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

Primary Purpose

Breast Cancer

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

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring HR+/HER2-, locally advanced or metastatic breast cancer, GB491

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • The First Affiliated Hospital of Bengbu Medical CollegeRecruiting
  • The First Hospital of Anhui Medical UniversityRecruiting
  • Anhui Cancer HospitalRecruiting
  • The Second Hosptial of Anhui Medical UniversityRecruiting
  • Betjing Tiantan Hosptial，Capital Medical UniversityRecruiting
  • Chinese PLA General HospialRecruiting
  • The First Affiliated Hospital of Chongqing Medical UniversityRecruiting
  • Chongqing University Cancer HospitalRecruiting
  • Fujian Medical University Union HospitalRecruiting
  • The First Hospital of Wenzhou Medical UniversityRecruiting
  • The First Affiliated Hosptial of Xiamen UniversityRecruiting
  • The First People's Hospital of FoshanRecruiting
  • Sun Yat-Sen University Cancer Center(Huangpu Campus)Recruiting
  • Sun Yat-Sen University Cancer Center(Yuexiu Campus)Recruiting
  • Maternal and Child Healh Hosptal of Guangdong ProvrceRecruiting
  • Meizhou People's HosptialRecruiting
  • Guangxi Medical University Cancer HospitalRecruiting
  • The Second Affiliated Hospital of Hainan Medical UniversityRecruiting
  • Xingtai People's HospitalRecruiting
  • The First Affiliated Hosptial of Henan University of Science and TechnologyRecruiting
  • The First Affiliated Hospital of Zhengzhou UniversityRecruiting
  • Union Hospital Tongji Medical College Huazhong University of Science and TechnologyRecruiting
  • Renmin Hospital of Wuhan UniversityRecruiting
  • Hubei Cancer HospitalRecruiting
  • Hunan Cancer HospitalRecruiting
  • Jiangsu Province HospitalRecruiting
  • First Affiliated Hospital of Gannan Medical UniversityRecruiting
  • The First Affiliated Hosptial of Nanchang UniversityRecruiting
  • The Nanchang theird people's HosptialRecruiting
  • Jiangxi Cancer HospitalRecruiting
  • Shangrao People's HospitalRecruiting
  • Jilin Cancer HospitalRecruiting
  • The First Hospital of Jilin UniversityRecruiting
  • Liaoning Cancer Hospital & InstituteRecruiting
  • General Hospital of Ningxia Medical UniversityRecruiting
  • Xi'an International Medical Center HospitalRecruiting
  • Jinan Central HospitalRecruiting
  • Shandong Provincial HospitalRecruiting
  • Shandong Cancer HospitalRecruiting
  • Affiliated Hospital of Jining Medical UniversityRecruiting
  • Liaocheng People's HospitalRecruiting
  • Linyi Cancer HospitalRecruiting
  • The Affiliated Hosptial of Qingdao UniversityRecruiting
  • Fudan University Shanghai Cancer CenterRecruiting
  • First Hosptial of Shanxi Medical UniversityRecruiting
  • West China Hospital, Sichuang UniversityRecruiting
  • Tianjin Mediacl University Cancer Institute & HospitalRecruiting
  • The Cancer Affiliated Hospital of Xingjiang Medical UniversityRecruiting
  • Yunnan Cancer HosptialRecruiting
  • Hangzhou Cancer HospitalRecruiting
  • The Second Affiliated Hospital Zhejiang University School of MedicineRecruiting
  • Ningbo Medical Center Lihuili HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GB491 combined with Letrozole

Placebo combined with Letrozole

Arm Description

Outcomes

Primary Outcome Measures

Investigator-assessed PFS based on RECIST v1.1
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).

Secondary Outcome Measures

BICR-assessed PFS based on RECIST v1.1.
OS
ORR
DOR
DCR
CBR
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

Full Information

First Posted
April 24, 2023
Last Updated
May 5, 2023
Sponsor
Genor Biopharma Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05851014
Brief Title
A Study of GB491 in Combination With Letrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 14, 2022 (Actual)
Primary Completion Date
January 30, 2026 (Anticipated)
Study Completion Date
January 30, 2027 (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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
HR+/HER2-, locally advanced or metastatic breast cancer, GB491

