NCT02467868

Efficacy and Safety Study With MYL-1401H and Neulasta

Multicenter, Double-Blind, Randomized, Comparative Efficacy and Safety Study of MYL-1401H and European Sourced Neulasta® in Stage II/III Breast Cancer Patients Receiving Neoadjuvant or Adjuvant Chemotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 193 (actual)
• Sponsor: Mylan Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

After successful screening, eligible patients will be randomly allocated to one of the two study arms, either receiving MYL-1401H or Neulasta. Randomization is 2:1 to MYL-1401H or Neulasta, respectively. Subjects will receive first of six cycles of background therapy (Docetaxel, Doxorubicin, Cyclophosphamide \[TAC\]) on day 1. Treatment with study drug (either MYL-1401H or Neulasta) is scheduled on Day 2 of each cycle, at least 24 hours after chemotherapy administration. Duration of each cycle is 3 weeks. Follow-up visit is scheduled 24 weeks after the first administration of study drug.

Conditions

• Breast Neoplasms
• Chemotherapy-Induced Febrile Neutropenia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-09-01
• Completion: 2016-02-01
• First posted: 2015-06-10
• Last updated: 2022-02-14

Locations

36 sites across 6 countries: Bulgaria, Georgia, Germany, Hungary, Poland, Ukraine