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Completed

NCT Number: NCT01519700

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

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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Key information

Conditions

Chemotherapy Associated Neutropenia Agranulocytosis Breast Cancer Breast Diseases Breast Neoplasms Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia Neoplasms Neoplasms by Site Neutropenia Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Insitut Onkologie a Rehabilitaca na Plesi, Ves Pod Plesi 110, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EP2006

Drug

Eligible patients will be teated with EP2006

Other names: Filgrastim

Filgrastim

Drug

Eligible patients will be teated with Filgrastim

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Registry information

Official study 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

Acronym: PIONEER

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 27, 2012
Registry last updated
May 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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