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Brief Title: Study of the Efficacy and Safety of Empegfilgrastim for Neutropenia Prophylaxis in Breast Cancer Patients
Official Title: Multicenter Randomized Double-blind Phase III Clinical Study Comparing the Efficacy and Safety of a Single Dose Extimia® Versus Daily Filgrastim for Neutropenia Prophylaxis in Breast Cancer Patients Receiving Myelosuppressive Chemotherapy
Study ID: NCT02104830
Brief Summary: The purpose of the study is to compare safety and efficacy of a single dose of empegfilgrastim and daily dosing of filgrastim for prevention of neutropenia in patients receiving AT (docetaxel 75 mg/m2 + doxorubicin 50 mg/m2).
Detailed Description: BCD-017-3 is an double-blind randomized phase III clinical study to compare the incidence of CTCAE grade 3/4 neutropenia after a single administration of recombinant human pegylated filgrastim empegfilgrastim (Extimia®) at a dose of 6 or 7.5 mg versus daily administration of filgrastim at a dose of 5 μg/kg/day for neutropenia prophylaxis in breast cancer patients receiving myelosuppressive chemotherapy. The study also includes the following determination of pharmacokinetic parameters after repeated administration of the study drug.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Arkhangelsk District Clinical Oncology Dispensary, Arkhangelsk, , Russian Federation
Clinical Hospital at Chelyabinsk Railway Station, Chelyabinsk, , Russian Federation
State public health institution "Republican Clinical Oncology Dispensary" of the Ministry of Health of the Republic of Tatarstan, Kazan, , Russian Federation
Non-governmental healthcare institution "Central Clinical Hospital № 2 Semashko" JSC "Russian Railways", Moscow, , Russian Federation
State Health Care Institution "Moscow City Oncology Hospital № 62" Moscow Health Department, Moscow, , Russian Federation
State public health institution "Nizhny Novgorod Regional Oncology Dispensary", Nizhny Novgorod, , Russian Federation
Perm Region Oncology Dispensary, Perm, , Russian Federation
Pyatigorsk Oncology Center, Pyatigorsk, , Russian Federation
Federal State Educational Institution of Higher Professional Education "Mordovia State University N.P. Ogareva ", Saransk, , Russian Federation
N.N.Petrov Oncology Research Center, St.Petersburg, , Russian Federation
State public health institution "Regional Clinical Oncology Dispensary", Ulyanovsk, , Russian Federation
Volgograd Regional Oncology Dispensary №3, Volgograd, , Russian Federation
State Health Care Institution "Volgograd Regional Clinical Oncology Dispensary № 1", Volgograd, , Russian Federation
Name: Roman Ivanov, MD, PhD
Affiliation: Biocad
Role: STUDY_DIRECTOR
Name: Larisa Bolotina, MD, PhD
Affiliation: Federal State Institution "Moscow Research Oncological Institute P.A.Gertsena "of the Ministry of Health of the Russian Federation
Role: PRINCIPAL_INVESTIGATOR
Name: Olga Brichkova, MD, PhD
Affiliation: State public health institution "Regional Oncology Dispensary №1
Role: PRINCIPAL_INVESTIGATOR
Name: Olga Burdaeva, MD
Affiliation: State Budget Institution of Health Arkhangelsk region "Arkhangelsk Clinical Oncology Dispensary"
Role: PRINCIPAL_INVESTIGATOR
Name: Byakhov Michael, MD, PhD
Affiliation: Non-governmental healthcare institution "Central Clinical Hospital № 2 Semashko" JSC "Russian Railways"
Role: PRINCIPAL_INVESTIGATOR
Name: Vladimir Vladimirov, MD, PhD
Affiliation: State Budget Institution of Health Stavropol area "Piatigorsky Oncology Dispensary"
Role: PRINCIPAL_INVESTIGATOR
Name: Rinat Galiulin, MD
Affiliation: State budget healthcare institution Omsk region "Clinical Oncology Dispensary"
Role: PRINCIPAL_INVESTIGATOR
Name: Oleg Gladkov, MD, PhD
Affiliation: State Budget Institution of Health "Chelyabinsk Regional Clinical Oncology Dispensary"
Role: PRINCIPAL_INVESTIGATOR
Name: Irina Davydenko, PhD
Affiliation: State Budget Institution of Health "Clinical Oncology Dispensary № 1" of the Ministry of Health of the Krasnodar area
Role: PRINCIPAL_INVESTIGATOR
Name: Victoria Elkova, MD
