drugset / Trial / NCT00309556

Randomized Neoadjuvant Study of Epirubicin and Docetaxel With/Without Capecitabine in Early Breast Cancer

NCT00309556

RandomizedParallel-groupOpen-labelTreatment

Summary

Primarily, this clinical investigation compares the rates (percentages) of pathological complete remissions attained at the time of final surgery following 6 cycles each of epirubicin + docetaxel + capecitabine-containing chemotherapy ± trastuzumab (in HER-2 positive disease) vs. epirubicin + docetaxel-containing chemotherapy ± trastuzumab (in HER-2 negative disease).

Timeline

Start
2005-02
Primary completion
2009-11
Completion
2011-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Capecitabine Small molecule 1000 mg/m2 Oral
Comparator Trastuzumab Monoclonal antibody 6 mg/kg Intravenous
Comparator Docetaxel Small molecule 75 mg/m2 Intravenous
Comparator Epirubicin Small molecule 75 mg/m2 Intravenous

Indications