drugset / Trial / NCT00826267
6 Weeks Treatment of Locally Advanced Breast Cancer With BIBW 2992 (Afatinib) or Lapatinib or Trastuzumab
RandomizedParallel-groupOpen-labelTreatment
Summary
An open-label, randomized three-arm Phase II trial to explore the efficacy of BIBW 2992 as a single agent versus lapatinib versus trastuzumab in patients with HER2-positive treatment-naïve Stage IIIa locally advanced breast cancer. Additional information will be obtained on the safety profile and pharmacokinetics of BIBW 2992.
Timeline
- Start
- 2009-01
- Primary completion
- 2011-08
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Afatinib | Small molecule | — | — |
| Comparator | Lapatinib | Small molecule | 1500 mg | — |
| Comparator | Trastuzumab | Monoclonal antibody | 2 mg/kg | Intravenous |