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

June 10, 2022 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

270

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, 233099
        • Recruiting
        • The First Affiliated Hospital of Bengbu Medical College
        • Contact:
      • Hefei, Anhui, China, 230601
        • Recruiting
        • The Second Hospital of Anhui Medical University
        • Contact:
      • Hefei, Anhui, China, 230031
        • Recruiting
        • Anhui Provincial Cancer Hospital
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:
      • Beijing, Beijing, China, 100039
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:
      • Beijing, Beijing, China, 100020
        • Recruiting
        • Beijing Chaoyang Hospital of Capital Medical University
        • Contact:
      • Beijing, Beijing, China, 100050
        • Active, not recruiting
        • Beijing Tiantan Hospital , Capital Medical University
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
      • Chongqing, Chongqing, China, 400030
        • Recruiting
        • Chongqing University Cancer Hospital
        • Contact:
      • Chongqing, Chongqing, China, 404000
        • Recruiting
        • Chognqing University Three Gorges Hospital
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
      • Xiamen, Fujian, China, 361003
        • Recruiting
        • First Affiliated Hospital 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
        • Contact:
          • Shusen Wang, Ph.D
          • Phone Number: 139 2616 8469
        • Contact:
          • wangshs@sysucc.org.cn
      • Guangzhou, Guangdong, China, 510080
        • Active, not recruiting
        • The First Affiliated Hospital, Sun Yat-sen University
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Guangdong provincial TCM hospital
        • Contact:
          • Qianjun Chen, Ph.D
          • Phone Number: 18688883505
          • Email: cqj55@163.com
      • Meizhou, Guangdong, China, 514031
        • Recruiting
        • Meizhou People's Hospital
        • Contact:
      • Shenzhen, Guangdong, China, 518172
        • Enrolling by invitation
        • Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center Shenzhen Cancer Hospital
    • Hainan
      • Haikou, Hainan, China, 570311
        • Recruiting
        • Hainan General Hospital
        • Contact:
      • Sanya, Hainan, China, 572000
        • Recruiting
        • Hainan Third People's Hospital
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China, 50011
        • Enrolling by invitation
        • The Fourth Hospital of Hebei Medical University
      • Shijiazhuang, Hebei, China, 500311
        • Recruiting
        • Affiliated Hospital of Hebei University
        • Contact:
    • Heilongjiang
      • Haerbin, Heilongjiang, China, 150081
        • Recruiting
        • Harbin Medcial Univercity cancer hospital
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • Henan Cancer Hospital
        • 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, 430022
        • Recruiting
        • Tongji Medical College of Huazhong University of Science and Technology
        • Contact:
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China, 750306
        • Recruiting
        • The Affiliated Hospital of Inner Mongolia Medical University
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Active, not recruiting
        • Jiangsu Province Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China, 330029
        • Recruiting
        • Jiangxi Provincial Hospital
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130012
        • Recruiting
        • Jilin Cancer Hospital
        • Contact:
      • Changchun, Jilin, China, 130041
        • Recruiting
        • The Second Hospital of Jilin University
        • Contact:
    • Jillin
      • Changchun, Jillin, China, 130061
        • Recruiting
        • Bethune First Hospital of Jilin University
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110022
        • Recruiting
        • Shengjing Hospital of China Medical University
        • Contact:
      • Shenyang, Liaoning, China, 110801
        • Recruiting
        • Liaoning Cancer Hospital & Institute
        • Contact:
    • Ningxia
      • Yinchuan, Ningxia, China, 750003
        • Recruiting
        • General Hospital of Ningxia Medical University
        • 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
        • Central Hospital Affiliated To Shandong First Medical University
        • Contact:
      • Jinan, Shandong, China, 250013
        • Recruiting
        • Shandong Provincial Qianfoshan Hospital
        • Contact:
      • Jining, Shandong, China, 272007
        • Recruiting
        • Affiliated Hospital of Jining Medical University
        • Contact:
      • Liaocheng, Shandong, China, 252004
        • Recruiting
        • Liaocheng People's Hospital
        • Contact:
      • Qingdao, Shandong, China, 266003
        • Recruiting
        • The Affiliated Hospital of Qingdao University
        • Contact:
      • Taian, Shandong, China, 271099
        • Recruiting
        • Taian City Central Hospital
        • Contact:
      • Yantai, Shandong, China, 264099
        • Active, not recruiting
        • Yantai Yuhuangding Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Enrolling by invitation
        • Zhongshan Hospital Fudan University
    • Shanxi
      • Taiyuan, Shanxi, China, 003001
        • Recruiting
        • The First Hospital of Shanxi Medical University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610044
        • Recruiting
        • West China School of Medicine
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300181
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
    • Xinjiang
      • Urumqi, Xinjiang, China, 830011
        • Recruiting
        • Affiliated Cancer Hospital of Xinjiang Medical University
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650118
        • Recruiting
        • The Third Affiliated Hospital of Kunming Medical University
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310005
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The Second Affiliated Hospital, Zhejiang University School of Medicine
        • 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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Females or males of 18 years of age or older at study screening
  2. Histologically or cytologically confirmed locally advanced or advanced metastatic breast cancer that is not amenable to curative surgical resection or radiation therapy
  3. The subject has been diagnosed with ER-positive breast cancer in the local laboratory
  4. Subject has HER2-negative breast cancer in the local laboratory
  5. Menopausal status is not limited (including Premenopausal/perimenopausal/postmenopausal state)
  6. 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 only bone metastases are present, there must be at least one osteolytic bone lesion that can be evaluated by CT/MRI
  7. ECOG performance status of 0 or 1
  8. Adequate organ and marrow function.

