Phase III Study Comparing the Efficacy and Safety of EP2006 and Filgrastim (PIONEER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01519700
Recruitment Status : Completed
First Posted : January 27, 2012
Results First Posted : April 7, 2015
Last Update Posted : May 6, 2015
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chemotherapy Associated Neutropenia Breast Cancer Drug: EP2006 Drug: Filgrastim Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomized, Double-blind, Parallel-group, Multi-center Phase III Study Comparing the Efficacy and Safety of EP2006 and Neupogen® in Breast Cancer Patients Treated With Myelosuppressive Chemotherapy
Study Start Date : December 2011
Primary Completion Date : June 2013
Study Completion Date : June 2013

Arm Intervention/treatment
Experimental: EP2006
Eligible patients will be teated with EP2006
Drug: EP2006
Eligible patients will be teated with EP2006
Other Name: Filgrastim
Active Comparator: Filgrastim
Eligible patients will be teated with Filgrastim
Drug: Filgrastim
Eligible patients will be teated with Filgrastim

Primary Outcome Measures :
  1. Mean Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy [ Time Frame: 21 days (Cycle 1 of chemotherapy treatment) ]
    Mean duration of severe neutropenia, defined as the mean number of consecutive days with Grade 4 neutropenia (ANC less than 0.5*10^9 cells/L)

Secondary Outcome Measures :
  1. Incidence of Febrile Neutropenia [ Time Frame: 21 weeks/ 6 cycles ]
    Incidence of febrile neutropenia by duraton within each cycle and across all cycles. Febrile neutropenia is defined as oral temperature greater than or equal 38.3°C while having an Absolute Neutrophil Count < 0.5*10^9 cells/L (both measured on the same day)

  2. Number of Days of Fever [ Time Frame: 21 weeks/ 6 cycles ]
    Number of days of fever by cycle. Fever is defined as oral temperature greater than or equal to 38.3°C.

  3. Depth of Absolute Neutrophil Count Nadir [ Time Frame: Cycle 1/ 21 days ]
    Depth of Absolute Neutrophil Count Nadir, defined as the patient's lowest Absolute Neutrophil Count in cycle 1

  4. Time to Absolute Neutrophil Count Recovery [ Time Frame: Cycle 1/ 21 days ]
    Time to Absolute Neutrophil Count recovery, defined as the time in days from Absolute Neutrophil Count nadir until the patient's Absolute Neutrophil Count increases to more or equal to 2*10^9 cells/L after the nadir in cycle 1

  5. Frequency of Infections [ Time Frame: 21 Weeks/ 6 cycles ]
    Frequency of infections by cycle and across all cycles

  6. Incidence of Hospitalizations Due to Febrile Neutropenia [ Time Frame: 21 Weeks/ 6 cycles ]
    Incidence of hospitalizations due to Febrile Neutropenia

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.:

Other protocol-defined inclusion/exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01519700

Czech Republic
Insitut Onkologie a Rehabilitaca na Plesi
Ves pod Plesi 110, Czech Republic, 26204
Semmelweis Egyetem, III. Belgyogyaszati Klinika
Budapest, Hungary, 1125
Fovarosi Onkormanyzat Uzsoki utcai Korhaz, Onkoradiologia
Budapest, Hungary, 1145
DE OEC, Onkologiai Tanszek
Debrecen, Hungary, 4032
Josa Andras Oktato Korhaz Nonprofit Kft
Nyiregyhaza, Hungary, 4400
Fejer Megyei Szent Gyorgy Korhaz, Onkologiai Osztaly
Szekesfehervar, Hungary, 8000
Vas Megyei Markusovszky Korhaz, Onkoradiologiai Osztaly
Szombathely, Hungary, 9700
Daugavpils Regional Hospital
Daugavpils, Latvia, 5400
Russian Federation
Institution of the Russian Academy of Medical Sciences Medical Radiology Research Center RAMS
Moscow, Krasnogorsk district, Russian Federation, 143423
State Healthcare Institution (SHI) "Leningrad Regional Oncological Dispensary" at the Surgery Department 2
Kuzmolovsky, Leningrad region, Russian Federation, 188663
State Medical-Prophylactic Institution SMPI Reginal Clinical Oncological Dispensary
Chelyabinsk, Russian Federation, 454087
State Healthcare Institution (SHI) "Clinical Oncological Dispensary №1" of Healthcare Department of Krasnodar Territory
Krasnodar, Russian Federation, 350040
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, Russian Federation, 115478
Affiliate No1 of State Healthcare Institution (SHI) "Nizhny Novgorod Regional Oncological Dispensary"
Nizhny Novgorod, Russian Federation, 603081
Institution of the Russian Academy of Medical Sciences Medical Radiology Research Center RAMS
Obninsk, Russian Federation, 249036
State Healthcare Institution SHI Pyatigorsk Oncological Dispensary
Pyatigorsk, Russian Federation, 357502
Non-State Healthcare Institution NSHI
Saint-Petersburg, Russian Federation, 195271
Saint-Petersburg State Healthcare Institution (SPb SHI) "City Clinical Oncological Dispensary"
Saint-Petersburg, Russian Federation, 197022
State Healthcare Institution (SHI)"Voronezh Regional Clinical Oncological Dispensary"
Voronezh, Russian Federation, 394000
Fakultna nemocnica Nitra, Oddelenie radioterapie a klinickej onkologie
Nitra, Slovakia, 95001
Communal Institution "Krivorizhskiy oncology dispensary" of Dnipropetrovsk regional Council, Chemotherapy Department
Kriviy Rig, Dnipropetrovsk region, Ukraine, 50048
Communal Institution "Dnipropetrovsk Сity multiple-discipline Clinical Hospital 4" of Dnipropetrovsk Regional Council
Dnipropetrovsk, Ukraine, 49102
Medical center of Limited Liability Company "Inter"
Lugansk, Ukraine, 91000
Lviv state oncological regional treatment-and-diagnostics center, Chemotherapy Department
Lviv, Ukraine, 79031
Communal Institution "Odesa regional clinical hospital", Mammology Center
Odesa, Ukraine, 65025
Vinnytsya Regional Clinical Oncological Center, Chemotherapy Department
Vinnitsya, Ukraine, 21029
Sponsors and Collaborators
Study Chair: Sandoz Sandoz

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sandoz Identifier: NCT01519700     History of Changes
Other Study ID Numbers: EP06-302
2010-024481-22 ( EudraCT Number )
First Posted: January 27, 2012    Key Record Dates
Results First Posted: April 7, 2015
Last Update Posted: May 6, 2015
Last Verified: April 2015

Keywords provided by Sandoz:
G-CSF, neutropenia
supportive care
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Leukocyte Disorders
Hematologic Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs