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

February 18, 2026 updated by: Centre Georges Francois Leclerc

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Bourgogne-Franche-Comté
      • Dijon, Bourgogne-Franche-Comté, France, 21000
        • Centre Georges François Leclerc (CGFL)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women
  • Patient over 18 years old
  • Patient with histologically documented, non-metastatic breast cancer who must receive dense dose Epirubicin-Cyclophosphamide (EC) type treatment as part of neoadjuvant or adjuvant treatment
  • Patient to receive granulocyte growth factors (G-CSF or peg-G-CSF) as a preventive measure from the first cycle
  • Neutrophils > 1,500 /mm3; platelets > 100,000 /mm3
  • Written informed consent, dated and signed
  • For patients of childbearing age, effective means of contraception during treatment and up to 3 months after stopping treatment

Exclusion Criteria:

  • Patient with a contraindication to treatment with anthracyclines
  • Patient already undergoing treatment with EC dense dose
  • Patient with a contraindication to treatment with G-CSF such as hypersensitivity to the active ingredient or to one of the excipients
  • Pregnant or breastfeeding women
  • Patient under guardianship or curatorship or subject to a protection regime for adults
  • Patient not affiliated to a social security scheme (beneficiary or beneficiary)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 : Dense dose epirubicin-cyclophosphamide chemotherapy with administration of G-CSF

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 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
Experimental: Arm 2 : Dense dose epirubicin-cyclophosphamide chemotherapy with administration of peg-G-CSF

2 cycles of chemotherapy with administration of peg-G-CSF (pegfilgrastim) on D2.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation of Neutrophils concentration in patient treated with G-CSF or peg-G-CSF
Time Frame: Day 4
Variation of Neutrophils concentration will be assess by blood count formula performed during the 2 first cycle of Epirubicin-cyclophosphamide treatment.
Day 4
Variation of Neutrophils concentration in patient treated with G-CSF or peg-G-CSF
Time Frame: Day 8
Variation of Neutrophils concentration will be assess by blood count formula performed during the 2 first cycle of Epirubicin-cyclophosphamide treatment.
Day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Georges Francois Leclerc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2022

Primary Completion (Actual)

September 26, 2025

Study Completion (Actual)

September 26, 2025

Study Registration Dates

First Submitted

January 24, 2022

First Submitted That Met QC Criteria

March 24, 2022

First Posted (Actual)

March 25, 2022

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A01407-34

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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