Randomized Neoadjuvant Study of Epirubicin and Docetaxel With/Without Capecitabine in Early Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

536

Participants

Timeline

Start Date

February 28, 2005

Primary Completion Date

November 30, 2009

Study Completion Date

November 30, 2011

Conditions
Breast Cancer
Interventions
DRUG

Epirubicin

6 cycles 75mg/m2 i.v. day 1 q3w

DRUG

Docetaxel

6 cycles 75mg/m2 i.v. day 1 q3w

DRUG

Capecitabine

6 cycles 1000mg/m2 oral, day 1-14 q2d

DRUG

Trastuzumab

cycle 1: 8mg/kg i.v. day 1 cycle 2-6: 6mg/kg i.v. day 1 (=6 cycles q3w)

Trial Locations (26)

1090

Medical University Vienna, General Hospital, Vienna

1130

State Hospital Vienna-Hietzing, Vienna

1140

Hanusch Hospital, Vienna

2500

Hospital Baden, Baden

2700

Hospital of Wiener Neustadt, Wiener Neustadt

3500

Hospital Krems, Krems

4010

Hospital BHS Linz, Linz

4020

General Hospital Linz, Linz

4400

State Hospital Steyr, Steyr

4560

State Hospital Kirchdorf, Kirchdorf

4600

Klinikum Wels-Grieskirchen, Wels

5020

Paracelsus Medical University Salzburg - Oncology, Salzburg

6020

Medical University of Innsbruck, Innsbruck

6330

District Hospital Kufstein, Kufstein

6807

State Hospital Feldkirch/Rankweil, Rankweil

7350

Hospital Oberpullendorf, Oberpullendorf

7400

Hospital Oberwart, Oberwart

7540

Hospital Guessing, Güssing

8036

Gynaegological Medical University Graz, Graz

Medical University of Graz, Oncology, Graz

8700

State Hospital Leoben, Leoben

9026

State Hospital Klagenfurt, Klagenfurt

9300

Ordination Dr. Wette, Saint Veit A. D. Glan

9330

Hospital BHB St. Veit/Glan, Surgery, Saint Veit A. D. Glan

9400

State Hospital Wolfsberg, Wolfsberg

9500

State Hospital Villach, Villach

Sponsors
All Listed Sponsors
collaborator

Amgen

INDUSTRY

collaborator

Ebewe Pharma GmbH

UNKNOWN

collaborator

Hoffmann-La Roche

INDUSTRY

collaborator

Sanofi

INDUSTRY

lead

Austrian Breast & Colorectal Cancer Study Group

NETWORK