This study aims to evaluate the safety, tolerability, efficacy and pharmacokinetics of HRS-6208 in combination with HRS-8080 ± HRS-6209, or in combination with fulvestrant ± HRS-6209, or in combination with letrozole ± HRS-6209 in patients with advanced unresectable or metastatic breast cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
HRS-6208 capsule.
HRS-6209 capsule.
HRS-8080 tablet.
Fulvestrant injection.
Letrozole tablets.
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
RECRUITINGWest China Hospital, Sichuan University
Chengdu, Sichuan, China
RECRUITINGDose-limiting toxicity (DLT)
Time frame: The DLT will be evaluated for the last participant in each dose group 28 days after the first dose.
Recommended phase II dose (RP2D)
Time frame: The evaluation of RP2D will be completed approximately one year later than DLT evaluation.
Incidence and severity of adverse events (AEs)
Time frame: Each individual participant will be followed for approximately 8 months, and the entire study process will last for approximately 36 months.
Objective response rate (ORR)
Time frame: For a single subject, the duration will be approximately 8 months, while the entire research process will last for 36 months.
Disease control rate (DCR)
Time frame: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
Duration of response (DoR)
Time frame: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
Progression-free survival (PFS)
Time frame: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
Overall survival (OS)
Time frame: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
The blood drug concentration of HRS-6208
Time frame: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
The blood drug concentration of HRS-8080
Time frame: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
The blood drug concentration of HRS-6209
Time frame: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
The blood drug concentration of Letrozole
Time frame: The duration for a single subject will be approximately 8 months, and the entire research process will last for 36 months.
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