drugset / Trial / NCT00429871

Randomized Phase III Trial With Docetaxel Plus Epirubicine Versus Docetaxel Plus Capecitabine for Metastatic Breast Cancer

NCT00429871

RandomizedParallel-groupOpen-labelTreatment

Summary

The combination of docetaxel+epirubicin is highly effective and well tolerated as first line treatment in patients with metastatic breast cancer (MBC). Capecitabine is an active drug in women with MBC pretreated with taxane and anthracycline. Docetaxel increases the intracellular levels of thymidilate phosphorylase and thus is synergistic with capecitabine. The combination of docetaxel plus capecitabine is highly active and superior to docetaxel monotherapy in women with MBC pretreated with an anthracycline

Timeline

Start
2002-05
Primary completion
2007-11
Completion
2007-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 950 mg/m2 Oral
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Epirubicin Small molecule 75 mg/m2 Intravenous

Indications