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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024481-22 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EP2006 | Experimental | Eligible patients will be teated with EP2006 |
|
| Filgrastim | Active Comparator | Eligible patients will be teated with Filgrastim |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EP2006 | Drug | Eligible patients will be teated with EP2006 |
|
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Sandoz | Sandoz | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Insitut Onkologie a Rehabilitaca na Plesi | Ves Pod Plesi 110 | 26204 | Czechia | |||
| Semmelweis Egyetem, III. Belgyogyaszati Klinika |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26122726 | Derived | 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. |
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The study started with a screening period of up to 21 days. During the screening period, the eligibility of the patients to participate in the study was assessed based on safety evaluations. After completion of the screening period, the patients were randomized to either EP2006 or US-licensed Neupogen® in four groups (see below).
The study population consisted of women of 18 years or older with histologically proven breast cancer who were eligible for neoadjuvant or adjuvant treatment with TAC chemotherapy. The study was aimed to randomize a total of 192 patients in approximately 65 centers worldwide.
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| ID | Title | Description |
|---|---|---|
| FG000 | EP2006 | Patients remained on EP2006 (their initial treatment) throughout the study daily dose of 5 mcg/kg body weight, subcutaneously |
| FG001 | EP2006 + Neupogen | Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle, daily dose of 5 mcg/kg body weight, subcutaneously |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Filgrastim | Drug | Eligible patients will be teated with Filgrastim |
|
| 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 |
| Budapest |
| 1125 |
| Hungary |
| Fovarosi Onkormanyzat Uzsoki utcai Korhaz, Onkoradiologia | Budapest | 1145 | Hungary |
| DE OEC, Onkologiai Tanszek | Debrecen | 4032 | Hungary |
| Josa Andras Oktato Korhaz Nonprofit Kft | NyÃregyháza | 4400 | Hungary |
| Fejer Megyei Szent Gyorgy Korhaz, Onkologiai Osztaly | Székesfehérvár | 8000 | Hungary |
| Vas Megyei Markusovszky Korhaz, Onkoradiologiai Osztaly | Szombathely | 9700 | Hungary |
| Daugavpils Regional Hospital | Daugavpils | 5400 | Latvia |
| Institution of the Russian Academy of Medical Sciences Medical Radiology Research Center RAMS | Moscow | Krasnogorsk District | 143423 | Russia |
| State Healthcare Institution (SHI) "Leningrad Regional Oncological Dispensary" at the Surgery Department 2 | Kuzmolovsky | Leningradskaya Oblast' | 188663 | Russia |
| State Medical-Prophylactic Institution SMPI Reginal Clinical Oncological Dispensary | Chelyabinsk | 454087 | Russia |
| State Healthcare Institution (SHI) "Clinical Oncological Dispensary â„–1" of Healthcare Department of Krasnodar Territory | Krasnodar | 350040 | Russia |
| 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 | 115478 | Russia |
| Affiliate No1 of State Healthcare Institution (SHI) "Nizhny Novgorod Regional Oncological Dispensary" | Nizhny Novgorod | 603081 | Russia |
| Institution of the Russian Academy of Medical Sciences Medical Radiology Research Center RAMS | Obninsk | 249036 | Russia |
| State Healthcare Institution SHI Pyatigorsk Oncological Dispensary | Pyatigorsk | 357502 | Russia |
| Non-State Healthcare Institution NSHI | Saint Petersburg | 195271 | Russia |
| Saint-Petersburg State Healthcare Institution (SPb SHI) "City Clinical Oncological Dispensary" | Saint Petersburg | 197022 | Russia |
| State Healthcare Institution (SHI)"Voronezh Regional Clinical Oncological Dispensary" | Voronezh | 394000 | Russia |
| Fakultna nemocnica Nitra, Oddelenie radioterapie a klinickej onkologie | Nitra | 95001 | Slovakia |
| Communal Institution "Krivorizhskiy oncology dispensary" of Dnipropetrovsk regional Council, Chemotherapy Department | Kryvyi Rih | Dnipropetrovsk Oblast | 50048 | Ukraine |
| Communal Institution "Dnipropetrovsk Сity multiple-discipline Clinical Hospital 4" of Dnipropetrovsk Regional Council | Dnipropetrovsk | 49102 | Ukraine |
| Medical center of Limited Liability Company "Inter" | Luhansk | 91000 | Ukraine |
| Lviv state oncological regional treatment-and-diagnostics center, Chemotherapy Department | Lviv | 79031 | Ukraine |
| Communal Institution "Odesa regional clinical hospital", Mammology Center | Odesa | 65025 | Ukraine |
| Vinnytsya Regional Clinical Oncological Center, Chemotherapy Department | Vinnitsya | 21029 | Ukraine |
| FG002 | Neupogen + EP2006 | Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle, daily dose of 5 mcg/kg body weight, subcutaneously |
| FG003 | Neupogen | Patients remained on Neupogen (their initial treatment) throughout the study, daily dose of 5 mcg/kg body weight, subcutaneously |
| Treated Cycle 1 EP2006 |
|
| Treated Cycle 1 Neupogen |
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| Treated Cycle 2 EP2006 |
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| Treated Cycle 2 Neupogen |
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| Treated Cycle 3 EP2006 |
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| Treated Cycle 3 Neupogen |
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| Treated Cycle 4 EP2006 |
|
| Treated Cycle 4 Neupogen |
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| Treated Cycle 5 EP2006 |
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| Treated Cycle 5 Neupogen |
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| Treated Cycle 6 EP2006 |
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| Treated Cycle 6 Neupogen |
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| COMPLETED |
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| NOT COMPLETED |
|
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The safety set consists of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
