Clinical efficacy of Filgrastim-AryaTinaGene

Recruitment & Eligibility

Status: Complete

Sex: Female

Target Recruitment: 100

Inclusion Criteria

The study population consisted of women = 18 years of age
with metastatic or localized histopathologically proven
breast cancer. Patients with localized cancer were required
to have = stage II disease with = 1 positive regional node.
Additional inclusion criteria included: Karnofsky performance
status = 70% for patients = 70 years of age and = 90%
for patients > 70 years of age; adequate hematologic function
(absolute neutrophil count [ANC] =3000 cells/µL,
platelet count >100,000/µL, hemoglobin [Hb] = 8 g/dL); adequate
hepatic function (bilirubin = 1.5 × upper limit of normal
[ULN], aspartate aminotransferase and alanine aminotransferase
= 2.5 × ULN, alkaline phosphatase = 5 × ULN);
creatinine = 2.0 × ULN; and normal cardiac function as determined
by MUGA (multiple-gated acquisition) scan or
echocardiography. All hematologic, renal, and hepatic valueshad to be within institutional normal limits in patients > 70
years of age. All women who had received prior chemotherapy
must have completed treatment at least 3 weeks prior to
study drug administration, and women of child-bearing age
had to agree to comply with effective contraception and have
done so since their last menses. Patients who had received
radiotherapy within 4 weeks of entry required special permission
from the study sponsors to enroll.

Patients were excluded if they had received a cumulative
lifetime dose of doxorubicin > 240 mg/m2 or epirubicin > 432
mg/m2, prior treatment with mitomycin-C or busulfan, or >
2 prior regimens of chemotherapy (excluding hormonal
treatment). Additional exclusion criteria included a history
of significant cardiac disease, arrhythmias, uncontrolled hypertension,
recent myocardial infarction, or ischemia. Patients
with human immunodeficiency virus infection, active
hepatitis, or a history of a serious comorbid condition, uncontrolled
metabolic disease, or psychiatric condition that
would impair tolerance or evaluation of the study drug were
also excluded.

Exclusion Criteria

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Days of severe neuropenia (ANC>200 per ul). Timepoint: Every chemotherapy cycle. Method of measurement: Absolute neutrophil count (per ul of blood).;Days of minor neuropenia (ANC>500-1000 per ul). Timepoint: Every chemotherapy cycle. Method of measurement: Absolute neutrophil count (per ul of blood).;Days of moderate neuropenia (ANC>200-500 per ul). Timepoint: Every chemotherapy cycle. Method of measurement: Absolute neutrophil count (per ul of blood).

Secondary Outcome Measures

Name	Time	Method
Occurance of febrile neutropenia. Timepoint: every chemotherapy cycle. Method of measurement: Fever of 38.5 C for at least 1 h and neutropenia less than 500 per ul.;Occurance of sepsis related to filgrastim. Timepoint: every chemotherapy cycle. Method of measurement: Blood analysis.;Occurance of increased hepatic enzymes related to filgrastim. Timepoint: every chemotherapy cycle. Method of measurement: Blood analysis.;Occurance of musculoskeletal pain related to filgrastim. Timepoint: every chemotherapy cycle. Method of measurement: Patient questionery.