The purpose of this study is to evaluate the efficacy in terms of the pathological complete response (pCR) rate and the efficacy to preoperative administration of Anthracycline-based regimen followed by Nab-paclitaxel and Trastuzumab in patients with HER2 positive operable breast cancer.
Four cycles of anthracycline-based regimen followed by four cycles of Nab-paclitaxel and Trastuzumab are administrated. Anthracycline-based regimen (d1, q3w): EC (Epirubicin 90mg/m2 and Cyclophosphamide 600mg/m2) AC (Doxorubicin 60mg/m2 and Cyclophosphamide 600mg/m2) FEC (Fluorouracil 500mg/m2, Epirubicin 100mg/m2 and Cyclophosphamide 500mg/m2) Nab-paclitaxel 260mg/m2 (d1, q3w) Trastuzumab (d1, q3w) is given at a dose of 8 mg/kg IV on day 1 of the first treatment cycle over 90 min, and subsequently given at a dose of 6 mg/kg over 30 min.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Nab-paclitaxel 260mg/m2 q3w
Osaka Medical College
Takatsuki, Osaka, Japan
To evaluate the pathological complete response rate
Time frame: 1 year from last patient enrolled
Disease free survival
Time frame: 5 years from the last patient enrolled
Overall response rate
Time frame: After the protocol therapy
Pathological response rate
Time frame: After the protocol therapy
Breast-conserving surgery rate
Time frame: After the protocol therapy
Safety
Time frame: Within the protocol thepapy
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