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

• Status: Not yet recruiting
• Trial end date: 2023-04-15
• Target enrollment: 0
• Participant gender: Female

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Georges Francois Leclerc
• Treatments: Cyclophosphamide; Epirubicin; Lenograstim

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)