EUCTR2004-001496-20-DE进行中（未招募）不适用
Breakthrough Breast Cancer & Cancer Research UK Genetic Breast Cancer Trial: A randomised phase II pilot trial of docetaxel compared to carboplatin for patients with metastatic genetic breast cancer. - BRCA Trial
niversity College London, UK0 个研究点目标入组 148 人开始时间: 2009年10月2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
- 148
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 with measurably confirmed metastatic disease in a known BRCA 1 or 2 carrier, where chemotherapy is the treatment of choice
- •- Patients with stable, treated brain metastases will be eligible providing informed consent can be given and that other sites of measurable disease are present
- •- Patients with bone metastases currently receiving bisphosphonates for palliation will be eligible providing other sites of measurable disease are present
- •- WHO Performance Status 0, 1 or 2 (see Appendix 4)
- •- Adequate haematology, biochemical indices (FBC, U & E’s)
- •- LFT’s = Normal bilirubin, AST and/or ALT =3 x ULN if Alk Phos >5 x ULN (or an isolated elevation AST/ALT of =5 x ULN)
- •- Adequate renal function (GFR =30 ml/min and normal urea and creatinine)
- •- Written informed consent and able to comply with treatment and follow-up
- •- Patients who have not received anthracycline based chemotherapy in the adjuvant setting may receive a non-taxane, anthracycline regimen as the first line metastatic treatment and enter the trial at confirmed progression (second line)
- •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 unfit for chemotherapy or those with neuropathy >grade 1 (sensory or motor)
- •- Known allergy to platinum compounds or to mannitol
- •- Known sensitivity to taxanes
- •- Previous treatment with a platinum chemotherapy drug, unless treatment was for non breast cancer related disease more than 10 years ago
- •- LFT’s = Abnormal bilirubin (> ULN), AST and/or ALT >3 x ULN and Alk Phos >5 x ULN (or an isolated elevation AST/ALT of =5 x ULN)
- •- Patients with a life expectancy of less than 3 months
- •- Previous malignancies other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin, unless there has been a disease-free interval of at least 10 years
- •- Patients with bone limited disease or suitable for endocrine therapy alone
- •- Other serious uncontrolled medical conditions or concurrent medical illness likely to compromise life expectancy and/or the completion of trial therapy
- •- Pregnant, lactating or potentially childbearing women not using adequate contraception (documentation of a negative serum HCG pregnancy test should be available for pre-menopausal women with intact reproductive organs, or women less than two years after the menopause. Fertile women and their partners must use a medically acceptable contraceptive throughout the treatment period and for six months following cessation of treatment. Subjects must be made aware before entering the trial of the risk in becoming pregnant).
- •n.b. Prior exposure to taxanes does not exclude patients providing that there is =12 months between previous exposure and trial entry.
研究者
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2 期
Breakthrough Breast Cancer & Cancer Research UK Genetic Breast Cancer TrialCancerBreast cancerISRCTN43372330niversity College London (UK)148
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Breakthrough Breast Cancer & Cancer Research UK Genetic Breast cancer Trial: A randomised phase II pilot trial of carboplatin compared to docetaxel for patients with metastatic genetic breast cancer. - BRCA trialmetastatic breast cancer in women with BRCA1 or BRCA2 mutationEUCTR2004-001496-20-SEniversity College London148
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Breakthrough Breast Cancer & Cancer Research UK Genetic Breast Cancer Trial: A randomised phase II pilot trial of carboplatin compared to docetaxel for patients with metastatic genetic breast cancer. - BRCA TrialMetastatic breast cancer in women with BRCA1 or BRCA 2 mutationMedDRA version: 9.1Level: LLTClassification code 10027475Term: Metastatic breast cancerEUCTR2004-001496-20-PTniversity College London148
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