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

Study Overview
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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.

Official Title
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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

Conditions
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Chemotherapy Associated Neutropenia, Breast Cancer

Intervention / Treatment
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* Drug: EP2006
* Drug: Filgrastim


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EP2006<br>Eligible patients will be teated with EP2006 | Drug: EP2006<br>* Eligible patients will be teated with EP2006<br>* Other names: Filgrastim;|
| Active Comparator: Filgrastim<br>Eligible patients will be teated with Filgrastim | Drug: Filgrastim<br>* Eligible patients will be teated with Filgrastim<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 21 days (Cycle 1 of chemotherapy treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 21 weeks/ 6 cycles | 
| 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. | 21 weeks/ 6 cycles | 
| Depth of Absolute Neutrophil Count Nadir | Depth of Absolute Neutrophil Count Nadir, defined as the patient's lowest Absolute Neutrophil Count in cycle 1 | Cycle 1/ 21 days | 
| 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 | Cycle 1/ 21 days | 
| Frequency of Infections | Frequency of infections by cycle and across all cycles | 21 Weeks/ 6 cycles | 
| Incidence of Hospitalizations Due to Febrile Neutropenia | Incidence of hospitalizations due to Febrile Neutropenia | 21 Weeks/ 6 cycles | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Filgrastim, G-CSF, neutropenia, supportive care, breast cancer