Study to examine the body response of Peg-filgrastim against Neulasta® along with Chemical agent in Patients with Breast Cancer who will be selected in any order to a known treatment.
- Conditions
- Health Condition 1: null- Breast CancerHealth Condition 2: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2018/02/011914
- Lead Sponsor
- upin Limited Biotechnology Division
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 138
1. Patients must be able and willing to give written informed consent prior to any study
related procedures
2. Ambulatory, female patients with an age ï?³18 years
3. Patients with histologically or cytologically proven diagnosis of breast cancer who are
eligible for neoadjuvant or adjuvant chemotherapy.
4. Patients who are planned and eligible to receive/ receiving myelosuppressive
chemotherapy regimen that contains at least one chemotherapeutic agent from
docetaxel/ paclitaxel / doxorubicin/ cyclophosphamide/ epirubicin
5. Patients who have not received any hematopoietic growth factors (e.g. G-CSF,
PegGCSF, erythropoietin) or cytokines (e.g. interleukins, interferons) anytime in the
past
6. Patients with baseline WBC greater than equal to LLN/ 3.5 x 109/L, ANC of greater than equal to 1.5 x 109/L, platelet count greater than equal to 100 x 109/L and hemoglobin greater than equal to 8.5 g/dL
7. Patients with ECOG Performance status of Lesser than equal to 2.
8. Patient who have estimated life expectancy of more than six months
9. No evidences of hemorrhage
1. Male patients
2. Hypersensitivity to any of the study drugs or its components like E.coli proteins or
similar product.
3. Patients weighing less than 45 Kg
4. Patients with myeloid malignancies and myelodysplasia or evidence of metastatic
disease in bone marrow or brain
5. Patients currently receiving radiation therapy or have completed radiation therapy
within 4 weeks before study entry or likely to receive radiotherapy during the study
6. Patients with prior bone marrow or stem cell transplantation
7. Patients with chronic use of oral corticosteroids (Except less than equal to 20 mg/day dose of prednisolone/ equivalent steroids), immunotherapy, monoclonal antibody therapy and/or biological therapy or use of any other pegylated drug.
8. Patients with history of systemic antibiotic use within 72 hours prior to chemotherapy
9. Patients with any active infection which may require systemic antimicrobial therapy.
Patients with inadequate hepatic and renal function [defined as Alkaline Phosphatase
greater than 2.5 X Upper limits of normal (ULN), serum SGOT greater than 2.5 X ULN, SGPT greater than 2.5 X ULN, Total bilirubin greater than 1.5 X ULN and Creatinine greater than 1.5 X ULN of the reference range at the screening assessment]
10. Patients with seropositivity for HIV or HBV or HCV
11. Known cases of Sickle Cell Anemia
12. Patients with radiographic evidence of active pulmonary infections and/or recent
history of pneumonia within 1 month of screening
13. Patients with clinically evident splenomegaly confirmed subsequently by
ultrasonography
14. Patients with any other clinically significant disease(s) which, in the opinion of the investigator, could compromise the patientâ??s involvement in the study or overall
interpretation of the data. [for e.g. uncontrolled hematologic, renal, hepatic, endocrine, neurologic, psychiatric, metabolic, pulmonary, cardiovascular disease/impaired
functioning or history of any autoimmune disease]
15. Patients who have participated in another therapeutic clinical study within the past 30
days prior to screening, or are likely to simultaneously participate in another
therapeutic clinical study
16. Patients who are doubtful to comply with study procedures for mental, psychological
or social reasons.
Women of child-bearing potential who are not willing to follow a reliable & effective
contraceptive measure during the course of the study & at least 3 months after the last
dose of study drug.
18. Pregnant and Breast feeding women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method