|

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

RECRUITINGN/ASponsored by Centre Georges Francois Leclerc
Actively Recruiting
PhaseN/A
SponsorCentre Georges Francois Leclerc
Started2022-09-02
Est. completion2025-09-02
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted

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

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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

Breast CancerCancerLocalized Breast Cancer

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.