drugset / Trial / NCT00038402

Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer

NCT00038402

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the addition of Herceptin to standard chemotherapy treatment of patients newly diagnosed with operable breast cancer. Other objectives: 1) to evaluate the potential of this therapy to reduce the size of the tumor and increase the possibility of breast conservative surgery, 2) evaluate the ability of this regimen to prevent recurrence of breast cancer and impact on survival, 3) determine side effect profile with the addition of Herceptin, and 4) evaluate significance of HER2 expression by two different methods.

Timeline

Start
2001-04
Primary completion
2004-11
Completion
2011-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Trastuzumab Monoclonal antibody 2 mg/kg Intravenous
Background Cyclophosphamide Other / unclassified 500 mg/m2 Intravenous
Background Epirubicin Small molecule 75 mg/m2 Intravenous
Background Paclitaxel Small molecule 225 mg/m2 Intravenous
Background fluorouracil Small molecule 500 mg/m2 Intravenous

Indications