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Breast Neoplasms

Breast Diseases

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Antibodies

Lenograstim

Immunoglobulins

6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4.

Lupin's Pegfilgrastim

Neulasta®

Dhananjay Bakhle, MD

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

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

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

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

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.

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

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

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

Lupin Ltd.

Any ongoing AE at the end of study visit were followed until the outcome was evident and resolved, clinically stabilized, or a plausible explanation had been found.

6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4.

Lupin's Pegfilgrastim: Administration of Pegfilgrastim

6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4.

Neulasta®: Administration of Neulasta®

6 mg, subcutaneous injection on day 2 or 3 of each 21 ± 3 day cycle. Number of cycles: 4.

Lupin's Pegfilgrastim: Administration of Pegfilgrastim

6 mg, subcutaneous injection on day 2 or 3 of each 21 ± 3 day cycle. Number of cycles: 4.

Neulasta®: Administration of Neulasta®

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

India

Region of Enrollment

The scale was developed by the Eastern Cooperative Oncology Group (ECOG). Grade 0: fully active. Grade 1: restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature Grade 2: ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours Grade 3: capable of only limited self-care, confined to bed or chair more than 50% of waking hours Grade 4: completely disabled, cannot carry on any self-care, totally confined to bed or chair Grade 5: dead

ECOG Status at Screening

The enrolled patients were all middle-aged Asian females with a diagnosis of breast cancer.

Dr. Chirag Shah, Director

Comparison of Cumulative Incidence of Anti-pegfilgrastim Antibodies (Binding and Neutralizing) to Pegfilgrastim Between Treatment Groups at the End of Cycle 4 (Day 84).

Comparison of Cumulative Incidence of Anti-peg Antibodies (Binding and Neutralizing) Between Treatment Groups at the End of Cycle 4 (Day 84).

Day 10

Day 21

Day 42

Day 63

Day 84 (EOS)

The Intention-to-Treat (ITT) population included all patients who received at least one dose of study medication and subsequently provided immunogenicity variable data.

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

Spots Global Cancer Trial Database for lupin's pegfilgrastim