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

Sponsor

Centre Georges Francois Leclerc (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05296317

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Localized Breast Cancer	Drug: Dense dose epirubicin-cyclophosphamide chemotherapy and G-CSF (filgrastim, lenograstim) Drug: Dense dose epirubicin-cyclophosphamide chemotherapy with administration of peg-G-CSF (pegfilgrastim)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Apr 15, 2022

Anticipated Primary Completion Date :

Apr 15, 2023

Anticipated Study Completion Date :

Apr 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 : Dense dose epirubicin-cyclophosphamide chemotherapy with administration of G-CSF 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 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
Experimental: Arm 2 : Dense dose epirubicin-cyclophosphamide chemotherapy with administration of peg-G-CSF 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) - 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

Intervention/Treatment

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

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 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

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

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)

- 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

Outcome Measures

Primary Outcome Measures

Variation of Neutrophils concentration in patient treated with G-CSF or peg-G-CSF [Day 4]
Variation of Neutrophils concentration will be assess by blood count formula performed during the 2 first cycle of Epirubicin-cyclophosphamide treatment.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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)