Lerociclib plus fulvestrant in patients with HR+/HER2− locally advanced or metastatic breast cancer who have progressed on prior endocrine therapy: LEONARDA-1 a phase III randomized trial

Binghe Xu (bhxu@hotmail.com), Qingyuan Zhang, Yang Luo, Zhongsheng Tong, Tao Sun, Changping Shan, Xinlan Liu, Yumin Yao, Bing Zhao, Shusen Wang, Xiaohua Zeng, Changlu Hu, Xi Yan, Xiaojia Wang, Hongyan Jia, Zhendong Chen, Fuming Qiu, Xinhong Wu, Deyong Zhang and Tong Li
Additional contact information
Binghe Xu: Chinese Academy of Medical Sciences and Peking Union Medical College
Qingyuan Zhang: Harbin Medical University Cancer Hospital
Yang Luo: Chinese Academy of Medical Sciences and Peking Union Medical College
Zhongsheng Tong: Tianjin Medical University Cancer Institute and Hospital
Tao Sun: Liaoning Cancer Hospital and Institute
Changping Shan: The Affiliated Hospital of Jining Medical University
Xinlan Liu: General Hospital of Ningxia Medical University
Yumin Yao: Liaocheng People’s Hospital
Bing Zhao: Cancer Hospital of Xinjiang Medical University
Shusen Wang: Sun Yat-sen University Cancer Center
Xiaohua Zeng: Affiliated Cancer Hospital of Chongqing University
Changlu Hu: Anhui Provincial Cancer Hospital
Xi Yan: Sichuan University
Xiaojia Wang: Chinese Academy of Sciences
Hongyan Jia: The First Hospital of Shanxi Medical University
Zhendong Chen: The Second Affiliated Hospital of Anhui Medical University
Fuming Qiu: The Second Affiliated Hospital Zhejiang University School of Medicine
Xinhong Wu: Hubei Cancer Hospital
Deyong Zhang: Genor Biopharma Co., Ltd
Tong Li: Genor Biopharma Co., Ltd

Nature Communications, 2025, vol. 16, issue 1, 1-9

Abstract: Abstract Lerociclib (GB491), a highly selective oral CDK4/6 inhibitor, has displayed anti-tumor activity and differentiated safety and tolerability profile in previous ph1/2 clinical trials. The LEONARDA-1, a randomized, double-blind, phase III study, was conducted to evaluate the efficacy and safety of lerociclib in HR+/HER2− locally advanced or metastatic breast cancer patients, who had relapsed or progressed on prior endocrine therapy. A total of 275 patients were randomized at 1:1 ratio to receive lerociclib (137 patients, 150 mg twice daily) or placebo (138 patients) plus fulvestrant. Progression-free survival (PFS) assessed by investigators was significantly improved in lerociclib arm versus placebo arm (11.07 vs 5.49 months; hazard ratio, 0.451, 95% CI: 0.311-0.656, P = 0.000016), meeting the pre-specified primary endpoint. The secondary endpoints included PFS assessed by Blinded Independent Central Review (BICR), objective response rate (ORR), duration of response (DOR), disease control rate (DCR), clinical benefit rate (CBR), overall survival (OS), safety and tolerability and pharmacokinetic profile. DOR is not reported, and OS data was immature at the data cut-off but unplanned ad hoc analysis is reported. These findings support lerociclib plus fulvestrant as a treatment option for patients with HR+/HER2− endocrine-resistant advanced breast cancer (ABC). (Funded by Genor Biopharma; LEONARDA-1 ClinicalTrials.gov identifier, NCT05054751.)

Date: 2025
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DOI: 10.1038/s41467-025-56096-2

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