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RecruitingNCT05851014Updated May 9, 2023

A Study of GB491 in Combination With Letrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer

A Phase 3 interventional study of GB491 combined with Letrozole and Placebo combined with Letrozole in Breast Cancer, sponsored by Genor Biopharma Co., Ltd.. Recruiting at 52 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-05-09.

Sponsored by Genor Biopharma Co., Ltd. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2026, 8 months ago, but the record still lists the study as recruiting.
  • Registered 1 year 3 months after the study started (first participant enrolled Jan 2022, registered Apr 2023).
  • Started Jan 2022; still recruiting 4 years 8 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
350
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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

02

Conditions studied

  • Breast Cancer

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Keywords

  • HR+/HER2-
  • locally advanced or metastatic breast cancer
  • GB491
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 350 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Genor Biopharma Co., Ltd. is the lead sponsor of 23 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    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;

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
350 participants (estimated)

Study arms

  • Experimental
    GB491 combined with Letrozole

    Drug: GB491 combined with Letrozole

  • Placebo comparator
    Placebo combined with Letrozole

    Drug: Placebo combined with Letrozole

Interventions

  • DrugGB491 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)

  • DrugPlacebo 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)

06

What researchers measure

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).

    Time frame: Approximately 60 months

Secondary outcomes

  1. BICR-assessed PFS based on RECIST v1.1.

    Time frame: Approximately 60 months

  2. OS

    Time frame: Approximately 60 months

  3. ORR

    Time frame: Approximately 60 months

  4. DOR

    Time frame: Approximately 60 months

  5. DCR

    Time frame: Approximately 60 months

  6. CBR

    Time frame: Approximately 60 months

  7. 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

07

Study locations

52 of 52 sites recruiting
  • The First Affiliated Hospital of Bengbu Medical College
    Bengbu, Anhui 233004, China
    Recruiting
  • The First Hospital of Anhui Medical University
    Hefei, Anhui 230022, China
    Recruiting
  • Anhui Cancer Hospital
    Hefei, Anhui 230031, China
    Recruiting
  • The Second Hosptial of Anhui Medical University
    Hefei, Anhui 230601, China
    Recruiting
  • Betjing Tiantan Hosptial，Capital Medical University
    Beijing, Beijing 100070, China
    Recruiting
  • Chinese PLA General Hospial
    Beijing, Beijing 100853, China
    Recruiting
  • The First Affiliated Hospital of Chongqing Medical University
    Chongqing, Chongqing 400016, China
    Recruiting
  • Chongqing University Cancer Hospital
    Chongqing, Chongqing 400030, China
    Recruiting
  • Fujian Medical University Union Hospital
    Fuzhou, Fujian 350001, China
    Recruiting
  • The First Hospital of Wenzhou Medical University
    Wenzhou, Fujian 325000, China
    Recruiting
  • The First Affiliated Hosptial of Xiamen University
    Xiamen, Fujian 361003, China
    Recruiting
  • The First People's Hospital of Foshan
    Foshan, Guangdong 528000, China
    Recruiting
  • Sun Yat-Sen University Cancer Center(Huangpu Campus)
    Guangzhou, Guangdong 510060, China
    Recruiting
  • Sun Yat-Sen University Cancer Center(Yuexiu Campus)
    Guangzhou, Guangdong 510060, China
    Recruiting
  • Maternal and Child Healh Hosptal of Guangdong Provrce
    Guangzhou, Guangdong, China
    Recruiting
