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

Not Applicable

Recruiting

• Conditions: Localized Breast Cancer
• Interventions: Drug: Dense dose epirubicin-cyclophosphamide chemotherapy and G-CSF (filgrastim, lenograstim); Drug: Dense dose epirubicin-cyclophosphamide chemotherapy with administration of peg-G-CSF (pegfilgrastim)

• Registration Number: NCT05296317
• Lead Sponsor: Centre Georges Francois Leclerc

Brief 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.

Study Timeline

• Study First Submitted: 2022-01-24
• Study First Submitted QC: 2022-03-24
• Study First Posted: 2022-03-25
• Study Start: 2022-09-02
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-02-29
• Primary Completion: 2025-09-02
• Study Completion: 2025-10-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Centre Georges François Leclerc (CGFL); 🇫🇷 Dijon, Bourgogne, France