drugset / Trial / NCT00820222

Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in ErbB2 (HER2) Positive Metastatic Breast Cancer

NCT00820222

Phase 3 Completed 540 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

This open label study was designed to evaluate Lapatinib effect on incidence of brain metastases in ErbB2 (HER2) positive metastatic breast cancer patients exposed to prior taxanes or anthracyclines.

Timeline

Start
2009-04-14
Primary completion
2012-06-11
Completion
2018-03-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 2000 mg/m2 Oral
Subject Capecitabine Small molecule 2500 mg/m2 Oral
Subject Lapatinib Small molecule 1250 mg Oral
Comparator Trastuzumab Monoclonal antibody 6 mg/kg Other