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

May 5, 2023 updated by: Genor Biopharma Co., Ltd.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China, 233004
        • Recruiting
        • The First Affiliated Hospital of Bengbu Medical College
        • Contact:
      • Hefei, Anhui, China, 230031
        • Recruiting
        • Anhui Cancer Hospital
        • Contact:
      • Hefei, Anhui, China, 230022
        • Recruiting
        • The First Hospital of Anhui Medical University
        • Contact:
      • Hefei, Anhui, China, 230601
        • Recruiting
        • The Second Hosptial of Anhui Medical University
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100070
        • Recruiting
        • Betjing Tiantan Hosptial，Capital Medical University
        • Contact:
      • Beijing, Beijing, China, 100853
        • Recruiting
        • Chinese PLA General Hospial
        • Contact:
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
      • Chongqing, Chongqing, China, 400030
        • Recruiting
        • Chongqing University Cancer Hospital
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
      • Wenzhou, Fujian, China, 325000
        • Recruiting
        • The first hospital of Wenzhou Medical University
        • Contact:
      • Xiamen, Fujian, China, 361003
        • Recruiting
        • The First Affiliated Hosptial of Xiamen University
        • Contact:
    • Guangdong
      • Foshan, Guangdong, China, 528000
        • Recruiting
        • The First People's Hospital of Foshan
        • Contact:
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-Sen University Cancer Center(Huangpu Campus)
        • Contact:
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-Sen University Cancer Center(Yuexiu Campus)
        • Contact:
      • Guangzhou, Guangdong, China
        • Recruiting
        • Maternal and Child Healh Hosptal of Guangdong Provrce
        • Contact:
      • Meizhou, Guangdong, China, 514031
        • Recruiting
        • Meizhou People's Hosptial
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530000
        • Recruiting
        • Guangxi Medical University Cancer Hospital
        • Contact:
          • Weimin Xie, Ph.D
          • Phone Number: 13907861028
          • Email: dd.xie@qq.com
    • Hainan
      • Haikou, Hainan, China, 571300
        • Recruiting
        • The Second Affiliated Hospital of Hainan Medical University
        • Contact:
    • Hebei
      • Xingtai, Hebei, China, 054001
        • Recruiting
        • Xingtai People's Hospital
        • Contact:
    • Henan
      • Luoyang, Henan, China, 471003
        • Recruiting
        • The First Affiliated Hosptial of Henan University of Science and Technology
        • Contact:
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Recruiting
        • Renmin Hospital of Wuhan University
        • Contact:
      • Wuhan, Hubei, China, 430079
        • Recruiting
        • Hubei Cancer Hospital
        • Contact:
      • Wuhan, Hubei, China, 430023
        • Recruiting
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer Hospital
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Jiangsu Province Hospital
        • Contact:
    • Jiangxi
      • Ganzhou, Jiangxi, China, 341000
        • Recruiting
        • First Affiliated hospital of Gannan Medical University
        • Contact:
      • Nanchang, Jiangxi, China, 330029
        • Recruiting
        • Jiangxi Cancer Hospital
        • Contact:
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The First Affiliated Hosptial of Nanchang University
        • Contact:
      • Nanchang, Jiangxi, China, 330009
        • Recruiting
        • The Nanchang theird people's Hosptial
        • Contact:
      • Shangrao, Jiangxi, China, 334000
        • Recruiting
        • Shangrao People's Hospital
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • Jilin Cancer Hospital
        • Contact:
      • Changchun, Jilin, China, 130031
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110042
        • Recruiting
        • Liaoning cancer Hospital & Institute
        • Contact:
    • Ningxia
      • Yingchuan, Ningxia, China, 750004
        • Recruiting
        • General Hospital of Ningxia Medical University
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710100
        • Recruiting
        • Xi'an International Medical Center Hospital
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250021
        • Recruiting
        • Shandong Provincial Hospital
        • Contact:
      • Jinan, Shandong, China, 250117
        • Recruiting
        • Shandong Cancer Hospital
        • Contact:
      • Jinan, Shandong, China, 250013
        • Recruiting
        • Jinan Central Hospital
        • Contact:
      • Jining, Shandong, China, 272007
        • Recruiting
        • Affiliated Hospital of Jining Medical University
        • Contact:
      • Liaocheng, Shandong, China, 252000
        • Recruiting
        • Liaocheng People's Hospital
        • Contact:
      • Linyi, Shandong, China, 276000
        • Recruiting
        • Linyi Cancer Hospital
        • Contact:
      • Qingdao, Shandong, China, 266000
        • Recruiting
        • The Affiliated Hosptial of Qingdao University
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Recruiting
        • First Hosptial of Shanxi Medical University
        • Contact:
    • Sichuang
      • Chengdu, Sichuang, China, 610044
        • Recruiting
        • West China Hospital, Sichuang University
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Mediacl University Cancer Institute & Hospital
        • Contact:
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830000
        • Recruiting
        • The Cancer Affiliated Hospital of Xingjiang Medical University
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650106
        • Recruiting
        • Yunnan Cancer Hosptial
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310002
        • Recruiting
        • Hangzhou Cancer Hospital
        • Contact:
      • Hangzhou, Zhejiang, China, 310052
        • Recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
      • Ningbo, Zhejiang, China, 315100
        • Recruiting
        • Ningbo Medical Center Lihuili Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GB491 combined with Letrozole
Drug: 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 Comparator: Placebo combined with Letrozole
Drug: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Approximately 60 months

Secondary Outcome Measures

Outcome Measure
Time Frame
BICR-assessed PFS based on RECIST v1.1.
Time Frame: Approximately 60 months
Approximately 60 months
OS
Time Frame: Approximately 60 months
Approximately 60 months
ORR
Time Frame: Approximately 60 months
Approximately 60 months
DOR
Time Frame: Approximately 60 months
Approximately 60 months
DCR
Time Frame: Approximately 60 months
Approximately 60 months
CBR
Time Frame: Approximately 60 months
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
Approximately 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genor Biopharma Co., Ltd.

Investigators

  • Principal Investigator: Xichun Hu, Ph.D, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2022

Primary Completion (Anticipated)

January 30, 2026

Study Completion (Anticipated)

January 30, 2027

Study Registration Dates

First Submitted

April 24, 2023

First Submitted That Met QC Criteria

May 5, 2023

First Posted (Actual)

May 9, 2023

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 5, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GB491-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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