Breast cancer MedDRA version: 14.1 Level: LLT Classification code 10006203 Term: Breast cancer stage unspecified System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: EP2006
Product Code: EP2006
Pharmaceutical Form: Solution for injection
INN or Proposed INN: FILGRASTIM
CAS Number: 121181-53-1
Current Sponsor code: EP2006
Concentration unit: µg/ml mic
Sponsors
Sandoz GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent before any assessment is performed 2. Patients with histologically proven breast cancer, eligible for neoadjuvant or adjuvant TAC chemotherapy 3. Women = 18 years of age 4. Estimated life expectancy of more than six months 5. Eastern Cooperative Oncology Group (ECOG) performance status = 2 6. Adequate bone marrow function on Cycle 1 Day 1, prior to chemotherapy administration: • ANC = 1.5 x 109/L • Platelet count = 100 x 109/L • Hemoglobin = 10 g/dL 7. Total bilirubin within normal limits, unless the patient has Gilbert’s syndrome 8. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) level = 2 x upper limit of normal (ULN) 9. Liver-derived alkaline phosphatase level = 3 x ULN 10. Creatinine = 1.5 x ULN 11. For all women of childbearing potential: negative serum pregnancy test within seven days prior to randomization, and using a highly effective method of birth control. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 163 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 29
Exclusion criteria
Exclusion criteria: 1. History of myelogenous leukemia or myelodysplastic syndrome 2. History or presence of sickle cell disease 3. 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 4. Any serious illness or medical condition, that may interfere with safety, compliance, response to the products under investigation or chemotherapy and their evaluation, such as: • Active uncontrolled infection • Clinically significant impairment of left ventricular ejection fraction (LVEF) (measured within three month before study entry by echocardiography or Multiple Gated Acquisition scan (MUGA) must be above the lower limit of normal for the respective center) • Severe valvular heart disease, myocardial infarction, unstable angina pectoris, uncontrolled hypertension or uncontrolled arrhythmias within six months from study entry • Significant neurologic or psychiatric disorders including psychotic disorders, dementia, or seizures that would prohibit the understanding and giving of informed consent 5. Concurrent or prior radiotherapy within four weeks of randomization 6. Concurrent or prior chemotherapy for breast cancer 7. Concurrent or prior anti-cancer treatment for breast cancer such as endocrine therapy, immunotherapy, monoclonal antibodies, and/or biological therapy 8. Concurrent prophylactic antibiotics 9. Prior bone marrow or stem cell transplant 10. Previous therapy with any rhG-CSF product 11. Known hypersensitivity to E. coli proteins or any of the excipients used in the IMPs 12. Patient known to have HIV, Hepatitis B, Hepatitis C or who have a positive serology for HIV, Hepatitis B or Hepatitis C at screening 13. Known control drug addiction, including alcoholism 14. Participation in any other clinical study using an IMP or device within three months before the screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of EP2006 compared to Neupogen® (US-licensed) with respect to the mean duration of severe neutropenia (DSN), defined as the number of consecutive days with Grade 4 neutropenia (absolute neutrophil count [ANC] less than 0.5 x 10 9/L), during Cycle 1 of the neoadjuvant or adjuvant TAC regimen (Taxotere® [docetaxel 75 mg/m2] in combination with Adriamycin® [doxorubicin 50 mg/m2] and Cytoxan® [cyclophosphamide 500 mg/m2]) in breast cancer patients.;Secondary Objective: The secondary objectives are to further assess the efficacy, safety, and immunogenicity of EP2006 and Neupogen® and to compare the effects of repeated switching between EP2006 and Neupogen®.;Primary end point(s): The primary efficacy endpoint the mean duration of severe (Grade 4) neutropenia in Cycle 1, defined as the number of consecutive days in which a patient has an ANC < 0.5 × 10 9/L;Timepoint(s) of evaluation of this end point: End Cycle 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Depth of ANC nadir, defined as the patient's lowest ANC 2. Time to ANC recovery, defined as the time from the chemotherapy administration until the ANC increases to = 2 × 10 9/L after the nadir 3. Incidence of febrile neutropenia (defined as orally temperature of =38.3°C concurrent with an ANC 0.5 x 10 9/L. 3. Incidence of febrile neutropenia will be evaluated across all cycles. | — |
Countries
Czech Republic, Hungary, India, Latvia, Lithuania, Russian Federation, Serbia, Slovakia, Ukraine
Contacts
Public ContactClinical Development Manager
Sandoz GmbH
Outcome results
None listed