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

Localized Breast Cancer Clinical Trial

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

Status Recruiting

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Localized Breast Cancer

• NCT number: NCT05296317
• Study type: Interventional
• Source: Centre Georges Francois Leclerc
• Contact: LADOIRE SL SYLVAIN, coordinator
• Phone: 03.80.73.75.00 poste 37.47
• Email: sladoire@cgfl.fr
• Status: Recruiting
• Phase: N/A
• Start date: September 2, 2022
• Completion date: October 2, 2025