This is a prospective, open-label, multi-cohort, phase II study to evaluate the efficacy and safety of Oral metronomic capecitabine combined with pyrotinib in patients with HER2-positive advanced breast cancer who had received prior anti-HER2 ADC drugs (including T-DXd, SHR-A1811, T-DM1, etc.) before treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
400mg or 320mg qd
500mg tid
Progression Free Survival (PFS)
Time frame: The observation period related to this endpoint is up to 36 months.
Objective response rate (ORR)
Time frame: The observation period related to this endpoint is up to 36 months.
Clinical Benefit Rate (CBR)
Time frame: The observation period related to this endpoint is up to 36 months.
Overall Survival (OS)
Time frame: The observation period related to this endpoint is up to 36 months.
Safety(adverse Events [AEs] and Serious Adverse Events [SAEs])
Time frame: From consent through 28 days following treatment completion
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