drugset / Trial / NCT00826267

6 Weeks Treatment of Locally Advanced Breast Cancer With BIBW 2992 (Afatinib) or Lapatinib or Trastuzumab

NCT00826267

Phase 2 Completed 29 enrolled Boehringer Ingelheim
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

EvaluationDrugModalityDoseRoute
Subject Afatinib Small molecule
Comparator Lapatinib Small molecule 1500 mg
Comparator Trastuzumab Monoclonal antibody 2 mg/kg Intravenous

Indications