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

Primary Purpose

Chemotherapy Associated Neutropenia, Breast Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
EP2006
Filgrastim
Sponsored by
Sandoz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chemotherapy Associated Neutropenia focused on measuring Filgrastim, G-CSF, neutropenia, supportive care, breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Insitut Onkologie a Rehabilitaca na Plesi
  • Semmelweis Egyetem, III. Belgyogyaszati Klinika
  • Fovarosi Onkormanyzat Uzsoki utcai Korhaz, Onkoradiologia
  • DE OEC, Onkologiai Tanszek
  • Josa Andras Oktato Korhaz Nonprofit Kft
  • Fejer Megyei Szent Gyorgy Korhaz, Onkologiai Osztaly
  • Vas Megyei Markusovszky Korhaz, Onkoradiologiai Osztaly
  • Daugavpils Regional Hospital
  • Institution of the Russian Academy of Medical Sciences Medical Radiology Research Center RAMS
  • State Healthcare Institution (SHI) "Leningrad Regional Oncological Dispensary" at the Surgery Department 2
  • State Medical-Prophylactic Institution SMPI Reginal Clinical Oncological Dispensary
  • State Healthcare Institution (SHI) "Clinical Oncological Dispensary №1" of Healthcare Department of Krasnodar Territory
  • 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
  • Affiliate No1 of State Healthcare Institution (SHI) "Nizhny Novgorod Regional Oncological Dispensary"
  • Institution of the Russian Academy of Medical Sciences Medical Radiology Research Center RAMS
  • State Healthcare Institution SHI Pyatigorsk Oncological Dispensary
  • Non-State Healthcare Institution NSHI
  • Saint-Petersburg State Healthcare Institution (SPb SHI) "City Clinical Oncological Dispensary"
  • State Healthcare Institution (SHI)"Voronezh Regional Clinical Oncological Dispensary"
  • Fakultna nemocnica Nitra, Oddelenie radioterapie a klinickej onkologie
  • Communal Institution "Krivorizhskiy oncology dispensary" of Dnipropetrovsk regional Council, Chemotherapy Department
  • Communal Institution "Dnipropetrovsk Сity multiple-discipline Clinical Hospital 4" of Dnipropetrovsk Regional Council
  • Medical center of Limited Liability Company "Inter"
  • Lviv state oncological regional treatment-and-diagnostics center, Chemotherapy Department
  • Communal Institution "Odesa regional clinical hospital", Mammology Center
  • Vinnytsya Regional Clinical Oncological Center, Chemotherapy Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EP2006

Filgrastim

Arm Description

Eligible patients will be teated with EP2006

Eligible patients will be teated with Filgrastim

Outcomes

Primary Outcome Measures

Mean Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy
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

Incidence of Febrile Neutropenia
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)
Number of Days of Fever
Number of days of fever by cycle. Fever is defined as oral temperature greater than or equal to 38.3°C.
Depth of Absolute Neutrophil Count Nadir
Depth of Absolute Neutrophil Count Nadir, defined as the patient's lowest Absolute Neutrophil Count in cycle 1
Time to Absolute Neutrophil Count Recovery
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
Frequency of Infections
Frequency of infections by cycle and across all cycles
Incidence of Hospitalizations Due to Febrile Neutropenia
Incidence of hospitalizations due to Febrile Neutropenia

Full Information

First Posted
January 13, 2012
Last Updated
April 14, 2015
Sponsor
Sandoz
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1. Study Identification

Unique Protocol Identification Number
NCT01519700
Brief Title
Phase III Study Comparing the Efficacy and Safety of EP2006 and Filgrastim
Acronym
PIONEER
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 Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sandoz

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy Associated Neutropenia, Breast Cancer
Keywords
Filgrastim, G-CSF, neutropenia, supportive care, breast cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EP2006
Arm Type
Experimental
Arm Description
Eligible patients will be teated with EP2006
Arm Title
Filgrastim
Arm Type
Active Comparator
Arm Description
Eligible patients will be teated with Filgrastim
Intervention Type
Drug
Intervention Name(s)
EP2006
Other Intervention Name(s)
Filgrastim
Intervention Description
Eligible patients will be teated with EP2006
Intervention Type
Drug
Intervention Name(s)
Filgrastim
Intervention Description
Eligible patients will be teated with Filgrastim
Primary Outcome Measure Information:
Title
Mean Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy
Description
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)
Time Frame
21 days (Cycle 1 of chemotherapy treatment)
Secondary Outcome Measure Information:
Title
Incidence of Febrile Neutropenia
Description
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)
Time Frame
21 weeks/ 6 cycles
Title
Number of Days of Fever
Description
Number of days of fever by cycle. Fever is defined as oral temperature greater than or equal to 38.3°C.
Time Frame
21 weeks/ 6 cycles
Title
Depth of Absolute Neutrophil Count Nadir
Description
Depth of Absolute Neutrophil Count Nadir, defined as the patient's lowest Absolute Neutrophil Count in cycle 1
Time Frame
Cycle 1/ 21 days
Title
Time to Absolute Neutrophil Count Recovery
Description
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
Time Frame
Cycle 1/ 21 days
Title
Frequency of Infections
Description
Frequency of infections by cycle and across all cycles
Time Frame
21 Weeks/ 6 cycles
Title
Incidence of Hospitalizations Due to Febrile Neutropenia
Description
Incidence of hospitalizations due to Febrile Neutropenia
Time Frame
21 Weeks/ 6 cycles

