drugset / Trial / NCT00615602
Six vs 12 Months of Trastuzumab With Docetaxel Following FEC as Adjuvant Treatment in N+ Breast Cancer
Phase 3
Completed
489 enrolled
Hellenic Oncology Research Group
University Hospital of Crete · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This trial will compare 6 versus 12 months of trastuzumab in combination with dose dense docetaxel following FE75C as adjuvant chemotherapy in women with axillary lymph node positive breast cancer overexpressing HER2
Timeline
- Start
- 2004-10
- Primary completion
- 2012-05
- Completion
- 2012-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 700 mg/m2 | Intravenous |
| Background | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Background | Epirubicin | Small molecule | 75 mg/m2 | Intravenous |
| Background | Pegfilgrastim | Protein / enzyme biologic | 5 ug/kg | — |
| Background | fluorouracil | Small molecule | 700 mg/m2 | Intravenous |