Status:
RECRUITING
Evaluation and Modeling of the Effect of G-CSF on the Evolution of Polynuclear Neutrophils During Dense Dose Epirubicin-Cyclophosphamide Regeneration
Lead Sponsor:
Centre Georges Francois Leclerc
Conditions:
Localized Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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 chemot...
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 2 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05296317
Start Date
September 2 2022
End Date
October 2 2025
Last Update
February 29 2024
Active Locations (1)
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1
Centre Georges François Leclerc (CGFL)
Dijon, Bourgogne-Franche-Comté, France, 21000