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

Genor Biopharma

Status and phase

Enrolling

Phase 3

Conditions

Breast Cancer

Treatments

Drug: GB491 combined with Letrozole

Drug: Placebo combined with Letrozole

Study type

Interventional

Funder types

Industry

Identifiers

NCT05851014

GB491-008

Details and patient eligibility

About

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

Enrollment

350 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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)