drugset / Trial / NCT01314833

Minus Anthracycline or Short-Term Versus Epirubicin and Cyclophosphamide Followed by Paclitaxel Regimen for Adjuvant Breast Cancer Therapy

NCT01314833

RandomizedParallel-groupOpen-labelTreatment

Summary

We aimed to evaluate the noninferiority of short-term anthracycline-free chemotherapy (TC, six cycles of docetaxel and cyclophosphamide) or short-term anthracycline-based chemotherapy (CEF-T, three cycles of cyclophosphamide/epirubicin/fluorouracil followed by three cycles of docetaxel) to a standard anthracycline/taxane-containing chemotherapy (EC-P, epirubicin, and cyclophosphamide for four cycles followed by paclitaxel for twelve weeks) in HER2-negative operable breast cancer.

Timeline

Start
2010-06-01
Primary completion
2017-06-01
Completion
2017-06-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 500 mg/m2 Intravenous
Subject Cyclophosphamide Other / unclassified 600 mg/m2 Intravenous
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Docetaxel Small molecule 100 mg/m2 Intravenous
Subject Epirubicin Small molecule 90 mg/m2 Intravenous
Subject Epirubicin Small molecule 100 mg/m2 Intravenous
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous
Subject fluorouracil Small molecule 500 mg/m2 Intravenous

Indications