Evaluation and Modeling of the G-CSF Effect on the Evolution of Neutrophils During Chemotherapy Based on Eribulin

Breast Cancer Clinical Trial

— EMEG-E-01  

Official title:

Evaluation and Modeling of the G-CSF Effect on the Evolution of Neutrophils During Chemotherapy Based on Eribulin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02841722
• Other study ID #: 2015-A00123-46
• Status: Completed
• Phase: N/A
• Start date: December 3, 2015
• Est. completion date: January 10, 2020

Study information

• Verified date: January 2020
• Source: Centre Georges Francois Leclerc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The anti-cancer cytotoxic chemotherapy is often the cause of neutropenia of grade IV or febrile neutropenia. Those neutropenia, in addition to being a comorbidity factor, result in dose reductions and/or temporary or permanent stop of chemotherapy, thus impacting clinical response. To avoid those episodes, or to shorten the duration and reduce the associated risk, administration of Granulocyte Colony Stimulating Factor (G-CSF) is recommended. Recombinant G-CSF reproduces the physiological effects of endogenous G-CSF by increasing the proliferation of granulocytes progenitors. Different forms of G-CSF are available: daily administration (such as filgrastim, lenograstim) and a single administration (pegfilgrastim).

Various international learned societies offer recommendations for primary care, secondary or curative neutropenia induced by chemotherapy based on G-CSF. However, guidance on the ideal time for the administration of growth factors and duration of administration are not very clear. If it seems clear that the treatment should not be initiated within the first 24 hours following administration of chemotherapy, summaries of the characteristics of different products do not provide evidence to optimize the administration day depending on the kinetics evolution of neutrophils. In addition, no information is given as to the choice of a formulation with respect to the other.

The pilot study the investigator propose aims to model the effect of exogenous G-CSF on the evolution of neutrophil function of time and explain the pharmacodynamic variability during the administration of chemotherapy based on eribulin. The description of the evolution of neutrophils when growth factors are administered give the opportunity to streamline administration regimens of these factors and to provide guidance on the circumstances in which they should or should not be given while weekly chemotherapy.

Expected benefits and foreseeable risks With the exception of surplus withdrawals during the first 2 cycles of treatment, this study will have no impact on the care of patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: January 10, 2020
• Est. primary completion date: December 3, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Women

• over 18 years

• Patient with locally or metastatic advanced breast cancer histologically documented who received at least one chemotherapy regimen that includes an anthracycline and a taxane unless in patients who can not receive these treatments

• Patient to be treated with eribulin

• Patient that should preventively receive granulocyte growth factors at the first cycle (patient who already experienced febrile neutropenia, patient with a low neutrophil count at baseline, patient with a Performance Status altered or any other condition requiring administration of granulocyte colony stimulating factor as recommended by the oncologist)

• Neutrophils> 1500 / mm3; platelets> 100,000 / mm3

• Dated and signed Informed consent

• For patients of childbearing age, effective contraception during treatment and up to 3 months after stopping treatment

Exclusion Criteria:

• Patient with against-indication to treatment with eribulin such as hypersensitivity to the active substance or to any of the excipients, congenital long QT syndrome

• Patient already being treated with eribulin

• Patient with clinically detectable brain metastases

• Patient with against-indication to treatment with G-CSF such as hypersensitivity to the active substance or to any of the excipients

• Pregnant women or nursing

• Patient under guardianship or subject to major people protection regime

• Patient not affiliated with a social security scheme (beneficiary or beneficiary)

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• ERIBULIN + G-CSF (Granulocyte-Colony Stimulating Factor)
8 additional blood samples

Locations

Country	Name	City	State
France	CGFL	Dijon

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 (Granulocyte-Colony Stimulating Factor)	variation of Neutrophil concentration will be assess by blood count formula performed during the 2 first cycle of Eribulin treatment: at the first and last day of G-CSF administration, at day 10 and day 15 of each cycle.	Variation of Neutrophil concentration will be assess during the two first cycle of Eribulin treatment (1 cycle is 21 days, so total time frame is 42 days)