Spots Global Cancer Trial Database for Primary Chemotherapy With Anthracycline Followed by Nab-paclitaxel and Trastuzumab
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Trial Identification
Brief Title: Primary Chemotherapy With Anthracycline Followed by Nab-paclitaxel and Trastuzumab
Official Title: Phase II Study of Primary Chemotherapy With Anthracycline-based Regimen Followed by Nab-paclitaxel and Trastuzumab in Patients With HER2 Positive Breast Cancer
Study ID: NCT01432223
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Osaka Medical College, Takatsuki, Osaka, Japan
Contact Details
Name: Mitsuhiko Iwamoto, MD, PhD
Affiliation: Osaka Medical College
Role: PRINCIPAL_INVESTIGATOR
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