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

Centre Georges Francois Leclerc

Status: Enrolling

Conditions: Localized Breast Cancer

Treatments: Drug: Dense dose epirubicin-cyclophosphamide chemotherapy with administration of peg-G-CSF (pegfilgrastim); Drug: Dense dose epirubicin-cyclophosphamide chemotherapy and G-CSF (filgrastim, lenograstim)

Study type: Interventional

Funder types: Other

Identifiers

NCT05296317

2021-A01407-34

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

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 group

Description:

2 cycles of chemotherapy with administration of peg-G-CSF (pegfilgrastim) on D2. Realization of blood sampling at D1, D4, D8 and D14

Treatment:

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