Evaluation and Modeling of the Effect of G-CSF on the Evolution of Polynuclear Neutrophils During Dense Dose Epirubicin-Cyclophosphamide Regeneration (EMEG-ECDD)
Primary Purpose
Localized Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dense dose epirubicin-cyclophosphamide chemotherapy and G-CSF (filgrastim, lenograstim)
Dense dose epirubicin-cyclophosphamide chemotherapy with administration of peg-G-CSF (pegfilgrastim)
Sponsored by
About this trial
This is an interventional supportive care trial for Localized Breast Cancer focused on measuring breast cancer, G-CSF, Epirubicin-cyclophosphamide dose-dense
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)
Sites / Locations
- Centre Georges François Leclerc (CGFL)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm 1 : Dense dose epirubicin-cyclophosphamide chemotherapy with administration of G-CSF
Arm 2 : Dense dose epirubicin-cyclophosphamide chemotherapy with administration of peg-G-CSF
Arm 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
2 cycles of chemotherapy with administration of peg-G-CSF (pegfilgrastim) on D2. Realization of blood sampling at D1, D4, D8 and D14
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05296317
First Posted
January 24, 2022
Last Updated
October 16, 2023
Sponsor
Centre Georges Francois Leclerc
1. Study Identification
Unique Protocol Identification Number
NCT05296317
Brief Title
Evaluation and Modeling of the Effect of G-CSF on the Evolution of Polynuclear Neutrophils During Dense Dose Epirubicin-Cyclophosphamide Regeneration
Acronym
EMEG-ECDD
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2, 2022 (Actual)
Primary Completion Date
April 2, 2024 (Anticipated)
Study Completion Date
April 2, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Georges Francois Leclerc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Localized Breast Cancer
Keywords
breast cancer, G-CSF, Epirubicin-cyclophosphamide dose-dense
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1 : Dense dose epirubicin-cyclophosphamide chemotherapy with administration of G-CSF
Arm Type
Experimental
Arm 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
Arm Title
Arm 2 : Dense dose epirubicin-cyclophosphamide chemotherapy with administration of peg-G-CSF
Arm Type
Experimental
Arm Description
2 cycles of chemotherapy with administration of peg-G-CSF (pegfilgrastim) on D2.
Realization of blood sampling at D1, D4, D8 and D14
Intervention Type
Drug
Intervention Name(s)
Dense dose epirubicin-cyclophosphamide chemotherapy and G-CSF (filgrastim, lenograstim)
Intervention Description
- 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
Intervention Type
Drug
Intervention Name(s)
Dense dose epirubicin-cyclophosphamide chemotherapy with administration of peg-G-CSF (pegfilgrastim)
Intervention Description
- 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
Primary Outcome Measure Information:
Title
Variation of Neutrophils concentration in patient treated with G-CSF or peg-G-CSF
Description
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
Title
Variation of Neutrophils concentration in patient treated with G-CSF or peg-G-CSF
Description
Variation of Neutrophils concentration will be assess by blood count formula performed during the 2 first cycle of Epirubicin-cyclophosphamide treatment.
Time Frame
Day 8
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
First inclusion criterion : Women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LADOIRE SL SYLVAIN, coordinator
Phone
03.80.73.75.00 poste 37.47
Email
sladoire@cgfl.fr
First Name & Middle Initial & Last Name or Official Title & Degree
SCHMITT AS ANTONIN, methodoordinator
Phone
03.80.73.75.00 poste 33.45
Email
aschmitt@cgfl.fr
Facility Information:
Facility Name
Centre Georges François Leclerc (CGFL)
City
Dijon
State/Province
Bourgogne
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LADOIRE SL SYLVAIN, principal investigator
Email
sladoire@cgfl.fr
First Name & Middle Initial & Last Name & Degree
Sophie Parnalland
Phone
03 45 34 80 77
Ext
+33
Email
sparnalland@cgfl.fr
12. IPD Sharing Statement
Learn more about this trial
Evaluation and Modeling of the Effect of G-CSF on the Evolution of Polynuclear Neutrophils During Dense Dose Epirubicin-Cyclophosphamide Regeneration
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