Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Neulasta® — PROTECT-1  

Breast Cancer Patients Treated With Myelosuppressive Chemotherapy Clinical Trial

Official title: A Randomized, Double-blind, Parallel-group, Multi-center Phase 3 Comparative Study Investigating Efficacy and Safety of LA-EP2006 and Neulasta® in Breast Cancer Patients Treated With Myelosuppressive Chemotherapy

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer Patients Treated With Myelosuppressive Chemotherapy
• Breast Neoplasms
• Neutropenic Complications

• NCT number: NCT01735175
• Study type: Interventional
• Source: Sandoz
• Status: Completed
• Phase: Phase 3
• Start date: June 2012
• Completion date: September 2013