Clinical trial NCT01519700: Phase III Study Comparing the Efficacy and Safety of EP2006 and Filgrastim
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chemotherapy Associated Neutropenia
Breast Cancer
Keywords: Filgrastim
G-CSF, neutropenia
supportive care
breast cancer
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2012-01-27
Enrollment: 218
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy
timeFrame: 21 days (Cycle 1 of chemotherapy treatment)
Secondary outcomes:
measure: Incidence of Febrile Neutropenia
timeFrame: 21 weeks/ 6 cycles
measure: Number of Days of Fever
timeFrame: 21 weeks/ 6 cycles
measure: Depth of Absolute Neutrophil Count Nadir
timeFrame: Cycle 1/ 21 days
measure: Time to Absolute Neutrophil Count Recovery
timeFrame: Cycle 1/ 21 days
measure: Frequency of Infections
timeFrame: 21 Weeks/ 6 cycles
measure: Incidence of Hospitalizations Due to Febrile Neutropenia
timeFrame: 21 Weeks/ 6 cycles
Other outcomes:
Locations:
city: Ves pod Plesi 110
country: Czech Republic
facility: Insitut Onkologie a Rehabilitaca na Plesi
city: Budapest
country: Hungary
facility: Semmelweis Egyetem, III. Belgyogyaszati Klinika
city: Budapest
country: Hungary
facility: Fovarosi Onkormanyzat Uzsoki utcai Korhaz, Onkoradiologia
city: Debrecen
country: Hungary
facility: DE OEC, Onkologiai Tanszek
city: Nyiregyhaza
country: Hungary
facility: Josa Andras Oktato Korhaz Nonprofit Kft
city: Szekesfehervar
country: Hungary
facility: Fejer Megyei Szent Gyorgy Korhaz, Onkologiai Osztaly
city: Szombathely
country: Hungary
facility: Vas Megyei Markusovszky Korhaz, Onkoradiologiai Osztaly
city: Daugavpils
country: Latvia
facility: Daugavpils Regional Hospital
city: Moscow
country: Russian Federation
facility: Institution of the Russian Academy of Medical Sciences Medical Radiology Research Center RAMS
state: Krasnogorsk district
city: Kuzmolovsky
country: Russian Federation
facility: State Healthcare Institution (SHI) "Leningrad Regional Oncological Dispensary" at the Surgery Department 2
state: Leningrad region
city: Chelyabinsk
country: Russian Federation
facility: State Medical-Prophylactic Institution SMPI Reginal Clinical Oncological Dispensary
city: Krasnodar
country: Russian Federation
facility: State Healthcare Institution (SHI) "Clinical Oncological Dispensary №1" of Healthcare Department of Krasnodar Territory
city: Moscow
country: Russian Federation
facility: 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
city: Nizhny Novgorod
country: Russian Federation
facility: Affiliate No1 of State Healthcare Institution (SHI) "Nizhny Novgorod Regional Oncological Dispensary"
city: Obninsk
country: Russian Federation
facility: Institution of the Russian Academy of Medical Sciences Medical Radiology Research Center RAMS
city: Pyatigorsk
country: Russian Federation
facility: State Healthcare Institution SHI Pyatigorsk Oncological Dispensary
city: Saint-Petersburg
country: Russian Federation
facility: Non-State Healthcare Institution NSHI
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg State Healthcare Institution (SPb SHI) "City Clinical Oncological Dispensary"
city: Voronezh
country: Russian Federation
facility: State Healthcare Institution (SHI)"Voronezh Regional Clinical Oncological Dispensary"
city: Nitra
country: Slovakia
facility: Fakultna nemocnica Nitra, Oddelenie radioterapie a klinickej onkologie
city: Kriviy Rig
country: Ukraine
facility: Communal Institution "Krivorizhskiy oncology dispensary" of Dnipropetrovsk regional Council, Chemotherapy Department
state: Dnipropetrovsk region
city: Dnipropetrovsk
country: Ukraine
facility: Communal Institution "Dnipropetrovsk Сity multiple-discipline Clinical Hospital 4" of Dnipropetrovsk Regional Council
city: Lugansk
country: Ukraine
facility: Medical center of Limited Liability Company "Inter"
city: Lviv
country: Ukraine
facility: Lviv state oncological regional treatment-and-diagnostics center, Chemotherapy Department
city: Odesa
country: Ukraine
facility: Communal Institution "Odesa regional clinical hospital", Mammology Center
city: Vinnitsya
country: Ukraine
facility: Vinnytsya Regional Clinical Oncological Center, Chemotherapy Department
Study officials:
affiliation: Sandoz
name: Sandoz
role: STUDY_CHAIR
References:
citation: Blackwell K, Semiglazov V, Krasnozhon D, Davidenko I, Nelyubina L, Nakov R, Stiegler G, Singh P, Schwebig A, Kramer S, Harbeck N. Comparison of EP2006, a filgrastim biosimilar, to the reference: a phase III, randomized, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy. Ann Oncol. 2015 Sep;26(9):1948-1953. doi: 10.1093/annonc/mdv281. Epub 2015 Jun 28.