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:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT02944604
Eligibility Criteria:
Inclusion Criteria:
1.18-65 years old, gender no limited.
2.Breast cancer diagnosed by pathology.
3.Did not receive chemotherapy previously and plans to receive 4 cycles intensive EC (epirubicin, cyclophosphamide) treatment.
4.No obvious blood system disease, ANC(absolute neutrophil count)≥ 1.5 × 10\^9/L, PLT（Platelet）≥80×10\^9 /L, Hb（hemoglobin）≥75g/L, WBC（White blood cell ）≥3×109/L, and no bleeding tendency.
5.KPS (Karnofsky performance status) score≥70.
6.Expected survival≥3 months.
7.Written informed consent are acquired.
Exclusion Criteria:
1. Severe or uncontrolled infection.
2. Sensitive to the product or other genetically engineered biological products from Escherichia coli strains.
3. Mental or nervous system disorders.
4. Severe heart, lung and central nervous system disorders.
5. Pregnant or lactating women.
6. TBIL(total bilirubin ), ALT（alanine aminotransferase）,AST（glutamic-oxalacetic transaminase） \> 2.5×ULN（upper limit of normal）; if it were caused by liver metastases, TBIL, ALT,AST \>5×ULN.
7. Cr（creatinine） \>1.5×ULN.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02944604
Study Brief:
Protocol Section:
NCT02944604