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Phase II Study of Primary Chemotherapy With Anthracycline-based Regimen Followed by Nab-paclitaxel and Trastuzumab in Patients With HER2 Positive Breast Cancer
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.
Age
20 - 70 years
Sex
FEMALE
Healthy Volunteers
No
Osaka Medical College
Takatsuki, Osaka, Japan
Start Date
September 1, 2011
Primary Completion Date
November 1, 2013
Completion Date
May 1, 2014
Last Updated
April 22, 2015
46
ACTUAL participants
Nab-paclitaxel
DRUG
Lead Sponsor
Osaka Medical College
NCT04550494
NCT05372640
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