Breast CancerPhase 3NCT05851014
A Study of GB491 in Combination With Letrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
A Phase 3 study testing GB491 combined with Letrozole in people with Breast Cancer, run by Genor Biopharma Co., Ltd. at 52 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- GB491 combined with Letrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 52 sitesChina
- Study dates
- 14 Jan 2022to 30 Jan 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. 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;
Who cannot join
- 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)
Trial locations and contacts
52 sites in 1 country. Contact the study team or a site near you to ask about taking part.
52 sites in 1 country
China52 sites, 52 recruiting
- Recruiting
Betjing Tiantan Hosptial，Capital Medical University
Beijing, Beijing Municipality, 100070
Xiaoyan Li, Ph.D, 13466383808, sharerha@126.com
- Recruiting
Chinese PLA General Hospial
Beijing, Beijing Municipality, 100853
Weihong Zhao, Ph.D, 15910853879, zhaowh0818@163.com
- Recruiting
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004
Gongsheng Jin, Ph.D, 13095520028, Jgs2007@139.com
- Recruiting
Jilin Cancer Hospital
Changchun, Jilin, 130021
Ying Cheng, Bachelor, 0431-85872488, ji.chen@163.com
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130031
Wei Li, Ph.D, 13756661267, jdyylw@163.com
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Quchang Ouyang, Ph.D, 13973135318, oyqc1969@126.com
- Recruiting
West China Hospital, Sichuang University
Chengdu, Sichuang, 610044
Xi Yan, Master, 18980601777, 852143552@qq.com
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Qiao Cheng, Ph.D, 13098794661, c914chengqiao@hotmail.com
- Recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Xin Zhou, Ph.D, 13452987363, zhouxin75324@163.com
- Recruiting
The First People's Hospital of Foshan
Foshan, Guangdong, 528000
Danmei Pan, Bachelor, 13923123318, 13923123318@139.con
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Cunsen Xu, Ph.D, 13306900948, xuchunsen@aliyun.com
- Recruiting
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, 341000
Guie Lai, Master, 15083736735, 15083736735@163.com
- Recruiting
Sun Yat-Sen University Cancer Center(Huangpu Campus)
Guangzhou, Guangdong, 510060
Shushen Wang, Ph.D, 13926168469, wangshs@sysucc.org.cn
- Recruiting
Sun Yat-Sen University Cancer Center(Yuexiu Campus)
Guangzhou, Guangdong, 510060
Shushen Wang, Ph.D, 13926168469, wangshs@sysucc.org.cn
- Recruiting
Maternal and Child Healh Hosptal of Guangdong Provrce
Guangzhou, Guangdong
Anqin Zhang, Master, 13925115929, 30452933@qq.com
- Recruiting
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 571300
Chaoying Wang, Bachelor, 13005005580, wangyishen809@sina.com
- Recruiting
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, 310002
Shangnao Xie, Master, 13505817153, xieshangnao@126.com
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310052
Fuming Qiu, Ph.D, 13858005908, qiufuming@zju.edu.cn
- Recruiting
The First Hospital of Anhui Medical University
Hefei, Anhui, 230022
Yingying Du, Ph.D, 13956012561, duyingying@126.com
- Recruiting
Anhui Cancer Hospital
Hefei, Anhui, 230031
Changlu Hu, Bachelor, 13955116061, 13955116061@139.com
- Recruiting
The Second Hosptial of Anhui Medical University
Hefei, Anhui, 230601
Zhengdong Chen, Master, 13805519892, az2fychenzhendong@163.com
- Recruiting
Jinan Central Hospital
Jinan, Shandong, 250013
Meili Sun, Ph.D, 18953116532, s18953116532@163.com
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong, 250021
Weibo Wang, Master, 15168888787, wbwb1620@163.com
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
Lihua Song, Master, 13665312188, slh9999@vip.163.com
- Recruiting
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272007
Changping Shan, Master, 18678766865, scp9933@163.com
- Recruiting
Yunnan Cancer Hosptial
Kunming, Yunnan, 650106
Dedian Chen, Master, 13888087308, chendedian2006@126.com
- Recruiting
Liaocheng People's Hospital
Liaocheng, Shandong, 252000
Yumin Yao, Bachelor, 13346528105, yaoyumin@sohu.com
- Recruiting
Linyi Cancer Hospital
Linyi, Shandong, 276000
Jingfen Wang, Bachelor, 15963976026, 2298641960@qq.com
- Recruiting
The First Affiliated Hosptial of Henan University of Science and Technology
Luoyang, Henan, 471003
Xinshuai Wang, Ph.D, 13837986128, xshuaiw@126.com
- Recruiting
Meizhou People's Hosptial
Meizhou, Guangdong, 514031
Liang Li, Bachelor, 13750559809, liliang@mzrnyy.com
- Recruiting
The First Affiliated Hosptial of Nanchang University
Nanchang, Jiangxi, 330006
Yingliang Li, Ph.D, 13907002935, liyingliang1977@163.com
- Recruiting
The Nanchang theird people's Hosptial
Nanchang, Jiangxi, 330009
Yili Wang, Bachelor, 13970013678, wangyili0823@126.com
- Recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
Chunlin Jiang, Ph.D, 13979109200, jclil2002@163.com
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Yongmei Yin, Ph.D, 13951842727, Ym.yin@hotmail.com
- Recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530000
Weimin Xie, Ph.D, 13907861028, dd.xie@qq.com
- Recruiting
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, 315100
Weizhu Wu, Bachelor, 13957402451, 1144184462@qq.com
- Recruiting
The Affiliated Hosptial of Qingdao University
