Evaluation and Modeling of the Effect of G-CSF on the Evolution of Polynuclear Neutrophils During Dense Dose Epirubicin-Cyclophosphamide Regeneration (EMEG-ECDD)
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
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bourgogne-Franche-Comté
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Dijon, Bourgogne-Franche-Comté, France, 21000
- Centre Georges François Leclerc (CGFL)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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 |
- 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 |
- 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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Variation of Neutrophils concentration in patient treated with G-CSF or peg-G-CSF
Time Frame: Day 4
|
Variation of Neutrophils concentration will be assess by blood count formula performed during the 2 first cycle of Epirubicin-cyclophosphamide treatment.
|
Day 4
|
|
Variation of Neutrophils concentration in patient treated with G-CSF or peg-G-CSF
Time Frame: Day 8
|
Variation of Neutrophils concentration will be assess by blood count formula performed during the 2 first cycle of Epirubicin-cyclophosphamide treatment.
|
Day 8
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Skin Diseases
- Breast Diseases
- Skin and Connective Tissue Diseases
- Breast Neoplasms
- Peptides
- Amino Acids, Peptides, and Proteins
- Proteins
- Biological Factors
- Carbohydrates
- Intercellular Signaling Peptides and Proteins
- Glycoproteins
- Glycoconjugates
- Colony-Stimulating Factors
- Hematopoietic Cell Growth Factors
- Cytokines
- Lenograstim
- Granulocyte Colony-Stimulating Factor
- Filgrastim
- pegfilgrastim
Other Study ID Numbers
- 2021-A01407-34
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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