An interventional study of ERIBULIN + G-CSF (Granulocyte-Colony Stimulating Factor) in Breast Cancer, sponsored by Centre Georges Francois Leclerc. Completed at 1 site in France. Open to female participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-06-24.
Sponsored by Centre Georges Francois Leclerc · Not applicable, Interventional, and Prevention
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.
Centre Georges Francois Leclerc is the lead sponsor of 75 studies on the registry; 23 are open to participants now.
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Exclusion Criteria:
Only one arm in this pilot study. All patient will have a follow up and treatment as per standard care for this pathology. Specifically for the study all patients will have 8 additional blood samples to be drawn during the first 2 cycles of treatment (1 cycles is 21 days).
Procedure: ERIBULIN + G-CSF (Granulocyte-Colony Stimulating Factor)
8 additional blood samples
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.
Time frame: 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)
Plan to share: No
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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Centre Georges Francois Leclerc