  • Meizhou People's Hosptial
    Meizhou, Guangdong 514031, China
    Recruiting
  • Guangxi Medical University Cancer Hospital
    Nanning, Guangxi 530000, China
    Recruiting
  • The Second Affiliated Hospital of Hainan Medical University
    Haikou, Hainan 571300, China
    Recruiting
  • Xingtai People's Hospital
    Xingtai, Hebei 054001, China
    Recruiting
  • The First Affiliated Hosptial of Henan University of Science and Technology
    Luoyang, Henan 471003, China
    Recruiting
  • The First Affiliated Hospital of Zhengzhou University
    Zhengzhou, Henan 450052, China
    Recruiting
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology
    Wuhan, Hubei 430023, China
    Recruiting
  • Renmin Hospital of Wuhan University
    Wuhan, Hubei 430060, China
    Recruiting
  • Hubei Cancer Hospital
    Wuhan, Hubei 430079, China
    Recruiting
  • Hunan Cancer Hospital
    Changsha, Hunan 410013, China
    Recruiting
  • Jiangsu Province Hospital
    Nanjing, Jiangsu 210029, China
    Recruiting
  • First Affiliated Hospital of Gannan Medical University
    Ganzhou, Jiangxi 341000, China
    Recruiting
  • The First Affiliated Hosptial of Nanchang University
    Nanchang, Jiangxi 330006, China
    Recruiting
  • The Nanchang theird people's Hosptial
    Nanchang, Jiangxi 330009, China
    Recruiting
  • Jiangxi Cancer Hospital
    Nanchang, Jiangxi 330029, China
    Recruiting
  • Shangrao People's Hospital
    Shangrao, Jiangxi 334000, China
    Recruiting
  • Jilin Cancer Hospital
    Changchun, Jilin 130021, China
    Recruiting
  • The First Hospital of Jilin University
    Changchun, Jilin 130031, China
    Recruiting
  • Liaoning Cancer Hospital & Institute
    Shenyang, Liaoning 110042, China
    Recruiting
  • General Hospital of Ningxia Medical University
    Yingchuan, Ningxia 750004, China
    Recruiting
  • Xi'an International Medical Center Hospital
    Xi'an, Shaanxi 710100, China
    Recruiting
  • Jinan Central Hospital
    Jinan, Shandong 250013, China
    Recruiting
  • Shandong Provincial Hospital
    Jinan, Shandong 250021, China
    Recruiting
  • Shandong Cancer Hospital
    Jinan, Shandong 250117, China
    Recruiting
  • Affiliated Hospital of Jining Medical University
    Jining, Shandong 272007, China
    Recruiting
  • Liaocheng People's Hospital
    Liaocheng, Shandong 252000, China
    Recruiting
  • Linyi Cancer Hospital
    Linyi, Shandong 276000, China
    Recruiting
  • The Affiliated Hosptial of Qingdao University
    Qingdao, Shandong 266000, China
    Recruiting
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai 200032, China
    Recruiting
  • First Hosptial of Shanxi Medical University
    Taiyuan, Shanxi 030001, China
    Recruiting
  • West China Hospital, Sichuang University
    Chengdu, Sichuang 610044, China
    Recruiting
  • Tianjin Mediacl University Cancer Institute & Hospital
    Tianjin, Tianjin 300060, China
    Recruiting
  • The Cancer Affiliated Hospital of Xingjiang Medical University
    Ürümqi, Xinjiang 830000, China
    Recruiting
  • Yunnan Cancer Hosptial
    Kunming, Yunnan 650106, China
    Recruiting
  • Hangzhou Cancer Hospital
    Hangzhou, Zhejiang 310002, China
    Recruiting
  • The Second Affiliated Hospital Zhejiang University School of Medicine
    Hangzhou, Zhejiang 310052, China
    Recruiting
  • Ningbo Medical Center Lihuili Hospital
    Ningbo, Zhejiang 315100, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05851014
Lead sponsor
Genor Biopharma Co., Ltd.
Responsible party
Sponsor
First posted
May 9, 2023
Start date
Jan 14, 2022
Primary completion
Jan 30, 2026 (estimated)
Completion
Jan 30, 2027 (estimated)
Last update
May 9, 2023

Study contacts

Yankun Fu, Master
Contact
yankun.fu@genorbio.com
021-60751991
Xichun Hu, Ph.D
principal investigator · Fudan University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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