A Study of GB491 in Combination With Letrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
Recruiting
Phase 3Interventional Study
Breast Cancer
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
350 (estimated)
Sponsor
Genor Biopharma Co., Ltd. · Industry
Who this trial is looking for
This trial is looking for patients with advanced breast cancer that is hormone receptor-positive and HER2-negative. Participants will receive a treatment combining GB491 and Letrozole or a placebo with Letrozole.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 75 years old.
I have been diagnosed with hormone receptor-positive breast cancer.
I have not had previous treatment for locally advanced or metastatic breast cancer.
I have good organ and marrow function.
I agree to participate by signing an informed consent.
You may not be able to join if
I have taken other CDK4/6 inhibitors.
I am allergic to GB491 or Letrozole.
I have been diagnosed with HER2 positive breast cancer.
I have uncontrolled brain metastases.
I had major surgery or treatment in the last 4 weeks.
I have previously received chemotherapy for recurrent or metastatic breast cancer.
I have significant heart or blood vessel issues.
I have a history of HIV infection.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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
Trial Locations
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Eligibility 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;
* Eas…
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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