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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genor Biopharma Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 14, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2026

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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