Exclusion Criteria:

  1. Previous treatment with fulvestrant, everolimus and any other CDK4/6 inhibitors
  2. Subjects 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 14 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. Subjects 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. Subjects have significant hepatic disease
  15. Coagulation abnormalities
  16. Subjects with a history of other primary malignancies, except for non-melanoma skin cancer and cervical cancer in situ disease-free status ≥ 3 years
  17. Lactating women

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+ Fulvestrant

GB491: The dose of GB491 is 150 mg, which should be taken with a meal and taken twice daily at approximately the same time each day, approximately 12 hours apart. 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.
Drug: GB491+ Fulvestrant

GB491: The dose of GB491 is 150 mg, which should be taken with a meal and taken twice daily at approximately the same time each day, approximately 12 hours apart.

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.

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

Placebo: The dose of placebo is 150 mg, which should be taken with a meal and taken twice daily at approximately the same time each day, approximately 12 hours apart. 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.
Drug: Placebo+Fulvestrant

Placebo: The dose of Placebo is 150 mg, which should be taken with a meal and taken twice daily at approximately the same time each day, approximately 12 hours apart.

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.

Other Names:
  • placebo control + Fulvestrant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS by BICR.
Time Frame: Approximately 1.5 years
To assess the progression free survial (PFS), which is assessed by BICR.
Approximately 1.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS by PI
Time Frame: Approximately 1.5 years
To assess the progression free survial (PFS), which is assessed by PI.
Approximately 1.5 years
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
CBR
Time Frame: Approximately 1.5 years
To assess the clinical benefit rate by BICR
Approximately 1.5 years
SAE
Time Frame: Approximately 3 years
To assess the incidence of SAE by Graded according to the National Cancer Institute (NCI CTCAE)
Approximately 3 years
AE
Time Frame: Approximately 3 years
To assess the incidence of AE by Graded according to the National Cancer Institute (NCI CTCAE)
Approximately 3 years
TEAE
Time Frame: Approximately 3 years
To assess the incidence of TEAE by Graded according to the National Cancer Institute (NCI CTCAE)
Approximately 3 years
Cmax
Time Frame: On Day15 of Cycle 1 and Day 1 of Cycle 2-4 (each cycle is 28 days)
To evaluate the Cmax of GB491 and its metabolites G1T30
On Day15 of Cycle 1 and Day 1 of Cycle 2-4 (each cycle is 28 days)
Tmax
Time Frame: On Day15 of Cycle 1 and Day 1 of Cycle 2-4 (each cycle is 28 days)
To evaluate the Tmax of GB491 and its metabolites G1T30
On Day15 of Cycle 1 and Day 1 of Cycle 2-4 (each cycle is 28 days)
AUC
Time Frame: On Day15 of Cycle 1 and Day 1 of Cycle 2-4 (each cycle is 28 days)
To evaluate the AUC of GB491 and its metabolites G1T30
On Day15 of Cycle 1 and Day 1 of Cycle 2-4 (each cycle is 28 days)

Collaborators and Investigators

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

Sponsor

Genor Biopharma Co., Ltd.

Investigators

  • 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)

September 10, 2021

Primary Completion (Anticipated)

October 31, 2023

Study Completion (Anticipated)

January 31, 2024

Study Registration Dates

First Submitted

August 13, 2021

First Submitted That Met QC Criteria

September 22, 2021

First Posted (Actual)

September 23, 2021

Study Record Updates

Last Update Posted (Actual)

June 13, 2022

Last Update Submitted That Met QC Criteria

June 10, 2022

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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