BIG 02/98 Docetaxel - Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

2,887

Participants

Timeline

Start Date

June 30, 1998

Primary Completion Date

September 30, 2011

Study Completion Date

September 30, 2011

Conditions
Breast Neoplasms
Interventions
DRUG

Doxorubicine + docetaxel sequential

doxorubicin 75 mg/m² i.v. day 1, q 21 days for 3 cycles, followed by docetaxel 100 mg/m² i.v., 1 hour infusion, day 1, q 21 days for 3 cycles, followed by CMF for 3 cycles

DRUG

doxorubicine + cyclophosphamide sequential

doxorubicin 75 mg/m² i.v. day 1 q 21 days for 4 cycles, followed by CMF (C: cyclophosphamide 100 mg/m² orally days 1-14, M: methotrexate: 40 mg/m² i.v. days 1 and 8, FU; 5-fluorouracil: 600 mg/m²) i.v. days 1 and 8, q 28 days for 3 cycles

DRUG

doxorubicine + cyclophosphamide combined

doxorubicin 60 mg/m² i.v. + cyclophosphamide 600 mg/m² i.v., day 1, q 21 days for 4 cycles, followed by CMF for 3 cycles.

DRUG

doxorubicine + docetaxel combined

doxorubicin 50 mg/m² i.v. + docetaxel 75 mg/m² i.v. 1 hour infusion (1 hour after doxorubicin), day 1, q 21 days for 4 cycles, followed by CMF for 3 cycles.

Trial Locations (21)

Unknown

Sanofi-Aventis, Macquarie Park

Sanofi-Aventis, Vienna

Sanofi-Aventis, Diegem

Sanofi-Aventis, Providencia Santiago

Sanofi-Aventis, Prague

Sanofi-Aventis, Hørsholm

Sanofi-Aventis, Berlin

Sanofi-Aventis, Budapest

Sanofi-Aventis, Dublin

Sanofi-Aventis, Netanya

Sanofi-Aventis, Milan

Sanofi-Aventis, Auckland

Sanofi-Aventis, Porto Salvo

Sanofi-Aventis, Bratislava

Sanofi-Aventis, Ljubljana

Sanofi-Aventis, Gauteng

Sanofi-Aventis, Barcelona

Sanofi-Aventis, Bromma

Sanofi-Aventis, Geneva

Sanofi-Aventis, Guildford Surrey

ao

Sanofi-Aventis, São Paulo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY