Health Condition 1: null- Breast Cancer Health Condition 2: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Lupins Pegfilgrastim: Supplied as Single-doseâ?? pre-filled syringes containing fixed dose of 6 mg (10 mg/ml) subcutaneous injection of Pegfilgrastim
Control Intervention1: Neulasta®:
Sponsors
Lupin Limited Biotechnology Division
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Comparison of cumulative incidence of anti-peg antibodies (binding & neutralizing) between treatment groups at the end of cycle 4 (Day 84). ï?· Comparison of incidence of anti-pegfilgrastim antibodies (binding & neutralizing) to Pegfilgrastim between treatment groups on Day 10, Day 21, Day 42, Day 63 and Day 84. ï?· Comparison of incidence of anti-peg antibodies (binding & neutralizing) between treatment groups on Day 10, Day 21, Day 42, Day 63 and Day 84.Timepoint: Comparison of cumulative incidence of anti-pegfilgrastim antibodies (binding & neutralizing) to Pegfilgrastim between treatment groups at the end of cycle 4 (Day 84). | — |
Primary
| Measure | Time frame |
|---|---|
| Comparison of cumulative incidence of anti-pegfilgrastim antibodies (binding & neutralizing) to Pegfilgrastim between treatment groups at the end of cycle 4 (Day 84).Timepoint: Comparison of cumulative incidence of anti-pegfilgrastim antibodies (binding & neutralizing) to Pegfilgrastim between treatment groups at the end of cycle 4 (Day 84). | — |
Countries
India
Contacts
Public ContactDr Dhananjay Bakhle
Lupin Limited
Outcome results
None listed