drugset / Trial / NCT01340430

Neoadjuvant 5-fluorouracil, Epirubicin and Cyclophosphamide (FEC) Followed by Weekly Paclitaxel and Trastuzumab in Her2 Positive Breast Cancer

NCT01340430 ↗

Phase 2 Completed 43 enrolled Lucia Del Mastro,MD
NaSingle-groupOpen-labelTreatment

Summary

The main purpose of this study is to confirm the high pathologic complete response rate after neoadjuvant chemotherapy with FEC followed by weekly paclitaxel and concurrent trastuzumab in Human Epidermal growth factor receptor2 (HER2) positive non operable breast cancer

Timeline

Start
2011-03
Primary completion
2015-12
Completion
2022-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Trastuzumab Monoclonal antibody — —
Background Cyclophosphamide Other / unclassified 600 mg/m2 —
Background Epirubicin Small molecule 90 mg/m2 —
Background Paclitaxel Small molecule 80 mg/m2 —
Background fluorouracil Small molecule 600 mg/m2 —