Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 1:16 AM
NCT ID:
NCT03619993
Eligibility Criteria:
Inclusion Criteria:
* Patients with early breast cancer planned to receive 3 weekly or dose-dense anthracycline/cyclophosphamide combination or 3 weekly taxane containing chemotherapy regimen or patients with NHL planned to receive R-CHOP-14 or R-CHOP-21 immunochemotherapy as 1st-line treatment with the indication for G-CSF prophylaxis with pegfilgrastim for the prevention of FN and reduction in CIN duration. Patients have to be included before start of their (immuno-) chemotherapy.
* ECOG (Eastern Cooperative Oncology Group) performance status 0, 1 or 2
* Life expectancy \> 3 months
* Absolute neutrophil count ≥ 1.5 x 109/L
* Ability to read and understand German
* Signed informed consent
Exclusion Criteria:
* Hypersensitivity to the active substance or to any of the excipients
* Subject is currently enrolled or has not yet completed at least 30 days since ending other investigational device or drug trial(s) or is receiving investigational agent(s)
* Active infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment
* Prior bone marrow or stem cell transplantion
* Subject of child-bearing potential is evidently pregnant (e.g. positive HCG (Human Chorionic Gonadotropin) test) or is breast feeding
* Subject is not using adequate contraceptive precautions.
* Other conditions which, in the opinion of the investigator, make participation in an investigational trial of this nature a poor risk
* Concerns for subject's compliance with the protocol procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03619993
Study Brief:
Protocol Section:
NCT03619993