Breast CancerEMEG-E-01NCT02841722
Evaluation and Modeling of the G-CSF Effect on the Evolution of Neutrophils During Chemotherapy Based on Eribulin
A study testing ERIBULIN + G-CSF (Granulocyte-Colony Stimulating Factor) in people with Breast Cancer, run by Centre Georges Francois Leclerc at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- ERIBULIN + G-CSF (Granulocyte-Colony Stimulating Factor)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteFrance
- Study dates
- 3 Dec 2015to 10 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Breast Cancer
- Being tested
- ERIBULIN + G-CSF (Granulocyte-Colony Stimulating Factor)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERIBULIN + G-CSF (Granulocyte-Colony Stimulating Factor)Procedure or surgery
8 additional blood samples
| Study group | Role | What they receive |
|---|---|---|
| Biological samples | Other | 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). Receives: Procedure: ERIBULIN + G-CSF (Granulocyte-Colony Stimulating Factor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study start3 Dec 2015
- Primary completion3 Dec 2015
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle DESMOULINS, MD, Principal investigator, Centre Georges François Leclerc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841722
- Sponsor's protocol ID
- 2015-A00123-46
- Acronym
- EMEG-E-01
- Status last verified
- Jan 2020
- First submitted
- 21 Apr 2016
- Last updated
- 24 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Modeling of the G-CSF Effect on the Evolution of Neutrophils During Chemotherapy Based on Eribulin
- ClinicalTrials.gov ID
- NCT02841722
- Acronym / sponsor ID
- EMEG-E-01 / 2015-A00123-46
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 3 Dec 2015 (actual)
- Primary completion
- 3 Dec 2015 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 22 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biological samples | Other | Procedure: ERIBULIN + G-CSF (Granulocyte-Colony Stimulating Factor)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). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERIBULIN + G-CSF (Granulocyte-Colony Stimulating Factor)8 additional blood samples | Procedure or surgery | Biological samples |
Primary outcome
Variation of Neutrophils concentration in patient treated with G-CSF (Granulocyte-Colony Stimulating Factor)
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)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle DESMOULINS, MD principal investigator
Centre Georges François Leclerc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERIBULIN + G-CSF (Granulocyte-Colony Stimulating Factor) in people with Breast Cancer, run by Centre Georges Francois Leclerc at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of Neutrophils concentration in patient treated with G-CSF (Granulocyte-Colony Stimulating Factor) (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2020.