This is a prospective, open label, single-arm study to evaluate the efficacy and safety of neoadjuvant pyrotinib in HER2+ breast cancer patients
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
113
400mg administered as continuous oral once daily from the first day of the study
90mg/m\^2 d1 iv Q2W for 4 cycles
600 mg/m\^2 d1 iv Q2W for 4 cycles
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
tpCR
It is defined as the absence of residual invasive carcinoma in the resected breast cancer specimens stained with hematoxylin and eosin, and no cancer metastasis in all ipsilateral lymph node samples, after completion of neoadjuvant therapy and surgery.
Time frame: immediately after surgery
Objective Response Rate(ORR)
Baseline to measured stable disease
Time frame: 2 years
Disease-free survival(DFS) Baseline to measured date of recurrence or death from any cause
Baseline to measured date of recurrence or death from any cause
Time frame: 3 years
bpCR
After neoadjuvant chemotherapy and surgery, breast was free of any invasive cancer
Time frame: immediately after surgery
Adverse Events rate
Evaluate the nature, incidence and severity of chemotherapy adverse events according to CTCAE 5.0
Time frame: 1-year
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Albumin paclitaxel(125mg/m2 d1、8 iv Q3W for 4 Cycles)/Docetaxel(100mg/m2 d1 iv Q3W for 4 Cycles )
the first cycle is a loading dose of 8 mg / kg, followed by 6 mg / kg. Iv Q3W