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
GB491 combined with Letrozole
Arm Type
Experimental
Arm Title
Placebo combined with Letrozole
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
GB491 combined with Letrozole
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebo combined with Letrozole
Intervention Description
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)
Primary Outcome Measure Information:
Title
Investigator-assessed PFS based on RECIST v1.1
Description
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).
Time Frame
Approximately 60 months
Secondary Outcome Measure Information:
Title
BICR-assessed PFS based on RECIST v1.1.
Time Frame
Approximately 60 months
Title
OS
Time Frame
Approximately 60 months
Title
ORR
Time Frame
Approximately 60 months
Title
DOR
Time Frame
Approximately 60 months
Title
DCR
Time Frame
Approximately 60 months
Title
CBR
Time Frame
Approximately 60 months
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yankun Fu, Master
Phone
021-60751991
Email
yankun.fu@genorbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xichun Hu, Ph.D
Organizational Affiliation
Fudan University
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
233004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gongsheng Jin, Ph.D
Phone
13095520028
Email
Jgs2007@139.com
Facility Name
The First Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingying Du, Ph.D
Phone
13956012561
Email
duyingying@126.com
Facility Name
Anhui 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, Bachelor
Phone
13955116061
Email
13955116061@139.com
Facility Name
The Second Hosptial 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
Zhengdong Chen, Master
Phone
13805519892
Email
az2fychenzhendong@163.com
Facility Name
Betjing Tiantan Hosptial，Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100070
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoyan Li, Ph.D
Phone
13466383808
Email
sharerha@126.com
Facility Name
Chinese PLA General Hospial
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
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
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400016
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiao Cheng, Ph.D
Phone
13098794661
Email
c914chengqiao@hotmail.com
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
Xin Zhou, Ph.D
Phone
13452987363
Email
zhouxin75324@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
Cunsen Xu, Ph.D
Phone
13306900948
Email
xuchunsen@aliyun.com
Facility Name
The First Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Fujian
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaohua Zhang, Bachelor
Phone
13600671188
Email
zhangxiaohua577@163.com
Facility Name
The First Affiliated Hosptial 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 Zhen, 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 Pan, Bachelor
Phone
13923123318
Email
13923123318@139.con
Facility Name
Sun Yat-Sen University Cancer Center(Huangpu Campus)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shushen Wang, Ph.D
Phone
13926168469
Email
wangshs@sysucc.org.cn
Facility Name
Sun Yat-Sen University Cancer Center(Yuexiu Campus)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shushen Wang, Ph.D
Phone
13926168469
Email
wangshs@sysucc.org.cn
Facility Name
Maternal and Child Healh Hosptal of Guangdong Provrce
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anqin Zhang, Master
Phone
13925115929
Email
30452933@qq.com
Facility Name
Meizhou People's Hosptial
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@mzrnyy.com
Facility Name
Guangxi Medical University Cancer Hospital
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weimin Xie, Ph.D
Phone
13907861028
Email
dd.xie@qq.com
Facility Name
The Second Affiliated Hospital of Hainan Medical University
City
Haikou
State/Province
Hainan
ZIP/Postal Code
571300
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chaoying Wang, Bachelor
Phone
13005005580
Email
wangyishen809@sina.com
Facility Name
Xingtai People's Hospital
City
Xingtai
State/Province
Hebei
ZIP/Postal Code
054001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangshun Kong, Bachelor
Phone
13831920816
Email
xtkongxiangshun@163.com
Facility Name
The First Affiliated Hosptial of Henan University of Science and Technology
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinshuai Wang, Ph.D
Phone
13837986128
Email
xshuaiw@126.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
Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430023
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Cheng, Ph.D
Phone
13006178752
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, Bachelor
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
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quchang Ouyang, Ph.D
Phone
13973135318
Email
oyqc1969@126.com
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongmei Yin, Ph.D
Phone
13951842727
Email
Ym.yin@hotmail.com
Facility Name
First Affiliated Hospital of Gannan Medical University
City
Ganzhou
State/Province
Jiangxi
ZIP/Postal Code
341000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guie Lai, Master
Phone
15083736735
Email
15083736735@163.com
Facility Name
The First Affiliated Hosptial of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingliang Li, Ph.D
Phone
13907002935
Email
liyingliang1977@163.com
Facility Name
The Nanchang theird people's Hosptial
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yili Wang, Bachelor
Phone
13970013678
Email
wangyili0823@126.com
Facility Name
Jiangxi Cancer 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
Chunlin Jiang, Ph.D
Phone
13979109200
Email
jclil2002@163.com
Facility Name
Shangrao People's Hospital
City
Shangrao
State/Province
Jiangxi
ZIP/Postal Code
334000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kairong Huang, Bachelor
Phone
13507039656
Email
huangkaitong@163.com
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Cheng, Bachelor
Phone
0431-85872488
Email
ji.chen@163.com
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130031
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
Liaoning Cancer Hospital & Institute
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Sun, Ph.D
Phone
18900918788
Email
Inzlrxnsy@163.com
Facility Name
General Hospital of Ningxia Medical University
City
Yingchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinlan Liu, Master
Phone
13709577339
Email
liuxinlan@csco.ac.cn
Facility Name
Xi'an International Medical Center Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710100
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Xue, Ph.D
Phone
13992830596
Email
1410605461@qq.com
Facility Name
Jinan Central 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
Meili Sun, Ph.D
Phone
18953116532
Email
s18953116532@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, Master
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, Master
Phone
13665312188
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, Master
Phone
18678766865
Email
scp9933@163.com
Facility Name
Liaocheng People's Hospital
City
Liaocheng
State/Province
Shandong
ZIP/Postal Code
252000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yumin Yao, Bachelor
Phone
13346528105
Email
yaoyumin@sohu.com
Facility Name
Linyi Cancer Hospital
City
Linyi
State/Province
Shandong
ZIP/Postal Code
276000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingfen Wang, Bachelor
Phone
15963976026
Email
2298641960@qq.com
Facility Name
The Affiliated Hosptial of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266000
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
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xichun Hu, Ph.D
Phone
13816110335
Email
xchu2009@hotmail.com
Facility Name
First Hosptial of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
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 Hospital, Sichuang University
City
Chengdu
State/Province
Sichuang
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 Mediacl University Cancer Institute & Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongsheng Tong, Master
Phone
18622221181
Email
18622221181@163.com
Facility Name
The Cancer Affiliated Hospital of Xingjiang Medical University
City
Ürümqi
State/Province
Xinjiang
ZIP/Postal Code
830000
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
Yunnan Cancer Hosptial
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650106
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dedian Chen, Master
Phone
13888087308
Email
chendedian2006@126.com
Facility Name
Hangzhou Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shangnao Xie, Master
Phone
13505817153
Email
xieshangnao@126.com
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310052
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
Ningbo Medical Center Lihuili Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315100
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weizhu Wu, Bachelor
Phone
13957402451
Email
1144184462@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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