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Spots Global Cancer Trial Database for Study of the Efficacy and Safety of Empegfilgrastim for Neutropenia Prophylaxis in Breast Cancer Patients

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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