Study of the Efficacy and Safety of Empegfilgrastim for Neutropenia Prophylaxis in Breast Cancer Patients

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).

Conditions

• Chemotherapy-induced Neutropenia

Interventions

BIOLOGICAL

Empegfilrastim 6 mg

Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 6 mg.

BIOLOGICAL

Filgrastim

Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir.

BIOLOGICAL

Placebo №1

Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0.

BIOLOGICAL

Placebo №2

Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.

BIOLOGICAL

Empegfilrastim 7.5 mg

Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 6 mg.

Sponsors & Collaborators

• Biocad

  lead INDUSTRY

Principal Investigators

• Roman Ivanov, MD, PhD · Biocad

• Larisa Bolotina, MD, PhD · Federal State Institution "Moscow Research Oncological Institute P.A.Gertsena "of the Ministry of Health of the Russian Federation

• Olga Brichkova, MD, PhD · State public health institution "Regional Oncology Dispensary №1

• Olga Burdaeva, MD · State Budget Institution of Health Arkhangelsk region "Arkhangelsk Clinical Oncology Dispensary"

• Byakhov Michael, MD, PhD · Non-governmental healthcare institution "Central Clinical Hospital № 2 Semashko" JSC "Russian Railways"

• Vladimir Vladimirov, MD, PhD · State Budget Institution of Health Stavropol area "Piatigorsky Oncology Dispensary"

• Rinat Galiulin, MD · State budget healthcare institution Omsk region "Clinical Oncology Dispensary"

• Oleg Gladkov, MD, PhD · State Budget Institution of Health "Chelyabinsk Regional Clinical Oncology Dispensary"

• Irina Davydenko, PhD · State Budget Institution of Health "Clinical Oncology Dispensary № 1" of the Ministry of Health of the Krasnodar area

• Victoria Elkova, MD · State public health institution "Voronezh Regional Clinical Oncology Dispensary"

• Igor Lifirenko, MD · State public health institution "Kursk Regional Oncology Dispensary"

• Nadezhda Kovalenko, PhD · State Budget Institution of Health "Volgograd regional oncologic dispensary № 3"

• Michael Kopp, MD, PhD · State Budget Institution of Health "Samara Regional Clinical Oncology Dispensary"

• Bogdan Kotiv, MD, PhD · S. M. Kirov Military Medical Academy of the Ministry of Defense of the Russian Federation

• Natalia Levchenko, PhD · State Budget Institution of Health Stavropol area "Stavropol Regional Clinical Oncology Dispensary"

• Marina Matrosova, MD · State public health institution "Nizhny Novgorod Regional Oncology Dispensary"

• Guzel Mukhametshina, MD · State public health institution "Republican Clinical Oncology Dispensary" of the Ministry of Health of the Republic of Tatarstan

• Sergei Panchenko, PhD · State public health institution "Regional Clinical Oncology Dispensary"

• Alexander Pecheny, PhD · Regional State Health Care Institution "Orlovsky Oncology Dispensary"

• Igor Pimenov, PhD · State Budget Institution health care "Tula Regional Oncology Dispensary"

• Andrei Sinykov, PhD · State Health Care Institution of Tyumen Region "Regional Oncological Dispensary"

• Pavel Skopin, PhD · Federal State Educational Institution of Higher Professional Education "Mordovia State University N.P. Ogareva "

• Daniil Stroyakovsky · State Health Care Institution "Moscow City Oncology Hospital № 62" Moscow Health Department

• Sergei Tyulyandin, MD, PhD · "Russian Oncological Scientific Center N.N.Blokhin" Russian Academy of Sciences

• Dmitriy Udovica, MD · State Health Care Institution "Oncologic Dispensary № 2" Health Department of Krasnodar Area

• Andrei Horinko, MD · State Health Care Institution "Perm Regional Oncology Dispensary"

• Petr Krivorotko, MD · N.N. Petrov Oncology Research Center of the Ministry of Health of the Russian Federation

• Yulia Shapovalova, PhD · Non-governmental healthcare institution "Chelyabinsk Road Clinical Hospital" JSC "Russian Railways"

• Ludmila Sheveleva, MD · State Health Care Institution "Volgograd Regional Clinical Oncology Dispensary № 1"

• Vadim Shirinkin, MD · State Health Care Institution "Orenburg Regional Clinical Oncology Dispensary"

• Shekar Patil, MD · Bangalore Institute of Oncology

• Prasad Narayanan, MD · Mazumdar Shaw Cancer Center and Narayana Hrudayalaya Multispecialty Hosptial

• Nalini Kilara, MD · M.S.Ramaiah Memorial Hospital

• Sergei Kulik, MD · Donetsk City Municipal Oncology Dispensary

• Igor Sedakov, MD, PhD · Donetsk Regional oncology centers

• Andrei Rusin, MD,PhD · Zakarpatskii Regional Clinical Oncology Dispensary

• Yuri Vinnik, MD, PhD · Kharkiv Regional Clinical Oncology Center

• Sergei Odarchenko, PhD · Vinnitskii Regional Oncology Dispensary

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-09-30

Primary Completion

2014-06-30

Completion

2014-10-31

Countries

• Russia

Study Locations