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A Study of GB491 in Combination With Letrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
Sponsor: Genor Biopharma Co., Ltd.
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
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of GB491 in Combination With Letrozole in Subjects With HR Positive and HER2 Negative Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Received Systemic Therapy in This Disease Setting
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
350
Start Date
2022-01-14
Completion Date
2027-01-30
Last Updated
2023-05-09
Healthy Volunteers
No
Conditions
Interventions
GB491 combined with Letrozole
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)
Placebo combined with Letrozole
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)
Locations (52)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
The First Hospital of Anhui Medical University
Hefei, Anhui, China
Anhui Cancer Hospital
Hefei, Anhui, China
The Second Hosptial of Anhui Medical University
Hefei, Anhui, China
Betjing Tiantan Hosptial，Capital Medical University
Beijing, Beijing Municipality, China
Chinese PLA General Hospial
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 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
The First People's Hospital of Foshan
Foshan, Guangdong, China
Sun Yat-Sen University Cancer Center(Huangpu Campus)
Guangzhou, Guangdong, China
Sun Yat-Sen University Cancer Center(Yuexiu Campus)
Guangzhou, Guangdong, China
Maternal and Child Healh Hosptal of Guangdong Provrce
Guangzhou, Guangdong, China
Meizhou People's Hosptial
Meizhou, Guangdong, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China
Xingtai People's Hospital
Xingtai, Hebei, 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
Hubei Cancer Hospital
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
The First Affiliated Hosptial of Nanchang University
Nanchang, Jiangxi, China
The Nanchang theird people's Hosptial
Nanchang, Jiangxi, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Shangrao People's Hospital
Shangrao, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, China
The First Hospital of Jilin University
Changchun, Jilin, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
Yingchuan, Ningxia, China
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, China
Jinan Central Hospital
Jinan, Shandong, China
Shandong Provincial Hospital
Jinan, Shandong, China
Shandong Cancer Hospital
Jinan, Shandong, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, China
Liaocheng People's Hospital
Liaocheng, Shandong, China
Linyi Cancer Hospital
Linyi, Shandong, China
The Affiliated Hosptial of Qingdao University
Qingdao, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
First Hosptial of Shanxi Medical University
Taiyuan, Shanxi, China
West China Hospital, Sichuang University
Chengdu, Sichuang, China
Tianjin Mediacl University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
The Cancer Affiliated Hospital of Xingjiang Medical University
Ürümqi, Xinjiang, 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