Clinical trial NCT05851014: 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
Overall status: RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Keywords: HR+/HER2-
locally advanced or metastatic breast cancer
GB491
Lead sponsor: Genor Biopharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-09
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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)

Primary outcomes:
measure: Investigator-assessed PFS based on RECIST v1.1
timeFrame: Approximately 60 months
Secondary outcomes:
measure: BICR-assessed PFS based on RECIST v1.1.
timeFrame: Approximately 60 months
measure: OS
timeFrame: Approximately 60 months
measure: ORR
timeFrame: Approximately 60 months
measure: DOR
timeFrame: Approximately 60 months
measure: DCR
timeFrame: Approximately 60 months
measure: CBR
timeFrame: Approximately 60 months
measure: 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
timeFrame: Approximately 60 months
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Hefei
country: China
facility: The First Hospital of Anhui Medical University
state: Anhui
city: Hefei
country: China
facility: Anhui Cancer Hospital
state: Anhui
city: Hefei
country: China
facility: The Second Hosptial of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Betjing Tiantan Hosptial，Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospial
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Wenzhou
country: China
facility: The First Hospital of Wenzhou Medical University
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hosptial of Xiamen University
state: Fujian
city: Foshan
country: China
facility: The First People's Hospital of Foshan
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center(Huangpu Campus)
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center(Yuexiu Campus)
state: Guangdong
city: Guangzhou
country: China
facility: Maternal and Child Healh Hosptal of Guangdong Provrce
state: Guangdong
city: Meizhou
country: China
facility: Meizhou People's Hosptial
state: Guangdong
city: Nanning
country: China
facility: Guangxi Medical University Cancer Hospital
state: Guangxi
city: Haikou
country: China
facility: The Second Affiliated Hospital of Hainan Medical University
state: Hainan
city: Xingtai
country: China
facility: Xingtai People's Hospital
state: Hebei
city: Luoyang
country: China
facility: The First Affiliated Hosptial of Henan University of Science and Technology
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Ganzhou
country: China
facility: First Affiliated Hospital of Gannan Medical University
state: Jiangxi
city: Nanchang
country: China
facility: The First Affiliated Hosptial of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: The Nanchang theird people's Hosptial
state: Jiangxi
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
state: Jiangxi
city: Shangrao
country: China
facility: Shangrao People's Hospital
state: Jiangxi
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute
state: Liaoning
city: Yingchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Xi'an
country: China
facility: Xi'an International Medical Center Hospital
state: Shaanxi
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Jining
country: China
facility: Affiliated Hospital of Jining Medical University
state: Shandong
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
state: Shandong
city: Linyi
country: China
facility: Linyi Cancer Hospital
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hosptial of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Taiyuan
country: China
facility: First Hosptial of Shanxi Medical University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital, Sichuang University
state: Sichuang
city: Tianjin
country: China
facility: Tianjin Mediacl University Cancer Institute & Hospital
state: Tianjin
city: Ürümqi
country: China
facility: The Cancer Affiliated Hospital of Xingjiang Medical University
state: Xinjiang
city: Kunming
country: China
facility: Yunnan Cancer Hosptial
state: Yunnan
city: Hangzhou
country: China
facility: Hangzhou Cancer Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Medical Center Lihuili Hospital
state: Zhejiang
Study officials:
affiliation: Fudan University
name: Xichun Hu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: