A Study of GB491 in Combination With Letrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
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
1 other identifier
interventional
350
1 country
52
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 breast-cancer
Started Jan 2022
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 14, 2022
CompletedFirst Submitted
Initial submission to the registry
April 24, 2023
CompletedFirst Posted
Study publicly available on registry
May 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2027
ExpectedMay 9, 2023
May 1, 2023
4 years
April 24, 2023
May 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Investigator-assessed PFS based on RECIST v1.1
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).
Approximately 60 months
Secondary Outcomes (7)
BICR-assessed PFS based on RECIST v1.1.
Approximately 60 months
OS
Approximately 60 months
ORR
Approximately 60 months
DOR
Approximately 60 months
DCR
Approximately 60 months
- +2 more secondary outcomes
Study Arms (2)
GB491 combined with Letrozole
EXPERIMENTALPlacebo combined with Letrozole
PLACEBO COMPARATORInterventions
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)
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
You may qualify if:
- \. 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;
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (52)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004, China
The First Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
Anhui Cancer Hospital
Hefei, Anhui, 230031, China
The Second Hosptial of Anhui Medical University
Hefei, Anhui, 230601, China
Betjing Tiantan Hosptial，Capital Medical University
Beijing, Beijing Municipality, 100070, China
Chinese PLA General Hospial
Beijing, Beijing Municipality, 100853, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
The First Hospital of Wenzhou Medical University
Wenzhou, Fujian, 325000, China
The First Affiliated Hosptial of Xiamen University
Xiamen, Fujian, 361003, China
The First People's Hospital of Foshan
Foshan, Guangdong, 528000, China
Sun Yat-Sen University Cancer Center(Huangpu Campus)
Guangzhou, Guangdong, 510060, China
Sun Yat-Sen University Cancer Center(Yuexiu Campus)
Guangzhou, Guangdong, 510060, China
Maternal and Child Healh Hosptal of Guangdong Provrce
Guangzhou, Guangdong, China
Meizhou People's Hosptial
Meizhou, Guangdong, 514031, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530000, China
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 571300, China
Xingtai People's Hospital
Xingtai, Hebei, 054001, China
The First Affiliated Hosptial of Henan University of Science and Technology
Luoyang, Henan, 471003, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430023, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, 341000, China
The First Affiliated Hosptial of Nanchang University
Nanchang, Jiangxi, 330006, China
The Nanchang theird people's Hosptial
Nanchang, Jiangxi, 330009, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029, China
Shangrao People's Hospital
Shangrao, Jiangxi, 334000, China
Jilin Cancer Hospital
Changchun, Jilin, 130021, China
The First Hospital of Jilin University
Changchun, Jilin, 130031, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110042, China
General Hospital of Ningxia Medical University
Yingchuan, Ningxia, 750004, China
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, 710100, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
Shandong Provincial Hospital
Jinan, Shandong, 250021, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272007, China
Liaocheng People's Hospital
Liaocheng, Shandong, 252000, China
Linyi Cancer Hospital
Linyi, Shandong, 276000, China
The Affiliated Hosptial of Qingdao University
Qingdao, Shandong, 266000, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
First Hosptial of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
West China Hospital, Sichuang University
Chengdu, Sichuang, 610044, China
Tianjin Mediacl University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060, China
The Cancer Affiliated Hospital of Xingjiang Medical University
Ürümqi, Xinjiang, 830000, China
Yunnan Cancer Hosptial
Kunming, Yunnan, 650106, China
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, 310002, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310052, China
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, 315100, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xichun Hu, Ph.D
Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2023
First Posted
May 9, 2023
Study Start
January 14, 2022
Primary Completion
January 30, 2026
Study Completion (Estimated)
January 30, 2027
Last Updated
May 9, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share