Trial Title:
A Study of GB491 in Combination With Letrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
NCT ID:
NCT05851014
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Letrozole
Conditions: Keywords:
HR+/HER2-
locally advanced or metastatic breast cancer
GB491
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
GB491 combined with Letrozole
Description:
Patients were randomized to receive GB491 150 mg orally twice daily, depending on their
assignment. Letrozole 2.5 mg orally once a day from the first day of cycle 1 (one cycle
every 28 days)
Arm group label:
GB491 combined with Letrozole
Intervention type:
Drug
Intervention name:
Placebo combined with Letrozole
Description:
Patients were randomized to receive placebo orally twice daily, depending on their
assignment. Letrozole 2.5 mg orally once a day from the first day of cycle 1 (one cycle
every 28 days)
Arm group label:
Placebo combined with Letrozole
Summary:
The main purpose of this study is to evaluate the efficacy and safety of GB491 combined
with Letrozole versus placebo combined with Letrozole in the treatment of HR+/HER2-
locally advanced or metastatic breast cancer without prior systemic antitumor therapy
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. Age: 18-75 years old;
- Have a pathologically-confirmed diagnosis of hormone receptor-positive (HR+), human
epidermal growth factor receptor 2-negative (HER2-) breast cancer;
- No previous systematic antitumor therapy for locally advanced or metastatic breast
cancer;
- Eastern Cooperative Oncology Group [ECOG] 0-1;
- Have adequate organ and marrow function;
- Agree to sign the informed consent;
Exclusion Criteria:
- Systematic treatment with any other CDK4/6 inhibitor；
- Subjects with known allergy to GB491 or any component of Letrozole；
- Confirmed diagnosis of HER2 positive disease;
- Known uncontrolled, or symptomatic central nervous system metastases;
- Had major surgery (or is expected to require major surgery during the study period),
chemotherapy, radiation, any investigational drug, or other antitumor therapy within
4 weeks prior to randomization;
- Have previously received chemotherapy for locoregionally recurrent or metastatic
breast cancer;
- Clinically significant cardiovascular and cerebrovascular diseases, including but
not limited to severe acute myocardial infarction within 6 months before enrollment,
unstable or severe angina, Congestive heart failure, or ventricular arrhythmia which
need medical intervention；
- Known history of HIV infection or HIV seropositivity (including HIV antibody
positive at the time of screening)
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Bengbu Medical College
Address:
City:
Bengbu
Zip:
233004
Country:
China
Status:
Recruiting
Contact:
Last name:
Gongsheng Jin, Ph.D
Phone:
13095520028
Email:
Jgs2007@139.com
Facility:
Name:
The First Hospital of Anhui Medical University
Address:
City:
Hefei
Zip:
230022
Country:
China
Status:
Recruiting
Contact:
Last name:
Yingying Du, Ph.D
Phone:
13956012561
Email:
duyingying@126.com
Facility:
Name:
Anhui Cancer Hospital
Address:
City:
Hefei
Zip:
230031
Country:
China
Status:
Recruiting
Contact:
Last name:
Changlu Hu, Bachelor
Phone:
13955116061
Email:
13955116061@139.com
Facility:
Name:
The Second Hosptial of Anhui Medical University
Address:
City:
Hefei
Zip:
230601
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhengdong Chen, Master
Phone:
13805519892
Email:
az2fychenzhendong@163.com
Facility:
Name:
Betjing Tiantan Hosptial，Capital Medical University
Address:
City:
Beijing
Zip:
100070
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoyan Li, Ph.D
Phone:
13466383808
Email:
sharerha@126.com
Facility:
Name:
Chinese PLA General Hospial
Address:
City:
Beijing
Zip:
100853
Country:
China
Status:
Recruiting
Contact:
Last name:
Weihong Zhao, Ph.D
Phone:
15910853879
Email:
zhaowh0818@163.com
Facility:
Name:
The First Affiliated Hospital of Chongqing Medical University
Address:
City:
Chongqing
Zip:
400016
Country:
China
Status:
Recruiting
Contact:
Last name:
Qiao Cheng, Ph.D
Phone:
13098794661
Email:
c914chengqiao@hotmail.com
Facility:
Name:
Chongqing University Cancer Hospital
Address:
City:
Chongqing
Zip:
400030
Country:
China
Status:
Recruiting
Contact:
Last name:
Xin Zhou, Ph.D
Phone:
13452987363
Email:
zhouxin75324@163.com
Facility:
Name:
Fujian Medical University Union Hospital
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Status:
Recruiting
Contact:
