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

Summary

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

Timeline

Start

2018-03-06

Primary completion

2019-01-09

Completion

2019-01-09

Outcome

Met primary endpoint

registry analysis (non-inferiority test); Lupin's Pegfilgrastim vs Neulasta®; p = 0.007; Difference in proportions -0.0296; Difference in proportion NCT03511378 ↗

Drugs

Indications