ISRCTN71711835已完成不适用
Pilot Phase III immunotherapy study in early breast cancer patients using oxidized mannan-MUC1
Prolipsis Medical Center (Greece)0 个研究点目标入组 31 人开始时间: 2006年3月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Postmenopausal women (no menstrual period for >12 months)
- •2. Histological proven adenocarcinoma of the breast treated primarily by modified radical or partial mastectomy and axillary dissection followed by radiation of the residual breast
- •3. No more than 4 ipsilateral lymph nodes with metastases, not extending into the surrounding tissue and surgical margin free of disease
- •4. Tumor tissue with positive estrogen receptor
- •5. Tamoxifen 20 mg daily commencing within three months of breast surgery and to continue for 5 years
- •6. Adequate bone marrow function (white blood cells >4.0 x 10^9 per litre, haemogoblin >100 g per litre, platelets >100 x 10^9 per litre)
- •7. Adequate liver function (billirubin <60 mmol/litre i.e. < x 3 upper limit of normal)
- •8. Adequate renal function (creatinine <140 mmol/litre)
- •9. Life expectancy >12 weeks
- •10. Eastern Cooperative Oncology Group (ECOG) status between 0-2 (in bed <50% of daytime)
- •11. Written informed consent by the patient
排除标准
- •1. Known metastatic breast cancer
- •2. Radiotherapy, chemotherapy, immunotherapy or investigation therapy within the last 4 weeks
- •3. Previous splenectomy or radiotherapy to spleen
- •4. Coexisting or previous other malignancies except in situ carcinoma of the cervix or basal cell carcinoma of the skin
- •5. Active uncontrolled infection
- •6. Psychiatric, addictive or any disorder which compromises ability to give truly informed consent for participation in this study or comply with the requirements of the study
- •7. Concurrent systematic corticosteroid treatment
- •8. Autoimmune disease i.e. rheumatoid arthritis, systematic lupus erythematosus, except autoimmune thyroiditis
研究者
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