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

NCT05296317 | Completed

• 1 other identifier: 2021-A01407-34
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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

Conditions

Localized Breast Cancer

Keywords

breast cancer; G-CSF; Epirubicin-cyclophosphamide dose-dense

Outcome Measures

Primary Outcomes (2)

• Variation of Neutrophils concentration in patient treated with G-CSF or peg-G-CSF

  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

  Variation of Neutrophils concentration will be assess by blood count formula performed during the 2 first cycle of Epirubicin-cyclophosphamide treatment.

  Day 8

Study Arms (2)

Arm 1 : Dense dose epirubicin-cyclophosphamide chemotherapy with administration of G-CSF

EXPERIMENTAL

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

EXPERIMENTAL

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)

Interventions

Dense dose epirubicin-cyclophosphamide chemotherapy and G-CSF (filgrastim, lenograstim) DRUG

\- 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

Arm 1 : Dense dose epirubicin-cyclophosphamide chemotherapy with administration of G-CSF

Dense dose epirubicin-cyclophosphamide chemotherapy with administration of peg-G-CSF (pegfilgrastim) DRUG

\- 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

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: First inclusion criterion : Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Georges Francois Leclerc: lead

Study Sites (1)

Centre Georges François Leclerc (CGFL)

Dijon, Bourgogne-Franche-Comté, 21000, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Granulocyte Colony-Stimulating Factor; Filgrastim; Lenograstim; pegfilgrastim

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized : * Either to a peg-G-CSF arm (with administration of peg-G-CSF on D2) * Either to a G-CSF arm (with administration from D4 to D7 or D8). Blood samplig will be taken at D1, D4, D8 and D14 for each arm.

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: March 25, 2022
• Study Start: September 2, 2022
• Primary Completion: September 26, 2025
• Study Completion: September 26, 2025
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

FR (1)