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

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 and Huajun Li
Additional contact information
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

Nature Communications, 2023, vol. 14, issue 1, 1-8

Abstract: 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.

Date: 2023
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DOI: 10.1038/s41467-023-41955-7

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