NCT01432223

Primary Chemotherapy With Anthracycline Followed by Nab-paclitaxel and Trastuzumab

Phase II Study of Primary Chemotherapy With Anthracycline-based Regimen Followed by Nab-paclitaxel and Trastuzumab in Patients With HER2 Positive Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Osaka Medical College · Academic / Other
• Sex: Female
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• HER-2 Positive Breast Cancer
• Effects of Chemotherapy

Interventions

Type	Name	Description
DRUG	Nab-paclitaxel	Nab-paclitaxel 260mg/m2 q3w

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-11-01
• Completion: 2014-05-01
• First posted: 2011-09-12
• Last updated: 2015-04-22

Locations

1 site across 1 country: Japan