EUCTR2007-006790-81-FR进行中（未招募）不适用
Phase II study of pegylated liposomal doxorubicin (Caelyxâ) in breast cancer patients with brain metastases and not candidate for an antiHER2 therapy - AROBASE
APREC0 个研究点目标入组 50 人开始时间: 2008年6月10日最近更新:
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
- 入组人数
- 50
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
- All
入选标准
- •-Histologically proven breast carcinoma with brain and/or CNS metastases,
- •-Minor neurological signs and symptoms,
- •-No active extra-CNS metastases,
- •-No contraindication for Caelyx? treatment,
- •-Age > 18 years,
- •-World Health Organization (WHO) performance status (PS) = 2,
- •-No previous radiotherapy of the brain,
- •-Life expectancy sup 3 months,
- •-Prior anthracyline-based treatment is allowed. Cumulative doses have to be less than 360 mg/m² for doxorubicin, and 600 mg/m² for epirubicin.
- •-Anthracyclines have to be stopped for at least 612 months before study entry,
- •-Adequate laboratory tests: hemoglobin (Hb) sup 10 g/dL, neutrophils sup 1.5 x 109/L, platelets sup 100 x 109/L, creatinine inf 1.5 upper limit of normal (ULN), bilirubin sup 1.5 ULN, alkaline phosphatases sup1.5 ULN, transaminases (ASAT/ALAT) and GGT inf 1.5 ULN except in case of liver metastases (inf normal value x 4),
- •-Patient should be recover to grade I or baseline of any toxicity due to previous anticancer therapy,,
- •-Satisfying cardiac function: NYHA stage inf 2 and left ventricular ejection fraction (LVEF) sup 50% at baseline,
- •-Adequate contraception in premenopausal women,
- •-Written informed consent.
- •-The patient must be affiliated to a Social Security regime or be a beneficiary of such a regime
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Disease progression during or within 6 months after anthracycline-based chemotherapy,
- •-Medical history of severe or uncontrolled cardiac disease: NYHA stage ? 3, myocardial infarct within the last 6 months, unstable angina, rhythm disorders requiring treatment,
- •-UncontrolledSymptomatic brain metastases and /or carcinomatous meningitis under symptomatic corrective treatment,
- •-Trastuzumab, Bevcitabin or lapatinib therapy within 4 weeks before inclusion,
- •-Hormonal treatment within the last 4 weeks
- •-Trastuzumab therapy within 24 weeks before inclusion,
- •-Severe or uncontrolled infection, or other severe concomitant disease impeding the administration of study drug,
- •-Positive serology for human immunodeficiency virus (HIV), hepatitis B (HBV) or C virus (HBC),
- •-Pregnant woman or breast-feeding period,
- •-Previous history of cancer within last 5 years except treated in situ uterine cervix carcinoma and basal-cell carcinoma of the skin correctly treated,
- •-Disability to be followed because of geographic, social or psychological reasons,
- •-Hypersensitivity to doxorubicin and/or to excipients, or contreindications
- •-Participation to any clinical trials within the last 30 days,
- •-Active extra-CNS metastases,
- •-Patient with previous EPP syndrome >grade 1,
- •-Local prior therapy of Brain metastasis,
- •-Anticancer therapy within the last 2 weeks before inclusion.
研究者
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