GB491 Combined With Fulvestrant for HR+ HER2- Locally Advanced or Metastatic Breast Cancer

October 7, 2024 updated by: Genor Biopharma Co., Ltd.

A Randomized, Double-blind, Placebo-controlled, Phase III Clinical Trial of GB491 Combined With Fulvestrant in Subjects With HR+, HER2- Locally Advanced or Metastatic Breast Cancer Who Have Progressed on Prior Endocrine Therapy

GB491-004 is a multicenter, randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of GB491 in combination with fulvestrant in patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer who have progressed on prior endocrine therapy.

Study Overview

Status

Status

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

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 (Actual)

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.
275

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, 233099
        • The First Affiliated Hospital of Bengbu Medical College
      • Hefei, Anhui, China, 230601
        • The Second Hospital of Anhui Medical University
      • Hefei, Anhui, China, 230031
        • Anhui Provincial Cancer Hospital
    • Beijing
      • Beijing, Beijing, China, 100021
        • Cancer Hospital Chinese Academy of Medical Sciences
      • Beijing, Beijing, China, 100039
        • Chinese PLA General Hospital
      • Beijing, Beijing, China, 100020
        • Beijing Chaoyang Hospital of Capital Medical University
      • Beijing, Beijing, China, 100050
        • Beijing Tiantan Hospital , Capital Medical University
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • The First Affiliated Hospital of Chongqing Medical University
      • Chongqing, Chongqing, China, 400030
        • Chongqing University Cancer Hospital
      • Chongqing, Chongqing, China, 404000
        • Chognqing University Three Gorges Hospital
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Medical University Union Hospital
      • Xiamen, Fujian, China, 361003
        • First Affiliated Hospital of Xiamen University
    • Guangdong
      • Foshan, Guangdong, China, 528000
        • The First People's Hospital of Foshan
      • Guangzhou, Guangdong, China, 510080
        • The First Affiliated Hospital, Sun Yat-sen University
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University Cancer Center
      • Guangzhou, Guangdong, China, 510120
        • Guangdong provincial TCM hospital
      • Meizhou, Guangdong, China, 514031
        • Meizhou People's hospital
      • Shenzhen, Guangdong, China, 518172
        • Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center Shenzhen Cancer Hospital
    • Hainan
      • Haikou, Hainan, China, 570311
        • Hainan General Hospital
      • Sanya, Hainan, China, 572000
        • Hainan Third People's Hospital
    • Hebei
      • Shijiazhuang, Hebei, China, 50011
        • The Fourth Hospital of Hebei Medical University
      • Shijiazhuang, Hebei, China, 500311
        • Affiliated Hospital of Hebei University
    • Heilongjiang
      • Haerbin, Heilongjiang, China, 150081
        • Harbin Medcial Univercity cancer hospital
    • Henan
      • Zhengzhou, Henan, China, 450052
        • The First Affiliated Hospital of Zhengzhou University
      • Zhengzhou, Henan, China, 450003
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Hubei Cancer Hospital
      • Wuhan, Hubei, China, 430060
        • Renmin Hospital of Wuhan University
      • Wuhan, Hubei, China, 430022
        • Tongji Medical College of Huazhong University of Science and Technology
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China, 750306
        • The Affiliated Hospital of Inner Mongolia Medical University
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Jiangsu Province Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China, 330029
        • Jiangxi Provincial Hospital
    • Jilin
      • Changchun, Jilin, China, 130041
        • The Second Hospital of Jilin University
      • Changchun, Jilin, China, 130012
        • Jilin Cancer Hospital
    • Jillin
      • Changchun, Jillin, China, 130061
        • Bethune First Hospital Of Jilin University
    • Liaoning
      • Shenyang, Liaoning, China, 110022
        • Shengjing Hospital of China Medical University
      • Shenyang, Liaoning, China, 110801
        • Liaoning Cancer Hospital & Institute
    • Ningxia
      • Yinchuan, Ningxia, China, 750003
        • General Hospital of Ningxia Medical University
    • Shandong
      • Jinan, Shandong, China, 250021
        • Shandong Provincial Hospital
      • Jinan, Shandong, China, 250117
        • Shandong Cancer Hospital
      • Jinan, Shandong, China, 250013
        • Shandong Provincial Qianfoshan Hospital
      • Jinan, Shandong, China, 250013
        • Central Hospital Affiliated to Shandong First Medical University
      • Jining, Shandong, China, 272007
        • Affiliated Hospital of Jining Medical University
      • Liaocheng, Shandong, China, 252004
        • Liaocheng People's Hospital
      • Qingdao, Shandong, China, 266003
        • The Affiliated Hospital of Qingdao University
      • Taian, Shandong, China, 271099
        • Taian City Central Hospital
      • Yantai, Shandong, China, 264099
        • Yantai Yuhuangding Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Zhongshan Hospital Fudan University
    • Shanxi
      • Taiyuan, Shanxi, China, 003001
        • The First Hospital of Shanxi Medical University
    • Sichuan
      • Chengdu, Sichuan, China, 610044
        • West China School of Medicine
    • Tianjin
      • Tianjin, Tianjin, China, 300181
        • Tianjin Medical University Cancer Institute & Hospital
    • Xinjiang
      • Urumqi, Xinjiang, China, 830011
        • Affiliated Cancer Hospital of Xinjiang Medical University
    • Yunnan
      • Kunming, Yunnan, China, 650118
        • The Third Affiliated Hospital of Kunming Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310005
        • Zhejiang Cancer Hospital
      • Hangzhou, Zhejiang, China, 310003
        • The Second Affiliated Hospital, Zhejiang University School of Medicine

