Clinical trial NCT05296317: Evaluation and Modeling of the Effect of G-CSF on the Evolution of Polynuclear Neutrophils During Dense Dose Epirubicin-Cyclophosphamide Regeneration
Official title: Evaluation and Modeling of the Effect of G-CSF on the Evolution of Polynuclear Neutrophils During Dense Dose Epirubicin-Cyclophosphamide Regeneration
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Localized Breast Cancer
Keywords: breast cancer
G-CSF
Epirubicin-cyclophosphamide dose-dense
Lead sponsor: Centre Georges Francois Leclerc
Sponsor class: OTHER
First posted: 2022-03-25
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Variation of Neutrophils concentration in patient treated with G-CSF or peg-G-CSF
timeFrame: Day 4
measure: Variation of Neutrophils concentration in patient treated with G-CSF or peg-G-CSF
timeFrame: Day 8
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Georges François Leclerc (CGFL)
state: Bourgogne
Study officials:
References: