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Study aim: Comparison of PDlasta & PDgrastim efficacy and safety in breast cancer patients on adjuvant and neoadjuvant treatment with Dose-dense ac4-t4 (Doxorubicin-Cyclophosphamide-Paclitaxel) Design: Randomized, interventional, two arm parallel group, single blind clinical trial Settings and conduct: Patients will be randomly assigned to the drug group (PDlasta) or to the control group (PDgrastim), after having recorded all the necessary information in their case, if they have indications of GCSF. These drugs are given free of charge. Patients in the two groups will receive up to 8 courses each time they undergo chemotherapy. In the next step, the patients' response to these treatments and the possible side effects of the drug are examined and in addition to the baseline, on days 7 and 14, ANC (Absolute neutrophil count) is examined. (Place of study: Clinic of breast cancer) Participants/Inclusion and exclusion criteria: Inclusion criteria: Breast cancer patients candidate of adjuvant and neoadjuvant therapy older than 18 years ;Exclusion criteria: Bilirubin > upper limit of normal; or aspartate transaminase and/or alanine transaminase >1.5 × upper limit of normal, concomitant with alkaline phosphatase >2.5 × upper limit of normal, radiation therapy within 4 weeks of randomization into this study, prior bone marrow or stem cell transplantation, total lifetime exposure to doxorubicin >240 mg/m^2 or epirubicin >600 mg/m^2, EF<40%, liver cirrhosis Intervention groups: Patients receive a single subcutaneous injection of 6 mg of PDlasta during each chemotherapy cycle on the first day after receiving chemotherapy (24 hours later). In the control group, PDgrastim is given as a subcutaneous injection of 300 micrograms per day for six consecutive days. Main outcome variables: Change of ANC at the beginning of each chemotherapy course, Determine the frequency of possible side effects in the process of treatment
IRCTID: IRCT20190504043465N1
  1. Follow-up of Severe Congenital Neutropenia Patients Receiving PegGCSF (PD lasta); Study of Early and Late Drug Complications
  2. 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.
  3. Comparison of the effects of Pegagen and G-csf in the chemotherapy induced cytopennia in the breast cancer patients
  4. Comparison of Paclinab serum level with its original serum brand, Abraxane in patients with metastatic breast cancer
  5. The effectiveness of a single dose of peg-filgrastim (PD-Lasta) compared with Filgrastim (PD-grastim) to increase the absolute number of neutrophils (ANC) in patients with AML after chemotherapy
  6. Comparison of clinical, radiologic and pathologic response rates of neoadjuvant chemotherapy regimen containing doxorubicin and cyclophosphamide with paclitaxel and gemcitabine in locally advanced breast cancer
  7. Evaluation of clinical and histopathological efficacy of carboplatin and gemcitabine as second line neoadjuvant therapy in locally advanced breast cancer patients
  8. A clinical trial evaluating the results and complications of intraoperative radiotherapy as boost after neoadjuvant chemotherapy in patients with nonmetastatic breast cancer candidate for breast conserving surgery
  9. Comparison evaluation of sleep disorders incidence in patients with primary breast cancer admitted to Imam Khomeini hospital in Tehran received melatonin during adjuvant chemotherapy
  10. Comparison of the effect of prophylactic granulocyte colony-stimulating factor versus placebo on neutrophil count before chemotherapy on children with malignant neuroblastoma
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