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IRCT20211218053442N1 IRCT 2022-02-15 Zistdaru Danesh Co. ® Evaluation the non-inferiority of zistdaru danesh filgrastim to neupogen (amgen) in the prevention of neutropenic complications in breast cancer patients Evaluation the non-inferiority of filgrastim (zistdaru danesh) to neupogen (amgen) in the prevention of neutropenic complications in breast cancer patients: A phase III , randomized, triple-blinded (patient, outcome assessor and statistical analysis team), two armed clinical study. 2022-02-20 anticipated 208 Complete https://irct.ir/trial/60757 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Build numerical sequences: Patient randomization program is done by an online system (http://www.sealedenvelope.com). The randomization method in this system is permuted block randomization. The length of each block includes 4 patients, which will be made for a total of 208 patients. When randomization is performed, each patient receives a code that will be recognized by the study. The code will consist of two numbers (according to the randomization number) and four letters (according to the first two letters of the name. The first two letters of the surname). Randomization numbers are determined sequentially. In each center, after examining the inclusion and non-inclusion criteria of patients, with a pre-determined telephone (clinical study partner in Tehran, whose specific task in the whole study is only to coordinate with researchers). ) Will be called and given a randomization code (written on the drug label in the stock of each site). Determining the group of patients (concealment process) A random chain is created and anonymous codes corresponding to each patient (generated by the online software) are pasted on the drug labels and prepared in advance at the patient's sites. After the patient enters the study, only the desired code will be announced on the site and the corresponding drug will be prescribed to the patient, Blinding description: Blinding process: This study is performed in a triple-blind manner. All staff involved in the study, patients and statistical analysis team are unaware that the person receiving the zistdaru danesh filgrastim under study or the neupogen. Filgrastim and AMGEN Neupogen are sent to centers in their original packaging. In each center, 1 unblinded person is responsible for the preparation (change of drug labels) based on the random code assigned to the patient, and each drug will be given to the person responsible for injection (blinded nurse) after preparation in the same package. For this reason, the group involved in the patient's treatment process and evaluating the results of the study will be completely different from the personnel involved in the preparation of the drug. The randomized table will remain strictly confidential with the randomization center and will not be provided except in legal cases. 3 Neutropenia. Intervention 1: Invention group : Administration of Filgrastim ZistDaru at a dose of 300 mcg, 24-48 hours after the first cycle of chemotherapy until ANC more than 5*10 9 and maximum for 10 days (each one occurred earlier). Intervention 2: Control group: group Administration of Neupogen (Filgrastim AMGEN company) at a dose of 300 mcg, 24-48 hours after the first cycle of chemotherapy until ANC more than 5*10 9 and maximum for 10 days (each one occurred earlier). No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information.
public Maryam Azimi
Unit 2, No. 14., 16th Gandi Ave., Valiasr street, Tehran
Tehran Iran (Islamic Republic of) 1517854313 +98 21 8866 0795 info@ppvcro.com Pharmed Pajoohan Viera scientific Farhad Samiei
Cancer Institute, Emam-Khomeini hospital, Keshavarz Blvd., Tehran
tehran Iran (Islamic Republic of) 1419733141 +98 21 8896 3546 samieifarhad@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Female gender age between 18 and 70 years with weight range of 40-100 kg . Agree to participate in the study and sign an informed consent form. Recognized with breast cancer treated with doxorubicin hydrochloride (Adriamycin) and cyclophosphamide (AC) regimen Eastern Cooperative Oncology Group (ECOG) one and zero Candidate for preventive use for neutropenia (according to American society of clinical oncology (ASCO) guideline recommendation for prophylaxis of filgrastim in patients receiving chemotherapy regimens with more than 20% chance of developing neutropenia fever) Use at least one method of contraception from 4 weeks before the study until the end of the study Life expectancy more than 3 months Having the ability to receive treatment and follow-up 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. 18 years 70 years Female Existence of any serious systemic disorders associated with granulocyte-colony stimulating factor (GCSF) incompatibility administration Uncontrolled blood pressure history or other systemic disease Heart failure regarding AC chemotherapy intolerability Known severe coagulation disorder (hemophilia A or B) Participate in another clinical trial up to 30 days prior to drug administration Any chemotherapy in the last five years Receive doxorubicin> 600 mg/m2 or Epirubicin > 240 mg/m2 History of hypersensitivity to natural GCSF or recombinant human albumin Systemic or local infection or receive any antibiotic up to 10 days prior to study recruitment Receive concomitant radiotherapy or 4 weeks before enrollment Pregnancy D70 Neutropenia Treatment - Drugs Treatment - Drugs Invention group : Administration of Filgrastim ZistDaru at a dose of 300 mcg, 24-48 hours after the first cycle of chemotherapy until ANC more than 5*10 9 and maximum for 10 days (each one occurred earlier) Control group: group Administration of Neupogen (Filgrastim AMGEN company) at a dose of 300 mcg, 24-48 hours after the first cycle of chemotherapy until ANC more than 5*10 9 and maximum for 10 days (each one occurred earlier) The number of Days that severe neutropenia occurs during the first chemotherapy cycle according to absolute neutrophil count < 500 per microliter of blood. Timepoint: The first chemotherapy cycle. Method of measurement: Absolute number of blood neutrophils in terms of number per microliter of blood. Occurance of febrile neutropenia. Timepoint: The start of medication in both groups until the last visit. Method of measurement: Fever over 38.5 centigrade degree for at least 1 hour and neutropenia less than 500 per microlitr blood coincidence. Incidence of neutropenia defined as absolute neutrophil count < 0.5 x 10e9/L not associated with fever. Timepoint: The start of medication in both groups until the last visit. Method of measurement: Absolute neutrophil count per microliter of blood and fever measurement with thermometer (temperature more than 38 degree of centigrade) . Determine the exact count of neutrophils. Timepoint: The start of medication administration in both groups until the last visit. Method of measurement: Absolute neutrophil count per each microliter of blood. Incidence of infections. Timepoint: The start of medication in both groups until the last visit. Method of measurement: According to blood, respiratory secretion or urine culture. Incidence of need for IV anti-infectives. Timepoint: The start of medication in both groups until the last visit. Method of measurement: According to the results of the culture or clinical symptoms. As a result of neutropenia Incidence of hospitalization. Timepoint: The start of medication in both groups until the last visit. Method of measurement: Patient history taking. As a result of neutropenia ,Duration of hospitalization. Timepoint: The start of medication in both groups until the last visit. Method of measurement: Patient visit. Ability to maintain planned chemotherapy dose on time for cycles 2 to 6. Timepoint: every chemotherapy cycle. Method of measurement: Patient visit. Cumulative r-G-CSF dose. Timepoint: The start of medication in both groups until the last visit. Method of measurement: The number of filgrastim during the study period. Zistdaru Danesh Co. ® Approved 2021-10-18 Tehran University of Medical Sciences Vice-Chancellor in Research Affairs-Tehran University of Medical Science, 6th floor, near Qods st, keshavarz blvd. Tehran Tehran Iran (Islamic Republic of)