drugset / Trial / NCT00712881

Combination Therapy With MYOCET® (Doxorubicin HCL Liposome for Injection) in Participants With HER2-Positive Breast Cancer

NCT00712881 ↗

Phase 2 Completed 126 enrolled Cephalon
RandomizedParallel-groupOpen-labelTreatment

Summary

To evaluate the efficacy and safety of treatment with MYOCET® (doxorubicin hydrochloride) in combination with cyclophosphamide and trastuzumab, 4 cycles, followed by docetaxel plus trastuzumab, 4 cycles, in women with stage II or III breast cancer whose tumour overexpresses the human epidermal growth factor receptor 2 (HER2) gene.

Timeline

Start
2008-10-13
Primary completion
2015-09-17
Completion
2015-09-17

Drugs

EvaluationDrugModalityDoseRoute
Comparator Doxorubicin Other / unclassified 60 mg/m2 Intravenous
Background Cyclophosphamide Other / unclassified 600 mg/m2 Intravenous
Background Docetaxel Small molecule 100 mg/m2 —
Background Trastuzumab Monoclonal antibody 6 mg/kg Intravenous

Indications