drugset
drugset / Trial / NCT00130507

Benefit of Adding Trastuzumab to Second Line Chemotherapy in Breast Cancer Patients Previously Treated With Trastuzumab

NCT00130507 ↗

Phase 2 Terminated 14 enrolled Spanish Breast Cancer Research Group Hoffmann-La Roche · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

Eligible patients must receive vinorelbine plus capecitabine, with or without trastuzumab, until disease progression or unbearable toxicity. Cycles will be administered every 3 weeks.Human epidermal growth factor receptor 2 (HER2) status must be locally assessed by immunohistochemistry (IHC). All 3+ patients are eligible. In 2+ patients, HER2 status must be confirmed by fluorescence in situ hybridization (FISH).

Timeline

Start
2005-11-04
Primary completion
2009-06
Completion
2009-07-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Trastuzumab Monoclonal antibody 2 mg/kg Intravenous
Background Capecitabine Small molecule 825 mg/m2 Oral
Background Vinorelbine Small molecule 25 mg/m2 Intravenous

Indications

breast cancer