A single-arm, multicenter, real-world observational study of pyrotinib combined with trastuzumab for maintenance therapy after first-line TH (P) therapy for HER2+ABC
In this study, after at least 4 cycles of taxoid chemotherapy combined with trastuzumab ± pertuzumab, the evaluation result reached SD, CR or PR, and capecitabine combined with pyrotinib + trastuzumab was given successively in the later period (capecitabine was used for 4-6 cycles; Single-arm, multicenter, real-world observational studies using endocrine therapy + pyrrotinib + trastuzumab in patients with HR+, and maintenance therapy after first-line TH (P) therapy for CNS events (if non-CNS recurrent, progressive events occur and the investigator decides to change the follow-up regimen). To evaluate the effect of pyrrotinib combined with trastuzumab in maintaining treatment phase delay/reduction of brain metastases after first-line TH (P) therapy for advanced breast cancer with HER-2 positivity, the incidence of first progression of brain metastases was used as the primary endpoint.
Study Type
OBSERVATIONAL
Enrollment
60
In this study, after at least 4 cycles of taxoid chemotherapy combined with trastuzumab ± pertuzumab, the evaluation result reached SD, CR or PR, and capecitabine combined with pyrotinib + trastuzumab was given successively in the later period (capecitabine was used for 4-6 cycles
Fujian Union Medical College Hospital
Fuzhou, Fujian, China
RECRUITINGIncidence of brain metastases
Incidence of brain metastases at first disease progression
Time frame: through study completion, an average of 2 year
ORR
Overall Response Rate
Time frame: 24 month
PFS
Progression-free survival
Time frame: through study completion, an average of 2 year
OS
overall survival
Time frame: through study completion, an average of 3 year
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