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

NCT01735175 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2017-08-07

Study results available
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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.

Conditions

  • Neutropenic Complications
  • Breast Neoplasms
  • Chemotherapy-induced Neutropenia
  • Chemotherapeutic Toxicity

Interventions

DRUG

LA-EP2006

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.

DRUG

Neulasta®

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.

Sponsors & Collaborators

  • Sandoz GmbH

    collaborator INDUSTRY

  • Sandoz

    lead INDUSTRY

Principal Investigators

  • Sandoz Biopharmaceutical Clinical Development · Sandoz

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-05-31
Completion
2014-02-28

Countries

  • Brazil
  • India
  • Mexico
  • Romania
  • Russia
  • Ukraine

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01735175 on ClinicalTrials.gov