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:
2025-12-26 @ 5:17 PM
Ignite Modification Date:
2025-12-26 @ 5:17 PM
NCT ID:
NCT02725606
Eligibility Criteria:
Inclusion Criteria:
* Aged 18 years to 70 years, female
* Patients with histologically-confirmed breast cancer and plan to accept adjuvant chemotherapy(epirubicin plus cyclophosphamide)
* Have an Eastern Cooperative Oncology Group(ECOG) performance status≤2
* Have no clinically significant impairment in cardiac, liver and kidney
* Adequate hematologic, hepatic and renal function which should meet the following requirements:
1. Absolute neutrophil count(ANC)≥1.5 x 10\^9/L
2. Blood platelet(PLT)≥100 x 10\^9/L
3. Serum creatinine(sCr)≤1.5 times the upper limit of normal(ULN)
4. Total bilirubin(TBIL)≤1.5×ULN
5. Aspartate aminotransferase(AST) /serum glutamic-oxaloacetic transaminase(SGOT) and/or alanine aminotransferase(ALT)/serum glutamic pyruvic transaminase(SGPT) ≤ 2.5 x ULN
6. Hemoglobin(Hb)\>9 g/dL
7. Alkaline phosphatase(ALP)≤1.5×ULN
* Expected to comply with protocol
* With urine human chorionic gonadotropin (hCG) negative
* Signed informed consent
Exclusion Criteria:
* With acute infection
* With history of bone marrow transplant and/or stem cell transplant
* With primary hematological diseases, such as myelodysplastic syndromes, aplastic anemia, sickle cell anemia
* Received surgery within 3 weeks before chemotherapy
* Received G-CSF within 4 weeks before involved in this study
* Females who are pregnant or lactating
* Participated in other clinical trials at the same time or within 4 weeks before screening
* Known allergy to chemotherapy drugs,recombinant human granulocyte-colony stimulating factor rh(rhG-CSF) or any other biological products
* With cacoethic addiction such as drug abuse or alcoholism
* With other cases which is not suitable for this study judged by investigator
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02725606
Study Brief:
Protocol Section:
NCT02725606