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 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT02761460
Eligibility Criteria:
Inclusion Criteria:
1. Provision of informed consent Histologically proven breast cancer
2. Patients need to accept many cycles chemotherapy alone
3. appears III/IV neutropenia after last cycle of chemotherapy, and plan in the subsequent cycle using the same chemotherapy program.
4. KPS≥70
5. Lifetime is expected to more than 3 months
6. Before enrollment,ANC≥ANC ≥1.5×109 /L,Platelet Count (PLT) ≥80×109 /L, White Blood Cell （WBC ）≥3.0×109 /L.
7. Sign Informed Consent Form （ICF）.
Exclusion Criteria:
1. There is any difficult to control infection, or within 72 h before chemotherapy received antibiotic treatment systematically
2. Any abnormal bone marrow hyperplasia and other hematopoietic function was abnormal
3. Suffer from other malignant tumor was not cured, or patients with brain metastasis
4. Total Bilirubin （TBIL）,Alanine Transminase （ALT）,Aspartate aminotransferase(AST)\>2.5×ULN
5. Cr\>1.5×ULN
6. Be allergic to this product or other genetically engineered e. coli sources of biological products
7. Mental or neurological disorders
8. Women with pregnancy or lactation; The childbearing age women refused to accept contraception
9. The investigators think that the person doesn't fit into the group
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02761460
Study Brief:
Protocol Section:
NCT02761460