Evaluation and Modeling of the Effect of G-CSF on the Evolution of Polynuclear Neutrophils During Dense Dose Epirubicin-Cyclophosphamide Regeneration
NCT05296317
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
Eligibility
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)
Conditions3
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NCT05296317