drugset / Trial / NCT04127019

Adjuvant 6 Cycles of Docetaxel and Cyclophosphamide or 3 Cycles of Cyclophosphamide/Epirubicin/Fluorouracil Followed by 3 Cycles of Docetaxel Versus 4 Cycles of Epirubicin and Cyclophosphamide Followed by Weekly Paclitaxel in Operable Breast Cancer (MASTER)

NCT04127019

Phase 3 Completed 2079 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

Summary

We aimed to evaluate the noninferiority of a short-term anthracycline-free chemotherapy (TC, six cycles of docetaxel and cyclophosphamide) or a 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 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