CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,015 enrolled
Drug / intervention
Epirubicin, cyclophosphamide and docetaxel +1 moredrug
Likely dose
Epirubicin, cyclophosphamide and docetaxel 90 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00689156
NCT00689156Phase 3Completed
CompareCT.gov

Randomized Trial of Epirubicin and Cyclophosphamide Followed by Docetaxel Against Docetaxel and Cyclophosphamide in Patients With TOP2A Normal Early Breast Cancer

Danish Breast Cancer Cooperative Group·interventional·Posted Jun 3, 2008·Updated Apr 5, 2018

In Brief

A Phase 3 clinical trial evaluating Epirubicin, cyclophosphamide and docetaxel and docetaxel, cyclophosphamide for Breast Neoplasms. Completed, enrolled 2,015 participants across 13 sites.

Detailed Summary

The Danish Breast Cancer Cooperative Group (DBCG) wishes to clarify if recurrence-free and overall life expectancy is longer after docetaxel and cyclophosphamide compared to epirubicin and cyclophosphamide followed by docetaxel in patients with TOP2A normal and operable breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms
CountriesDenmark
CollaboratorsFonden Til Fremme af Klinisk- Eksperimentel Cancerforskning, Sanofi, Dako

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 3, 2008
Enrollment StartJun 1, 2008
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 18.1 years ago

Interventions

Epirubicin, cyclophosphamide and docetaxeldrug

Epirubicin 90 mg/m2 iv day 1 every 3 weeks plus Cyclophosphamide 600 mg/m2 iv day 1 every 3 weeks times 3 followed by Docetaxel 100 mg/m2 iv day 1 every 3 weeks times 3

docetaxel, cyclophosphamidedrug

Docetaxel 75 mg/m2 plus cyclophosphamide 600 mg/m2 intravenously day 1 every 3 weeks times six