drugset / Trial / NCT02643420
SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE)
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study was to compare the efficacy of a single dose 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) in Cycle 1.
Timeline
- Start
- 2016-01-19
- Primary completion
- 2018-01-24
- Completion
- 2018-10-31
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 |