Affiliation: State public health institution "Voronezh Regional Clinical Oncology Dispensary"
Role: PRINCIPAL_INVESTIGATOR
Name: Igor Lifirenko, MD
Affiliation: State public health institution "Kursk Regional Oncology Dispensary"
Role: PRINCIPAL_INVESTIGATOR
Name: Nadezhda Kovalenko, PhD
Affiliation: State Budget Institution of Health "Volgograd regional oncologic dispensary № 3"
Role: PRINCIPAL_INVESTIGATOR
Name: Michael Kopp, MD, PhD
Affiliation: State Budget Institution of Health "Samara Regional Clinical Oncology Dispensary"
Role: PRINCIPAL_INVESTIGATOR
Name: Bogdan Kotiv, MD, PhD
Affiliation: S. M. Kirov Military Medical Academy of the Ministry of Defense of the Russian Federation
Role: PRINCIPAL_INVESTIGATOR
Name: Natalia Levchenko, PhD
Affiliation: State Budget Institution of Health Stavropol area "Stavropol Regional Clinical Oncology Dispensary"
Role: PRINCIPAL_INVESTIGATOR
Name: Marina Matrosova, MD
Affiliation: State public health institution "Nizhny Novgorod Regional Oncology Dispensary"
Role: PRINCIPAL_INVESTIGATOR
Name: Guzel Mukhametshina, MD
Affiliation: State public health institution "Republican Clinical Oncology Dispensary" of the Ministry of Health of the Republic of Tatarstan
Role: PRINCIPAL_INVESTIGATOR
Name: Sergei Panchenko, PhD
Affiliation: State public health institution "Regional Clinical Oncology Dispensary"
Role: PRINCIPAL_INVESTIGATOR
Name: Alexander Pecheny, PhD
Affiliation: Regional State Health Care Institution "Orlovsky Oncology Dispensary"
Role: PRINCIPAL_INVESTIGATOR
Name: Igor Pimenov, PhD
Affiliation: State Budget Institution health care "Tula Regional Oncology Dispensary"
Role: PRINCIPAL_INVESTIGATOR
Name: Andrei Sinykov, PhD
Affiliation: State Health Care Institution of Tyumen Region "Regional Oncological Dispensary"
Role: PRINCIPAL_INVESTIGATOR
Name: Pavel Skopin, PhD
Affiliation: Federal State Educational Institution of Higher Professional Education "Mordovia State University N.P. Ogareva "
Role: PRINCIPAL_INVESTIGATOR
Name: Daniil Stroyakovsky
Affiliation: State Health Care Institution "Moscow City Oncology Hospital № 62" Moscow Health Department
Role: PRINCIPAL_INVESTIGATOR
Name: Sergei Tyulyandin, MD, PhD
Affiliation: "Russian Oncological Scientific Center N.N.Blokhin" Russian Academy of Sciences
Role: PRINCIPAL_INVESTIGATOR
Name: Dmitriy Udovica, MD
Affiliation: State Health Care Institution "Oncologic Dispensary № 2" Health Department of Krasnodar Area
Role: PRINCIPAL_INVESTIGATOR
Name: Andrei Horinko, MD
Affiliation: State Health Care Institution "Perm Regional Oncology Dispensary"
Role: PRINCIPAL_INVESTIGATOR
Name: Petr Krivorotko, MD
Affiliation: N.N. Petrov Oncology Research Center of the Ministry of Health of the Russian Federation
Role: PRINCIPAL_INVESTIGATOR
Name: Yulia Shapovalova, PhD
Affiliation: Non-governmental healthcare institution "Chelyabinsk Road Clinical Hospital" JSC "Russian Railways"
Role: PRINCIPAL_INVESTIGATOR
Name: Ludmila Sheveleva, MD
Affiliation: State Health Care Institution "Volgograd Regional Clinical Oncology Dispensary № 1"
Role: PRINCIPAL_INVESTIGATOR
Name: Vadim Shirinkin, MD
Affiliation: State Health Care Institution "Orenburg Regional Clinical Oncology Dispensary"
Role: PRINCIPAL_INVESTIGATOR
Name: Shekar Patil, MD
Affiliation: Bangalore Institute of Oncology
Role: PRINCIPAL_INVESTIGATOR
Name: Prasad Narayanan, MD
Affiliation: Mazumdar Shaw Cancer Center and Narayana Hrudayalaya Multispecialty Hosptial
Role: PRINCIPAL_INVESTIGATOR
Name: Nalini Kilara, MD
Affiliation: M.S.Ramaiah Memorial Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Sergei Kulik, MD
Affiliation: Donetsk City Municipal Oncology Dispensary
Role: PRINCIPAL_INVESTIGATOR
Name: Igor Sedakov, MD, PhD
Affiliation: Donetsk Regional oncology centers
Role: PRINCIPAL_INVESTIGATOR
Name: Andrei Rusin, MD,PhD
Affiliation: Zakarpatskii Regional Clinical Oncology Dispensary
Role: PRINCIPAL_INVESTIGATOR
Name: Yuri Vinnik, MD, PhD
Affiliation: Kharkiv Regional Clinical Oncology Center
Role: PRINCIPAL_INVESTIGATOR
Name: Sergei Odarchenko, PhD
Affiliation: Vinnitskii Regional Oncology Dispensary
Role: PRINCIPAL_INVESTIGATOR