A Study of GB491 in Combination With Letrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
NCT ID: NCT05851014
Last Updated: 2023-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
350 participants
INTERVENTIONAL
2022-01-14
2027-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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GB491 combined with Letrozole
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
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
75 Years
ALL
No
Sponsors
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Genor Biopharma Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Xichun Hu, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GB491-008
Identifier Type: -
Identifier Source: org_study_id
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