To explore the efficacy and safety of pyrotinib combined with docetaxel regimen in the first-line treatment of HER2-positive metastatic breast cancer.
A multi-center, one-arm, open label design study,which is planned to enroll 79 patients with HER2-positive metastatic breast cancer receiving first-line treatment with pyrotinib and docetaxel. The main purpose of this study was to observe the efficacy and safety of first-line treatment with pyrrolidine and docetaxel for HER2-positive metastatic breast cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
79
Pyrotinib Maleate combine with Docetaxel as the first-line treatment to HER2-positive Metastatic Breast Cancer
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Objective Response Rate
Ratio of CR and PR in all subjects
Time frame: from enrollment to progression or death (for any reason), assessed up to 100 months
PFS
Progression-Free Survival
Time frame: from enrollment to progression or death (for any reason),assessed up to 100 months
DoR
Duration of Response
Time frame: The first evaluation of CR or PR to progression or death (for any reason),assessed up to 100 months
Clinical Benefit Rate
Ratio of CR,PR and SD greater than or equal to 24 weeks in all subjects
Time frame: from enrollment to progression or death (for any reason),assessed up to 100 months
OS
Overall Survival
Time frame: from enrollment to death (for any reason).assessed up to 100 months
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