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

Primary Purpose

Locally Advanced or Metastatic Breast Cancer

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
GB491+ Fulvestrant
Placebo+Fulvestrant
Sponsored by
Genor Biopharma Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced or Metastatic Breast Cancer focused on measuring CDK46, Phase III, GB491

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First Affiliated Hospital of Bengbu Medical CollegeRecruiting
  • Anhui Provincial Cancer HospitalRecruiting
  • The Second Hospital of Anhui Medical UniversityRecruiting
  • Beijing Chaoyang Hospital of Capital Medical UniversityRecruiting
  • Cancer hospital Chinese Academy of Medical SciencesRecruiting
  • Chinese PLA General HospitalRecruiting
  • Beijing Tiantan Hospital , Capital Medical University
  • Chongqing University Cancer HospitalRecruiting
  • The First Affiliated Hospital of Chongqing Medical UniversityRecruiting
  • Chognqing University Three Gorges HospitalRecruiting
  • Fujian Medical University Union HospitalRecruiting
  • First Affiliated Hospital of Xiamen UniversityRecruiting
  • The First people's hospital of FoshanRecruiting
  • Sun Yat-sen University Cancer CenterRecruiting
  • The First Affiliated Hospital, Sun Yat-sen University
  • Guangdong provincial TCM hospitalRecruiting
  • Meizhou People's HospitalRecruiting
  • Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center Shenzhen Cancer Hospital
  • Hainan General HospitalRecruiting
  • Hainan Third People's HospitalRecruiting
  • The Fourth Hospital of Hebei Medical University
  • Affiliated hospital of Hebei UniversityRecruiting
  • Harbin Medcial Univercity cancer hospitalRecruiting
  • Henan Cancer HospitalRecruiting
  • The First Affiliated Hospital of Zhengzhou UniversityRecruiting
  • Tongji Medical College of Huazhong University of Science and TechnologyRecruiting
  • Renmin Hospital of Wuhan UniversityRecruiting
  • Hubei Cancer HospitalRecruiting
  • The Affiliated hospital of Inner Mongolia Medical UniversityRecruiting
  • Jiangsu Province Hospital
  • Jiangxi Provincial HospitalRecruiting
  • Jilin Cancer HospitalRecruiting
  • The Second Hospital of Jilin UniversityRecruiting
  • Bethune First Hospital Of Jilin UniversityRecruiting
  • Shengjing Hospital of China Medical UniversityRecruiting
  • Liaoning Cancer hospital & InstituteRecruiting
  • General Hospital of Ningxia Medical UniversityRecruiting
  • Central Hospital Affiliated to Shandong First Medical UniversityRecruiting
  • Shandong Provincial Qianfoshan HospitalRecruiting
  • Shandong Provincial HospitalRecruiting
  • Shandong Cancer HospitalRecruiting
  • Affiliated hospital of Jining Medical UniversityRecruiting
  • Liaocheng People's HospitalRecruiting
  • The Affiliated Hospital of Qingdao UniversityRecruiting
  • Taian City Central HospitalRecruiting
  • Yantai Yuhuangding Hospital
  • Zhongshan Hospital Fudan University
  • The first hospital of Shanxi Medical UniversityRecruiting
  • West China School of MedicineRecruiting
  • Tianjin Medical University Cancer Institute & HospitalRecruiting
  • Affiliated Cancer Hospital of Xinjiang Medical UniversityRecruiting
  • The Third Affiliated Hospital of Kunming Medical UniversityRecruiting
  • The Second Affiliated Hospital, Zhejiang University School of MedicineRecruiting
  • Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GB491+ Fulvestrant

Placebo+Fulvestrant

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

PFS by BICR.
To assess the progression free survial (PFS), which is assessed by BICR.

