drugset / Trial / NCT02104830
Study of the Efficacy and Safety of Empegfilgrastim for Neutropenia Prophylaxis in Breast Cancer Patients
RandomizedParallel-groupDouble-blindSupportive care
Summary
The purpose of the study is to compare safety and efficacy of a single dose of empegfilgrastim and daily dosing of filgrastim for prevention of neutropenia in patients receiving AT (docetaxel 75 mg/m2 + doxorubicin 50 mg/m2).
Timeline
- Start
- 2013-09
- Primary completion
- 2014-06
- Completion
- 2014-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Empegfilgrastim | Protein / enzyme biologic | 6 mg | Subcutaneous |
| Subject | Empegfilgrastim | Protein / enzyme biologic | 7.5 mg | Subcutaneous |
| Comparator | filgrastim | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |