NCT01539876撤回1 期
Assessing Serial Tumour Necrosis Factor Release in Locally Advanced Breast Cancer Patients Receiving Neo-adjuvant Taxane Chemotherapy
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- measure tissue TNFa levels
研究概览
简要总结
The purpose of this study is to assess the fine needle aspiration methodology in collecting sufficient tumour cells to measure tissue TNFa levels serially in human breast cancer sample receiving Taxane treatment
详细描述
This pilot study will begin to test the clinical relevance of the TNFa pathway in docetaxel response in breast cancer patients receiving Taxane chemotherapy.
- Assess whether docetaxel can induce TNFa expression in breast cancer patients being treated with docetaxel
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven LABC, Locally advanced breast cancer. (operable or non-operable)
- •Any T3/T4 or N2, N3 Clinical TNM stage breast cancer without metastases
- •ECOG Performance Status of 0, 1 or
- •Patients should be able to comprehend the Letter of Information and be capable of giving informed consent.
- •Female age 18 years old
- •History and physical
- •Negative serum pregnancy test for women of child bearing age
排除标准
- •Inflammatory cancer (as defined by clinical evidence of dermal-lymphatic tumour involvement.)
- •Ineligible for chemotherapy
- •Patients with metastatic disease.
- •Patients who have received prior chemotherapy or radiotherapy for this or any other malignancy.
- •Previous breast cancer diagnosis
- •Pregnant or lactating females are ineligible.
- •Female patients of reproductive potential who decline to employ an adequate contraceptive method are ineligible.
- •Participation in any concomitant trials.
研究组 & 干预措施
Fine Needle aspiration will be done X5:
Other
Fine Needle aspiration will be done X5: 1 hr pre-treatment, 1hr post treatment,24 hrs post treatment, 48 hrs post treatment, and following last chemotherapy cycle
干预措施: Fine needle aspiration assessing tumour TNFa levels (Procedure)
结局指标
主要结局
measure tissue TNFa levels
时间窗: 18 months
The TNFa levels will be evaluated using ELISA method
次要结局
未报告次要终点
研究者
Muriel Brackstone
Principal Investigator
Lawson Health Research Institute
研究点 (1)
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