Docetaxel, Doxorubicin and Cyclophosphamide Versus Vinorelbine and Capecitabine in Patients Not Sufficiently / Sufficiently Responding as Preoperative Treatment of Locally Advanced or Operable Primary Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

2,014

Participants

Timeline

Start Date

September 30, 2002

Primary Completion Date

February 29, 2008

Study Completion Date

February 29, 2008

Conditions
Breast Cancer
Interventions
DRUG

TAC

Docetaxel 75 mg/m² as a 1 hour i.v. infusion on day 1 every 3 weeks in combination with Doxorubicin 50 mg/m² as an i.v. bolus and Cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks

DRUG

NX

Vinorelbine 25 mg/m² as a \< 10 min i.v. infusion on days 1 and 8 repeated every 3 weeks and Capecitabine 2000 mg/m² orally in 2 daily doses on days 1-14 repeated every 3 weeks

Sponsors
All Listed Sponsors
collaborator

Roche Pharma AG

INDUSTRY

collaborator

Sanofi

INDUSTRY

collaborator

Amgen

INDUSTRY

collaborator

Goethe University

OTHER

lead

GBG Forschungs GmbH

OTHER