Secondary Outcome Measures

PFS by PI
To assess the progression free survial (PFS), which is assessed by PI.
OS
To assess the overall survival (OS)
ORR
To assess the objective response rate (ORR)
DOR
To assess the duration of response
DCR
To assess the disease control rate
CBR
To assess the clinical benefit rate by BICR
SAE
To assess the incidence of SAE by Graded according to the National Cancer Institute (NCI CTCAE)
AE
To assess the incidence of AE by Graded according to the National Cancer Institute (NCI CTCAE)
TEAE
To assess the incidence of TEAE by Graded according to the National Cancer Institute (NCI CTCAE)
Cmax
To evaluate the Cmax of GB491 and its metabolites G1T30
Tmax
To evaluate the Tmax of GB491 and its metabolites G1T30
AUC
To evaluate the AUC of GB491 and its metabolites G1T30

Full Information

First Posted
August 13, 2021
Last Updated
June 10, 2022
Sponsor
Genor Biopharma Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05054751
Brief Title
GB491 Combined With Fulvestrant for HR+ HER2- Locally Advanced or Metastatic Breast Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 10, 2021 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genor Biopharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced or Metastatic Breast Cancer
Keywords
CDK46, Phase III, GB491

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GB491+ Fulvestrant
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo+Fulvestrant
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
GB491+ Fulvestrant
Other Intervention Name(s)
test drug + Fulvestrant
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo+Fulvestrant
Other Intervention Name(s)
placebo control + Fulvestrant
Intervention Description
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.
Primary Outcome Measure Information:
Title
PFS by BICR.
Description
To assess the progression free survial (PFS), which is assessed by BICR.
Time Frame
Approximately 1.5 years
Secondary Outcome Measure Information:
Title
PFS by PI
Description
To assess the progression free survial (PFS), which is assessed by PI.
Time Frame
Approximately 1.5 years
Title
OS
Description
To assess the overall survival (OS)
Time Frame
Approximately 3 years
Title
ORR
Description
To assess the objective response rate (ORR)
Time Frame
Approximately 1.5 years
Title
DOR
Description
To assess the duration of response
Time Frame
Approximately 1.5 years
Title
DCR
Description
To assess the disease control rate
Time Frame
Approximately 1.5 years
Title
CBR
Description
To assess the clinical benefit rate by BICR
Time Frame
Approximately 1.5 years
Title
SAE
Description
To assess the incidence of SAE by Graded according to the National Cancer Institute (NCI CTCAE)
Time Frame
Approximately 3 years
Title
AE
Description
To assess the incidence of AE by Graded according to the National Cancer Institute (NCI CTCAE)
Time Frame
Approximately 3 years
Title
TEAE
Description
To assess the incidence of TEAE by Graded according to the National Cancer Institute (NCI CTCAE)
Time Frame
Approximately 3 years
Title
Cmax
Description
To evaluate the Cmax of GB491 and its metabolites G1T30
Time Frame
On Day15 of Cycle 1 and Day 1 of Cycle 2-4 (each cycle is 28 days)
Title
Tmax
Description
To evaluate the Tmax of GB491 and its metabolites G1T30
Time Frame
On Day15 of Cycle 1 and Day 1 of Cycle 2-4 (each cycle is 28 days)
Title
AUC
Description
To evaluate the AUC of GB491 and its metabolites G1T30
Time Frame
On Day15 of Cycle 1 and Day 1 of Cycle 2-4 (each cycle is 28 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Females or males of 18 years of age or older at study screening Histologically or cytologically confirmed locally advanced or advanced metastatic breast cancer that is not amenable to curative surgical resection or radiation therapy The subject has been diagnosed with ER-positive breast cancer in the local laboratory Subject has HER2-negative breast cancer in the local laboratory Menopausal status is not limited (including Premenopausal/perimenopausal/postmenopausal state) 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 ECOG performance status of 0 or 1 Adequate organ and marrow function. Exclusion Criteria: Previous treatment with fulvestrant, everolimus and any other CDK4/6 inhibitors Subjects with known hypersensitivity to any component of GB491 or Fulvestrant 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 Visceral crisis Patients with skin lesion only and radiographically non-measurable at baseline Persistent toxicities (CTCAE Grade >2) caused by previous anticancer therapy, excluding alopecia Patients who have been on bisphosphonates and denosumab therapy at a stable dose for less than 14 days prior to randomization 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 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 Patients with long-term systematic use of corticosteroids Any severe and/or uncontrollable medical conditions Patients with severely impaired lung function Known history of HIV infection or history of HIV seropositivity Subjects have significant hepatic disease Coagulation abnormalities Subjects with a history of other primary malignancies, except for non-melanoma skin cancer and cervical cancer in situ disease-free status ≥ 3 years Lactating women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shawn YU, MD
