Evaluation and Modeling of the Effect of G-CSF on the Evolution of Polynuclear Neutrophils During… (NCT05296317) | Clinical Trial Compass
CompletedNot Applicable
Evaluation and Modeling of the Effect of G-CSF on the Evolution of Polynuclear Neutrophils During Dense Dose Epirubicin-Cyclophosphamide Regeneration
France97 participantsStarted 2022-09-02
Plain-language 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
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Variation of Neutrophils concentration in patient treated with G-CSF or peg-G-CSF
Timeframe: Day 4
2
Variation of Neutrophils concentration in patient treated with G-CSF or peg-G-CSF