Breast cancer. Malignant neoplasm of breast
Conditions
Interventions
Intervention 1: Intervention group: Patients receive the subcutaneous injection of 6 mg of Pegfilgrastim (PDlasta) in each chemotherapy cycle (on the first day after chemotherapy (24 hours later). Int
Sponsors
Pooyesh Darou
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Investigator diagnosis of breast cancer candidate of adjuvant and neoadjuvant therapy Absolute neutrophil count =1.5 × 10^9/L Platelet count =100 × 10^9/L Serum creatinine <1.5 × upper limit of normal Dose-dense ac4-t4 regimen
Exclusion criteria
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/m2 or Epirubicin >600 mg/m2 Ejection fraction<40% Liver cirrhosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute Neutrophil Count. Timepoint: Before intervention (baseline), 7th day and 14th day after each chemotherapy course. Method of measurement: Blood sample.;White blood cell. Timepoint: Before intervention (baseline), 7th day and 14th day after each chemotherapy course. Method of measurement: Blood sample. | — |
Secondary
| Measure | Time frame |
|---|---|
| Febrile neutropenia. Timepoint: 7th day and 14th day after each chemotherapy course. Method of measurement: Clinical evaluation. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSafa Najjar Najafi
Breast Cancer Research Center
Outcome results
None listed