Comparison of filgrastim produced by Samen Pharmaceutical Company and Neupogen as a standard drug

Phase 3

• Conditions: Breast cancer.; Malignant neoplasm of breast

• Registration Number: IRCT201206279801N3
• Lead Sponsor: Samen Pharmaceutical 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: 168

Inclusion Criteria

Age>18 yr; Diagnosis of locally advanced breast cancer; WHO Performance Status less than or equal of 2; Absence of neutropenia (ANC <1500/mm3) before starting chemotherapy; Completing the Consent form.
Exclusion criteria: History of hypersensitivity reaction to biologic drugs; Existence of renal failure ; Existence of hepatic failure ; Coadministration of neutropoietic drugs; Existence of cardiac arrythmia.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of neutropenia. Timepoint: between day 1 to day 21 post chemotherapy. Method of measurement: laboratory.

Secondary Outcome Measures

Name	Time	Method
Frequency of neutropenia episode. Timepoint: between day 1 to 21 post chemotherapy. Method of measurement: laboratory.