drugset / Trial / NCT00837265

Balugrastim (Neugranin) in Breast Cancer Participants Receiving Doxorubicin/Docetaxel

NCT00837265

Phase 2/3 Completed 334 enrolled Teva Branded Pharmaceutical Products R&D, Inc.
RandomizedParallel-groupOpen-labelSupportive care

Summary

Determination of the effect of balugrastim on the duration and severity of severe neutropenia.

Timeline

Start
2008-08-21
Primary completion
2009-06-26
Completion
2009-06-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Balugrastim Protein / enzyme biologic Subcutaneous
Comparator Pegfilgrastim Protein / enzyme biologic 6 mg Subcutaneous
Background Docetaxel Small molecule 75 mg/m2 Intravenous
Background Doxorubicin Other / unclassified 60 mg/m2 Intravenous

Indications