Phone
18600332657
Ext
18600332657
Email
shawn.yu@genorbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Binghe Xu, PhD
Organizational Affiliation
Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233099
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tingjing Yao, Master
Phone
13855200468
Email
13855200468@163.com
Facility Name
Anhui Provincial Cancer Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changlu Hu, Ph.D
Phone
13955116061
Email
13955116061@139.com
Facility Name
The Second Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230601
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhendong Chen, Ph.D
Phone
13805519892
Email
ay2fychenzhendong@163.com
Facility Name
Beijing Chaoyang Hospital of Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guangyu An, Ph.D
Phone
13811831430
Email
anguangyu@hotmail.com
Facility Name
Cancer hospital Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Binghe Xu, Ph.D
Phone
13501028690
Email
xubinghe@csco.org.cn
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weihong Zhao, Ph.D
Phone
15910853879
Email
zhaowh0818@163.com
Facility Name
Beijing Tiantan Hospital , Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Chongqing University Cancer Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaohua Zeng, Ph.D
Phone
18996340992
Email
1340110079@qq.com
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongyuan Li, Ph.D
Phone
13594232091
Email
c914chengqiao@hotmail.com
Facility Name
Chognqing University Three Gorges Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
404000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huawen Liu, Master
Phone
15023828690
Email
liuhw008@163.com
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunsen Xu, Ph.D
Phone
13306900948
Email
xuchunsen@aliyun.com
Facility Name
First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ru Zeng, Master
Phone
13696951139
Email
499689541@qq.com
Facility Name
The First people's hospital of Foshan
City
Foshan
State/Province
Guangdong
ZIP/Postal Code
528000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danmei Pang, Ph.D
Phone
13923123318
Email
13923123318@139.com
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shusen Wang, Ph.D
Phone
139 2616 8469
First Name & Middle Initial & Last Name & Degree
wangshs@sysucc.org.cn
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Guangdong provincial TCM hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qianjun Chen, Ph.D
Phone
18688883505
Email
cqj55@163.com
Facility Name
Meizhou People's Hospital
City
Meizhou
State/Province
Guangdong
ZIP/Postal Code
514031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Li, Bachelor
Phone
13750559809
Email
liliang@mzrmyy.com
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center Shenzhen Cancer Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518172
Country
China
Individual Site Status
Enrolling by invitation
Facility Name
Hainan General Hospital
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570311
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haixia Wang, Ph.D
Phone
18907568536
Email
wanghaixia74@163.com
Facility Name
Hainan Third People's Hospital
City
Sanya
State/Province
Hainan
ZIP/Postal Code
572000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cuiying Wang, Ph.D
Phone
18889917849
Email
wang.cui.ying2005@163.com
Facility Name
The Fourth Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
50011
Country
China
Individual Site Status
Enrolling by invitation
Facility Name
Affiliated hospital of Hebei University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
500311
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aimin Zang, Ph.D
Phone
13930881628
Email
booszam@sina.com
Facility Name
Harbin Medcial Univercity cancer hospital
City
Haerbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingyuan Zhang, Ph.D
Phone
13313612989
Email
ns86298333@163.com
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongqiang Guo, Ph.D
