Clinical trial · Interventional
Evaluation and Modeling of the Effect of G-CSF on the Evolution of Polynuclear Neutrophils During Dense Dose Epirubicin-Cyclophosphamide Regeneration
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Localized Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dense dose epirubicin-cyclophosphamide chemotherapy and G-CSF (filgrastim, lenograstim) | Drug | — | UNRESOLVED |
| Dense dose epirubicin-cyclophosphamide chemotherapy with administration of peg-G-CSF (pegfilgrastim) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1 : Dense dose epirubicin-cyclophosphamide chemotherapy with administration of G-CSF
- description
- 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
- interventionNames
- Drug: Dense dose epirubicin-cyclophosphamide chemotherapy and G-CSF (filgrastim, lenograstim)
- type
- EXPERIMENTAL
- label
- Arm 2 : Dense dose epirubicin-cyclophosphamide chemotherapy with administration of peg-G-CSF
- description
- 2 cycles of chemotherapy with administration of peg-G-CSF (pegfilgrastim) on D2. Realization of blood sampling at D1, D4, D8 and D14
- interventionNames
- Drug: Dense dose epirubicin-cyclophosphamide chemotherapy with administration of peg-G-CSF (pegfilgrastim)
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available