Last name:
Cunsen Xu, Ph.D
Phone:
13306900948
Email:
xuchunsen@aliyun.com
Facility:
Name:
The First Hospital of Wenzhou Medical University
Address:
City:
Wenzhou
Zip:
325000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaohua Zhang, Bachelor
Phone:
13600671188
Email:
zhangxiaohua577@163.com
Facility:
Name:
The First Affiliated Hosptial of Xiamen University
Address:
City:
Xiamen
Zip:
361003
Country:
China
Status:
Recruiting
Contact:
Last name:
Ru Zhen, Master
Phone:
13696951139
Email:
499689541@qq.com
Facility:
Name:
The First People's Hospital of Foshan
Address:
City:
Foshan
Zip:
528000
Country:
China
Status:
Recruiting
Contact:
Last name:
Danmei Pan, Bachelor
Phone:
13923123318
Email:
13923123318@139.con
Facility:
Name:
Sun Yat-Sen University Cancer Center(Huangpu Campus)
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Shushen Wang, Ph.D
Phone:
13926168469
Email:
wangshs@sysucc.org.cn
Facility:
Name:
Sun Yat-Sen University Cancer Center(Yuexiu Campus)
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Shushen Wang, Ph.D
Phone:
13926168469
Email:
wangshs@sysucc.org.cn
Facility:
Name:
Maternal and Child Healh Hosptal of Guangdong Provrce
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Anqin Zhang, Master
Phone:
13925115929
Email:
30452933@qq.com
Facility:
Name:
Meizhou People's Hosptial
Address:
City:
Meizhou
Zip:
514031
Country:
China
Status:
Recruiting
Contact:
Last name:
Liang Li, Bachelor
Phone:
13750559809
Email:
liliang@mzrnyy.com
Facility:
Name:
Guangxi Medical University Cancer Hospital
Address:
City:
Nanning
Zip:
530000
Country:
China
Status:
Recruiting
Contact:
Last name:
Weimin Xie, Ph.D
Phone:
13907861028
Email:
dd.xie@qq.com
Facility:
Name:
The Second Affiliated Hospital of Hainan Medical University
Address:
City:
Haikou
Zip:
571300
Country:
China
Status:
Recruiting
Contact:
Last name:
Chaoying Wang, Bachelor
Phone:
13005005580
Email:
wangyishen809@sina.com
Facility:
Name:
Xingtai People's Hospital
Address:
City:
Xingtai
Zip:
054001
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiangshun Kong, Bachelor
Phone:
13831920816
Email:
xtkongxiangshun@163.com
Facility:
Name:
The First Affiliated Hosptial of Henan University of Science and Technology
Address:
City:
Luoyang
Zip:
471003
Country:
China
Status:
Recruiting
Contact:
Last name:
Xinshuai Wang, Ph.D
Phone:
13837986128
Email:
xshuaiw@126.com
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Zip:
450052
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuanting Gu, Ph.D
Phone:
13703844321
Email:
guyuanting2009@163.com
Facility:
Name:
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430023
Country:
China
Status:
Recruiting
Contact:
Last name:
Jing Cheng, Ph.D
Phone:
13006178752
Email:
Chenjin1118@hotmail.com
Facility:
Name:
Renmin Hospital of Wuhan University
Address:
City:
Wuhan
Zip:
430060
Country:
China
Status:
Recruiting
Contact:
Last name:
Weiping Tao, Bachelor
Phone:
13971698695
Email:
taowpwp@sina.com
Facility:
Name:
Hubei Cancer Hospital
Address:
City:
Wuhan
Zip:
430079
Country:
China
Status:
Recruiting
Contact:
Last name:
Xinhong Wu, Ph.D
Phone:
18602726300
Email:
369423971@qq.com
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Recruiting
Contact:
Last name:
Quchang Ouyang, Ph.D
Phone:
13973135318
Email:
oyqc1969@126.com
Facility:
Name:
Jiangsu Province Hospital
Address:
City:
Nanjing
Zip:
210029
Country:
China
Status:
Recruiting
Contact:
Last name:
Yongmei Yin, Ph.D
Phone:
13951842727
Email:
Ym.yin@hotmail.com
Facility:
Name:
First Affiliated Hospital of Gannan Medical University
Address:
City:
Ganzhou
Zip:
341000
Country:
China
Status:
Recruiting
Contact:
Last name:
Guie Lai, Master
Phone:
15083736735
Email:
15083736735@163.com
Facility:
Name:
The First Affiliated Hosptial of Nanchang University
Address:
City:
Nanchang
Zip:
330006
Country:
China
Status:
Recruiting
Contact:
Last name:
Yingliang Li, Ph.D
Phone:
13907002935
Email:
liyingliang1977@163.com
Facility:
Name:
The Nanchang theird people's Hosptial
Address:
City:
Nanchang
Zip:
330009
Country:
China
Status:
Recruiting
Contact:
Last name:
Yili Wang, Bachelor
Phone:
13970013678
Email:
wangyili0823@126.com
Facility:
Name:
Jiangxi Cancer Hospital
Address:
City:
Nanchang
Zip:
330029
Country:
China
Status:
Recruiting
Contact:
Last name:
Chunlin Jiang, Ph.D
Phone:
13979109200
Email:
jclil2002@163.com
Facility:
Name:
Shangrao People's Hospital
Address:
City:
Shangrao
Zip:
334000
Country:
China
Status:
Recruiting
Contact:
Last name:
