Clinical Trial: Efficacy and Safety Study With MYL-1401H and Neulasta

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 C

Brief 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 Summary:

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.

Sponsor: Mylan Inc.

Current Primary Outcome: Mean Duration of Severe Neutropenia (DSN), defined as consecutive days with absolute neutrophil count (ANC) < 0.5 × 109/L [ Time Frame: Cycle 1 of chemotherapy (approx 21 days) ]

Original Primary Outcome: Same as current

Current Secondary Outcome: The rate of febrile neutropenia (FN) [ Time Frame: Week 24 (End of the study) ]

Original Secondary Outcome: Same as current

Information By: Mylan Inc.

Dates:
Date Received: June 8, 2015
Date Started: March 2015
Date Completion:
Last Updated: March 15, 2016
Last Verified: March 2016