Preoperative Epirubicin Paclitaxel Aranesp Study (PREPARE)

PHASE3CompletedINTERVENTIONAL
Enrollment

720

Participants

Timeline

Start Date

August 31, 2002

Primary Completion Date

September 30, 2006

Study Completion Date

September 30, 2006

Conditions
Breast Cancer
Interventions
DRUG

Epirubicin, paclitaxel, cyclophosphamide, Methotrexate, 5 FU, darbepoetin alfa

"Epirubicin (90 mg/m2) d1, q21d - 4× / cyclophosphamide (600 mg/m2) d1, q21d - 4× followed by paclitaxel (175 mg/m2) d1, q21d - 4×~+/- Darbepoetin alfa 1 × 4.5 μg/kg of body weight every two weeks with the start of the first epirubicin dose (day 1) to 14 days after the last dose of paclitaxel"

DRUG

Epirubicin, Cyclophosphamide, Paclitaxel, dabepoetin alfa

"Epirubicin (150 mg/m2) d1, q14d - 3× followed by paclitaxel (225 mg/m2) d1, q14d - 3×, followed by CMF d1/d8, q28d - 3× Obligatory pegfilgratim 6 mg, subcutaneous injection on day 2 after epirubicin and/or paclitaxel and secondary prophylactic dose after CMF~+/- Darbepoetin alfa 1 × 4.5 μg/kg of body weight every two weeks with the start of the first dose of epirubicin (day 1) until 14 days after the last dose of CMF"

Sponsors
All Listed Sponsors
collaborator

Pharmacia

INDUSTRY

collaborator

Amgen

INDUSTRY

collaborator

Bristol-Myers Squibb

INDUSTRY

lead

GBG Forschungs GmbH

OTHER