drugset / Trial / NCT00503750

Phase II Neoadjuvant Trial of Trastuzumab in Combination With Dose-Dense ABI-007 (Abraxane™)

NCT00503750

Phase 2 Completed 27 enrolled Emory University
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a phase II one arm study. Patients with HER2 (Human Epidermal Growth Factor Receptor 2)positive early stage breast cancer will receive ABI-007 and vinorelbine in combination with trastuzumab before having breast surgery.

Timeline

Start
2008-04
Primary completion
2011-07
Completion
2011-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Paclitaxel Small molecule 260 mg/m2 Other
Comparator Trastuzumab Monoclonal antibody 2 mg/kg Other
Comparator Vinorelbine Small molecule 25 mg/m2 Other

Indications