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

Phase 3

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
EP2006	EP2006	Eligible patients will be teated with EP2006
Filgrastim	Filgrastim	Eligible patients will be teated with Filgrastim

Primary Outcome Measures

Name	Time	Method
Mean Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy	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

Name	Time	Method
Depth of Absolute Neutrophil Count Nadir	Cycle 1/ 21 days	Depth of Absolute Neutrophil Count Nadir, defined as the patient's lowest Absolute Neutrophil Count in cycle 1
Time to Absolute Neutrophil Count Recovery	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
Incidence of Hospitalizations Due to Febrile Neutropenia	21 Weeks/ 6 cycles	Incidence of hospitalizations due to Febrile Neutropenia
Number of Days of Fever	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.
Frequency of Infections	21 Weeks/ 6 cycles	Frequency of infections by cycle and across all cycles
Incidence of Febrile Neutropenia	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)

Locations (25): Insitut Onkologie a Rehabilitaca na Plesi
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Ves pod Plesi 110, Czech Republic
Semmelweis Egyetem, III. Belgyogyaszati Klinika
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Budapest, Hungary
Fovarosi Onkormanyzat Uzsoki utcai Korhaz, Onkoradiologia
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Budapest, Hungary
DE OEC, Onkologiai Tanszek
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Debrecen, Hungary
Josa Andras Oktato Korhaz Nonprofit Kft
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Nyiregyhaza, Hungary
Fejer Megyei Szent Gyorgy Korhaz, Onkologiai Osztaly
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Szekesfehervar, Hungary
Vas Megyei Markusovszky Korhaz, Onkoradiologiai Osztaly
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Szombathely, Hungary
Daugavpils Regional Hospital
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Daugavpils, Latvia
Institution of the Russian Academy of Medical Sciences Medical Radiology Research Center RAMS
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Obninsk, Russian Federation
State Healthcare Institution (SHI) "Leningrad Regional Oncological Dispensary" at the Surgery Department 2
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Kuzmolovsky, Leningrad region, Russian Federation
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Insitut Onkologie a Rehabilitaca na Plesi
🇨🇿Ves pod Plesi 110, Czech Republic