EUCTR2010-024481-22-SK进行中（未招募）不适用
A randomized, double-blind, parallel-group, multi-center Phase III studycomparing the efficacy and safety of EP2006 and Neupogen® in breastcancer patients treated with myelosuppressive chemotherapy
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Sandoz GmbH
- 入组人数
- 192
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •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
- •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
排除标准
- •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
研究者
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