ISRCTN97330959
招募中
3 期
Triple Negative Trial: a randomised phase III trial of carboplatin compared to docetaxel for patients with advanced oestrogen receptor-progesterone receptor-human epidermal growth factor receptor two-breast cancer
Institute of Cancer Research and King's College London (UK)0 个研究点目标入组 400 人2007年3月20日
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Metastatic or recurrent locally advanced disease
- 发起方
- Institute of Cancer Research and King's College London (UK)
- 入组人数
- 400
- 状态
- 招募中
- 最后更新
- 7年前
概览
简要总结
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29713086
研究者
入排标准
入选标准
- •1\. Histologically confirmed ER\-, PR\-, primary breast cancer (Allred less than three or H score less than ten or ER\- and PR\- negative, if other cut\-offs used \[e.g., 1%, 5% or 10%])
- •2\. Histologically confirmed HER2\- primary breast cancer (ImmunoHistoChemistry \[IHC] scoring 0 or 1\+ for HER2 or non\-amplified for HER2 \[Fluorescence In Situ Hybridisation {FISH}])
- •3\. Measurable confirmed metastatic or recurrent locally advanced disease unsuitable for local therapy
- •4\. Patients with stable, treated brain metastases will be eligible providing informed consent can be given and that other sites of measurable disease are present
- •5\. Eastern Cooperative Oncology Group (ECOG) performance status zero, one or two
- •6\. Adequate haematology, biochemical indices (Full Blood Count \[FBC], Urea and Electrolytes \[U \& Es])
- •7\. Liver Function Tests (LFTs): normal bilirubin, Aspartate Aminotransferase (AST) and/or Alanine Aminotransferase (ALT) less than or equal to 3 x Upper Limit of Normal (ULN) if Alkaline Phosphatase is greater than 5 x ULN (or an isolated elevation AST/ALT of less than or equal to 5 x ULN)
- •8\. Adequate renal function
- •9\. Written informed consent, able to comply with treatment and follow\-up
排除标准
- •1\. Original primary tumour or subsequent relapse known to be positive for any of ER, PR, or HER2 receptors
- •2\. Patients with inoperable locally advanced disease suitable for local radiotherapy or an anthracycline containing regimen
- •3\. Patients unfit for chemotherapy or those with neuropathy greater than grade one (sensory or motor)
- •4\. Known allergy to platinum compounds or to mannitol
- •5\. Known sensitivity to taxanes
- •6\. Previous exposure to a taxane in adjuvant chemotherapy within 12 months of trial entry
- •7\. Previous treatment with a taxane for recurrent/metastatic disease
- •8\. Previous treatment with a platinum chemotherapy drug
- •9\. LFTs: abnormal bilirubin (greater than ULN), AST and/or ALT greater than 3 x ULN and Alkaline Phosphatase greater than 5 x ULN (or an isolated elevation AST/ALT of greater than or equal to 5 x ULN)
- •10\. Patients with a life expectancy of less than three months
结局指标
主要结局
未指定
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