The purpose of this study is to assess the efficacy and safety of pyrotinib combined with trastuzumab and abraxane in HER2-positive MBC with brain metastasis.
Overexpression of HER2 is associated with increased incidence of brain metastases in breast cancer, accounting for about 20-50% of HER2 positive breast cancer. Treatment strategy ranged from local therapies to systemic anti-HER2 therapies, prognosis of patients with brain metastases remains poor. Previous clinical trials had demonstrated the efficacy of trastuzumab and TKIs for brain metastasis. Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. We designed the study to explore the efficacy and safety of pyrotinib combined with trastuzumab and abraxane in HER2-positive MBC with brain metastasis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Pyrotinib::400mg/d,qd,po
8 mg/kg intravenously (IV) on Day 1 of Cycle 1, followed by 6 mg/kg on Day1 of each 21-day cycle
Abraxane 125mg/M2, qw iv
Zhiyong Yu
Jinan, Shandong, China
Objective Response Rate (ORR) of Intracranial Lesion
Refers to the proportion of patients whose Intracranial Lesion have shrunk to a certain proportion and maintained for a certain period of time, including cases of CR and PR, RECIST 1.1 were used to assess objective tumor remission
Time frame: Estimated up to 1 year
Progression Free Survival(PFS) of Intracranial Lesion
the date from the first dose to the first occurrence of Intracranial Lesion progression or death from any cause, whichever occurs first
Time frame: Estimated up to 1 year
Progression Free Survival(PFS)
the date from the first dose to the first occurrence of disease progression or death from any cause, whichever occurs first
Time frame: Estimated up to 1 year
Objective Response Rate (ORR)
Refers to the proportion of patients whose lesion have shrunk to a certain proportion and maintained for a certain period of time, including cases of CR and PR, RECIST 1.1 were used to assess objective tumor remission
Time frame: Estimated up to 1 year
disease control rate(DCR)
Percentage of confirmed complete remission (CR), partial remission (PR), and disease stable (SD) cases in patients with evaluable efficacy
Time frame: Estimated up to 1 year
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