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

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ClinicalTrials.gov Identifier: NCT01519700
Recruitment Status : Completed
First Posted : January 27, 2012
Results First Posted : April 7, 2015
Last Update Posted : May 6, 2015
Sponsor:
Information provided by (Responsible Party):
Sandoz

Study Description
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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 Design
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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
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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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


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

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.

Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01519700


Locations
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Sponsors and Collaborators
Sandoz
Investigators
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Study Chair: Sandoz Sandoz
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT01519700    
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:
Filgrastim
G-CSF, neutropenia
supportive care
breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neutropenia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Agranulocytosis
 Leukopenia
Leukocyte Disorders
Hematologic Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs