drugset / Trial / NCT01998906
A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Women With Locally Advanced Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This study will assess the efficacy and safety of adding Herceptin to a paclitaxel-containing regimen followed by cyclophosphamide/methotrexate/fluorouracil (CMF) chemotherapy in women with locally advanced breast cancer and HER2/c-erbB-2 gene amplification. In a parallel observational study patients with HER2-negative disease will receive the same chemotherapy without Herceptin.
Timeline
- Start
- 2002-05
- Primary completion
- 2012-07
- Completion
- 2012-07
Outcome
Met primary endpoint
registry analysis (superiority or other test); HER2+ TC vs HER2+ C; p = 0.0275; Hazard Ratio (HR) 0.65 (95% CI 0.44 to 0.96); Log Rank NCT01998906 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 600 mg/m2 | Intravenous |
| Background | Doxorubicin | Other / unclassified | 60 mg/m2 | Intravenous |
| Background | Methotrexate | Small molecule | 40 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 600 mg/m2 | Intravenous |