Comparison of PDlasta® (Pegfilgrastim) & PDgrastim® (Filgrastim) efficacy and safety in increasing absolute neutrophil count in breast cancer patients on adjuvant and neoadjuvant treatment with Dose-dense ac4-t4

Comparison of PDlasta & PDgrastim efficacy and safety in breast cancer patients on adjuvant and neoadjuvant treatment with Dose-dense ac4-t4 (Doxorubicin-Cyclophosphamide-Paclitaxel)

Randomized, interventional, two arm parallel group, single blind clinical trial

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)

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

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.

Change of ANC at the beginning of each chemotherapy course, Determine the frequency of possible side effects in the process of treatment

For random allocation of participants into two arm of treatments, the permuted block randomization was used with quadruple blocks. According to the identified sample size of 80, twenty blocks were produced. Four persons of each group were randomly and equally assigned to treatment A or B using a toss. In order to apply the concealment in the randomization process, 20 thick pocket were selected randomly by the software (www.sealedenvelope.com). By this method, nobody was aware of allocation sequence of participants to treatment groups.

Due to the different protocol of prescribing two drugs and the necessity of monitoring an oncologist, there is no possibility of blinding the patient and the therapist. The results analyst specialist will not be informed about how people are assigned to groups.