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

Breast Cancer Clinical Trial

— PIONEER  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01519700
• Other study ID #: EP06-302
• Secondary ID: 2010-024481-22
• Status: Completed
• Phase: Phase 3
• First received: January 13, 2012
• Last updated: April 14, 2015
• Start date: December 2011
• Est. completion date: June 2013

Study information

• Verified date: April 2015
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian FederationHungary: Ministry of Health, Social and Family AffairsHungary: National Institute of PharmacyCzech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chemotherapy Associated Neutropenia
• Neutropenia

Intervention

Drug:
• EP2006
Eligible patients will be teated with EP2006
• Filgrastim
Eligible patients will be teated with Filgrastim

Locations

Country	Name	City	State
Czech Republic	Insitut Onkologie a Rehabilitaca na Plesi	Ves pod Plesi 110
Hungary	Fovarosi Onkormanyzat Uzsoki utcai Korhaz, Onkoradiologia	Budapest
Hungary	Semmelweis Egyetem, III. Belgyogyaszati Klinika	Budapest
Hungary	DE OEC, Onkologiai Tanszek	Debrecen
Hungary	Josa Andras Oktato Korhaz Nonprofit Kft	Nyiregyhaza
Hungary	Fejer Megyei Szent Gyorgy Korhaz, Onkologiai Osztaly	Szekesfehervar
Hungary	Vas Megyei Markusovszky Korhaz, Onkoradiologiai Osztaly	Szombathely
Latvia	Daugavpils Regional Hospital	Daugavpils
Russian Federation	State Medical-Prophylactic Institution SMPI Reginal Clinical Oncological Dispensary	Chelyabinsk
Russian Federation	State Healthcare Institution (SHI) "Clinical Oncological Dispensary ?1" of Healthcare Department of Krasnodar Territory	Krasnodar
Russian Federation	State Healthcare Institution (SHI) "Leningrad Regional Oncological Dispensary" at the Surgery Department 2	Kuzmolovsky	Leningrad region
Russian Federation	Institution of the Russian Academy of Medical Sciences Medical Radiology Research Center RAMS	Moscow	Krasnogorsk district
Russian Federation	Institution of the Russian Academy of Medical Sciences Russian Oncology Research Center n.a. N.N.Blochin of RAMS", Surgery Department of the Female Reproductive System Tumors	Moscow
Russian Federation	Affiliate No1 of State Healthcare Institution (SHI) "Nizhny Novgorod Regional Oncological Dispensary"	Nizhny Novgorod
Russian Federation	Institution of the Russian Academy of Medical Sciences Medical Radiology Research Center RAMS	Obninsk
Russian Federation	State Healthcare Institution SHI Pyatigorsk Oncological Dispensary	Pyatigorsk
Russian Federation	Non-State Healthcare Institution NSHI	Saint-Petersburg
Russian Federation	Saint-Petersburg State Healthcare Institution (SPb SHI) "City Clinical Oncological Dispensary"	Saint-Petersburg
Russian Federation	State Healthcare Institution (SHI)"Voronezh Regional Clinical Oncological Dispensary"	Voronezh
Slovakia	Fakultna nemocnica Nitra, Oddelenie radioterapie a klinickej onkologie	Nitra
Ukraine	Communal Institution "Dnipropetrovsk ?ity multiple-discipline Clinical Hospital 4" of Dnipropetrovsk Regional Council	Dnipropetrovsk
Ukraine	Communal Institution "Krivorizhskiy oncology dispensary" of Dnipropetrovsk regional Council, Chemotherapy Department	Kriviy Rig	Dnipropetrovsk region
Ukraine	Medical center of Limited Liability Company "Inter"	Lugansk
Ukraine	Lviv state oncological regional treatment-and-diagnostics center, Chemotherapy Department	Lviv
Ukraine	Communal Institution "Odesa regional clinical hospital", Mammology Center	Odesa
Ukraine	Vinnytsya Regional Clinical Oncological Center, Chemotherapy Department	Vinnitsya

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz

Countries where clinical trial is conducted

Czech Republic,  Hungary,  Latvia,  Russian Federation,  Slovakia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Frequency of Infections	Frequency of infections by cycle and across all cycles	21 Weeks/ 6 cycles	No
Secondary	Incidence of Hospitalizations Due to Febrile Neutropenia	Incidence of hospitalizations due to Febrile Neutropenia	21 Weeks/ 6 cycles	No