drugset / Trial / NCT01125566
LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Afatinib | Small molecule | 40 mg | Oral |
| Comparator | Trastuzumab | Monoclonal antibody | 2 mg/kg | Intravenous |
| Background | Vinorelbine | Small molecule | 25 mg/m2 | Intravenous |