A phase III, clinical Trial of Tinapeg(Produced by AryaTinaGene.) versus Neulastim for Preventing Chemotherapy induced Febrile Neutropenia in breast Cancer Patients

Phase 3

• Conditions: Breast cancer.; Breast cancer

• Registration Number: IRCT2017061234487N1
• Lead Sponsor: AryaTinaGene Biopharmaceutical Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Prevention
Inclusion criteria for patients in detail, is defined as follows 1. Confirm the diagnosis of breast cancer pathology 2- 1-4 stage diagnosed by NCCN guideline requires chemotherapy regimens have AC. 3. Age between 18 to 70 years 4. The probability of pregnancy in female patients who have them must somehow fit during pregnancy, they avoid chemotherapy (using reliable contraception). Postmenopausal women at least 12 months have passed menopause, they do not need to take care of contraception. 5. Lack of symptomatic infection and fever specialist physician colleague 6. Adequate bone marrow activity is defined as follows: leukocytes >/=3,000/µl absolute neutrophil count >/=1,500/µl hemoglobin >/=8.0g/dl platelets >/=100,000/µl total bilirubin and serum creatinine must be < 1.5 mg/dl. 7. Adequate ability to read and understand the informed consent and to enter the study voluntarily and to sign the form.
Exclusion criteria for patients in detail, is defined as follows: 1. The patient has received systemic chemotherapy before entering the study. 2. Undergoing major surgery during the past 4 weeks. 3. History of uncontrolled seizures, coma, psychological disorders or any other disorder that may decrease the patient ability to decide and sign the form. 4. Presence of any serious and uncontrolled diseases such as active infection, congestive heart failure, variant angina pectoris, cardiac arrhythmia. 5. Pregnancy or breast-feeding.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In this clinical trial, equality, the absolute number of neutrophils per cubic millimeter of blood is frequently used as little. Timepoint: 14 days after administration of the drug in the 4 cycles of chemotherapy. Method of measurement: blood test.