EUCTR2006-005592-17-SE进行中（未招募）不适用
Caelyx® in Breast Cancer in the ElderlyPegylated Liposomal Doxorubicin (Caelyx®) as monotherapy in elderly patients with locally advanced and/or metastatic breast cancer
Schering-Plough AB Sweden0 个研究点开始时间: 2006年10月27日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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. Female patients with histologic or cytologic diagnosis of breast cancer that is inoperable locally advanced or metastatic.
- •2. Age = 65 years.
- •3. WHO Performance Status 0 - 2
- •4. Measurable disease in accordance with RECIST criteria. Patients with bone metastasis can also be included but will be evaluated according to WHO criteria. Patients with non-measurable disease can also be included.
- •5. LVEF =50% verified by UCG, no clinical signs of heart disease
- •6. Normal organ function, except due to disease involvement, however maximum deviation:
- •a. Creatinine = 1.5 x upper normal limit
- •b. Bilirubin = 2 x upper normal limit
- •c. ALAT and/or ASAT = 3 x upper normal limit. In case of liver metastases, ALAT and/or ASAT = 5 x upper normal limit.
- •7. Adequate bone marrow function, i.e.:
- •d. Platelets =100 x 1 000 000 000/L
- •e. Neutrophils =1,5 x 1 000 000 000/l
- •f. WBC =3,0 x 1 000 000 000/L
- •g. Hemoglobin > 90 g/l
- •8. Life expectancy = 12 weeks
- •9. Patients having received oral and written information and having provided written informed consent
- •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
- •1. Previous chemotherapy for metastatic disease. (The patient may have received previous endocrine therapy or singeldrug Herceptin. Intrapleural or intrapericardial Novantrone is allowed.)
- •2. Recurrence =12 months after adjuvant anthracycline containing treatment and/or prior doxorubicin >300 mg/m2 or epirubicin > 540 mg/m2
- •3. Myocardial infarction within 6 months of planned inclusion
- •4. Symptomatic brain metastases
- •5. HER-2 positivity eligible for treatment with trastuzumab or ER positivity eligible for hormonal therapy
- •6. Allergy to anthracyclines
- •7. Uncontrolled infection
- •8. Other not radically treated malignancy
- •9. Other disease or condition contraindicating treatment or not allowing follow up
研究者
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