EUCTR2012-002039-28-ES进行中（未招募）1 期
Pivotal study in breast cancer patients investigating efficacy and safety of LA-EP2006 and Neulasta®
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Sandoz GmbH
- 入组人数
- 308
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 109/L
- •?Platelet count ? 100 x 109/L
- •?Hemoglobin ? 10 g/dL
- •7.Total bilirubin not higher than the upper limit of normal (ULN), unless the patient has Gilbert`s syndrome
- •8.Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) level ? 2 x 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 297
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •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 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.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 control 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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