drugset / Trial / NCT05296317
Evaluation and Modeling of the Effect of G-CSF on the Evolution of Polynuclear Neutrophils During Dense Dose Epirubicin-Cyclophosphamide Regeneration
RandomizedParallel-groupSingle-blindSupportive care
Summary
Patients including of localized breast cancer will require chemotherapy treatment with epirubicin - cyclophosphamide (EC) followed by treatment with docetaxel or paclitaxel. In addition to this chemotherapy, the investigator will prescribe injections of granulocyte growth factors (G-CSF), to stimulate the growth of white blood cells. Patients will be randomized to either a peg-G-CSF arm or a G-CSF arm, prescribed at different times. The aim is to determine whether one of the two treatment regimens best limits the risk of a decrease in white blood cells
Timeline
- Start
- 2022-09-02
- Primary completion
- 2025-09-26
- Completion
- 2025-09-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenograstim | Protein / enzyme biologic | — | — |
| Subject | Pegfilgrastim | Protein / enzyme biologic | — | — |
| Subject | filgrastim | Protein / enzyme biologic | — | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Epirubicin | Small molecule | — | — |