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

Phase 3CompletedNCT01519700

Sandoz218 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

218

Conditions

Chemotherapy Associated Neutropenia Breast Cancer

Interventions

EP2006DRUG

Eligible patients will be teated with EP2006

FilgrastimDRUG

Eligible patients will be teated with Filgrastim

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (26)

Outcomes

Primary Outcomes

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)

Time frame: 21 days (Cycle 1 of chemotherapy treatment)

Secondary Outcomes

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)

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: Cycle 1/ 21 days

Frequency of Infections

Frequency of infections by cycle and across all cycles

Time frame: 21 Weeks/ 6 cycles

Incidence of Hospitalizations Due to Febrile Neutropenia

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Insitut Onkologie a Rehabilitaca na Plesi

Ves Pod Plesi 110, Czechia

Semmelweis Egyetem, III. Belgyogyaszati Klinika

Budapest, Hungary

Fovarosi Onkormanyzat Uzsoki utcai Korhaz, Onkoradiologia

Budapest, Hungary

DE OEC, Onkologiai Tanszek

Debrecen, Hungary

Josa Andras Oktato Korhaz Nonprofit Kft

Nyíregyháza, Hungary

Fejer Megyei Szent Gyorgy Korhaz, Onkologiai Osztaly

Székesfehérvár, Hungary

Vas Megyei Markusovszky Korhaz, Onkoradiologiai Osztaly

Szombathely, Hungary

Daugavpils Regional Hospital

Daugavpils, Latvia

Institution of the Russian Academy of Medical Sciences Medical Radiology Research Center RAMS

Moscow, Krasnogorsk District, Russia

State Healthcare Institution (SHI) "Leningrad Regional Oncological Dispensary" at the Surgery Department 2

Kuzmolovsky, Leningradskaya Oblast', Russia

...and 16 more locations