Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

3,010

Participants

Timeline

Start Date

June 30, 2001

Primary Completion Date

June 30, 2009

Study Completion Date

December 31, 2009

Conditions
Breast Cancer
Interventions
BIOLOGICAL

Trastuzumab

8 mg/kg at month M6, followed by a maintenance dose of 6 mg/kg every 3 weeks for a 1 year (i.e. 18 injections in total)

DRUG

Cyclophosphamide

500 mg/m², D1 and every 3 weeks

DRUG

docetaxel

on day D1 of each cycle : dose: 75 mg/m², route: i.v. injection over 1 hour, every 3 weeks

DRUG

Epirubicin

100 mg/m², D1 and every 3 weeks

DRUG

Fluorouracil

500 mg/m², D1 and every 3 weeks

Trial Locations (29)

13273

Institut J. Paoli and I. Calmettes, Marseille

14076

Centre Regional Francois Baclesse, Caen

21079

Centre de Lutte Contre le Cancer Georges-Francois Leclerc, Dijon

25209

Centre Hospitalier General Andre Boulloche, Montbéliard

31052

Institut Claudius Regaud, Toulouse

33076

Institut Bergonie, Bordeaux

34298

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle, Montpellier

35042

Centre Eugene Marquis, Rennes

38100

Institut Prive de Cancerologie, Grenoble

44805

Centre Regional Rene Gauducheau, Nantes-Saint Herblain

49036

Centre Paul Papin, Angers

51056

Institut Jean Godinot, Reims

57038

Centre Hospitalier Regional Metz Thionville, Metz

63011

Centre Jean Perrin, Clermont-Ferrand

67065

Centre Paul Strauss, Strasbourg

67091

Hopitaux Universitaire de Strasbourg, Strasbourg

68051

Centre Hospitalier de Mulhouse, Mulhouse

75674

Hopital Avicenne, Paris

76600

CMC Les Ormeaux, Le Havre

76700

Clinique du Petit Colmouilins, Harfleur

77405

Centre Hospitalier de Lagny, Lagny-sur-Marne

78157

Hopital Andre Mignot, Le Chesnay

86021

CHU Poitiers, Poitiers

94010

Hopital Intercommunal De Creteil, Créteil

97492

Clinique Sainte Clotilde, Sainte Clotilde

74011 Cedex

Centre Hospitalier d'Annecy, Annecy

01012

C.H. Bourg En Bresse, Bourg-en-Bresse

Unknown

Clinique Saint - Pierre, Perpignan

F-94805

Institut Gustave Roussy, Villejuif

All Listed Sponsors
lead

UNICANCER

OTHER

NCT00054587 - Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer | Biotech Hunter | Biotech Hunter