CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 316 enrolled
Drug / intervention
LA-EP2006 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01735175
NCT01735175Phase 3Completed

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

Sandoz·interventional·Posted Nov 28, 2012·Updated Aug 7, 2017

In Brief

A Phase 3 clinical trial evaluating LA-EP2006 and Neulasta® for Neutropenic Complications and 3 related conditions. Completed, enrolled 316 participants across 41 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil, India, Mexico, Romania, Russia, Ukraine
CollaboratorsSandoz GmbH

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 28, 2012
Enrollment StartJun 1, 2012
Primary CompletionMay 1, 2013
Study CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 13.6 years ago

Interventions

LA-EP2006drug

Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.

Neulasta®drug

Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.