Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Nanogen Pharmaceutical Biotechnology Joint Stock Company
Age
18–65
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | Nanogen Pegcyte Clinical Study for the Prevention of CIN in Breast-cancer Patients.
