EUCTR2004-002839-10-GB进行中（未招募）不适用
Phase II trial assessing the impact on instrumental and daily living autonomy of a chemotherapy regimen with bi-weekly docetaxel in the treatment of metastatic breast cancer in patients over the age of 70 - Bi-weekly docetaxel
Fédération Nationale des Centres de Lutte Contre le Cancer0 个研究点目标入组 58 人开始时间: 2005年2月24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
- 58
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. Women aged = 70.
- •2. Histologically confirmed breast adenocarcinoma.
- •3. Metastatic disease measurable by scan or MRI (RECIST criteria).
- •4. First-line metastatic chemotherapy (only one line of prior metastatic hormone therapy is allowed). Prior (neo)adjuvant chemotherapy for breast cancer is allowed.
- •5. Prior hormone therapy stopped at least 10 days before patient’s enrolment in the study.
- •6. Satisfactory autonomy of daily activity: IADL = 4 or ADL = 4.
- •7. Satisfactory haematological and hepatic function: Hb >10g/dL, neutrophil count > 1.5x109/L, platelets > 100x109/L, transaminases < 1.5N, bilirubin <1.0N, alkaline phosphatases < 2.5N.
- •8. Creatinine clearance > 30 ml/min calculated according to Cokroft's formula.
- •9. Signed informed consent.
- •10. Life expectancy > 3 months
- •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. All patients that do not fulfil the inclusion criteria.
- •2. Other serious illness or medical conditions, including:
- •- Congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from trial entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias
- •- History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would hamper understanding and giving informed consent
- •- Active uncontrolled infection
- •- Active peptic ulcer, uncontrolled diabetes mellitus, inflammatory bowel disease
- •3. Concurrent treatment with any other anti-cancer therapy: trastuzumab, other chemotherapy or hormone therapy. Bisphosphonates for management of bone metastases or osteoporosis/osteopenia are allowed.
- •4. Patients having a history of treatment by trastuzumab.
- •5. Patients having a history of treatment by taxanes (docetaxel or paclitaxel) within the two (2) years from trial entry.
- •6. Chronic treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose (< ou = 20 mg methylprednisolone per day or equivalent).
- •7. Definite contraindications for the use of corticosteroids.
- •8. Past or current history of neoplasm other than breast carcinoma, except:
- •- Curatively treated non-melanoma skin cancer
- •- in situ carcinoma of the cervix
- •- Other cancer curatively treated and with no evidence of disease for at least 5 years
- •9. Patients having a GDS (geriatric depression scale) score = 12.
- •10. History of hypersensitivity to docetaxel or drugs formulated in polysorbate 80.
- •11. Patients who, for family, social, geographic or psychological reasons, cannot be adequately followed up; Incapacity for undergoing regular checks.
- •12. Concurrent treatment with other investigational drugs. Active treatment as part of another clinical therapeutic trial within 30 days prior to study entry.
- •13. Male subject.
研究者
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