drugset / Trial / NCT00038402
Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |