489
Participants
Start Date
October 31, 2004
Primary Completion Date
May 31, 2012
Study Completion Date
May 31, 2012
Docetaxel
Docetaxel 75 mg/m2 as an IV infusion over 1h every two weeks for 4 cycles
Trastuzumab
Trastuzumab 6 mg/Kg IV over 30 min every two weeks for 4 cycles. Subsequently,trastuzumab 6 mg/Kg IV over 30 min for 12 months
Epirubicin
Epirubicin 75 mg/m2 IV push on day 1 every 2 weeks for 4 cycles
Cyclophosphamide
Cyclophosphamide 700 mg/m2 IV push on day 1 every 4 weeks
5-fluoruracil
5-fluoruracil 700 mg/m2 IV push on day 1 every 4 weeks
Granulocyte-colony stimulating growth factor
rhG-CSF 5 μg/kg/d on days 3-10 after each cycle
Trastuzumab
Trastuzumab 6mg/Kg IV over 30 min every 2 weeks for 4 cycles. Subsequently, trastuzumab 6mg/Kg IV over 30 min for 6 months
University Hospital of Crete, Heraklion
University General Hospital of Alexandroupolis, Dep of Medical Oncology, Alexandroupoli
"IASO General Hospital of Athens, 1st Dep of Medical Oncology", Athens
"Laikon General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine", Athens
"Marika Iliadis Hospital of Athens, Dep of Medical Oncology", Athens
401 Military Hospital of Athens, Athens
Air Forces Military Hospital of Athens, Athens
State General Hospital of Larissa, Dep of Medical Oncology, Larissa
"Metaxa's Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology", Piraeus
"Theagenion Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology", Thessaloniki
Lead Sponsor
University Hospital of Crete
OTHER
Hellenic Oncology Research Group
OTHER