Actively Recruiting
Phase 3 Study of GB491 with Letrozole for HR Positive, HER2 Negative Advanced Breast Cancer Evaluating Treatment in Patients Without Prior Systemic Therapy
Led by Genor Biopharma Co., Ltd. · Updated on 2023-05-09
350
Participants Needed
52
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of GB491 combined with Letrozole compared to placebo combined with Letrozole in treating patients with hormone receptor-positive HR and human epidermal growth factor receptor 2-negative HER2- locally advanced or metastatic breast cancer. This study focuses on patients who have not previously received systemic antitumor therapy for this condition and aims to provide new treatment insights. Participants are randomly assigned to one of two groups one receives GB491 at 150 mg orally twice daily along with Letrozole 2.5 mg orally once daily, while the other receives a placebo twice daily with the same Letrozole dose. Treatment cycles last 28 days, and the study is designed as a randomized, double-blind, placebo-controlled phase III trial. During the study, participants will be closely monitored for progression-free survival assessed by investigators using RECIST v1.1 criteria over approximately 60 months. Additional measures include overall survival, response rates, duration of response, disease control rates, clinical benefit rates, and the frequency and severity of adverse events. Regular assessments ensure safety and treatment adherence throughout the study period.
CONDITIONS
Brief Title
A Study of GB491 in Combination With Letrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
Research Team
Y
Yankun Fu, Master
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