Localized Breast CancerEMEG-ECDDNCT05296317
Evaluation and Modeling of the Effect of G-CSF on the Evolution of Polynuclear Neutrophils During Dense Dose Epirubicin-Cyclophosphamide Regeneration
A study testing Dense dose epirubicin-cyclophosphamide chemotherapy and G-CSF (filgrastim, lenograstim) and Dense dose epirubicin-cyclophosphamide chemotherapy with administration of peg-G-CSF (pegfilgrastim) in people with Localized Breast Cancer, run by Centre Georges Francois Leclerc at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Localized Breast Cancer
- What is being tested?
- Dense dose epirubicin-cyclophosphamide chemotherapy and G-CSF (filgrastim, lenograstim) and Dense dose epirubicin-cyclophosphamide chemotherapy with administration of peg-G-CSF (pegfilgrastim)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteFrance
- Study dates
- 2 Sep 2022to 26 Sep 2025
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Georges François Leclerc (CGFL)
Dijon, Bourgogne-Franche-Comté, 21000
About this study
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
Read the 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
- Being tested
- Dense dose epirubicin-cyclophosphamide chemotherapy and G-CSF (filgrastim, lenograstim), Dense dose epirubicin-cyclophosphamide chemotherapy with administration of peg-G-CSF (pegfilgrastim)
- Keywords
- breast cancer, G-CSF, Epirubicin-cyclophosphamide dose-dense
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dense dose epirubicin-cyclophosphamide chemotherapy and G-CSF (filgrastim, lenograstim)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
Dense dose epirubicin-cyclophosphamide chemotherapy with administration of peg-G-CSF (pegfilgrastim)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
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 : Dense dose epirubicin-cyclophosphamide chemotherapy with administration of G-CSF | Experimental | 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 Receives: Drug: Dense dose epirubicin-cyclophosphamide chemotherapy and G-CSF (filgrastim, lenograstim) |
| Arm 2 : Dense dose epirubicin-cyclophosphamide chemotherapy with administration of peg-G-CSF | Experimental | 2 cycles of chemotherapy with administration of peg-G-CSF (pegfilgrastim) on D2.
Realization of blood sampling at D1, D4, D8 and D14 Receives: Drug: Dense dose epirubicin-cyclophosphamide chemotherapy with administration of peg-G-CSF (pegfilgrastim) |
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 or peg-G-CSF
Variation of Neutrophils concentration will be assess by blood count formula performed during the 2 first cycle of Epirubicin-cyclophosphamide treatment.
Measured: Day 4
Variation of Neutrophils concentration in patient treated with G-CSF or peg-G-CSF
Variation of Neutrophils concentration will be assess by blood count formula performed during the 2 first cycle of Epirubicin-cyclophosphamide treatment.
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start2 Sep 2022
- Primary completion26 Sep 2025
- Study completion26 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized : * Either to a peg-G-CSF arm (with administration of peg-G-CSF on D2) * Either to a G-CSF arm (with administration from D4 to D7 or D8). Blood samplig will be taken at D1, D4, D8 and D14 for each arm.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296317
- Sponsor's protocol ID
- 2021-A01407-34
- Acronym
- EMEG-ECDD
- Status last verified
- Feb 2026
- First submitted
- 24 Jan 2022
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Modeling of the Effect of G-CSF on the Evolution of Polynuclear Neutrophils During Dense Dose Epirubicin-Cyclophosphamide Regeneration
- ClinicalTrials.gov ID
- NCT05296317
- Acronym / sponsor ID
- EMEG-ECDD / 2021-A01407-34
- Conditions
- Localized Breast Cancer
- Keywords
- breast cancer, G-CSF, Epirubicin-cyclophosphamide dose-dense
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- 26 Sep 2025 (actual)
- Study completion
- 26 Sep 2025 (actual)
- First posted
- 25 Mar 2022 (actual)
- 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be randomized : * Either to a peg-G-CSF arm (with administration of peg-G-CSF on D2) * Either to a G-CSF arm (with administration from D4 to D7 or D8). Blood samplig will be taken at D1, D4, D8 and D14 for each arm.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 : Dense dose epirubicin-cyclophosphamide chemotherapy with administration of G-CSF | Experimental | Drug: Dense dose epirubicin-cyclophosphamide chemotherapy and G-CSF (filgrastim, lenograstim)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 | Experimental | Drug: Dense dose epirubicin-cyclophosphamide chemotherapy with administration of peg-G-CSF (pegfilgrastim)2 cycles of chemotherapy with administration of peg-G-CSF (pegfilgrastim) on D2. Realization of blood sampling at D1, D4, D8 and D14 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| 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 | Drug | Arm 1 : Dense dose epirubicin-cyclophosphamide chemotherapy with administration of G-CSF |
| 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 | Drug | Arm 2 : Dense dose epirubicin-cyclophosphamide chemotherapy with administration of peg-G-CSF |
Primary outcome
Variation of Neutrophils concentration in patient treated with G-CSF or peg-G-CSF
Time frame: Day 4
Variation of Neutrophils concentration will be assess by blood count formula performed during the 2 first cycle of Epirubicin-cyclophosphamide treatment.
Variation of Neutrophils concentration in patient treated with G-CSF or peg-G-CSF
Time frame: Day 8
Variation of Neutrophils concentration will be assess by blood count formula performed during the 2 first cycle of Epirubicin-cyclophosphamide treatment.
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 19 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dense dose epirubicin-cyclophosphamide chemotherapy and G-CSF (filgrastim, lenograstim) and Dense dose epirubicin-cyclophosphamide chemotherapy with administration of peg-G-CSF (pegfilgrastim) in people with Localized 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 7 inclusion and 6 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 19 Feb 2026. 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 or peg-G-CSF (time frame: Day 4). The study lists 2 primary outcomes in all. 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 19 Feb 2026.