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

Centre Georges Francois Leclerc97 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Localized Breast Cancer

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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.

Time frame: Day 4