LEONARDA-1: Phase III randomized study of lerociclib plus fulvestrant in patients with HR+, HER2- locally advanced or metastatic breast cancer that has progressed on prior endocrine therapy.

医学 富维斯特朗 耐受性 转移性乳腺癌 内科学 临床终点 乳腺癌 肿瘤科 安慰剂 癌症 阿那曲唑 随机对照试验 不利影响 三苯氧胺 病理 替代医学
作者
Bo Xu,Qingyuan Zhang,Yang Luo,Zhongsheng Tong,Tao Sun,Changping Shan,Xinlan Liu,Yali Yao,Bing Zhao,Shusen Wang,Xiaohua Zeng,Changlu Hu,Xi Yan,Xiaojia Wang,Hong-Ti Jia,Zhendong Chen,Fuming Qiu,Xinhong Wu,Deyong Zhang,Tong Li
出处
期刊:Journal of Clinical Oncology [Lippincott Williams & Wilkins]
卷期号:41 (16_suppl): 1017-1017 被引量:1
标识
DOI:10.1200/jco.2023.41.16_suppl.1017
摘要

1017 Background: Lerociclib (GB491), a novel oral CDK4/6 inhibitor with continuously daily dosing, which has demonstrated anti-tumor response and a differentiated safety & tolerability profile in previous clinical trials. The LEONARDA-1 study assessed the efficacy of lerociclib and fulvestrant in endocrine-resistant advanced BC. Methods: This is a randomized, double-blind, placebo-controlled phase III study assessing lerociclib in combination with fulvestrant in pre/peri-menopausal or postmenopausal, HR+, HER2- locally advanced or metastatic BC patients (pts) who had relapsed or progressed on prior endocrine therapy (ET). Eligible patients were allowed one prior line of chemotherapy for metastatic disease. Pre-/peri-menopausal pts also received goserelin. Pts were randomized 1:1 to receive lerociclib (150mg po bid, d1-28, q4w) or placebo (P) plus fulvestrant (F). The primary endpoint was investigator-assessed progression-free survival (PFS) based on RECIST v1.1. Secondary endpoints included PFS (assessed by BICR), overall survival (OS), response assessment, safety and tolerability, pharmacokinetic (PK) profile. Results: By December 2 nd 2022 as data cut-off date, 275 pts were randomized, 137 to receive lerociclib + F and 138 to P + F. Median follow-up time was 7.36 months (range, 0.03-11.93+) for lerociclib + F vs 7.33 months (range, 0.03-11.27) for P + F. Baseline characteristics were well balanced (The median age was 54 years and 53.5 years, 41.6%% and 44.9% were Pre/peri-menopausal, 64.2% and 62.3% had visceral disease, 24.8% and 26.1% were primary resistant to prior ET, 28.5% and 29.0% received one line of chemotherapy for metastatic disease, respectively). At the time of cut-off date, 125 PFS events were observed with a median PFS of 11.07 months for lerociclib + F and 5.49 months for P + F (HR: 0.458; 95% CI: 0.317, 0.661, P< 0.001 by log-rank test). In patients with measurable disease (n=240, 87.3%), the ORR was significantly higher in lerociclib + F 26.9% (2.5% complete response [CR]) vs 9.9% (0% CR) for P + F. Consistent benefit from lerociclib was seen in pre/peri-menopausal and postmenopausal subjects. The most common adverse events (AEs) for lerociclib + F versus P + F were neutropenia (90.5% vs. 4.3%), leucopenia (86.9% vs. 6.5%), anemia (34.3% vs. 10.1%), thrombocytopenia (19.7% vs. 3.6%), and diarrhea (19.7% vs. 3.6%). Grade 3 or 4 neutropenia was reported in 46.7% pts on lerociclib + F (G3: 41.6%, G4: 5.1%) vs 0% pts on P + F. There was no case of ≥Grade3 diarrhea reported. The discontinuation rate due to AEs was 0.7% on lerociclib + F and 0% on P + F. Serious AEs were reported for 5.8% and 8.0%, respectively. Conclusions: Lerociclib at 150mg twice daily plus fulvestrant significantly improved PFS and ORR and demonstrated a favorable tolerable safety profile in pts with HR+ / HER2- endocrine-resistant advanced BC. Clinical trial information: NCT05054751 .
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
xiaoting应助kysl采纳,获得10
刚刚
1秒前
李健的小迷弟应助自由井采纳,获得10
2秒前
klb13完成签到,获得积分0
2秒前
yy发布了新的文献求助20
2秒前
CipherSage应助syx采纳,获得10
3秒前
李健的小迷弟应助GALAXY采纳,获得10
3秒前
kaio完成签到,获得积分10
4秒前
4秒前
大鱼完成签到,获得积分20
4秒前
4秒前
xiao完成签到,获得积分10
4秒前
难过的笑天完成签到,获得积分10
4秒前
5秒前
lailai完成签到 ,获得积分10
5秒前
桐桐应助狂野怜蕾采纳,获得10
5秒前
淡定映之完成签到,获得积分20
5秒前
lynn完成签到,获得积分10
5秒前
Joff_W完成签到,获得积分10
5秒前
Jiang完成签到,获得积分10
6秒前
丘比特应助洁净斑马采纳,获得10
6秒前
xt完成签到,获得积分10
6秒前
liusx123完成签到,获得积分20
8秒前
烂漫念柏发布了新的文献求助10
8秒前
爆米花应助Lancent采纳,获得10
9秒前
9秒前
10秒前
鹿鹿鹿鹿发布了新的文献求助10
10秒前
桀桀桀发布了新的文献求助10
10秒前
11秒前
11秒前
ziyue发布了新的文献求助10
12秒前
乐乐应助yy采纳,获得10
12秒前
12秒前
12秒前
12秒前
Lik完成签到,获得积分10
13秒前
13秒前
napnap完成签到 ,获得积分10
13秒前
lalala发布了新的文献求助10
13秒前
高分求助中
A new approach to the extrapolation of accelerated life test data 1000
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
Picture Books with Same-sex Parented Families: Unintentional Censorship 500
Nucleophilic substitution in azasydnone-modified dinitroanisoles 500
不知道标题是什么 500
A Preliminary Study on Correlation Between Independent Components of Facial Thermal Images and Subjective Assessment of Chronic Stress 500
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 360
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3970843
求助须知:如何正确求助?哪些是违规求助? 3515550
关于积分的说明 11178897
捐赠科研通 3250660
什么是DOI,文献DOI怎么找? 1795393
邀请新用户注册赠送积分活动 875828
科研通“疑难数据库(出版商)”最低求助积分说明 805188