A study comparing the efficacy and safety of EP2006 and Neupogen® in breast cancer patients being treated with types of chemotherapy which decrease white blood cells
- Conditions
- Breast cancerMedDRA version: 15.0Level: LLTClassification code 10006203Term: Breast cancer stage unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-024481-22-LT
- Lead Sponsor
- Sandoz GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 192
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 10 9/L
• Platelet count = 100 x 10 9/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. Negative serum pregnancy test within seven days prior to
randomization for all women of childbearing potential
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
1. History of myelogenous leukemia or myelodysplastic syndrome
2. History of presence of sickle cell disease
3. Previous or concurrent malignancy except non-invasive nonmelanoma 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 and their evaluation, e.g.:
• Active uncontrolled infection
• Clinically significant impairment of left ventricular ejection fraction
(LVEF measured by echocardiography 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
• History of 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 recombinant human granulocyte-colony stimulating factor (rhG-CSF) product
11. Known hypersensitivity to Escherichia coli (E. coli) proteins or any of the excipients used in the investigational medicinal products (IMPs)
12. Positive serology for human immunodeficiency virus (HIV)1/2,
Hepatitis B, or Hepatitis C
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)<br>neutropenia in Cycle 1, defined as the number of consecutive days in<br>which a patient has an ANC < 0.5 × 10 9/L;Timepoint(s) of evaluation of this end point: End Cycle 1
- Secondary Outcome Measures
Name Time Method