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IRCT2013062613776N1 IRCT 2013-07-05 AryaTinaGene Biopharm Co. Clinical efficacy of Filgrastim-AryaTinaGene Phase III Trial Comparing Filgrastim (AryaTinaGene) to Neupogen (Amgen) in the Prevention of Neutropenic Complications in Breast Cancer Patients in Pange-Azar hospital of Gorgan 2013-07-01 anticipated 100 Complete https://irct.ir/trial/13555 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other. 3 Neutropenia. Invention was granlocyte-colony stimulating factor as recombinant product made by AryaTinaGene Biopharm Co namely Filgrastim-ATG for group A and Neupogen (Amgen) for group B as standard treatment. Administration of filgrastim 1 day after chemotherapy at least for 5 days and maximum for 14 days at a dose of 5 ug/kg/day and comparison of clinical outcomes.
public Hossein Amini
Gorgan, Shast cola Road, Falsafi Buldings
Gorgan Iran (Islamic Republic of) +98 17 1552 5972 hamini@sbmu.ac.ir Golestan University of Medical sciences scientific Dr. Abasali Keshtkar
Tehran, Shariati Hospital Osteoprosis research Center
Tehran Iran (Islamic Republic of) +98 912 717 9137 abkeshtkar@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) The study population consisted of women ≥ 18 years of age with metastatic or localized histopathologically proven breast cancer. Patients with localized cancer were required to have ≥ stage II disease with ≥ 1 positive regional node. Additional inclusion criteria included: Karnofsky performance status ≥ 70% for patients ≤ 70 years of age and ≥ 90% for patients > 70 years of age; adequate hematologic function (absolute neutrophil count [ANC] ≥3000 cells/μL, platelet count >100,000/μL, hemoglobin [Hb] ≥ 8 g/dL); adequate hepatic function (bilirubin ≤ 1.5 × upper limit of normal [ULN], aspartate aminotransferase and alanine aminotransferase ≤ 2.5 × ULN, alkaline phosphatase ≤ 5 × ULN); creatinine ≤ 2.0 × ULN; and normal cardiac function as determined by MUGA (multiple-gated acquisition) scan or echocardiography. All hematologic, renal, and hepatic valueshad to be within institutional normal limits in patients > 70 years of age. All women who had received prior chemotherapy must have completed treatment at least 3 weeks prior to study drug administration, and women of child-bearing age had to agree to comply with effective contraception and have done so since their last menses. Patients who had received radiotherapy within 4 weeks of entry required special permission from the study sponsors to enroll. Patients were excluded if they had received a cumulative lifetime dose of doxorubicin > 240 mg/m2 or epirubicin > 432 mg/m2, prior treatment with mitomycin-C or busulfan, or > 2 prior regimens of chemotherapy (excluding hormonal treatment). Additional exclusion criteria included a history of significant cardiac disease, arrhythmias, uncontrolled hypertension, recent myocardial infarction, or ischemia. Patients with human immunodeficiency virus infection, active hepatitis, or a history of a serious comorbid condition, uncontrolled metabolic disease, or psychiatric condition that would impair tolerance or evaluation of the study drug were also excluded. 18 years 90 years Female D70 Treatment - Drugs Invention was granlocyte-colony stimulating factor as recombinant product made by AryaTinaGene Biopharm Co namely Filgrastim-ATG for group A and Neupogen (Amgen) for group B as standard treatment. Administration of filgrastim 1 day after chemotherapy at least for 5 days and maximum for 14 days at a dose of 5 ug/kg/day and comparison of clinical outcomes Days of severe neuropenia (ANC>200 per ul). Timepoint: Every chemotherapy cycle. Method of measurement: Absolute neutrophil count (per ul of blood). Days of minor neuropenia (ANC>500-1000 per ul). Timepoint: Every chemotherapy cycle. Method of measurement: Absolute neutrophil count (per ul of blood). Days of moderate neuropenia (ANC>200-500 per ul). Timepoint: Every chemotherapy cycle. Method of measurement: Absolute neutrophil count (per ul of blood). Occurance of febrile neutropenia. Timepoint: every chemotherapy cycle. Method of measurement: Fever of 38.5 C for at least 1 h and neutropenia less than 500 per ul. Occurance of sepsis related to filgrastim. Timepoint: every chemotherapy cycle. Method of measurement: Blood analysis. Occurance of increased hepatic enzymes related to filgrastim. Timepoint: every chemotherapy cycle. Method of measurement: Blood analysis. Occurance of musculoskeletal pain related to filgrastim. Timepoint: every chemotherapy cycle. Method of measurement: Patient questionery. AryaTinaGene Biopharm Co. Approved 2013-06-25 Golestan University of Medical Sciences Gorgan, Shast cola road, Falsafi Building Gorgan Iran (Islamic Republic of)