Determining the effectiveness, safety and tolerability of Actoverco Filgrastim and Actoverco Pegfilgrastim compared to Neupogen in preventing the chemotherapy induced neutopenia in treatment of the breast cancer
- Conditions
- breast cancer.breast cancer
- Registration Number
- IRCT2013042212398N4
- Lead Sponsor
- Actoverco Pharmaceutic Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 156
Inclusion Criteria: Female patients aged 18 to 70 years old; Signed informed consent obtained prior to initiation the study; Patients diagnosed having high risk stage 2 or stage 3 and or 4 of breast cancer (by histopathological or cytological diagnosis) and need chemotherapy; A priori has been decided to be treated with G-CSF and subjects eligible for G-CSF therapy according to indications and clinical use in the product monograph; Any acute adverse effects of prior therapy must have resolved to = NCI CTCAE (Version 4.0) grade 1 (excluding alopecia) prior to Day 1 of Cycle 1; ECOG Performance Status 0 or 1 as determined on Day 1 of Cycle 1 prior to administration of chemotherapy; Patients must have adequate organ function including the following: a. Adequate bone marrow functions, as determined within 1 day prior to administration of chemotherapy on Day 1 of Cycle 1 and as indicated by: Hb=10 g/dL (transfusion permitted to be included in the trial WBC=3,5 x 109/L,Absolute neutrophil count (ANC) =1.5 x 109/L Platelets =100 x 109/L , b. Adequate renal and hepatic function, as determined within 1 day prior to administration of chemotherapy on Day 1 of Cycle 1 and as indicated by: i. Hepatic: Bilirubin = 1.5 x the upper limit of normal (ULN) (unless elevation is known to be due to Gilbert's disease), Subjects must also meet one of the following criteria: ii. a) Alkaline phosphatase within normal reference range and both AST and ALT >2.5 x ULN; or b) Alkaline phosphatase <2.5 x ULN and both AST and ALT <1.5 x ULN; or c ) Alkaline phosphatase <5 x ULN and both AST and ALT within normal reference range; Renal: Serum creatinine = 1.5 mg/dL or = 90 ml/min GFR; Patients of child-bearing potential must have a negative pregnancy test within 3 days prior to the first dose of chemotherapy (Day 1 of Cycle 1) and use at least one form of contraception as approved by the Investigator for four weeks prior to the study and during the study. For the purposes of this study, child-bearing potential is defined as: All female patients unless they are post-menopausal for at least one year or are surgically sterile”. Acceptable methods of contraception include IUD, oral contraceptive, subdermal implant and double barrier (condom with a contraceptive sponge or contraceptive suppository); Life expectancy more than 3 months; Entering to the study before the second cycle of chemotherapy; Ability to co-operate with the treatment and follow up.
Safety of treatment dependent criteria: Presence of any serious concomitant systemic disorders incompatible with the administration of G-CSF or any systemic disease that can influence the patient's safety (according to doctor’s diagnosis); history of hypersensitivity to natural or recombinant G-CSF, or hypersensitivity to human albumin or any other component of the formulation; History of poorly controlled hypertension (BP > 180/110 mmHg) and/or other clinically significant major disease (according to doctor’s diagnosis); Serious local infection or active systemic infection within 10 days prior to enrollment or patients who have taken antibiotics within the previous 10 days; Pregnant or breast-feeding patients; Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV; Known bleeding disorder Criteria dependent on compliance with study procedures, or the evaluation of the response: Unwilling to use a reliable and acceptable contracept
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of Severe Neutropenia. Timepoint: The number of days that patients have severe neutropenia (defined as above). Method of measurement: Daily Hematology During severe neutropenia.;Severe Neutropenia. Timepoint: before intervention, from day 6 to 14 after chemotherapy in first cycle. Method of measurement: Hematology.;Drug intolerance. Timepoint: 14 and 21 days after intervention in each cycle. Method of measurement: Doctor`s diagnosis.;Febrile neutropenia. Timepoint: before intervention, day 7 and 14 after chemotherapy in each cycle and 30 days after the last dose of chemotherapy. Method of measurement: Physical exam and Para clinic.;Serious adverse events. Timepoint: Whenever it happens. Method of measurement: Doctor`s observation and report.
- Secondary Outcome Measures
Name Time Method