drugset / Trial / NCT01569087
Dose-finding Study of Empegfilgrastim for Neutropenia Prophylaxis in Patients With Breast Cancer
RandomizedParallel-groupOpen-labelSupportive care
Summary
The purpose of the study is to compare safety and efficacy of a single dose of empegfilgrastimt a dose of 3 or 6 mg versus daily administration of filgrastim at a dose of 5 μg/kg/day.
Timeline
- Start
- 2012-05
- Primary completion
- 2013-01
- Completion
- 2013-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Empegfilgrastim | Protein / enzyme biologic | 3 mg | Subcutaneous |
| Subject | Empegfilgrastim | Protein / enzyme biologic | 6 mg | Subcutaneous |
| Comparator | filgrastim | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |