drugset / Trial / NCT00352378

Primary Chemotherapy With Adriamycin/Cyclophosphamide(AC) vs Taxotere/Xeloda(TX) for Stage II and III Breast Cancer

NCT00352378 ↗

Phase 3 Completed 209 enrolled National Cancer Center, Korea
RandomizedCrossoverOpen-labelTreatment

Summary

This is an open labeled phase III randomized trial. The patients with clinical stage II and III will undergo mammotome biopsy of breast tumor for histologic diagnosis, immunohistochemical studies for estrogen receptor(ER), progesterone receptor(PR), HER-2/neu and others. PET results will determine the positivity of lymph node metastasis.

Timeline

Start
2002-06
Primary completion
2005-10
Completion
2006-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Cyclophosphamide Other / unclassified 600 mg/m2 Intravenous
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Doxorubicin Other / unclassified 60 mg/m2 Intravenous

Indications