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| ID | Title | Description |
|---|---|---|
| BG000 | EP2006 | Patients remained on EP2006 (their initial treatment) throughout the study |
| BG001 | EP2006 + Neupogen | Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle |
| BG002 | Neupogen + EP2006 | Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle |
| BG003 | Neupogen | Patients remained on Neupogen (their initial treatment) throughout the study |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | PP population | Posted | Mean | Standard Deviation | Days | 21 days (Cycle 1 of chemotherapy treatment) |
|
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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) | SAF-I (alternating safety) set: patients who received at least one dose of study medication after Cycle 1. | Posted | Number | participants | 21 weeks/ 6 cycles |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | PP-I (alternating Per-Protocol) set: randomized patients who completed all six chemotherapy cycles without major protocol violations. | Posted | Number | participants | 21 weeks/ 6 cycles |
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| 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 | FAS (full analysis) set: all patients who received at least one dose of study medication, analyzed according to randomization allocation | Posted | Mean | Standard Deviation | 10^9 cells/L | Cycle 1/ 21 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | FAS (full analysis) set: all patients who received at least one dose of study medication, analyzed according to randomization allocation. In the EP2006 + EP2006 & Neupogen group, one patient's time to Absolute Neutrophil Count recovery could not be measured as the nadir was the last measured timepoint. | Posted | Median | Full Range | Days | Cycle 1/ 21 days |
|
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| Secondary | Frequency of Infections | Frequency of infections by cycle and across all cycles | SAF-I (alternating safety) set: patients who received at least one dose of study medication after Cycle 1. Comparison made for alternating versus non-alternating treatment groups. | Posted | Number | participants | 21 Weeks/ 6 cycles |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Hospitalizations Due to Febrile Neutropenia | Incidence of hospitalizations due to Febrile Neutropenia | SAF-I (alternating safety) set: patients who received at least one dose of study medication after Cycle 1. | Posted | Number | participants | 21 Weeks/ 6 cycles |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EP2006 | Patients remained on EP2006 (their initial treatment) throughout the study | 6 | 53 | 50 | 53 | ||
| EG001 | EP2006 + Neupogen | Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle | 4 | 54 | 51 | 54 | ||
| EG002 | Neupogen + EP2006 | Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle | 1 | 55 | 52 | 55 | ||
| EG003 | Neupogen | Patients remained on Neupogen (their initial treatment) throughout the study | 3 | 52 | 50 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders |
| |||
| Anaemia | Blood and lymphatic system disorders |
| |||
| Leukopenia | Blood and lymphatic system disorders |
| |||
| Diarrhoea | Gastrointestinal disorders |
| |||
| Embolism | Vascular disorders |
| |||
| Hypertensive crisis | Vascular disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders |
| |||
| Erythema | Skin and subcutaneous tissue disorders |
| |||
| Asthenia | General disorders |
| |||
| Fatigue | General disorders |
| |||
| Hypothermia | General disorders |
| |||
| Pyrexia | General disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Diarrhoea | Gastrointestinal disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Abdominal pain upper | Gastrointestinal disorders |
| |||
| Abdominal pain | Gastrointestinal disorders |
| |||
| Stomatitis | Gastrointestinal disorders |
| |||
| Bone pain | Musculoskeletal and connective tissue disorders |
| |||
| Arthralgia | Musculoskeletal and connective tissue disorders |
| |||
| Myalgia | Musculoskeletal and connective tissue disorders |
| |||
| Musculosceletal pain | Musculoskeletal and connective tissue disorders |
| |||
| Neutropenia | Blood and lymphatic system disorders |
| |||
| Anaemia | Blood and lymphatic system disorders |
| |||
| Leucopenia | Blood and lymphatic system disorders |
| |||
| Febrile neutropenia | Blood and lymphatic system disorders |
| |||
| Dizziness | Nervous system disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Periferal sensory neur. | Nervous system disorders |
| |||
| Decreased Appetite | Metabolism and nutrition disorders |
| |||
| Flushing | Vascular disorders |
|
PI shall provide Sponsor with any presentation at least 15 working days prior to disclosure and any other publication at least 45 working days prior to disclosure. Sponsor may require amendments on reasonable grounds: (a) accuracy of publication; (b) confidentiality of proprietary information; (c) intellectual property protection; (d) to enable further information to be provided. Sponsor may require publications or presentations to be delayed up to four (4) months to enable patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Roumen Nakov, Global Programme Medical Director | Sandoz | +49 8024 4764704 | roumen.nakov@sandoz.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009503 | Neutropenia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
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| ID | Term |
|---|---|
| C455861 | pegfilgrastim |
| D000069585 | Filgrastim |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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| Male |
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| OG004 | Total | All patients |
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All patients |
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| Participants |
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All patients
|
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