NCT05296317

Evaluation and Modeling of the Effect of G-CSF on the Evolution of Polynuclear Neutrophils During Dense Dose Epirubicin-Cyclophosphamide Regeneration

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Centre Georges Francois Leclerc · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

For this tudy : patients will be randomized to either : * with administration of peg-G-CSF (administration on D2) * with administration of G-CSF (administration on D4 to D7 or D8) This study aims to model the effect of exogenous G-CSF for the evolution of polymorphonuclear neutrophils as a function of time and to explain the pharmacodynamic variability during the administration of chemotherapy such as EC-dense dose administered as an adjuvant or neo-adjuvant in patients treated for localized breast cancer.

Conditions

• Localized Breast Cancer

Interventions

Type	Name	Description
DRUG	Dense dose epirubicin-cyclophosphamide chemotherapy and G-CSF (filgrastim, lenograstim)	\- Arm 1: 2 cycles of chemotherapy with administration of G-CSF (filgrastim or lenograstim) on D2, D4 to D7 or D8.. Realization of blood sampling at D1, D4, D8 and D14
DRUG	Dense dose epirubicin-cyclophosphamide chemotherapy with administration of peg-G-CSF (pegfilgrastim)	\- Arm 2: 2 cycles of chemotherapy with administration of peg-G-CSF (pegfilgrastim) on D2. Realization of blood sampling at D1, D4, D8 and D14

Timeline

• Start date: 2022-09-02
• Primary completion: 2025-09-26
• Completion: 2025-09-26
• First posted: 2022-03-25
• Last updated: 2026-02-19

Locations

1 site across 1 country: France