drugset / Trial / NCT02953340
SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to compare the efficacy of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) as measured by the duration of severe neutropenia (DSN).
Timeline
- Start
- 2017-05-10
- Primary completion
- 2018-06-08
- Completion
- 2019-05-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Eflapegrastim | Protein / enzyme biologic | 13.2 mg | Subcutaneous |
| Subject | Pegfilgrastim | Protein / enzyme biologic | 6 mg | Subcutaneous |
| Background | Cyclophosphamide | Other / unclassified | 600 mg/m2 | Intravenous |
| Background | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |