The aim of this project is to evaluate whether the sequence of Trastuzumab,pyrotinib and Nab-Paclitaxel in first line followed by SHR-A1811 in second line is superior to the sequence of SHR-A1811 in first line followed by Trastuzumab,pyrotinib and Nab-Paclitaxel in second line for HER2 positive breast cancer brain metastases.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
SHR-A1811:4.8mg/kg tratuzumab:Initial 8mg/kg followed by 6mg/kg pyrotinib:320mg Nab-Paclitaxel:100-150mg/m2
PFS2
Progression-free survival after two lines of treatment (PFS2)
Time frame: 2 years
overall survival(OS)
Date of randomization until date of death due to any cause
Time frame: 4 years
Intracranial CNS progression-free survival
Time from randomization to progression of intracranial lesions
Time frame: 2 years
Progression-free survival
Time from randomization to disease progression
Time frame: 2 years
adverse event
The proportion of patients with adverse reactions according to CTCAE5.0
Time frame: 2 years
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