CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 308 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/NCT01516736
NCT01516736Phase 3Completed
CompareCT.gov

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

Sandoz·interventional·Posted Jan 25, 2012·Updated Aug 30, 2017

In Brief

A Phase 3 clinical trial evaluating LA-EP2006 and Neulasta® for Chemotherapy-induced Neutropenia and Breast Cancer. Completed, enrolled 308 participants across 53 sites in 8 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--
ConditionsChemotherapy-induced Neutropenia, Breast Cancer
CountriesArgentina, Chile, India, Malaysia, Puerto Rico, Russia, Spain, United States
CollaboratorsSandoz GmbH

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 25, 2012
Enrollment StartMar 1, 2012
Primary CompletionAug 1, 2013
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 14.4 years ago

Interventions

LA-EP2006drug

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.

Neulasta®drug

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.