NCT01735175 - Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Neulasta® | Biotech Hunter

Enrollment

316

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

May 31, 2013

Study Completion Date

February 28, 2014

Conditions

Neutropenic ComplicationsBreast NeoplasmsChemotherapy-induced NeutropeniaChemotherapeutic Toxicity

Interventions

DRUG

LA-EP2006

Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim 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 pegfilgrastim is injected s.c. post chemotherapy application.

Trial Locations (41)

11461

Sandoz Investigational Site, Bucharest

18009

Sandoz Investigational Site, Cherkasy

20230

Sandoz Investigational Site, Aguascalientes

21029

Sandoz Investigational Site, Vinnytsia

23423

Sandoz Investigational Site, Bucharest

49102

Sandoz Investigational Site, Dnipropetrovsk

50048

Sandoz Investigational Site, Kryvyi Rih

58013

Sandoz Investigational Site, Chernivtsi

61176

Sandoz Investigational Site, Kharkiv

69040

Sandoz Investigational Site, Zaporizhzhia

70000

Sandoz Investigational Site, Juchitán

87500

Sandoz Investigational Site, Mariupol

91000

Sandoz Investigational Site, Luhansk

110095

Sandoz Investigational Site, Delhi

115478

Sandoz Investigational Site, Moscow

153040

Sandoz Investigational Site, Ivanovo

173016

Sandoz Investigational Site, Veliky Novgorod

188663

Sandoz Investigational Site, Saint Petersburg

195067

Sandoz Investigational Site, Saint Petersburg

300053

Sandoz Investigational Site, Tula

302013

Sandoz Investigational Site, Rajasthan

305035

Sandoz Investigational Site, Kursk

354057

Sandoz Investigational Site, Krasnodar

355047

Sandoz Investigational Site, Oktyabrskaya

361045

Sandoz Investigational Site, Kabardino

390011

Sandoz Investigational Site, Ryazan

411001

Sandoz Investigational Site, Maharashtra

416008

Sandoz Investigational Site, Maharashtra

420029

Sandoz Investigational Site, Kazan'

422005

Sandoz Investigational Site, Mumbai

440010

Sandoz Investigational Site, Maharashtra

450054

Sandoz Investigational Site, Bashkortostan

530002

Sandoz Investigational Site, Andhra Pradesh

625107

Sandoz Investigational Site, Madurai

633004

Sandoz Investigational Site, Berdsk

656052

Sandoz Investigational Site, Barnaul

700106

Sandoz Investigational Site, Iași

720237

Sandoz Investigational Site, Suceava

98700-000

Sandoz Investigational Site, Ijuí

95900-000

Sandoz Investigational Site, Lajeado

0960-650

Sandoz Investigational Site, Santo André