breast cancer. breast cancer
Conditions
Interventions
Intervention 1: Intervention group: Twenty four hours after each cycle of chemotherapy, injections of filgrastim (0.5 mIU/kg/day until post nadir ANC recovery)or Pegfilgrastim (6 mg, single dose)will
Treatment - Drugs
Intervention group: Twenty four hours after each cycle of chemotherapy, injections of filgrastim (0.5 mIU/kg/day until post nadir ANC recovery)or Pegfilgrastim (6 mg, single dose)will be done. Protoco
Control group: Twenty four hours after each cycle of chemotherapy, injections of Neopogen (0.5 mIU/kg/day until post nadir ANC recovery)will be done. Protocol of chemotherapy drugs On the first day of
Sponsors
Actoverco Pharmaceutic Company
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 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 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
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Fever. Timepoint: before intervention, from day 6 to 14 after chemotherapy in first cycle, day 14 after chemotherapy in second till forth cycle and 30 days after the last dose of chemotherapy. Method of measurement: Thermometer.;Fever duration. Timepoint: Whenever a patient has fever. Method of measurement: Physical exam.;Height. Timepoint: before intervention. Method of measurement: Meter.;ANC. Timepoint: before intervention, from day 6 to 14 after chemotherapy in first cycle, day 7 and 14 after chemotherapy in second till forth cycle and 30 days after the last dose of chemotherapy. Method of measurement: multiplied the percentage of neutrophils in the WBC count.;Ability to continue chemotherapy. Timepoint: 14 days after chemotherapy in each cycle. Method of measurement: Doctor`s Report.;Weight. Timepoint: befor intervention, 14 days after chemotherapy in each cycle and 30 days after the last dose of chemotherapy. Method of measurement: Carriage scales.;Bone pain. Timepoint: befor intervention, 14 days after chemotherapy in each cycle and 30 days after the last dose of chemotherapy. Method of measurement: According to patient's Statement.;Non-life-threatening side effects. Timepoint: 14 days after chemotherapy in each cycle and 30 days after the last dose of chemotherapy. Method of measurement: Doctor`s observation and report.;Severity of bone pain. Timepoint: 14 days after chemotherapy in each cycle and 30 days after the last dose of chemotherapy. Method of measurement: according to VAS criteria.;Age. Timepoint: before intervention. Method of measurement: According to birthday.;Race. Timepoint: before intervention. Method of measurement: According to patient's Statement.;Laboratory abnormalities. Timepoint: Before intervention, from day 6 to 14 after chemotherapy in first cycle, day 7 and 14 after chemotherapy in second till forth cycle and 30 days after the last dose of chemotherapy. Method of measurement: Hematology.;Hospitalization. Timepoint: Whenever needed d | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Shirin Pournourmohammadi
ACTOVERCO Pharmaceutical Company
Outcome results
None listed