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

Author

Listed:
  • 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)

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.

Suggested Citation

  • 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 Wan, 2025. "Capivasertib plus fulvestrant in patients with HR-positive/HER2-negative advanced breast cancer: phase 3 CAPItello-291 study extended Chinese cohort," Nature Communications, Nature, vol. 16(1), pages 1-12, December.
    • Handle: RePEc:nat:natcom:v:16:y:2025:i:1:d:10.1038_s41467-025-59210-6
    DOI: 10.1038/s41467-025-59210-6
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    1. Guan-Tian Lang & Yi-Zhou Jiang & Jin-Xiu Shi & Fan Yang & Xiao-Guang Li & Yu-Chen Pei & Chen-Hui Zhang & Ding Ma & Yi Xiao & Peng-Chen Hu & Hai Wang & Yun-Song Yang & Lin-Wei Guo & Xun-Xi Lu & Meng-Zh, 2020. "Characterization of the genomic landscape and actionable mutations in Chinese breast cancers by clinical sequencing," Nature Communications, Nature, vol. 11(1), pages 1-13, December.
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