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

NCT ID: NCT05296317

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-02
• Study Completion Date: 2025-10-02

Brief 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

Detailed 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.

Conditions

Localized Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Arm 1 : Dense dose epirubicin-cyclophosphamide chemotherapy with administration of G-CSF

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

Group Type: EXPERIMENTAL

Dense dose epirubicin-cyclophosphamide chemotherapy and G-CSF (filgrastim, lenograstim)

Intervention Type: DRUG

• 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

Arm 2 : Dense dose epirubicin-cyclophosphamide chemotherapy with administration of peg-G-CSF

2 cycles of chemotherapy with administration of peg-G-CSF (pegfilgrastim) on D2.

Realization of blood sampling at D1, D4, D8 and D14

Group Type: EXPERIMENTAL

Dense dose epirubicin-cyclophosphamide chemotherapy with administration of peg-G-CSF (pegfilgrastim)

Intervention Type: DRUG

• 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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Georges Francois Leclerc

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Georges François Leclerc (CGFL)

Dijon, Bourgogne-Franche-Comté, France

Site Status: RECRUITING

Countries

France

Central Contacts

LADOIRE SL SYLVAIN, coordinator

Role: CONTACT

sladoire@cgfl.fr

03.80.73.75.00 poste 37.47

SCHMITT AS ANTONIN, methodoordinator

Role: CONTACT

aschmitt@cgfl.fr

03.80.73.75.00 poste 33.45

Facility Contacts

LADOIRE SL SYLVAIN, principal investigator

Role: primary

sladoire@cgfl.fr

Sophie Parnalland

Role: backup

sparnalland@cgfl.fr

03 45 34 80 77 ext. +33

Other Identifiers

2021-A01407-34

Identifier Type: -

Identifier Source: org_study_id