Qingdao, Shandong, 266000
Wenfeng Li, Ph.D, 13589381517, li_wenfeng@126.com
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xichun Hu, Ph.D, 13816110335, xchu2009@hotmail.com
- Recruiting
Shangrao People's Hospital
Shangrao, Jiangxi, 334000
Kairong Huang, Bachelor, 13507039656, huangkaitong@163.com
- Recruiting
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110042
Tao Sun, Ph.D, 18900918788, Inzlrxnsy@163.com
- Recruiting
First Hosptial of Shanxi Medical University
Taiyuan, Shanxi, 030001
Hongyan Jia, Ph.D, 13700515784, 13700515784@163.com
- Recruiting
Tianjin Mediacl University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Zhongsheng Tong, Master, 18622221181, 18622221181@163.com
- Recruiting
The Cancer Affiliated Hospital of Xingjiang Medical University
Ürümqi, Xinjiang, 830000
Bing Zhao, Ph.D, 13899908184, 819502412@qq.com
- Recruiting
The First Hospital of Wenzhou Medical University
Wenzhou, Fujian, 325000
Xiaohua Zhang, Bachelor, 13600671188, zhangxiaohua577@163.com
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430023
Jing Cheng, Ph.D, 13006178752, Chenjin1118@hotmail.com
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Weiping Tao, Bachelor, 13971698695, taowpwp@sina.com
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Xinhong Wu, Ph.D, 18602726300, 369423971@qq.com
- Recruiting
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, 710100
Yan Xue, Ph.D, 13992830596, 1410605461@qq.com
- Recruiting
The First Affiliated Hosptial of Xiamen University
Xiamen, Fujian, 361003
Ru Zhen, Master, 13696951139, 499689541@qq.com
- Recruiting
Xingtai People's Hospital
Xingtai, Hebei, 054001
Xiangshun Kong, Bachelor, 13831920816, xtkongxiangshun@163.com
- Recruiting
General Hospital of Ningxia Medical University
Yingchuan, Ningxia, 750004
Xinlan Liu, Master, 13709577339, liuxinlan@csco.ac.cn
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Yuanting Gu, Ph.D, 13703844321, guyuanting2009@163.com
About this study
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
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
- Breast Cancer
- Being tested
- GB491 combined with Letrozole, Placebo combined with Letrozole
- Keywords
- HR+/HER2-, locally advanced or metastatic breast cancer, GB491
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB491 combined with LetrozoleDrug
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 LetrozoleDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| GB491 combined with Letrozole | Experimental | Not described Receives: Drug: GB491 combined with Letrozole |
| Placebo combined with Letrozole | Placebo comparator | Not described Receives: Drug: Placebo combined with Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Approximately 60 months
Secondary outcomes (7)
BICR-assessed PFS based on RECIST v1.1.
Measured: Approximately 60 months
OS
Measured: Approximately 60 months
ORR
Measured: Approximately 60 months
DOR
Measured: Approximately 60 months
DCR
Measured: Approximately 60 months
CBR
Measured: 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
Measured: Approximately 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start14 Jan 2022
- Primary completion30 Jan 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genor Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xichun Hu, Ph.D, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851014
- Sponsor's protocol ID
- GB491-008
- Status last verified
- May 2023
- First submitted
- 24 Apr 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05851014
- Acronym / sponsor ID
- GB491-008
- Conditions
- Breast Cancer
- Keywords
- HR+/HER2-, locally advanced or metastatic breast cancer, GB491
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Genor Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GB491 combined with Letrozole | Experimental | Drug: GB491 combined with Letrozole |
| Placebo combined with Letrozole | Placebo comparator | Drug: Placebo combined with Letrozole |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GB491 combined with LetrozolePatients 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) | Drug | GB491 combined with Letrozole |
| Placebo combined with LetrozolePatients 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) | Drug | Placebo combined with Letrozole |
Primary outcome
Investigator-assessed PFS based on RECIST v1.1
Time frame: 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).
7 secondary outcomes
BICR-assessed PFS based on RECIST v1.1.
Time frame: Approximately 60 months
OS
Time frame: Approximately 60 months
ORR
Time frame: Approximately 60 months
DOR
Time frame: Approximately 60 months
DCR
Time frame: Approximately 60 months
CBR
Time frame: 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
Time frame: Approximately 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xichun Hu, Ph.D principal investigator
Fudan University
52 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GB491 combined with Letrozole in people with Breast Cancer, run by Genor Biopharma Co., Ltd. at 52 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yankun Fu, Master (021-60751991, yankun.fu@genorbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator-assessed PFS based on RECIST v1.1 (time frame: Approximately 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.