EUCTR2005-002467-86-FI进行中（未招募）不适用
A Randomised Multicenter Trial Comparing Docetaxel q2w and Docetaxel q3w in the Treatment of Patients with Metastatic Breast Cancer - FinDoke bi/triweekly
iisa Elomaa0 个研究点目标入组 144 人开始时间: 2005年7月12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
- 144
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
- •Histologically confirmed breast cancer
- •Metastatic disease confirmed by x-ray/ CT/ US/ bone scan,biopsy is optional
- •Female > 18 years of age
- •ECOG performance status under or equal to 2
- •If patient has received taxanes as adjuvant therapy, a minimum of 6 months has passed since the end of taxane treatment prior randomization · Patient has not received taxanes for metastatic disease. Other chemotherapy for metastatic disease is allowed.
- •Prior hormonal treatment regimens are allowed
- •At least one measurable lesion by CT/MRI/US. if only bone metastases present, at least one of them have to be lytic.
- •Adequate hematology: - neutrophils > 1.5 x 109/l - platelets > 100 x 109/l - Hb > 100 g/l (after transfusion when needed)
- •Adequate renal function: serum creatinine under or equal to 1.25 x upper normal limit
- •Adequate liver function - bilirubin under or equal to upper normal limit (except if liver metastasis present, 1.25 x UNL allowed) - ASAT/ALAT under or equal to 1.5 x upper normal limit - alkaline phosphatase under or ewual to 5 x upper normal limit; patients with bone metastases who have alkaline phosphatase over or equal to 5 x upper normal limit are allowed to participate if they have normal liver function and no hepatic lesions)
- •Consent form signed and dated before randomisation
- •Able to comply with the scheduled follow-up and with the management of toxicities
- •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
- •Patients with pre-existing fluid retention such as pleural effusion, pericardial effusion and ascites are not excluded from the study but should be monitored closely for any deterioration.
- •Concurrent severe and/or uncontrolled co-morbid medical condition such as uncontrolled infection, uncontrolled hypertension, ischemic heart disease, congestive heart failure, pulmonary embolism or myocardial infarction within previous 12 months, unstable diabetes or other reason preventing use of corticosteroids, autoimmune disease.
- •History of previous or concurrent malignancy within the previous 5 years except curatively treated carcinoma in situ of the uterine cervix or basal cell carcinoma of the skin
- •Pregnant or lactating women (or potentially fertile women not using adequate contraception)• Peripheral neuropathy = grade 2, unless related to mechanical etiology
- •Concurrent use of corticosteroids unless chronic treatment (i.e. initiated > 6 months prior to study entry) at low doses (under or equal to 20 mg methylprednisolone or equivalent)
- •History of allergic reaction to docetaxel or other drugs containing the excipient TWEEN 80®.
- •Concomitant administration of any other experimental drug under investigation: concurrent treatment with any other anti-cancer therapy
- •Patients who cannot be regularly followed up for psychological, social, family or geographic reasons.
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