Efficacy and safety of PDlasta® and PDgrastim® in breast cancer
Phase 3
- Conditions
- Breast cancer.Malignant neoplasm of breast
- Registration Number
- IRCT20190504043465N1
- Lead Sponsor
- Pooyesh Darou
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 80
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Febrile neutropenia. Timepoint: 7th day and 14th day after each chemotherapy course. Method of measurement: Clinical evaluation.