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 @ 4:27 PM
Ignite Modification Date:
2025-12-24 @ 4:27 PM
NCT ID:
NCT01724866
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed breast cancer and candidate for adjuvant or neoadjuvant chemotherapy
* Candidate for docetaxel and cyclophosphamide chemotherapy
* Female or male at least 18 years of age
* Eastern Cooperative Oncology Group (ECOG) ≤ 2
* Absolute neutrophil count (ANC) ≥ 1.5×109/L
* Platelet count ≥ 100 x 10\^9/L
* Creatinine ≤ 1.5 x upper limit of normal (ULN)
* Total bilirubin ≤1.5 mg/dL(≤ 25.65 μmol/L).
* Aspartate aminotransferase per serum glutamic-oxaloacetic transaminase (AST/SGOT) and/or alanine aminotransferase per serum glutamic-pyruvic transaminase (ALT/SGPT) ≤ 2.5 x ULN
* Hemoglobin \> 9 g/dL
* Alkaline phosphatase ≤ 1.5 x ULN
Exclusion Criteria:
* Known sensitivity to E. coli-derived products or known sensitivity to any of the products to be administered
* Known Human Immunodeficiency Virus (HIV) infection
* Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) diagnosis with detectable viral load or immunological evidence of chronic active disease
* Active infection or any serious underlying medical condition that would impair ability to receive protocol treatment
* Prior bone marrow or stem cell transplant
* Prolonged exposure to glucocorticosteroids and immunosuppressive agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01724866
Study Brief:
Protocol Section:
NCT01724866