Immunogenicity Assessment of Peg-filgrastim vs. Neulasta® as Adjunct to Chemotherapy in Patients With Breast Cancer

Study Overview
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Brief Summary
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The purpose of this study is to compare the immunogenicity of Peg-filgrastim versus Neulasta® as an adjunct to chemotherapy in patients with breast cancer

Detailed Description
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An open-label, randomized, comparative, parallel group study to assess the Immunogenicity of Lupin's Peg-filgrastim versus Neulasta® as an Adjunct to Chemotherapy in Patients with Breast Cancer Primary Objective: To assess the immunogenicity of Lupin's Peg-filgrastim with Neulasta® in patients with breast cancer. Secondary Objectives: To assess the safety of Lupin's Peg-filgrastim with Neulasta® in patients with breast cancer

Official Title
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An Open-label, Randomized, Comparative, Parallel Group Study to Assess the Immunogenicity of Lupin's Peg-filgrastim Versus Neulasta® as an Adjunct to Chemotherapy in Patients With Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Lupin's Pegfilgrastim
* Drug: Neulasta®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be able and willing to give written informed consent prior to any study related procedures Ambulatory, female patients with an age ≥ 18 years Patients with histologically or cytologically proven diagnosis of breast cancer who are eligible for neoadjuvant or adjuvant chemotherapy. 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 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 Patients with baseline WBC ≥ LLN/ 3.5 x 109/L, ANC of ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L and hemoglobin ≥ 8.5 g/dL Patients with ECOG Performance status of ≤ 2 Patient who have estimated life expectancy of more than six months No evidences of hemorrhage 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 <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 ≤ 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 > 2.5 X Upper limits of normal (ULN), serum SGOT > 2.5 X ULN, SGPT > 2.5 X ULN, Total bilirubin > 1.5 X ULN and Creatinine > 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 patient'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. 17. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lupin's Pegfilgrastim<br>6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4. | Drug: Lupin's Pegfilgrastim<br>* Administration of Pegfilgrastim<br>* Other names: INvestigational product;|
| Experimental: Neulasta®<br>6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4. | Drug: Neulasta®<br>* Administration of Neulasta®<br>* Other names: Reference;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Cumulative Incidence of Anti-pegfilgrastim Antibodies (Binding and Neutralizing) to Pegfilgrastim Between Treatment Groups at the End of Cycle 4 (Day 84). | The difference in cumulative incidence of anti-pegfilgrastim antibodies (binding and neutralizing) (measured as difference in proportion of patients with antibodies) to Pegfilgrastim between study groups at the end of cycle 4 will be calculated. Those samples confirmed to be positive for binding antibodies were analyzed for presence of neutralizing antibodies to Pegfilgrastim. | End of cycle 4, Day 84 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Cumulative Incidence of Anti-peg Antibodies (Binding and Neutralizing) Between Treatment Groups at the End of Cycle 4 (Day 84). | The presence of anti-peg antibodies (binding) (measured as difference in proportion of patients with antibodies) between treatment groups at the end of cycle 4 (Day 84) were compared and analysis for the ITT population | Day 84. | 
| 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 | Comparison of incidence of anti-pegfilgrastim antibodies (binding & neutralizing) (measured as difference in proportion of patients with antibodies) to pegfilgrastim between treatment groups on Day 10, Day 21, Day 42, Day 63, Day 84. Analysis population : ITT | Assessment at each study visit on Day 10, Day 21, Day 42, Day 63, Day 84 | 
| Secondary Immunogenicity Endpoint | Comparison of incidence of anti-peg antibodies (binding & neutralizing) (measured as difference in proportion of patients with antibodies) between treatment groups on Day 10, Day 21, Day 42, Day 63 and Day 84. Analysis population: ITT population | Day 10, Day 21, Day 42, Day 63 and Day 84. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Carcinoma, Breast neoplasms, Breast Tumors, Cancer of Breast, Anti-Drug Antibodies (ADA), Immunogenicity