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Dalpiciclib and pyrotinib in women with HER2-positive advanced breast cancer: a single-arm phase II trial

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  • Min Yan

    (Henan Breast Cancer Center/The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital)

  • Limin Niu

    (Henan Breast Cancer Center/The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital)

  • Huimin Lv

    (Henan Breast Cancer Center/The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital)

  • Mengwei Zhang

    (Henan Breast Cancer Center/The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital)

  • Jing Wang

    (Henan Breast Cancer Center/The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital)

  • Zhenzhen Liu

    (Henan Breast Cancer Center/The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital)

  • Xiuchun Chen

    (Henan Breast Cancer Center/The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital)

  • Zhenduo Lu

    (Henan Breast Cancer Center/The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital)

  • Chongjian Zhang

    (Henan Breast Cancer Center/The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital)

  • Huiai Zeng

    (Henan Breast Cancer Center/The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital)

  • Shengnan Zhao

    (Henan Breast Cancer Center/The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital)

  • Yajing Feng

    (Henan Breast Cancer Center/The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital)

  • Huihui Sun

    (Henan Breast Cancer Center/The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital)

  • Huajun Li

    (Jiangsu Hengrui Pharmaceuticals Co., Ltd)

Abstract

CDK4/6 inhibitors have shown a synergistic effect with anti-HER2 therapy in hormone receptor (HR)-positive and HER2-positive breast cancer (BC). In this phase 2 study (NCT04293276), we aim to evaluate a dual-oral regimen of CDK4/6 inhibitor dalpiciclib combined with HER2 tyrosine kinase inhibitor pyrotinib as front-line treatment in women with HER2-positive advanced BC (n = 41) including those with HR-negative disease. The primary endpoint is the objective response rate, and secondary endpoints include progression-free survival (PFS), overall survival (OS), and safety. With a median follow-up of 25.9 months, 70% (28/40) of assessable patients have a confirmed objective response, meeting the primary endpoint. The median PFS is 11.0 months (95% CI = 7.3–19.3), and OS data are not mature. The most common grade 3 or 4 treatment-related adverse events (AEs) are decreased white blood cell count (68.3%), decreased neutrophil count (65.9%), and diarrhea (22.0%). Most AEs are manageable, and no treatment-related deaths occur. These findings suggest that this combination may have promising activity and manageable toxicity. Further investigation is needed.

Suggested Citation

  • Min Yan & Limin Niu & Huimin Lv & Mengwei Zhang & Jing Wang & Zhenzhen Liu & Xiuchun Chen & Zhenduo Lu & Chongjian Zhang & Huiai Zeng & Shengnan Zhao & Yajing Feng & Huihui Sun & Huajun Li, 2023. "Dalpiciclib and pyrotinib in women with HER2-positive advanced breast cancer: a single-arm phase II trial," Nature Communications, Nature, vol. 14(1), pages 1-8, December.
    • Handle: RePEc:nat:natcom:v:14:y:2023:i:1:d:10.1038_s41467-023-41955-7
    DOI: 10.1038/s41467-023-41955-7
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    References listed on IDEAS

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    1. Alison E. Smith & Emanuela Ferraro & Anton Safonov & Cristina Bernado Morales & Enrique J. Arenas Lahuerta & Qing Li & Amanda Kulick & Dara Ross & David B. Solit & Elisa Stanchina & Jorge Reis-Filho &, 2021. "HER2 + breast cancers evade anti-HER2 therapy via a switch in driver pathway," Nature Communications, Nature, vol. 12(1), pages 1-10, December.
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