Localized Breast Cancer
Conditions
Keywords
breast cancer, G-CSF, Epirubicin-cyclophosphamide dose-dense
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.
Interventions
DRUGDense 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
DRUGDense 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
Sponsors
Centre Georges Francois Leclerc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Outcome results
None listed