drugset / Trial / NCT03252431
Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a randomized, multi-center, single dose, open-label and Neulasta controlled phase 3 study to evaluate the efficacy and safety of F-627 in women with Stage I - III invasive breast cancer receiving chemotherapy treatment.
Timeline
- Start
- 2018-04-12
- Primary completion
- 2019-09-25
- Completion
- 2020-03-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | F-627 | Protein / enzyme biologic | 20 mg | Other |
| Comparator | Pegfilgrastim | Protein / enzyme biologic | 6 mg | Other |