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 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
NCT ID:
NCT03575520
Eligibility Criteria:
Inclusion Criteria:
* Histological or cytological diagnosis of a primary breast cancer (stage I-III)
* Age \> 18 years of age and Age \< 66 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 1
* Patients who have plan to receive neoadjuvant or adjuvant dose-dense AC chemotherapy
* Adequate organ functions
1. ANC ≥1500 cells/mm3
2. PLT ≥100,000 cells/mm3
3. CCr ≥50 mL/min, or Serum Cr \<1.5 x (upper limit of normal, ULN)
4. Total bilirubin ≤1.5 x ULN
5. AST (SGOT) ≤2.5 x ULN
6. ALT (SGPT) ≤2.5 x ULN
Exclusion Criteria:
* Previous chemotherapy history
* Previous bone marrow transplantation history
* Sickle cell anemia
* Radiation therapy within 4 weeks from enrollment
* Previous pegfilgrastim, filgrastim or other colony-stimulating factor treatment within 4 weeks from enrollment
* Clinically significant systemic illness (serious infection, liver, kidney, heart disease)
* Pregnant, breast feeding women
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
19 Years
Maximum Age:
65 Years
Study:
NCT03575520
Study Brief:
Protocol Section:
NCT03575520