53
Participants
Start Date
December 31, 2011
Primary Completion Date
August 25, 2014
Study Completion Date
September 12, 2016
5-FU, leucovorin, docetaxel, oxaliplatin (FLOT), trastuzumab
"Pre-operative treatment 4 cycles and post-operative treatment 4 cycles:~Trastuzumab 4 mg/kg BW (6 mg loading dose at 1st administration), iv over 1 h on day 1 of each 14 day cycle~Docetaxel 50 mg/m², iv over 2 h on day 1 of each 14 day cycle~Oxaliplatin 85 mg/m² in 500 ml G5%, iv over 2h on day 1 of each 14 day cycle~Leucovorin 200 mg/m² in 250 ml NaCl 0,9%, iv over 1 h on day 1 of each cycle~5-FU 2600 mg/m², iv over 24 h on day 1 of each 14 day cycle"
Post-operative treatment trastuzumab mono therapy
"Trastuzumab mono therapy for 9 cycles:~Trastuzumab 6 mg/kg BW, iv over 1 h on day 1 of each 21 day cycle"
Tagestherapiezentrum am ITM & III. Medizinische Klinik Universitätsmedizin Mannheim, Mannheim
Roche Pharma AG
INDUSTRY
AIO-Studien-gGmbH
OTHER