drugset / Trial / NCT00148876

TBP Study With Capecitabine Plus Minus Trastuzumab

NCT00148876

Phase 3 Completed 482 enrolled GBG Forschungs GmbH Hoffmann-La Roche · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is done in patients having Breast Cancer with metastasis (patients with positive receptor HER2) whose disease progressed after receiving Trastuzumab. The primary objective of this study is to compare the time until disease progression between the Treatment Arm CAPECITABINE and the Treatment Arm CAPECITABINE + TRASTUZUMAB The study has also other secondary and tertiary objectives.

Timeline

Start
2003-09
Primary completion
2011-01
Completion
2011-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 2500 mg/m2 Oral
Subject Trastuzumab Monoclonal antibody 6 mg/kg Intravenous

Indications