Kairong Huang, Bachelor
Phone:
13507039656
Email:
huangkaitong@163.com
Facility:
Name:
Jilin Cancer Hospital
Address:
City:
Changchun
Zip:
130021
Country:
China
Status:
Recruiting
Contact:
Last name:
Ying Cheng, Bachelor
Phone:
0431-85872488
Email:
ji.chen@163.com
Facility:
Name:
The First Hospital of Jilin University
Address:
City:
Changchun
Zip:
130031
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Li, Ph.D
Phone:
13756661267
Email:
jdyylw@163.com
Facility:
Name:
Liaoning Cancer Hospital & Institute
Address:
City:
Shenyang
Zip:
110042
Country:
China
Status:
Recruiting
Contact:
Last name:
Tao Sun, Ph.D
Phone:
18900918788
Email:
Inzlrxnsy@163.com
Facility:
Name:
General Hospital of Ningxia Medical University
Address:
City:
Yingchuan
Zip:
750004
Country:
China
Status:
Recruiting
Contact:
Last name:
Xinlan Liu, Master
Phone:
13709577339
Email:
liuxinlan@csco.ac.cn
Facility:
Name:
Xi'an International Medical Center Hospital
Address:
City:
Xi'an
Zip:
710100
Country:
China
Status:
Recruiting
Contact:
Last name:
Yan Xue, Ph.D
Phone:
13992830596
Email:
1410605461@qq.com
Facility:
Name:
Jinan Central Hospital
Address:
City:
Jinan
Zip:
250013
Country:
China
Status:
Recruiting
Contact:
Last name:
Meili Sun, Ph.D
Phone:
18953116532
Email:
s18953116532@163.com
Facility:
Name:
Shandong Provincial Hospital
Address:
City:
Jinan
Zip:
250021
Country:
China
Status:
Recruiting
Contact:
Last name:
Weibo Wang, Master
Phone:
15168888787
Email:
wbwb1620@163.com
Facility:
Name:
Shandong Cancer Hospital
Address:
City:
Jinan
Zip:
250117
Country:
China
Status:
Recruiting
Contact:
Last name:
Lihua Song, Master
Phone:
13665312188
Email:
slh9999@vip.163.com
Facility:
Name:
Affiliated Hospital of Jining Medical University
Address:
City:
Jining
Zip:
272007
Country:
China
Status:
Recruiting
Contact:
Last name:
Changping Shan, Master
Phone:
18678766865
Email:
scp9933@163.com
Facility:
Name:
Liaocheng People's Hospital
Address:
City:
Liaocheng
Zip:
252000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yumin Yao, Bachelor
Phone:
13346528105
Email:
yaoyumin@sohu.com
Facility:
Name:
Linyi Cancer Hospital
Address:
City:
Linyi
Zip:
276000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jingfen Wang, Bachelor
Phone:
15963976026
Email:
2298641960@qq.com
Facility:
Name:
The Affiliated Hosptial of Qingdao University
Address:
City:
Qingdao
Zip:
266000
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenfeng Li, Ph.D
Phone:
13589381517
Email:
li_wenfeng@126.com
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Xichun Hu, Ph.D
Phone:
13816110335
Email:
xchu2009@hotmail.com
Facility:
Name:
First Hosptial of Shanxi Medical University
Address:
City:
Taiyuan
Zip:
030001
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongyan Jia, Ph.D
Phone:
13700515784
Email:
13700515784@163.com
Facility:
Name:
West China Hospital, Sichuang University
Address:
City:
Chengdu
Zip:
610044
Country:
China
Status:
Recruiting
Contact:
Last name:
Xi Yan, Master
Phone:
18980601777
Email:
852143552@qq.com
Facility:
Name:
Tianjin Mediacl University Cancer Institute & Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhongsheng Tong, Master
Phone:
18622221181
Email:
18622221181@163.com
Facility:
Name:
The Cancer Affiliated Hospital of Xingjiang Medical University
Address:
City:
Ürümqi
Zip:
830000
Country:
China
Status:
Recruiting
Contact:
Last name:
Bing Zhao, Ph.D
Phone:
13899908184
Email:
819502412@qq.com
Facility:
Name:
Yunnan Cancer Hosptial
Address:
City:
Kunming
Zip:
650106
Country:
China
Status:
Recruiting
Contact:
Last name:
Dedian Chen, Master
Phone:
13888087308
Email:
chendedian2006@126.com
Facility:
Name:
Hangzhou Cancer Hospital
Address:
City:
Hangzhou
Zip:
310002
Country:
China
Status:
Recruiting
Contact:
Last name:
Shangnao Xie, Master
Phone:
13505817153
Email:
xieshangnao@126.com
Facility:
Name:
The Second Affiliated Hospital Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310052
Country:
China
Status:
Recruiting
Contact:
Last name:
Fuming Qiu, Ph.D
Phone:
13858005908
Email:
qiufuming@zju.edu.cn
Facility:
Name:
Ningbo Medical Center Lihuili Hospital
Address:
City:
Ningbo
Zip:
315100
Country:
China
Status:
Recruiting
Contact:
Last name:
Weizhu Wu, Bachelor
Phone:
13957402451
Email:
1144184462@qq.com
Start date:
January 14, 2022
Completion date:
January 30, 2027
Lead sponsor:
Agency:
Genor Biopharma Co., Ltd.
Agency class:
Industry
Source:
Genor Biopharma Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05851014
