NCT01516736

Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim

Pivotal Study in Breast Cancer Patients Investigating Efficacy and Safety of LA-EP2006 and Neulasta®

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 308 (actual)
• Sponsor: Sandoz · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.

Detailed description

The Pegfilgrastim Randomized Oncology (Supportive Care) Trial to Evaluate Comparative Treatment (PROTECT-2) was a confirmatory efficacy and safety study designed to compare the proposed biosimilar LA-EP2006 with the reference pegfilgrastim in woman with early stage breast cancer receiving (neo)-adjuvant myelosuppressive chemotherapy. Patient received TAC (intravenous docetaxel 75mg/m\^2, doxorubicin 50 mg/m\^2, and cyclophosphamide 500mg/m\^2) on day1 of each cycle, for six or more cycles. A total of 308 patients were randomized to LA-EP2006 (n=155) or reference Neulasta® (n=153). Treatment was given subcutaneously on day 2 of each cycle. The primary end point was the duration of severe neutropenia (DSN) during Cycle 1 (defined as number of consecutive days with absolute neutrophil count \<0.5 × 10\^9 cells/L). LA-EP2006 was equivalent to the reference product in DSN (difference: -0.16 days; 95% CI \[-0.40, 0.08\]). Further, LA-EP2006 and the reference pegfilgrastim showed no clinically meaningful differences regarding efficacy and safety.

Conditions

• Chemotherapy-induced Neutropenia
• Breast Cancer

Interventions

Type	Name	Description
DRUG	LA-EP2006	Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application.
DRUG	Neulasta®	Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle Neulasta® is injected s.c. post chemotherapy application.

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-08-01
• Completion: 2013-12-01
• First posted: 2012-01-25
• Last updated: 2017-08-30
• Results posted: 2017-06-28

Locations

53 sites across 8 countries: United States, Argentina, Chile, India, Malaysia, Puerto Rico, Russia, Spain