A Study of GB491 in Combination With Letrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT05851014
- Lead Sponsor
- Genor Biopharma Co., Ltd.
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 350
-
- 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;
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GB491 combined with Letrozole GB491 combined with Letrozole - Placebo combined with Letrozole Placebo combined with Letrozole -
- Primary Outcome Measures
Name Time Method Investigator-assessed PFS based on RECIST v1.1 Approximately 60 months To evaluate progression-free survival (PFS) of GB491 plus Letrozole versus placebo plus Letrozole in HR+/HER2- locally advanced or metastatic breast cancer without prior systemic antitumor therapy (as assessed by the investigator).
- Secondary Outcome Measures
Name Time Method DCR Approximately 60 months Number of Participants With adverse events (AEs) and serious adverse events (SAEs) Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0 Approximately 60 months BICR-assessed PFS based on RECIST v1.1. Approximately 60 months OS Approximately 60 months CBR Approximately 60 months ORR Approximately 60 months DOR Approximately 60 months
Trial Locations
- Locations (52)
Xingtai People's Hospital
🇨🇳Xingtai, Hebei, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
The Nanchang theird people's Hosptial
🇨🇳Nanchang, Jiangxi, China
Shangrao People's Hospital
🇨🇳Shangrao, Jiangxi, China
Jilin Cancer Hospital
🇨🇳Changchun, Jilin, China
General Hospital of Ningxia Medical University
🇨🇳Yingchuan, Ningxia, China
Liaoning Cancer Hospital & Institute
🇨🇳Shenyang, Liaoning, China
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
The First Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
The Second Hosptial of Anhui Medical University
🇨🇳Hefei, Anhui, China
Betjing Tiantan Hosptial，Capital Medical University
🇨🇳Beijing, Beijing, China
Anhui Cancer Hospital
🇨🇳Hefei, Anhui, China
Chinese PLA General Hospial
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Chongqing University Cancer Hospital
🇨🇳Chongqing, Chongqing, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
The First Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Fujian, China
The First Affiliated Hosptial of Xiamen University
🇨🇳Xiamen, Fujian, China
Meizhou People's Hosptial
🇨🇳Meizhou, Guangdong, China
Sun Yat-Sen University Cancer Center(Huangpu Campus)
🇨🇳Guangzhou, Guangdong, China
The First People's Hospital of Foshan
🇨🇳Foshan, Guangdong, China
Sun Yat-Sen University Cancer Center(Yuexiu Campus)
🇨🇳Guangzhou, Guangdong, China
Maternal and Child Healh Hosptal of Guangdong Provrce
🇨🇳Guangzhou, Guangdong, China
Guangxi Medical University Cancer Hospital
🇨🇳Nanning, Guangxi, China
The Second Affiliated Hospital of Hainan Medical University
🇨🇳Haikou, Hainan, China
The First Affiliated Hosptial of Henan University of Science and Technology
🇨🇳Luoyang, Henan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Renmin Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
The First Affiliated Hosptial of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
First Affiliated Hospital of Gannan Medical University
🇨🇳Ganzhou, Jiangxi, China
Jiangxi Cancer Hospital
🇨🇳Nanchang, Jiangxi, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Shandong Provincial Hospital
🇨🇳Jinan, Shandong, China
Jinan Central Hospital
🇨🇳Jinan, Shandong, China
Xi'an International Medical Center Hospital
🇨🇳Xi'an, Shaanxi, China
Shandong Cancer Hospital
🇨🇳Jinan, Shandong, China
Affiliated Hospital of Jining Medical University
🇨🇳Jining, Shandong, China
Linyi Cancer Hospital
🇨🇳Linyi, Shandong, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Liaocheng People's Hospital
🇨🇳Liaocheng, Shandong, China
The Affiliated Hosptial of Qingdao University
🇨🇳Qingdao, Shandong, China
Tianjin Mediacl University Cancer Institute & Hospital
🇨🇳Tianjin, Tianjin, China
The Cancer Affiliated Hospital of Xingjiang Medical University
🇨🇳Ürümqi, Xinjiang, China
First Hosptial of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
West China Hospital, Sichuang University
🇨🇳Chengdu, Sichuang, China
Yunnan Cancer Hosptial
🇨🇳Kunming, Yunnan, China
Hangzhou Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
The Second Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Ningbo Medical Center Lihuili Hospital
🇨🇳Ningbo, Zhejiang, China