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. Females or males of 18 years of age or older and less than 75 years of age at study screening
  2. Histologically or cytologically confirmed locally advanced or metastatic breast cancer that is not amenable to curative surgical resection or radiation therapy
  3. Patients have been diagnosed with ER-positive breast cancer in the local laboratory
  4. Patents have been diagnosed with HER2-negative breast cancer in the local laboratory
  5. Menopausal status is not limited (including Premenopausal/perimenopausal/postmenopausal state)
  6. Prior endocrine therapy and chemotherapy, the following are permitted:

1) Prior endocrine adjuvant therapy: a) Radiologic evidence of progressive disease (PD) during or within 12 months following (neo)adjuvant therapy with an aromatase inhibitor (AI) or an anti-estrogen such as tamoxifen, and no subsequent endocrine therapy for locally advanced or metastatic breast cancer; b) Radiologic evidence of PD during or within 12 months following (neo)adjuvant therapy with an AI or an anti-estrogen such as tamoxifen, after receiving the first-line endocrine therapy for locally advanced or metastatic breast cancer, and who developed radiologically documented PD after receiving therapy for ≥ 6 months; c) Radiologically documented PD more than 12 months following the end of adjuvant therapy with AIs or anti-estrogens such as tamoxifen, followed by radiographic progression following first-line therapy with AIs or anti-estrogens for locally advanced or metastatic breast cancer; 2) Progression with radiographic evidence of disease following prior first-line endocrine therapy for locally advanced or metastatic breast cancer in subjects who have not received prior (neo) adjuvant therapy; 3) Prior chemotherapy: In addition to endocrine therapy, subjects are eligible if they received a maximum of 1 prior line of chemotherapy for locally advanced or metastatic breast cancer and discontinued treatment for at least 28 days prior to randomization; 7.According to RECIST V1.1, the patient has at least one measurable lesion that has not been irradiated by radiotherapy and can be evaluated by CT/MRI; If there is no measurable lesion, there must be at least one osteolytic bone lesion that can be evaluated by CT/MRI 8.ECOG performance status of 0 or 1 9.Adequate organ and marrow function.

Key Exclusion Criteria:

