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 @ 7:44 PM
Ignite Modification Date:
2025-12-24 @ 7:44 PM
NCT ID:
NCT03376503
Eligibility Criteria:
Inclusion Criteria:
* Female patients aged between 18 - 65 years.
* Patients with histological confirmed primary invasive breast cancer; stage I, II or III.
* Patients had no prior chemotherapy treatments.
* Patients scheduled to undergo myelosuppressive Doxorubicin and Cyclophosphamide chemotherapy for 04 cycles, and Paclitaxel chemotherapy for the next 04 cycles; patients were available for 14 days of each cycle for the first 03 chemotherapy cycles.
* Patients with baseline ANC ≥ 1.5 x 109/L, PLT ≥ 100 x 109/L, HgB ≥ 9 g/dL, WBC ≥ 3,000/mL and albumin ≥ 3.0 g/dL.
* Performance status as per ECOG (Eastern Cooperative Oncology Group) score 0, 1 or 2.
* Willing to give written and signed informed consent
Exclusion Criteria:
* Patients with prior exposure of G-CSF or GM-CSF or its pegylated products in clinical development less than 6 months prior to randomization.
* Myelotoxic concomitant treatment such as chloramphenicol, methotrexate, immunomodulating agents, interferons during 10 days before randomization.
* Received systemic antibiotic treatment within 72 hours of chemotherapy.
* Chronic use of corticosteroids, prior bone marrow or stem cell transplant.
* Patients who had an immediate/ concurrent exposure to radiotherapy or surgery (within 4 weeks).
* Severe medical disease: cardiovascular, hepatic, renal, pulmonary…
* Known cases of hematological disease (sickle cell anemia, AML…)
* History of HIV positive, active hepatitis.
* Pregnant and lactating women or patients planning to become pregnant.
* Known allergic reactions to study medications.
* Positive to anti-pegfilgrastim antibody test.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03376503
Study Brief:
Protocol Section:
NCT03376503