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.

Determining clinical efficacy of ZistDaru Danesh Company Filgrastim in preventing neutropenia versus Neopogen.

A Phase 3,non Inferiority, two-arm, triple -blinded clinical trial study (patient, outcome assessor and statistical analysis team), parallel, active control. The randomization method is permuted block that consist of 4 blocks for total 208 patients.

Two groups of 104 patients will be randomly allocated to receive Filgrastim (ZDD company) and Neupogen 5 micrograms per kilogram of body weight daily since 24 hours after the start of each chemotherapy cycle (each chemotherapy cycle is 21 days ) for 6 days (up to a maximum of 8 days). Investigators, patients and evaluators will not aware of the type of medicines.

Inclusion criteria: 1.Female gender age between 18 and 70 years. 2.Recognized with breast cancer treated with ac regimen 3.ECOG score one and zero Exclusion criteria: 1.Existence of any serious systemic disorders associated with GCSF incompatibility administration 2.Uncontrolled blood pressure history or other systemic disease .3.Heart failure 4.Known coagulation disorder 5.Received any stem cell transplants 6.Any chemotherapy in the last five years 7.Receive doxorubicin or epirubicin 8.History of hypersensitivity to natural GCSF or recombinant human albumin 9.Systemic or local infection or receive any antibiotic up to 10 days prior to study recruitment

Granlocyte-colony stimulating factor (GCSF) made by zistdaru danesh company versus Neupogen as standard treatment.

The number of days that severe neutropenia occurs during the first chemotherapy cycle (Absolute Neutrophil Count<500/microliter)

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 process: This study is performed in a three-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. Zistdaru company filgrastim and amgen neupogen have exactly the same packaging and vials. for this reason, the study evaluation team will be completely different from the personnel involved in the patient's treatment process. The randomized table will remain strictly confidential with the randomization center and will not be provided except in legal cases.

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