Actively Recruiting
A Study of GB491 in Combination With Letrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
Led by Genor Biopharma Co., Ltd. · Updated on 2023-05-09
350
Participants Needed
52
Research Sites
263 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Study of GB491 in Combination With Letrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Pathologically confirmed HR+ and HER2- breast cancer
- No prior systemic antitumor therapy for locally advanced or metastatic breast cancer
- ECOG performance status 0 or 1
- Adequate organ and marrow function
- Signed informed consent
You will not qualify if you...
- Previous treatment with any other CDK4/6 inhibitor
- Known allergy to GB491 or any component of Letrozole
- Diagnosis of HER2 positive disease
- Uncontrolled or symptomatic central nervous system metastases
- Major surgery, chemotherapy, radiation, investigational drugs, or other antitumor therapy within 4 weeks prior to randomization
- Prior chemotherapy for locoregionally recurrent or metastatic breast cancer
- Significant cardiovascular or cerebrovascular disease including recent acute myocardial infarction, unstable angina, congestive heart failure, or ventricular arrhythmia requiring intervention
- Known HIV infection or HIV seropositivity at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 52 locations
1
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China, 233004
Actively Recruiting
2
The First Hospital of Anhui Medical University
Hefei, Anhui, China, 230022
Actively Recruiting
3
Anhui Cancer Hospital
Hefei, Anhui, China, 230031
Actively Recruiting
4
The Second Hosptial of Anhui Medical University
Hefei, Anhui, China, 230601
Actively Recruiting
5
Betjing Tiantan Hosptial，Capital Medical University
Beijing, Beijing Municipality, China, 100070
Actively Recruiting
6
Chinese PLA General Hospial
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
7
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400016
Actively Recruiting
8
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030
Actively Recruiting
9
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
10
The First Hospital of Wenzhou Medical University
Wenzhou, Fujian, China, 325000
Actively Recruiting
11
The First Affiliated Hosptial of Xiamen University
Xiamen, Fujian, China, 361003
Actively Recruiting
12
The First People's Hospital of Foshan
Foshan, Guangdong, China, 528000
Actively Recruiting
13
Sun Yat-Sen University Cancer Center(Huangpu Campus)
Guangzhou, Guangdong, China, 510060
Actively Recruiting
14
Sun Yat-Sen University Cancer Center(Yuexiu Campus)
Guangzhou, Guangdong, China, 510060
Actively Recruiting
15
Maternal and Child Healh Hosptal of Guangdong Provrce
Guangzhou, Guangdong, China
Actively Recruiting
16
Meizhou People's Hosptial
Meizhou, Guangdong, China, 514031
Actively Recruiting
17
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China, 530000
Actively Recruiting
18
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China, 571300
Actively Recruiting
19
Xingtai People's Hospital
Xingtai, Hebei, China, 054001
Actively Recruiting
20
The First Affiliated Hosptial of Henan University of Science and Technology
Luoyang, Henan, China, 471003
Actively Recruiting
21
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
22
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China, 430023
Actively Recruiting
23
Renmin Hospital of Wuhan University
Wuhan, Hubei, China, 430060
Actively Recruiting
24
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079
Actively Recruiting
25
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Actively Recruiting
26
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Actively Recruiting
27
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China, 341000
Actively Recruiting
28
The First Affiliated Hosptial of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
29
The Nanchang theird people's Hosptial
Nanchang, Jiangxi, China, 330009
Actively Recruiting
30
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China, 330029
Actively Recruiting
31
Shangrao People's Hospital
Shangrao, Jiangxi, China, 334000
Actively Recruiting
32
Jilin Cancer Hospital
Changchun, Jilin, China, 130021
Actively Recruiting
33
The First Hospital of Jilin University
Changchun, Jilin, China, 130031
Actively Recruiting
34
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China, 110042
Actively Recruiting
35
General Hospital of Ningxia Medical University
Yingchuan, Ningxia, China, 750004
Actively Recruiting
36
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, China, 710100
Actively Recruiting
37
Jinan Central Hospital
Jinan, Shandong, China, 250013
Actively Recruiting
38
Shandong Provincial Hospital
Jinan, Shandong, China, 250021
Actively Recruiting
39
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Actively Recruiting
40
Affiliated Hospital of Jining Medical University
Jining, Shandong, China, 272007
Actively Recruiting
41
Liaocheng People's Hospital
Liaocheng, Shandong, China, 252000
Actively Recruiting
42
Linyi Cancer Hospital
Linyi, Shandong, China, 276000
Actively Recruiting
43
The Affiliated Hosptial of Qingdao University
Qingdao, Shandong, China, 266000
Actively Recruiting
44
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
45
First Hosptial of Shanxi Medical University
Taiyuan, Shanxi, China, 030001
Actively Recruiting
46
West China Hospital, Sichuang University
Chengdu, Sichuang, China, 610044
Actively Recruiting
47
Tianjin Mediacl University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
48
The Cancer Affiliated Hospital of Xingjiang Medical University
Ürümqi, Xinjiang, China, 830000
Actively Recruiting
49
Yunnan Cancer Hosptial
Kunming, Yunnan, China, 650106
Actively Recruiting
50
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, China, 310002
Actively Recruiting
51
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310052
Actively Recruiting
52
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China, 315100
Actively Recruiting
Research Team
Y
Yankun Fu, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here