drugset / Trial / NCT01441596

Lux-Breast 3; Afatinib Alone or in Combination With Vinorelbine in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer Suffering From Brain Metastases

NCT01441596

Phase 2 Completed 121 enrolled Boehringer Ingelheim
RandomizedParallel-groupOpen-labelTreatment

Summary

The aim of this study is to investigate the efficacy and safety of afatinib alone or in combination with vinorelbine, as treatment in patients with HER2-overexpressing metastatic breast cancer, who have progressive brain lesions after trastuzumab and/or lapatinib based therapy

Timeline

Start
2011-10
Primary completion
2014-02
Completion
2014-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Afatinib Small molecule 40 mg Oral
Subject Vinorelbine Small molecule 25 mg/m2 Intravenous