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 @ 11:47 PM
Ignite Modification Date:
2025-12-24 @ 11:47 PM
NCT ID:
NCT03135951
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed, histologically confirmed early-stage breast cancer, defined as operable Stage I to Stage IIIA breast cancer.
* Candidate to receive adjuvant or neoadjuvant TC chemotherapy.
* ANC ≥1.5x10\^9/L
* Platelet count ≥100x10\^9/L
* Hemoglobin \>9 g/dL
* Calculated creatinine clearance \>50 mL/min
* Total bilirubin ≤1.5 mg/dL
* AST and ALT ≤2.5xULN
* Alkaline phosphatase ≤2.0xULN
* ECOG ≤2
Exclusion Criteria:
* Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of cervix) or life-threatening disease. If history of prior malignancies or contralateral breast cancer, must be disease free for at least 5 years.
* Known sensitivity to E. coli derived products or known sensitivity to any of the products to be administered during dosing.
* Concurrent adjuvant cancer therapy.
* Locally recurrent/metastatic breast cancer.
* 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 antibiotics or any serious underlying medical condition which would impair the ability of the patient to receive protocol-specified treatment.
* Prior bone marrow or hematopoietic stem cell transplant
* Used 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.
* Prior 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:
NCT03135951
Study Brief:
Protocol Section:
NCT03135951