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Phase III Study Comparing the Efficacy and Safety of EP2006 and Filgrastim

NCT ID: NCT01519700

Last Updated: 2015-05-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-06-30

Brief Summary

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The study will assess the efficacy of EP2006 compared to Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.

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Detailed Description

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Conditions

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Chemotherapy Associated Neutropenia Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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EP2006

Eligible patients will be teated with EP2006

Group Type EXPERIMENTAL

EP2006

Intervention Type DRUG

Eligible patients will be teated with EP2006

Filgrastim

Eligible patients will be teated with Filgrastim

Group Type ACTIVE_COMPARATOR

Filgrastim

Intervention Type DRUG

Eligible patients will be teated with Filgrastim

Interventions

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EP2006

Eligible patients will be teated with EP2006

Intervention Type DRUG

Filgrastim

Eligible patients will be teated with Filgrastim

Intervention Type DRUG

Other Intervention Names

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Filgrastim

Eligibility Criteria

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Inclusion Criteria

1. Patients with histologically proven breast cancer, eligible for neoadjuvant or adjuvant myelosuppressive chemotherapy
2. Women ≥ 18 years of age
3. Estimated life expectancy of more than six months

Exclusion Criteria

1. Previous or concurrent malignancy except non-invasive non-melanoma skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least ten years prior to study entry
2. Any serious illness or medical condition that may interfere with safety, compliance, response to the products under investigation and their evaluation, e.g.:
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sandoz

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sandoz

Role: STUDY_CHAIR

Sandoz

Locations

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Insitut Onkologie a Rehabilitaca na Plesi

Ves Pod Plesi 110, , Czechia

Site Status

Semmelweis Egyetem, III. Belgyogyaszati Klinika

Budapest, , Hungary

Site Status

Fovarosi Onkormanyzat Uzsoki utcai Korhaz, Onkoradiologia

Budapest, , Hungary

Site Status

DE OEC, Onkologiai Tanszek

Debrecen, , Hungary

Site Status

Josa Andras Oktato Korhaz Nonprofit Kft

Nyíregyháza, , Hungary

Site Status

Fejer Megyei Szent Gyorgy Korhaz, Onkologiai Osztaly

Székesfehérvár, , Hungary

Site Status

Vas Megyei Markusovszky Korhaz, Onkoradiologiai Osztaly

Szombathely, , Hungary

Site Status

Daugavpils Regional Hospital

Daugavpils, , Latvia

Site Status

Institution of the Russian Academy of Medical Sciences Medical Radiology Research Center RAMS

Moscow, Krasnogorsk District, Russia

Site Status

State Healthcare Institution (SHI) "Leningrad Regional Oncological Dispensary" at the Surgery Department 2

Kuzmolovsky, Leningradskaya Oblast', Russia

Site Status

State Medical-Prophylactic Institution SMPI Reginal Clinical Oncological Dispensary

Chelyabinsk, , Russia

Site Status

State Healthcare Institution (SHI) "Clinical Oncological Dispensary №1" of Healthcare Department of Krasnodar Territory

Krasnodar, , Russia

Site Status

Institution of the Russian Academy of Medical Sciences Russian Oncology Research Center n.a. N.N.Blochin of RAMS", Surgery Department of the Female Reproductive System Tumors

Moscow, , Russia

Site Status

Affiliate No1 of State Healthcare Institution (SHI) "Nizhny Novgorod Regional Oncological Dispensary"

Nizhny Novgorod, , Russia

Site Status

Institution of the Russian Academy of Medical Sciences Medical Radiology Research Center RAMS

Obninsk, , Russia

Site Status

State Healthcare Institution SHI Pyatigorsk Oncological Dispensary

Pyatigorsk, , Russia

Site Status

Non-State Healthcare Institution NSHI

Saint Petersburg, , Russia

Site Status

Saint-Petersburg State Healthcare Institution (SPb SHI) "City Clinical Oncological Dispensary"

Saint Petersburg, , Russia

Site Status

State Healthcare Institution (SHI)"Voronezh Regional Clinical Oncological Dispensary"

Voronezh, , Russia

Site Status

Fakultna nemocnica Nitra, Oddelenie radioterapie a klinickej onkologie

Nitra, , Slovakia

Site Status

Communal Institution "Krivorizhskiy oncology dispensary" of Dnipropetrovsk regional Council, Chemotherapy Department

Kryvyi Rih, Dnipropetrovsk Oblast, Ukraine

Site Status

Communal Institution "Dnipropetrovsk Сity multiple-discipline Clinical Hospital 4" of Dnipropetrovsk Regional Council

Dnipropetrovsk, , Ukraine

Site Status

Medical center of Limited Liability Company "Inter"

Luhansk, , Ukraine

Site Status

Lviv state oncological regional treatment-and-diagnostics center, Chemotherapy Department

Lviv, , Ukraine

Site Status

Communal Institution "Odesa regional clinical hospital", Mammology Center

Odesa, , Ukraine

Site Status

Vinnytsya Regional Clinical Oncological Center, Chemotherapy Department

Vinnitsya, , Ukraine

Site Status

Countries

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Czechia Hungary Latvia Russia Slovakia Ukraine

References

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Blackwell K, Semiglazov V, Krasnozhon D, Davidenko I, Nelyubina L, Nakov R, Stiegler G, Singh P, Schwebig A, Kramer S, Harbeck N. Comparison of EP2006, a filgrastim biosimilar, to the reference: a phase III, randomized, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy. Ann Oncol. 2015 Sep;26(9):1948-1953. doi: 10.1093/annonc/mdv281. Epub 2015 Jun 28.

Reference Type DERIVED
PMID: 26122726 (View on PubMed)

Other Identifiers

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2010-024481-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EP06-302

Identifier Type: -

Identifier Source: org_study_id

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