  1. Previous treatment with fulvestrant, everolimus or any other CDK4/6 inhibitors
  2. Patients with known hypersensitivity to any component of GB491 or Fulvestrant
  3. Known active, uncontrolled, or symptomatic central nervous system metastasis, carcinomatous meningitis, or clinically manifested leptomeningeal disease, cerebral edema, spinal compression or/and tumor progressive growth
  4. Visceral crisis
  5. Patients with skin lesion only and radiographically non-measurable at baseline
  6. Persistent toxicities (CTCAE Grade >2) caused by previous anticancer therapy, excluding alopecia
  7. Patients who have been on bisphosphonates and denosumab therapy at a stable dose for less than 7 days prior to randomization
  8. Patients who have received limited field radiotherapy in 2 weeks or extended field radiotherapy in 4 weeks before randomization or radiation with more than 30% of the bone marrow
  9. Patients use drugs or fruits containing strong inducers or inhibitors of CYP3A4/5, or drugs with narrow therapeutic window that are mainly metabolized by CYP3A4/5 in 14 days before randomization
  10. Patients with long-term systematic use of corticosteroids
  11. Any severe and/or uncontrollable medical conditions
  12. Patients with severely impaired lung function
  13. Known history of HIV infection or history of HIV seropositivity
  14. Patients have significant hepatic disease

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+ Fulvestrant
Drug: GB491+ Fulvestrant

GB491: The dose of GB491 is 150 mg, BID, which should be taken with a meal. The drug is administered according to the patient's dose group until the progression of disease or an intolerable toxicity occur or meet the criteria for termination of treatment or the patient withdraw informed consent or the sponsor discontinues the trial.

Fulvestrant: Intramuscular injection of flurvexine 500mg on day 1 and day 15 of the first cycle, and flurvexine 500mg on day 1 of the second and subsequent cycles. Flurvexine 500mg should be given slowly (1-2 minutes per injection) on both sides of the buttocks, once 250 mg on each side. The drug is administered according to the patient's dose group until the progression of disease or an intolerable toxicity occur or meet the criteria for termination of treatment or the patient withdraw informed consent or the sponsor discontinues the trial.

Other Names:
  • test drug + Fulvestrant
Placebo Comparator: Placebo+Fulvestrant
Drug: Placebo+Fulvestrant

Placebo: The dose of Placebo is 150 mg, BID, which should be taken with a meal. The placebo is administered according to the patient's dose group until the progression of disease occur or meet the criteria for termination of treatment or the patient withdraw informed consent or the sponsor discontinues the trial.

Fulvestrant: Intramuscular injection of flurvexine 500mg on day 1 and day 15 of the first cycle, and flurvexine 500mg on day 1 of the second and subsequent cycles. Flurvexine 500mg should be given slowly (1-2 minutes per injection) on both sides of the buttocks, once 250 mg on each side. The drug is administered according to the patient's dose group until the progression of disease or an intolerable toxicity occur or meet the criteria for termination of treatment or the patient withdraw informed consent or the sponsor discontinues the trial.

Other Names:
  • placebo control + Fulvestrant

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
PFS assessed by the investigator
Time Frame: Approximately 1.5 years
To assess the PFS assessed by the investigator
Approximately 1.5 years

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
Measure Description
Time Frame
OS
Time Frame: Approximately 3 years
To assess the overall survival (OS)
Approximately 3 years
ORR
Time Frame: Approximately 1.5 years
To assess the objective response rate (ORR)
Approximately 1.5 years
DOR
Time Frame: Approximately 1.5 years
To assess the duration of response
Approximately 1.5 years
DCR
Time Frame: Approximately 1.5 years
To assess the disease control rate
Approximately 1.5 years
PFS assessed by the blinded independent central review (BICR)
Time Frame: Approximately 1.5 years
To assess the PFS assessed by the BICR
Approximately 1.5 years
CBR
Time Frame: Approximately 1.5 years
To assess the clinical benefit rate
Approximately 1.5 years
Safety and tolerability
Time Frame: Approximately 3 years
To assess the safety and tolerability assessed by incidence and severity of adverse events (AEs) and serious AEs (SAEs) according to NCI-CTCAE version 5.0
Approximately 3 years
PK
Time Frame: From Cycle 1 to Cycle 4, approximately 4 months
To assess the PK assessed by population pharmacokinetic analysis based on plasma concentrations of GB491
From Cycle 1 to Cycle 4, approximately 4 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: Binghe Xu, PHD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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.
September 10, 2021

Primary Completion (Actual)

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.
December 2, 2022

Study Completion (Actual)

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.
March 30, 2024

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).
August 13, 2021

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.
September 22, 2021

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.
September 23, 2021

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.
October 10, 2024

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.
October 7, 2024

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.
August 1, 2021

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.
  • GB491-004

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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