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

RecruitingPhase 3Ages 18 Years - 75 YearsAllGenor Biopharma Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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)
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What it tests

  • GB491 combined with Letrozole
  • Placebo combined with Letrozole
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Where

52 sites
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China
The First Hospital of Anhui Medical University
Hefei, China
Anhui Cancer Hospital
Hefei, China
The Second Hosptial of Anhui Medical University
Hefei, China
Betjing Tiantan Hosptial,Capital Medical University
Beijing, China
Chinese PLA General Hospial
Beijing, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
Chongqing University Cancer Hospital
Chongqing, China

…and 44 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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