Breast Cancer MedDRA version: 14.1 Level: LLT Classification code 10006203 Term: Breast cancer stage unspecified System Organ Class: 100000004864
Conditions
Interventions
Product Name: LA-EP2006
Product Code: LA-EP2006
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PEGFILGRASTIM
CAS Number: 208265-92-3
Current Sponsor code: LA-EP2006
Concentration un
Sponsors
Sandoz GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patients must fulfill all of the following criteria to be eligible for admission to the study: •Written informed consent before any assessment is performed •Patients with histologically proven breast cancer, eligible for neoadjuvant or adjuvant TAC chemotherapy •Women = 18 years of age •Estimated life expectancy of more than six months •Eastern cooperative oncology group (ECOG) performance status = 2 •Adequate bone marrow function on Cycle 1 Day 1 prior to chemotherapy administration: •ANC = 1.5 x 10 9/L •Platelet count = 100 x 10 9/L •Hemoglobin = 10 g/dL •Total bilirubin not higher than the upper limit of normal (ULN), unless the patient has Gilbert`s syndrome •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) level = 2 x ULN •Liver-derived alkaline phosphatase level = 3 x ULN •Creatinine = 1.5 x ULN •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 302 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: The patients meeting any of the following exclusion criteria will not be enrolled in the study: 1. History of chronic myeloid leukemia or myelodysplastic syndrome 2. History or presence of sickle cell disease 3. Previous or concurrent malignancy except non-invasive non-melanomatous 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 infection or who have positive serology for HIV, Hepatitis B or Hepatitis C at screening 13. Known active 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 LA-EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia (DSN), defined as 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 compare LA-EP2006 and Neulasta® with respect to the efficacy, safety, and immunogenicity of both products. ;Primary end point(s): • Mean duration of Grade 4 neutropenia, defined as the number of consecutive days in which the patient had an ANC < 0.5 × 10 9/L during Cycle 1 of chemotherapy;Timepoint(s) of evaluation of this end point: • Mean duration of Grade 4 neutropenia, defined as the number of consecutive days in which the patient had an ANC <0.5 x 10 9/L during Cycle 1 of chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Incidence of febrile neutropenia (FN), defined as oral temperature = 38.3 °C while having an ANC < 0.5 x 10 9/L (both measured on the same day) by cycle and across all cycles • Number of days of fever, defined as oral temperature = 38.3 °C, for each cycle • Depth of ANC nadir, defined as the patient`s lowest ANC in Cycle 1 • Time to ANC recovery, defined as the time in days from the chemotherapy administration until the patient`s ANC increased to = 2 x 10 9/L after the nadir, in Cycle 1 • Frequency of infection by cycle and across all cycles • Mortality due to infection ;Timepoint(s) of evaluation of this end point: • Incidence of febrile neutropenia (FN), defined as oral temperature = 38.3 °C while having an ANC < 0.5 x 10 9/L (both measured on the same day) by cycle and across all cycles • Number of days of fever, defined as oral temperature = 38.3 °C, for each cycle • Depth of ANC nadir, defined as the patient`s lowest ANC in Cycle 1 • Time to ANC recovery, defined as the time in days from the chemotherapy administration until the patient`s ANC increased to = 2 x 10 9/L after the nadir, in Cycle 1 • Frequency of infection by cycle and across all cycles | — |
Countries
Brazil, Bulgaria, India, Mexico, Poland, Romania, Russian Federation, Turkey, Ukraine
Contacts
Public ContactClinical Development Manager
Sandoz GmbH
Outcome results
None listed