EUCTR2005-002995-13-BE进行中（未招募）1 期
An open label Phase II trial to investigate the cardiac effects of pegylated liposomal doxorubicine (Caelyx?) in elderly breast cancer patients with new imaging and biochemical techniques.
ZLeuven0 个研究点目标入组 16 人开始时间: 2005年12月20日最近更新:
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
- 入组人数
- 16
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
- •Patients must meet all of the following inclusion criteria in order to be eligible for participation in this study:
- •histologically proven early breast cancer requiring adjuvant chemotherapy according to the treating physician (lymph node positive or other features of high risk according to St-Gallen criteria).
- •Age ? 65 years
- •Normal cardiac function (assessment of LVEF by MUGA scan or echocardiography above the lower limit of normal for the institution).
- •Performance status 0 to 2 (WHO scale)
- •The determination of ER and PgR is mandatory (immunohistochemical methods required; ER and/or PgR positivity is defined as > 1% of positive cells). Also determination of Her2neu is mandatory, either by immunohistochemistry or by FISH
- •Adequate organ function (as defined by neutrophils ? 1.5 x109/L, Platelets ? 100 x 109/L, Hemoglobin ? 10 g/dl, total bilirubin ? 1.5 UNL, ASAT (SGOT) and ALAT (SGPT) ? 1.5 UNL, alkaline phosphatase ? 2.5 UNL, creatinine ? 1.5 mg/dl (150 µmol/L)
- •Complete staging work-up within 2 months prior to registration. All patients will have bilateral mammography, chest X-ray (PA and lateral) and/or CT-scan, abdominal ultrasound and/or CT scan, bone scan. In case of positive bone scan suspicious for metastases, bone X-ray (or bone CT-scan on spinal hot spots) is mandatory to rule out the possibility of metastatic disease. Other tests may be performed as clinically indicated.
- •Patients must be accessible for treatment and follow-up.
- •absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- •before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Metastatic disease (M1)
- •prior systemic anticancer therapy for breast cancer (chemotherapy, hormone therapy of immunotherapy)
- •prior radiation therapy for breast cancer.
- •pre-existing motor or sensory neurotoxicity of a severity ? grade 2 by NCI criteria.
- •serious illness or medical condition:
- •a/ congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrythmias
- •b/ history of significant neurological or psychiatric disorders that would prohibit the understanding and giving of informed consent.
- •c/ active uncontrolled infection
- •d/ active peptic ulcer, unstable diabetes.
- •past (less than 5 years) or current history of other neoplasm except for curatively treated basal cell skin cancer or in situ carcinoma of the cervix.
- •concurrent treatment with hormonal replacement therapy: this treatment should be stopped at least 15 days before study entry
- •concurrent treatment with other experimental drugs. No participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.
- •concurrent treatment with any other anti-cancer therapy.
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