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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 :
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 : Dense dose epirubicin-cyclophosphamide chemotherapy with administration of G-CSF | Experimental | 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 2 : Dense dose epirubicin-cyclophosphamide chemotherapy with administration of peg-G-CSF | Experimental | 2 cycles of chemotherapy with administration of peg-G-CSF (pegfilgrastim) on D2. Realization of blood sampling at D1, D4, D8 and D14 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dense dose epirubicin-cyclophosphamide chemotherapy and G-CSF (filgrastim, lenograstim) | Drug | - 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 4 |
| 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. | Day 8 |
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Inclusion Criteria:
Exclusion Criteria:
First inclusion criterion : Women
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Georges François Leclerc (CGFL) | Dijon | Bourgogne-Franche-Comté | 21000 | France |
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Patients will be randomized :
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| Dense dose epirubicin-cyclophosphamide chemotherapy with administration of peg-G-CSF (pegfilgrastim) | Drug | - 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 |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D000069585 | Filgrastim |
| D000078224 | Lenograstim |
| C455861 | pegfilgrastim |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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