A Study of GB491 in Combination With Letrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT05851014
- Lead Sponsor
- Genor Biopharma Co., Ltd.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 350
-
- 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;
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GB491 combined with Letrozole GB491 combined with Letrozole - Placebo combined with Letrozole Placebo combined with Letrozole -
- Primary Outcome Measures
Name Time Method Investigator-assessed PFS based on RECIST v1.1 Approximately 60 months 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
Name Time Method DCR Approximately 60 months 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 Approximately 60 months BICR-assessed PFS based on RECIST v1.1. Approximately 60 months OS Approximately 60 months CBR Approximately 60 months ORR Approximately 60 months DOR Approximately 60 months
Trial Locations
- Locations (52)
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
The First Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Anhui Cancer Hospital
🇨🇳Hefei, Anhui, China
The Second Hosptial of Anhui Medical University
🇨🇳Hefei, Anhui, China
Betjing Tiantan Hosptial，Capital Medical University
🇨🇳Beijing, Beijing, China
Chinese PLA General Hospial
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Chongqing University Cancer Hospital
🇨🇳Chongqing, Chongqing, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
The First Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Fujian, China
Scroll for more (42 remaining)The First Affiliated Hospital of Bengbu Medical College🇨🇳Bengbu, Anhui, ChinaGongsheng Jin, Ph.DContact13095520028Jgs2007@139.com