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with histologically proven breast cancer, eligible for neoadjuvant or adjuvant myelosuppressive chemotherapy Women ≥ 18 years of age Estimated life expectancy of more than six months Exclusion Criteria: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandoz
Organizational Affiliation
Sandoz
Official's Role
Study Chair
Facility Information:
Facility Name
Insitut Onkologie a Rehabilitaca na Plesi
City
Ves pod Plesi 110
ZIP/Postal Code
26204
Country
Czech Republic
Facility Name
Semmelweis Egyetem, III. Belgyogyaszati Klinika
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Fovarosi Onkormanyzat Uzsoki utcai Korhaz, Onkoradiologia
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
DE OEC, Onkologiai Tanszek
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Josa Andras Oktato Korhaz Nonprofit Kft
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Fejer Megyei Szent Gyorgy Korhaz, Onkologiai Osztaly
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Vas Megyei Markusovszky Korhaz, Onkoradiologiai Osztaly
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Daugavpils Regional Hospital
City
Daugavpils
ZIP/Postal Code
5400
Country
Latvia
Facility Name
Institution of the Russian Academy of Medical Sciences Medical Radiology Research Center RAMS
City
Moscow
State/Province
Krasnogorsk district
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
State Healthcare Institution (SHI) "Leningrad Regional Oncological Dispensary" at the Surgery Department 2
City
Kuzmolovsky
State/Province
Leningrad region
ZIP/Postal Code
188663
Country
Russian Federation
Facility Name
State Medical-Prophylactic Institution SMPI Reginal Clinical Oncological Dispensary
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
State Healthcare Institution (SHI) "Clinical Oncological Dispensary №1" of Healthcare Department of Krasnodar Territory
City
Krasnodar
ZIP/Postal Code
350040
Country
Russian Federation
Facility Name
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
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Affiliate No1 of State Healthcare Institution (SHI) "Nizhny Novgorod Regional Oncological Dispensary"
City
Nizhny Novgorod
ZIP/Postal Code
603081
Country
Russian Federation
Facility Name
Institution of the Russian Academy of Medical Sciences Medical Radiology Research Center RAMS
City
Obninsk
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
State Healthcare Institution SHI Pyatigorsk Oncological Dispensary
City
Pyatigorsk
ZIP/Postal Code
357502
Country
Russian Federation
Facility Name
Non-State Healthcare Institution NSHI
City
Saint-Petersburg
ZIP/Postal Code
195271
Country
Russian Federation
Facility Name
Saint-Petersburg State Healthcare Institution (SPb SHI) "City Clinical Oncological Dispensary"
City
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
State Healthcare Institution (SHI)"Voronezh Regional Clinical Oncological Dispensary"
City
Voronezh
ZIP/Postal Code
394000
Country
Russian Federation
Facility Name
Fakultna nemocnica Nitra, Oddelenie radioterapie a klinickej onkologie
City
Nitra
ZIP/Postal Code
95001
Country
Slovakia
Facility Name
Communal Institution "Krivorizhskiy oncology dispensary" of Dnipropetrovsk regional Council, Chemotherapy Department
City
Kriviy Rig
State/Province
Dnipropetrovsk region
ZIP/Postal Code
50048
Country
Ukraine
Facility Name
Communal Institution "Dnipropetrovsk Сity multiple-discipline Clinical Hospital 4" of Dnipropetrovsk Regional Council
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Medical center of Limited Liability Company "Inter"
City
Lugansk
ZIP/Postal Code
91000
Country
Ukraine
Facility Name
Lviv state oncological regional treatment-and-diagnostics center, Chemotherapy Department
City
Lviv
ZIP/Postal Code
79031
Country
Ukraine
Facility Name
Communal Institution "Odesa regional clinical hospital", Mammology Center
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Vinnytsya Regional Clinical Oncological Center, Chemotherapy Department
City
Vinnitsya
ZIP/Postal Code
21029
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
26122726
Citation
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.
Results Reference
derived

Learn more about this trial

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

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