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- Title
Dalpiciclib and pyrotinib in women with HER2-positive advanced breast cancer: a single-arm phase II trial.
- Authors
Yan, Min; Niu, Limin; Lv, Huimin; Zhang, Mengwei; Wang, Jing; Liu, Zhenzhen; Chen, Xiuchun; Lu, Zhenduo; Zhang, Chongjian; Zeng, Huiai; Zhao, Shengnan; Feng, Yajing; Sun, Huihui; Li, Huajun
- 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. Dalpiciclib is a CDK4/6 inhibitor, recently approved for treatment in advanced breast cancer patients in China. Here, the authors report the results of a phase II trial investigating oral dalpiciclib (CDK4/6 inhibitor) and pyrotinib (pan-HER inhibitor) in patients with HER2-positive metastatic breast cancer.
- Subjects
CHINA; HER2 positive breast cancer; METASTATIC breast cancer; CYCLIN-dependent kinase inhibitors; LEUKOCYTE count; BREAST; CANCER patients; HORMONE receptors
- Publication
Nature Communications, 2023, Vol 14, Issue 1, p1
- ISSN
2041-1723
- Publication type
Article
- DOI
10.1038/s41467-023-41955-7