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 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT02643420
Eligibility Criteria:
Key Inclusion Criteria:
* New diagnosis of histologically confirmed early-stage breast cancer (ESBC), defined as operable Stage I to Stage IIIA breast cancer
* Candidate for adjuvant or neoadjuvant TC chemotherapy
* Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
* Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L
* Platelet count ≥ 100×10\^9/L
* Hemoglobin \> 9 g/dL
* Creatinine clearance \> 50 mL/min
* Total bilirubin ≤ 1.5 mg/dL
* Aspartate Aminotransferase per Serum Glutamic-Oxaloacetic Transaminase (AST/SGOT) and Alanine Aminotransferase per Serum Glutamic-Pyruvic Transaminase (ALT/SGPT) ≤ 2.5× Upper Limit of Normal (ULN).
* Alkaline phosphatase ≤ 2.0×ULN
Key Exclusion Criteria:
* Active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix) or life-threatening disease
* Locally recurrent or metastatic breast cancer
* Known sensitivity to E. coli -derived products or to any products to be administered during dosing
* Concurrent adjuvant cancer therapy
* Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical development within 12 months prior to the administration of study drug
* Active infection, receiving anti-infectives, or any serious underlying medical condition that would impair ability to receive protocol treatment
* Prior bone marrow or stem cell transplant
* Use of any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study
* Radiation therapy within 30 days prior to enrollment
* Major surgery within 30 days prior to enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02643420
Study Brief:
Protocol Section:
NCT02643420