Huihua Xiong, Wei Li, Yuee Teng, Yen-Shen Lu, Ling-Ming Tseng, Min Yan, Hongsheng Li, Danmei Pang, Shin-Cheh -Chen, Wenyan Chen, Ou Jiang, Jingfen Wang, Xinhong Wu, Xian Wang, Aimin Zang, Xiaojia Wang, Julie M. Collins, Ethan Fan, Lin Jiang, Xiaoling Zeng and Nicholas C. Turner
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Xichun Hu: Fudan University Shanghai Cancer Center; Fudan University
Qingyuan Zhang: Harbin Medical University Cancer Hospital
Tao Sun: Liaoning Cancer Hospital
Huihua Xiong: Huazhong University of Science & Technology
Wei Li: The First Hospital of Jilin University Cancer Center
Yuee Teng: The First Hospital of China Medical University
Yen-Shen Lu: National Taiwan University Hospital
Ling-Ming Tseng: Taipei Veterans General Hospital
Min Yan: The Affiliated Cancer Hospital of Zhengzhou University
Hongsheng Li: Affiliated Tumor Hospital of Guangzhou Medical University
Danmei Pang: The First People’s Hospital of Foshan
Shin-Cheh -Chen: Linkou
Wenyan Chen: The Third Hospital of Nanchang
Ou Jiang: The Second People’s Hospital of Neijiang
Jingfen Wang: Linyi Cancer Hospital
Xinhong Wu: Tongji Medical College
Xian Wang: Zhejiang University School of Medicine
Aimin Zang: Affiliated Hospital of Hebei University
Xiaojia Wang: Zhejiang Cancer Hospital
Julie M. Collins: AstraZeneca
Ethan Fan: AstraZeneca
Lin Jiang: AstraZeneca
Xiaoling Zeng: AstraZeneca
Nicholas C. Turner: Institute of Cancer Research

Nature Communications, 2025, vol. 16, issue 1, 1-12

Abstract: Abstract In the global CAPItello-291 randomized phase 3 study (NCT04305496) in patients with hormone receptor-positive/HER2-negative advanced breast cancer and progression during/after aromatase inhibitor treatment, capivasertib–fulvestrant significantly improved progression-free survival (PFS) in the overall population and patients with PIK3CA/AKT1/PTEN-altered tumors versus placebo–fulvestrant. We assessed efficacy and safety of capivasertib–fulvestrant in a prespecified exploratory analysis of a Chinese cohort (n = 24) and extended study with the same protocol (n = 110). Clinically meaningful PFS benefit for capivasertib–fulvestrant was observed in the overall population (median PFS: 6.9 [capivasertib–fulvestrant] versus 2.8 [placebo–fulvestrant] months; hazard ratio 0.51, 95% CI 0.34–0.76), patients with PIK3CA/AKT1/PTEN-altered tumors (n = 46; 5.7 versus 1.9 months; hazard ratio 0.41, 95% CI 0.19–0.85) and PIK3CA/AKT1/PTEN-non-altered tumors (patients with confirmed next-generation sequencing results [n = 68]; 9.2 versus 2.7 months; hazard ratio 0.38; 95% CI 0.21–0.68). The most frequent adverse events (AEs) with capivasertib–fulvestrant were diarrhea (60.6% versus 11.3% with placebo–fulvestrant) and hyperglycemia (57.7% versus 17.7%). AEs leading to capivasertib–fulvestrant discontinuation were reported in 11.3% of patients versus 3.2% for placebo–fulvestrant. The benefit-risk profile of capivasertib–fulvestrant in the Chinese cohort was favorable; further exploration in patients with PIK3CA/AKT1/PTEN-non-altered tumors is warranted.

Date: 2025
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DOI: 10.1038/s41467-025-59210-6

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