NCT02104830 - Study of the Efficacy and Safety of Empegfilgrastim for Neutropenia Prophylaxis in Breast Cancer Patients | Biotech Hunter

Enrollment

135

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

June 30, 2014

Study Completion Date

October 31, 2014

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.

Trial Locations (13)

163045

Arkhangelsk District Clinical Oncology Dispensary, Arkhangelsk

197758

N.N.Petrov Oncology Research Center, Saint Petersburg

357502

Pyatigorsk Oncology Center, Pyatigorsk

404130

Volgograd Regional Oncology Dispensary №3, Volgograd

614066

Perm Region Oncology Dispensary, Perm

Unknown

Clinical Hospital at Chelyabinsk Railway Station, Chelyabinsk

"State public health institution Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan", Kazan'

"Non-governmental healthcare institution Central Clinical Hospital № 2 Semashko JSC Russian Railways", Moscow

"State Health Care Institution Moscow City Oncology Hospital № 62 Moscow Health Department", Moscow

"State public health institution Nizhny Novgorod Regional Oncology Dispensary", Nizhny Novgorod

"Federal State Educational Institution of Higher Professional Education Mordovia State University N.P. Ogareva ", Saransk

"State public health institution Regional Clinical Oncology Dispensary", Ulyanovsk

"State Health Care Institution Volgograd Regional Clinical Oncology Dispensary № 1", Volgograd