This study is a prospective, open, multi-center, single arm trial. The treatment group will receive six cycles of docetaxel, carboplatin combined with Inetetamab and Pyrotinib before surgery. By focusing on tpCR (ypT0/is, ypN0) evaluated by pathology, the efficacy of docetaxel, carboplatin combined with Inetetamab and Pyrotinib in the preoperative treatment of locally advanced HER2-positive breast cancer will be evaluated. During long-term follow-up, event-free survival (EFS), disease-free survival (DFS), distant metastasis-free survival (DDFS), overall survival (OS), central nervous system disease-free survival (CNSDFS) under this treatment regimen will be evaluated, and the efficacy-related biomarkers will be explored. The cardiotoxicity of Inetetamab and Pyrotinib in the treatment of breast cancer is also be evaluated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
154
75mg/m2 iv escalating to 100mg/m2 iv 3-weekly
AUC=6 min/mL iv 3-weekly
8mg/kg iv loading dose, followed by 6mg/kg iv 3-weekly
400mg orally daily
the First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
RECRUITINGtpCR
total pathological complete response
Time frame: Approximately 5 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 6)
EFS
Event-free survival
Time frame: Randomization up to a maximum of 329 weeks
DFS
Disease-free survival
Time frame: Randomization up to a maximum of 329 weeks
DDFS
Distant disease free survival
Time frame: Randomization up to a maximum of 329 weeks
OS
Overall survival
Time frame: Up to 2 years
CNS-DFS
Central nervous system disease-free survival
Time frame: Randomization up to a maximum of 329 weeks
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