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Efficacy and Safety Study With MYL-1401H and Neulasta

NCT02467868 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 193

Last updated 2022-02-14

No results posted yet for this study

Summary

This is a Multicenter, Double-Blind, Randomized, Comparative Efficacy and Safety Study of MYL-1401H and Neulasta (Pegfilgrastim) in Stage II/III Breast Cancer Patients Receiving Neoadjuvant or Adjuvant Chemotherapy.

Conditions

  • Breast Neoplasms
  • Chemotherapy-Induced Febrile Neutropenia

Interventions

BIOLOGICAL

MYL-1401H

During each chemotherapy cycle MYL-1401H (6 mg) is administered s.c. 24 hours after chemotherapy.

BIOLOGICAL

Neulasta

During each chemotherapy cycle Neulasta (6 mg) is administered s.c. 24 hours after chemotherapy.

Sponsors & Collaborators

  • Mylan GmbH

    collaborator INDUSTRY

  • Mylan Inc.

    lead INDUSTRY

Principal Investigators

  • Rasmus Rojkjaer, MD · Mylan GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-09-30
Completion
2016-02-29

Countries

  • Bulgaria
  • Georgia
  • Germany
  • Hungary
  • Poland
  • Ukraine

Study Locations

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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 NCT02467868 on ClinicalTrials.gov