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

Localized Breast Cancer Clinical Trial

— EMEG-ECDD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05296317
• Other study ID #: 2021-A01407-34
• Status: Recruiting
• Phase: N/A
• Start date: September 2, 2022
• Est. completion date: October 2, 2025

Study information

• Verified date: February 2024
• Source: Centre Georges Francois Leclerc
• Contact: LADOIRE SL SYLVAIN, coordinator
• Phone: 03.80.73.75.00 poste 37.47
• Email: sladoire[@]cgfl.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 model the effect of exogenous G-CSF for the evolution of polymorphonuclear neutrophils as a function of time and to explain the pharmacodynamic variability during the administration of chemotherapy such as EC-dense dose administered as an adjuvant or neo-adjuvant in patients treated for localized breast cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2, 2025
• Est. primary completion date: September 2, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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)

Related Conditions & MeSH terms

• Breast Neoplasms
• Localized Breast Cancer

Intervention

Drug:
• Dense dose epirubicin-cyclophosphamide chemotherapy and G-CSF (filgrastim, lenograstim)
- Arm 1: 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
• Dense dose epirubicin-cyclophosphamide chemotherapy with administration of peg-G-CSF (pegfilgrastim)
- Arm 2: 2 cycles of chemotherapy with administration of peg-G-CSF (pegfilgrastim) on D2. Realization of blood sampling at D1, D4, D8 and D14

Locations

Country	Name	City	State
France	Centre Georges François Leclerc (CGFL)	Dijon	Bourgogne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Georges Francois Leclerc

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of Neutrophils concentration in patient treated with G-CSF or peg-G-CSF	Variation of Neutrophils concentration will be assess by blood count formula performed during the 2 first cycle of Epirubicin-cyclophosphamide treatment.	Day 4
Primary	Variation of Neutrophils concentration in patient treated with G-CSF or peg-G-CSF	Variation of Neutrophils concentration will be assess by blood count formula performed during the 2 first cycle of Epirubicin-cyclophosphamide treatment.	Day 8