Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Wounds and Injuries

Blood and Lymph Conditions

Rare Diseases

Breast Neoplasms

Hyperthermia

Neutropenia

Fever

Febrile Neutropenia

Agranulocytosis

Leukopenia

Cytopenia

Hematologic Diseases

Leukocyte Disorders

Granulocytopenia

Antineoplastic Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Doxorubicin

Liposomal doxorubicin

Docetaxel

Lenograstim

Adjuvants, Immunologic

Immunologic Factors

Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy and placebo #2 in a dose of 0.0083 ml/kg in 24-27 hour after chemotherapy, then patient received placebo #2 in dose 0.0083 ml/kg until ANC ≥ 10x109/L or during 14 days

Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy and placebo #2 in a dose of 0.0083 ml/kg in 24-27 hour after chemotherapy, then patient received placebo #2 in dose 0.0083 ml/kg until ANC ≥ 10x109/L or during 14 days

Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy and placebo #1 in dose 1.0 ml subcutaneously, 24 h after the chemotherapy.

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.

Empegfilrastim 6 mg

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.

Filgrastim

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.

Placebo №1

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.

Placebo №2

Empegfilrastim 7.5 mg

Roman Ivanov, MD, PhD

Larisa Bolotina, MD, PhD

Olga Brichkova, MD, PhD

Olga Burdaeva, MD

Byakhov Michael, MD, PhD

Vladimir Vladimirov, MD, PhD

Rinat Galiulin, MD

Oleg Gladkov, MD, PhD

Irina Davydenko, PhD

Victoria Elkova, MD

Igor Lifirenko, MD

Nadezhda Kovalenko, PhD

Michael Kopp, MD, PhD

Bogdan Kotiv, MD, PhD

Natalia Levchenko, PhD

Marina Matrosova, MD

Guzel Mukhametshina, MD

Sergei Panchenko, PhD

Alexander Pecheny, PhD

Igor Pimenov, PhD

Andrei Sinykov, PhD

Pavel Skopin, PhD

Daniil Stroyakovsky

Sergei Tyulyandin, MD, PhD

Dmitriy Udovica, MD

Andrei Horinko, MD

Petr Krivorotko, MD

Yulia Shapovalova, PhD

Ludmila Sheveleva, MD

Vadim Shirinkin, MD

Shekar Patil, MD

Prasad Narayanan, MD

Nalini Kilara, MD

Sergei Kulik, MD

Igor Sedakov, MD, PhD

Andrei Rusin, MD,PhD

Yuri Vinnik, MD, PhD

Sergei Odarchenko, PhD

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).

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.

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

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

The primary endpoint, which will allow to compare the efficacy of the single dose of Extimia® versus nonpegylated daily filgrastim is the number of breast cancer patients developing CTCAE grade 3/4 neutropenia after the first AT chemotherapy cycle (doxorubicin+docetaxel).

Biocad

In general, any AEs were reported in all patients in both groups over a period of study. The vast majority of AEs were due to myelosuppressive chemotherapy. When comparing the frequency of registration of individual AEs there was no significant difference. AEs specific for all G-CSF drugs were observed rarely.

Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy

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.

Empegfilgrastim 6 mg

Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy

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.

Empegfilgrastim 7.5 mg

Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy

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.

Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy and placebo #2 in a dose of 0.0083 ml/kg in 24-27 hour after chemotherapy, then patient received placebo #2 in dose 0.0083 ml/kg until ANC ≥ 10x109/L or during 14 days

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.

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.

Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy and placebo #2 in a dose of 0.0083 ml/kg in 24-27 hour after chemotherapy, then patient received placebo #2 in dose 0.0083 ml/kg until ANC ≥ 10x109/L or during 14 days

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.

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.

Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy and placebo #1 in dose 1.0 ml ubcutaneously, 24 h after the chemotherapy.

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.

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.

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Russian Federation

Region of Enrollment

Infiltrative ductal

Infiltrative lobular

Medullar

Squamous cell cancer

Infiltrative not specified

Low-grade differentiated carcinoma

Undifferentiated cancer

Histologic type

IIIA

IIIB

IIIС

Disease stage

Adjuvant chemotherapy

Neoadjuvant chemotherapy

Radiotherapy

Hormone therapy

Surgery treatment

Any treatment

Patients with previous therapy could be treated with several different types of therapy (for example surgery treatment and adjuvant chemotherapy)

History previous therapy of breast cancer

Duration of a disease

Roman Ivanov, Director of Clinical Trials

The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.

Duration of Neutropenia CTCAE Grade 4

2nd cycle (week 6)

3rd cycle (week 9)

4th cycle (week 12)

The Duration of Grade 4 Neutropenia From the 2nd (Week 6) to 4th Cycle (Week 12);

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