A Study of GB491 in Combination With Letrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
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
Genor Biopharma Co., Ltd.
350 participants
Jan 14, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- \. 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 Criteria8
- 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)
Interventions
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)
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)
Locations(52)
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NCT05851014