drugset / Trial / NCT01125566

LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment

NCT01125566

Phase 3 Completed 508 enrolled Boehringer Ingelheim
RandomizedParallel-groupOpen-labelTreatment

Summary

To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) treatment

Timeline

Start
2010-06-22
Primary completion
2013-06-08
Completion
2018-07-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Afatinib Small molecule 40 mg Oral
Comparator Trastuzumab Monoclonal antibody 2 mg/kg Intravenous
Background Vinorelbine Small molecule 25 mg/m2 Intravenous

Indications