Phone
15188329236
Email
guohq365@aliyun.com
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuanting Gu, Ph.D
Phone
13703844321
Email
guyuanting2009@163.com
Facility Name
Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Cheng, Ph.D
Phone
13697170525
Email
Chenjin1118@hotmail.com
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiping Tao, Ph.D
Phone
13971698695
Email
taowpwp@sina.com
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinhong Wu, Ph.D
Phone
18602726300
Email
369423971@qq.com
Facility Name
The Affiliated hospital of Inner Mongolia Medical University
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
750306
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ranhua Cao, Master
Phone
15034792565
Email
15034792565@163.com
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Jiangxi Provincial Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhengkui Sun, Ph.D
Phone
13907000210
Email
sunzhengkui616@163.com
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Cheng, Ph.D
Phone
0431-85872488
Email
jl.cheng@163.com
Facility Name
The Second Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingwei Xu, Ph.D
Phone
13843193488
Email
jingweix2000@163.com
Facility Name
Bethune First Hospital Of Jilin University
City
Changchun
State/Province
Jillin
ZIP/Postal Code
130061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Li, Ph.D
Phone
13756661267
Email
jdyylw@163.com
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caigang Liu, Ph.D
Phone
18940254967
Email
niun@sj-hospital.org
Facility Name
Liaoning Cancer hospital & Institute
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110801
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Sun, Ph.D
Phone
13940404526
Email
lnzlrxnsy@163.com
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinlan Liu, Master
Phone
13709577339
Email
nxliuxinlan@163.com
Facility Name
Central Hospital Affiliated to Shandong First Medical University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meili Sun, Ph.D
Phone
18953116532
Email
s18953116532@163.com
Facility Name
Shandong Provincial Qianfoshan Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Liang, Ph.D
Phone
18663761275
Email
liangjing0531@163.com
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weibo Wang, Ph.D
Phone
15168888787
Email
wbwb1620@163.com
Facility Name
Shandong Cancer Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lihua Song, Ph.D
Phone
17653115562
Email
slh9999@vip.163.com
Facility Name
Affiliated hospital of Jining Medical University
City
Jining
State/Province
Shandong
ZIP/Postal Code
272007
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changping Shan, Ph.D
Phone
18678766865
Email
scp9933@163.com
Facility Name
Liaocheng People's Hospital
City
Liaocheng
State/Province
Shandong
ZIP/Postal Code
252004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yumin Yao, Ph.D
Phone
13346258105
Email
yaoyumin@sohu.com
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenfeng Li, Ph.D
Phone
13589381517
Email
li_wenfeng@126.com
Facility Name
Taian City Central Hospital
City
Taian
State/Province
Shandong
ZIP/Postal Code
271099
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhaofeng Zhu, Ph.D
Phone
13375389119
Email
zhuzf8498607@163.com
Facility Name
Yantai Yuhuangding Hospital
City
Yantai
State/Province
Shandong
ZIP/Postal Code
264099
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Enrolling by invitation
Facility Name
The first hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
003001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongyan Jia, Ph.D
Phone
13700515784
Email
13700515784@163.com
Facility Name
West China School of Medicine
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xi Yan, Master
Phone
18980601777
Email
852143552@qq.com
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300181
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongsheng Tong, Ph.D
Phone
022-23340123
Ext
2131
Email
18622221181@163.com
Facility Name
Affiliated Cancer Hospital of Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bing Zhao, Ph.D
Phone
13899908184
Email
819502412@qq.com
Facility Name
The Third Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650118
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianyun Nie, Ph.D
Phone
13608815577
Email
njyvip@sina.com
Facility Name
The Second Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fuming Qiu, Ph.D
Phone
13858005908
Email
qiufuming@zju.edu.cn
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojia Wang, Ph.D
Phone
13906500190
Email
wxiaojia0803@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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