Evaluating the effect of G-CSF on white blood cell recovery during breast cancer chemotherapy
Evaluation and Modeling of the Effect of G-CSF on the Evolution of Polynuclear Neutrophils During Dense Dose Epirubicin-Cyclophosphamide Regeneration
NA · Centre Georges Francois Leclerc · NCT05296317
This study is testing whether a new timing for a white blood cell booster can help women with breast cancer recover their white blood cell counts better during chemotherapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Centre Georges Francois Leclerc (other) |
| Drugs / interventions | Cyclophosphamide, chemotherapy |
| Locations | 1 site (Dijon, Bourgogne) |
| Trial ID | NCT05296317 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of granulocyte colony-stimulating factor (G-CSF) on the recovery of white blood cells in women undergoing dense dose chemotherapy with epirubicin and cyclophosphamide for localized breast cancer. Patients will be randomized to receive either peg-G-CSF or standard G-CSF at different times during their treatment. The goal is to determine which regimen better supports white blood cell levels and reduces the risk of neutropenia. The study will model the pharmacodynamic effects of G-CSF in relation to chemotherapy administration.
Who should consider this trial
Good fit: Ideal candidates are women over 18 with non-metastatic breast cancer requiring dense dose epirubicin-cyclophosphamide treatment.
Not a fit: Patients with contraindications to anthracyclines or G-CSF, as well as those already undergoing similar treatments, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of white blood cell counts in breast cancer patients undergoing chemotherapy, potentially reducing complications and improving treatment outcomes.
How similar studies have performed: Other studies have shown positive outcomes with G-CSF in supporting white blood cell recovery during chemotherapy, indicating this approach is supported by prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Dijon, Bourgogne
- Centre Georges François Leclerc (CGFL) — Dijon, Bourgogne, France (RECRUITING)
Study contacts
- Study coordinator: LADOIRE SL SYLVAIN, coordinator
- Email: sladoire@cgfl.fr
- Phone: 03.80.73.75.00 poste 37.47
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Localized Breast Cancer, breast cancer, G-CSF, Epirubicin-cyclophosphamide dose-dense