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Clinical Trials in China / NCT05851014
Recruiting Phase 3

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

NCT05851014 · tracked via the Priya Life Science China tracker
Sponsor
Genor Biopharma Co., Ltd.
Phase
Phase 3
Started
2022-01-14
Last updated
2023-05-09

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

GB491 combined with Letrozole →Placebo combined with Letrozole

GB491 combined with Letrozole: 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)

Placebo combined with Letrozole: 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)

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 outcome measure(s)

Trial sites (52)

FacilityCityRegionStatus
The First Affiliated Hospital of Bengbu Medical College Bengbu Anhui Recruiting
The First Hospital of Anhui Medical University Hefei Anhui Recruiting
Anhui Cancer Hospital Hefei Anhui Recruiting
The Second Hosptial of Anhui Medical University Hefei Anhui Recruiting
Betjing Tiantan Hosptial,Capital Medical University Beijing Beijing Municipality Recruiting
Chinese PLA General Hospial Beijing Beijing Municipality Recruiting
The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality Recruiting
Chongqing University Cancer Hospital Chongqing Chongqing Municipality Recruiting
Fujian Medical University Union Hospital Fuzhou Fujian Recruiting
The First Hospital of Wenzhou Medical University Wenzhou Fujian Recruiting
The First Affiliated Hosptial of Xiamen University Xiamen Fujian Recruiting
The First People's Hospital of Foshan Foshan Guangdong Recruiting
Sun Yat-Sen University Cancer Center(Huangpu Campus) Guangzhou Guangdong Recruiting
Sun Yat-Sen University Cancer Center(Yuexiu Campus) Guangzhou Guangdong Recruiting
Maternal and Child Healh Hosptal of Guangdong Provrce Guangzhou Guangdong Recruiting
Meizhou People's Hosptial Meizhou Guangdong Recruiting
Guangxi Medical University Cancer Hospital Nanning Guangxi Recruiting
The Second Affiliated Hospital of Hainan Medical University Haikou Hainan Recruiting
Xingtai People's Hospital Xingtai Hebei Recruiting
The First Affiliated Hosptial of Henan University of Science and Technology Luoyang Henan Recruiting
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan Hubei Recruiting
Renmin Hospital of Wuhan University Wuhan Hubei Recruiting
Hubei Cancer Hospital Wuhan Hubei Recruiting
Hunan Cancer Hospital Changsha Hunan Recruiting
Jiangsu Province Hospital Nanjing Jiangsu Recruiting
First Affiliated Hospital of Gannan Medical University Ganzhou Jiangxi Recruiting
The First Affiliated Hosptial of Nanchang University Nanchang Jiangxi Recruiting
The Nanchang theird people's Hosptial Nanchang Jiangxi Recruiting
Jiangxi Cancer Hospital Nanchang Jiangxi Recruiting
Shangrao People's Hospital Shangrao Jiangxi Recruiting
Jilin Cancer Hospital Changchun Jilin Recruiting
The First Hospital of Jilin University Changchun Jilin Recruiting
Liaoning Cancer Hospital & Institute Shenyang Liaoning Recruiting
General Hospital of Ningxia Medical University Yingchuan Ningxia Recruiting
Xi'an International Medical Center Hospital Xi'an Shaanxi Recruiting
Jinan Central Hospital Jinan Shandong Recruiting
Shandong Provincial Hospital Jinan Shandong Recruiting
Shandong Cancer Hospital Jinan Shandong Recruiting
Affiliated Hospital of Jining Medical University Jining Shandong Recruiting

+ 12 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05851014 on ClinicalTrials.gov ↗ ← All trials in China