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

• Status: Recruiting
• Trial end date: 2027-01-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genor Biopharma Co., Ltd.
• Treatments: Letrozole

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)