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Brief Title: Phase III Study Comparing the Efficacy and Safety of EP2006 and Filgrastim
Official Title: A Randomized, Double-blind, Parallel-group, Multi-center Phase III Study Comparing the Efficacy and Safety of EP2006 and Neupogen® in Breast Cancer Patients Treated With Myelosuppressive Chemotherapy
Study ID: NCT01519700
Brief Summary: The study will assess the efficacy of EP2006 compared to Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Insitut Onkologie a Rehabilitaca na Plesi, Ves pod Plesi 110, , Czech Republic
Semmelweis Egyetem, III. Belgyogyaszati Klinika, Budapest, , Hungary
Fovarosi Onkormanyzat Uzsoki utcai Korhaz, Onkoradiologia, Budapest, , Hungary
DE OEC, Onkologiai Tanszek, Debrecen, , Hungary
Josa Andras Oktato Korhaz Nonprofit Kft, Nyiregyhaza, , Hungary
Fejer Megyei Szent Gyorgy Korhaz, Onkologiai Osztaly, Szekesfehervar, , Hungary
Vas Megyei Markusovszky Korhaz, Onkoradiologiai Osztaly, Szombathely, , Hungary
Daugavpils Regional Hospital, Daugavpils, , Latvia
Institution of the Russian Academy of Medical Sciences Medical Radiology Research Center RAMS, Moscow, Krasnogorsk district, Russian Federation
State Healthcare Institution (SHI) "Leningrad Regional Oncological Dispensary" at the Surgery Department 2, Kuzmolovsky, Leningrad region, Russian Federation
State Medical-Prophylactic Institution SMPI Reginal Clinical Oncological Dispensary, Chelyabinsk, , Russian Federation
State Healthcare Institution (SHI) "Clinical Oncological Dispensary №1" of Healthcare Department of Krasnodar Territory, Krasnodar, , Russian Federation
Institution of the Russian Academy of Medical Sciences Russian Oncology Research Center n.a. N.N.Blochin of RAMS", Surgery Department of the Female Reproductive System Tumors, Moscow, , Russian Federation
Affiliate No1 of State Healthcare Institution (SHI) "Nizhny Novgorod Regional Oncological Dispensary", Nizhny Novgorod, , Russian Federation
Institution of the Russian Academy of Medical Sciences Medical Radiology Research Center RAMS, Obninsk, , Russian Federation
State Healthcare Institution SHI Pyatigorsk Oncological Dispensary, Pyatigorsk, , Russian Federation
Non-State Healthcare Institution NSHI, Saint-Petersburg, , Russian Federation
Saint-Petersburg State Healthcare Institution (SPb SHI) "City Clinical Oncological Dispensary", Saint-Petersburg, , Russian Federation
State Healthcare Institution (SHI)"Voronezh Regional Clinical Oncological Dispensary", Voronezh, , Russian Federation
Fakultna nemocnica Nitra, Oddelenie radioterapie a klinickej onkologie, Nitra, , Slovakia
Communal Institution "Krivorizhskiy oncology dispensary" of Dnipropetrovsk regional Council, Chemotherapy Department, Kriviy Rig, Dnipropetrovsk region, Ukraine
Communal Institution "Dnipropetrovsk Сity multiple-discipline Clinical Hospital 4" of Dnipropetrovsk Regional Council, Dnipropetrovsk, , Ukraine
Medical center of Limited Liability Company "Inter", Lugansk, , Ukraine
Lviv state oncological regional treatment-and-diagnostics center, Chemotherapy Department, Lviv, , Ukraine
Communal Institution "Odesa regional clinical hospital", Mammology Center, Odesa, , Ukraine
Vinnytsya Regional Clinical Oncological Center, Chemotherapy Department, Vinnitsya, , Ukraine
Name: Sandoz
Affiliation: Sandoz
Role: STUDY_CHAIR