A phase III, Randomized, two armed, parallel, double blind Controlled non inferiority clinical Trial of Tinapeg(Produced by AryaTinaGene.) versus Neulastim for Preventing Chemotherapy induced Febrile Neutropenia in breast Cancer Patients

AryaTinaGene Biopharmaceutical Company0 sites100 target enrollmentStarted: TBDLast updated: February 22, 2018

Conditions

Trial Snapshot

No summary available.

•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.

Sponsor

AryaTinaGene Biopharmaceutical Company