NCT00284336已完成2 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.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Investigate the effect on cardiac strain rate imaging (SRI) of Caelyx
研究概览
简要总结
This is an open label Phase II study in elderly patients (65y or older) with early breast cancer who are candidate for adjuvant chemotherapy. A scheme with liposomal doxorubicin (Caelyx) and cyclophosphamide (endoxan) will be used. The aim is to study the cardiac effects of liposomal doxorubicin with new non-invasive techniques, ie strain rate imaging, classical echocardiography, and special blood tests measuring troponin I and BNP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
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:
- •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
- •History of significant neurological or psychiatric disorders that would prohibit the understanding and giving of informed consent.
- •Active uncontrolled infection
- •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.
结局指标
主要结局
Investigate the effect on cardiac strain rate imaging (SRI) of Caelyx
The relation between cardiac SRI and classical ejection fraction measurement.
The relation between strain rate and blood markers such as troponin-I and BNP
次要结局
- To assess the tolerability of Caelyx containing regimens in elderly breast cancer patients.
研究者
prof. dr. Hans Wildiers
adjunct head of clinic
Universitaire Ziekenhuizen KU Leuven
研究点 (4)
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