Phase II Study of Primary Chemotherapy With Anthracycline-based Regimen Followed by Nab-paclitaxel and Trastuzumab in Patients With HER2 Positive 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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the pathological complete response rate
1 year from last patient enrolled
Mitsuhiko Iwamoto, MD, PhD
Osaka Medical College
Japan: Institutional Review Board