Breast Cancer
Conditions
Keywords
HR+/HER2-, locally advanced or metastatic breast cancer, GB491
Brief 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
Interventions
DRUGGB491 combined with Letrozole
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)
DRUGPlacebo combined with Letrozole
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)
Sponsors
Genor Biopharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator-assessed PFS based on RECIST v1.1 | Approximately 60 months | To evaluate progression-free survival (PFS) of GB491 plus Letrozole versus placebo plus Letrozole in HR+/HER2- locally advanced or metastatic breast cancer without prior systemic antitumor therapy (as assessed by the investigator). |
Secondary
| Measure | Time frame |
|---|---|
| OS | Approximately 60 months |
| ORR | Approximately 60 months |
| DOR | Approximately 60 months |
| BICR-assessed PFS based on RECIST v1.1. | Approximately 60 months |
| CBR | Approximately 60 months |
| Number of Participants With adverse events (AEs) and serious adverse events (SAEs) Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0 | Approximately 60 months |
| DCR | Approximately 60 months |
Countries
China
Contacts
Primary ContactYankun Fu, Master
Outcome results
None listed