Epirubicin or Not in Patients With TOP2A (Topoisomerase (DNA) II Alpha (170kD)) Normal Early Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

2,015

Participants

Timeline

Start Date

June 30, 2008

Primary Completion Date

January 31, 2013

Study Completion Date

January 31, 2013

Conditions
Breast Neoplasms
Interventions
DRUG

Epirubicin, cyclophosphamide and docetaxel

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

DRUG

docetaxel, cyclophosphamide

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

Trial Locations (13)

DK-9000

Dept. of Oncology; Aalborg Sygehus, Aalborg

DK-8000

Dept. of Oncology; Århus Sygehus, Aarhus

DK-2100

Dept. of Oncology; Rigshospitalet, Copenhagen

DK-6700

Dept. of Oncology; Sydvestjysk Sygehus Esbjerg, Esbjerg

DK-2730

Dept. of Oncology; Herlev Hospital, Herlev

DK-7400

Dept. of Oncology; Regionshospitalet Herning, Herning

DK-3400

Dept. of Oncology; Nordsjællands Hospital Hillerød, Hillerød

DK-4700

Dept. of Oncology; Sygehus Syd Næstved, Næstved

DK-5000

Dept. of Oncology; Odense University Hospital, Odense

DK-4000

Dept. of Oncology; Sygehus Øst Roskilde, Roskilde

DK-3700

Dept. of internal medicine; Bornholms Hospital, Rønne

DK-7100

Dept. of Oncology; Vejle Sygehus, Vejle

DK-8800

Dept. of Oncology; Regionshospitalet Viborg, Viborg

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Fonden Til Fremme af Klinisk- Eksperimentel Cancerforskning

OTHER

collaborator

Sanofi

INDUSTRY

collaborator

Dako

INDUSTRY

lead

Danish Breast Cancer Cooperative Group

OTHER