EUCTR2011-004532-58-BG进行中（未招募）不适用
A randomized, double-blind, parallel-group, multi-center Phase 3 comparative study investigating efficacy and safety of LA-EP2006 and Neulasta® in breast cancer 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
- 302
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
- •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
排除标准
- •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.
研究者
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