Addition of Carboplatin to Neoadjuvant Therapy for Triple-negative and HER2-positive Early Breast Cancer

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

595

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

May 31, 2013

Study Completion Date

August 31, 2013

Conditions
Tubular Breast Cancer Stage IIMucinous Breast Cancer Stage IIBreast Cancer Female NOSInvasive Ductal Breast CancerTubular Breast Cancer Stage IIIHER-2 Positive Breast CancerInflammatory Breast Cancer Stage IVInflammatory Breast Cancer
Interventions
DRUG

Carboplatin

Carboplatin, AUC, 2 min/mL weekly, infusion

DRUG

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)."

Trial Locations (3)

15517

Praxis Dr. Heinrich, Fürstenwalde

40235

Luisenkrankenhaus, Düsseldorf

Unknown

NCT Heidelberg, Heidelberg

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Teva Pharmaceuticals USA

INDUSTRY

collaborator

Roche Pharma AG

INDUSTRY

collaborator

GlaxoSmithKline

INDUSTRY

lead

GBG Forschungs GmbH

OTHER

NCT01426880 - Addition of Carboplatin to Neoadjuvant Therapy for Triple-negative and HER2-positive Early Breast Cancer | Biotech Hunter | Biotech Hunter