Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim

PHASE3CompletedINTERVENTIONAL
Enrollment

308

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

August 31, 2013

Study Completion Date

December 31, 2013

Conditions
Chemotherapy-induced NeutropeniaBreast Cancer
Interventions
DRUG

LA-EP2006

Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 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 Neulasta® is injected s.c. post chemotherapy application.

Trial Locations (53)

4000

Sandoz Investigational Site, San Miguel de Tucumán

11200

Sandoz Investigational Site, George Town

11600

Sandoz Investigational Site, George Town

15706

Sandoz Investigational Site, Santiago de Compostela

16150

Sandoz Investigational Site, Kelantan

23601

Sandoz Investigational Site, Newport News

28040

Sandoz Investigational Site, Madrid

38138

Sandoz Investigational Site, Germantown

40353

Sandoz Investigational Site, Mount Sterling

46014

Sandoz Investigational Site, Valencia

48202

Sandoz Investigational Site, Detroit

50024

Sandoz Investigational Site, Hyderabad

58501

Sandoz Investigational Site, Bismarck

67214

Sandoz Investigational Site, Wichita

71800

Sandoz Investigational Site, Kampung Baharu Nilai

71913

Sandoz Investigational Site, Hot Springs

72401

Sandoz Investigational Site, Jonesboro

92879

Sandoz Investigational Site, Corona

97401

Sandoz Investigational Site, Eugene

110092

Sandoz Investigational Site, Delhi

115478

Sandoz Investigational Site, Moscow

163045

Sandoz Investigational Site, Arkhangelsk

194017

Sandoz Investigational Site, Saint Petersburg

194044

Sandoz Investigational Site, Saint Petersburg

195271

Sandoz Investigational Site, Saint Petersburg

197022

Sandoz Investigational Site, Saint Petersburg

197758

Sandoz Investigational Site, Saint Petersburg

226003

Sandoz Investigational Site, Lucknow

241033

Sandoz Investigational Site, Bryansk

302020

Sandoz Investigational Site, Oryol

344037

Sandoz Investigational Site, Rostov-on-Don

380009

Sandoz Investigational Site, Gujarat

388325

Sandoz Investigational Site, Karamsad

391760

Sandoz Investigational Site, Vadodara

395010

Sandoz Investigational Site, Surat

400010

Sandoz Investigational Site, Mumbai

420029

Sandoz Investigational Site, Kazan'

422004

Sandoz Investigational Site, Maharashtra

450054

Sandoz Investigational Site, Bashkortostan

460021

Sandoz Investigational Site, Orenburg

520002

Sandoz Investigational Site, Pradesh

530017

Sandoz Investigational Site, Visakhapatnam

575001

Sandoz Investigational Site, Mangalore

600021

Sandoz Investigational Site, Vladimir

600031

Sandoz Investigational Site, Chennai

632004

Sandoz Investigational Site, Vellore

634009

Sandoz Investigational Site, Tomsk

644046

Sandoz Investigational Site, Omsk

660133

Sandoz Investigational Site, Krasnoyarsk

4810469

Sandoz Investigational Site, Temuco

00910

Sandoz Investigational Site, San Juan

00927

Sandoz Investigational Site, San Juan

08035

Sandoz Investigational Site, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Sandoz GmbH

INDUSTRY

lead

Sandoz

INDUSTRY

NCT01516736 - Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim | Biotech Hunter | Biotech Hunter