Status:
COMPLETED
Nanogen Pegcyte Clinical Study for the Prevention of CIN in Breast-cancer Patients.
Lead Sponsor:
Nanogen Pharmaceutical Biotechnology Joint Stock Company
Conditions:
Breast Cancer Female
Eligibility:
FEMALE
18-65 years
Phase:
PHASE3
Brief Summary
Accelerated AC regimen-Doxorubicin 60 mg/m2,Cyclophosphamide 600 mg/m2 on day 1 \& day 14 of each cycle along with G-CSF support for up to 4 cycles, followed by Paclitaxel 175 mg/m2 in the next 4 cycl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 6 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2017
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT03381417
Start Date
October 6 2016
End Date
November 6 2017
Last Update
January 2 2018
Active Locations (1)
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1
Vietnam National Cancer Institute (Hospital K)
Hanoi, Vietnam