Efficacy and Safety Study With MYL-1401H and Neulasta

PHASE3CompletedINTERVENTIONAL
Enrollment

193

Participants

Timeline

Start Date

March 31, 2015

Primary Completion Date

September 30, 2015

Study Completion Date

February 29, 2016

Conditions
Breast NeoplasmsChemotherapy-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.

Trial Locations (36)

Unknown

Mylan Investigational Site 3502, Plovdiv

Mylan Investigational Site 3506, Plovdiv

Mylan Investigational Site 3507, Plovdiv

Mylan Investigational Site 3503, Sofia

Mylan Investigational Site 3505, Sofia

Mylan Investigational Site 3504, Varna

Mylan Investigational SIte 3501, Veliko Tarnovo

Mylan Investigational Site 9901, Tbilisi

Mylan Investigational Site 9902, Tbilisi

Mylan Investigational Site 9903, Tbilisi

Mylan Investigational Site 9904, Tbilisi

Mylan Investigational Site 9905, Tbilisi

Mylan Investigational Site 9906, Tbilisi

Mylan Investigational Site 9907, Tbilisi

Mylan Investigational site 4905, Bonn

Mylan Investigational Site 3604, Budapest

Mylan Investigational SIte 3606, Budapest

Mylan Investigational Site 3607, Budapest

Mylan Investigational Site 3609, Debrecen

Mylan Investigational Site 3601, Gyula

Mylan Investigational SIte 3605, Nyíregyháza

Mylan Investigational Site 3603, Szombathely

Mylan Investigational Site 3602, Zalaegerszeg

Mylan Investigational site 4802, Bydgoszcz

Mylan Investigational Site 4805, Kościerzyna

Mylan Investigational SIte 4804, Krakow

Mylan Investigational SIte 3804, Chernivtsi

Mylan Investigational site 3801, Dniepropetrovsk

Mylan Investigational Site 3805, Dniepropetrovsk

Mylan Investigational Site 3808, Kharkiv

Mylan Investigational Site 3810, Kyiv

Mylan Investigatational Site 3802, Lutsk

Mylan Investigational SIte 3807, Lviv

Mylan Investigational SIte 3803, Odesa

Mylan Investigational Site 3809, Sumy

Mylan Investigational Site 3806, Uzhhorod

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Mylan GmbH

INDUSTRY

lead

Mylan Inc.

INDUSTRY