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
机构：[1]Chinese Acad Med Sci & Peking Union Med Coll, Natl Canc Ctr, Natl Clin Res Ctr Canc, Canc Hosp, Beijing, Peoples R China[2]Harbin Med Univ Canc Hosp, Harbin, Peoples R China[3]Tianjin Med Univ Canc Inst & Hosp, Tianjin, Peoples R China[4]China Med Univ, Dalian Univ Technol, Canc Hosp, Liaoning Canc Hosp & Inst, Shenyang, Peoples R China[5]Jining Med Univ, Affiliated Hosp, Jining, Peoples R China[6]Ningxia Med Univ, Gen Hosp, Yinchuan 750004, Ningxia, Peoples R China[7]Liaocheng Peoples Hosp, Liaocheng, Peoples R China[8]Xinjiang Med Univ, Canc Hosp, Urumqi, Peoples R China[9]Sun Yat Sen Univ, Canc Ctr, Guangzhou, Peoples R China[10]Chongqing Univ, Affiliated Canc Hosp, Breast Canc Ctr, Chongqing 400030, Peoples R China[11]Anhui Prov Canc Hosp, Hefei, Peoples R China[12]Sichuan Univ, West China Hosp, Chengdu, Peoples R China四川大学华西医院[13]Univ Chinese Acad Sci, Univ Chinese Acad Sci Zhejiang Canc Hosp, Chinese Acad Sci, Inst Canc & Basic Med,Canc Hosp, Hangzhou, Peoples R China浙江省肿瘤医院[14]Shanxi Med Univ, Hosp 1, Taiyuan, Peoples R China[15]Anhui Med Univ, Affiliated Hosp 2, Hefei, Peoples R China[16]Zhejiang Univ, Affiliated Hosp 2, Sch Med, Hangzhou, Peoples R China[17]Hubei Canc Hosp, Wuhan, Peoples R China[18]Genor Biopharm Co Ltd, Beijing, Peoples R China
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.)
第一作者机构：[1]Chinese Acad Med Sci & Peking Union Med Coll, Natl Canc Ctr, Natl Clin Res Ctr Canc, Canc Hosp, Beijing, Peoples R China
共同第一作者：
通讯作者：
推荐引用方式(GB/T 7714)：
Xu Binghe,Zhang Qingyuan,Luo Yang,et al.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[J].NATURE COMMUNICATIONS.2025,16(1):doi:10.1038/s41467-025-56096-2.
APA：
Xu, Binghe,Zhang, Qingyuan,Luo, Yang,Tong, Zhongsheng,Sun, Tao...&Li, Tong.(2025).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.NATURE COMMUNICATIONS,16,(1)
MLA：
Xu, Binghe,et al."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".NATURE COMMUNICATIONS 16..1(2025)
综合性期刊