This is a study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HRS-6209 combined with other treatment regimens in breast cancer patients, and preliminarily observe its anti-tumor efficacy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGDose-limiting toxicity (DLT)
Time frame: 28 days after the first dose.
Maximum tolerated dose (MTD)
Time frame: 28 days after the first dose.
Recommended phase II dose (RP2D)
Time frame: 28 days after the first dose.
Adverse events (AEs)
Time frame: About 1 year.
Serious adverse events (SAEs)
Time frame: About 1 year.
Objective response rate (ORR)
Time frame: About 1 year.
Best overall response (BOR)
Time frame: About 1 year.
Duration of response (DoR)
Time frame: About 1 year.
Clinical benefit rate (CBR)
Time frame: About 1 year.
Progression-free survival (PFS)
Time frame: About 1 year.
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