This is a multicenter, open-label, single-arm, prospective, phase II study. conducted to evaluate the efficacy, safety and tolerability of nab-paclitaxel plus pyrotinib in patients with lymph node-negative and tumor size ≤3 cm, HER2 positive breast cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
261
Nab-paclitaxel I.V. 260mg/m2 every 3 weeks for 12 weeks plus pyrotinib oral 240mg daily for one year
3-year-DFS
3-years-disease free survival rate
Time frame: From the start of treatment to 3 years
AEs+SAEs
Adverse Events and Serious Adverse Events are described in terms of CTC AE 5.0
Time frame: from the first drug administration to within 28 days for the last pyrotinib dose
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