595
Participants
Start Date
August 31, 2011
Primary Completion Date
May 31, 2013
Study Completion Date
August 31, 2013
Carboplatin
Carboplatin, AUC, 2 min/mL weekly, infusion
background treatment
"background treatment according to standards fpr triple negative and Her2pos breast cancer patients Paclitaxel: 80 mg/m² i.v. given weekly on day 1 q day 8 for 18 weeks. NPLD (Myocet®): 20 mg/m² weekly on day 1 q day 8 for 18 weeks Trastuzumab (only for HER2-positive patients): Loading dose: 8 mg/kg, Maintenance dose: 6 mg/kg, day 1 q day 22 for 6 cycles. Post-surgery: up to a total duration of 1 year according to current AGO guidelines Lapatinib 750 mg/day p.o. continuously for 18 weeks; in case of good tolerability (no CTC grade II toxicity except alopecia and nausea/vomiting) during the first cycle the dose may be escalated to 1000 mg.~Bevacizumab: 15 mg/kg i.v., day 1 q day 22 for 6 cycles (only in TNBC patients)."
Praxis Dr. Heinrich, Fürstenwalde
Luisenkrankenhaus, Düsseldorf
NCT Heidelberg, Heidelberg
Collaborators (1)
Teva Pharmaceuticals USA
INDUSTRY
Roche Pharma AG
INDUSTRY
GlaxoSmithKline
INDUSTRY
GBG Forschungs GmbH
OTHER