EUCTR2016-000494-20-SE进行中（未招募）1 期
A Clinical Trial to Compare Efficacy and Tolerability of Atorvastatin in Addition to Endocrine Based Treatment with Focus on Mechanisms of Resistance to Endocrine Based Treatment (fulvestrant/aromatase inhibitors alone or in combination with a cdk4/6 inhibitor) in Patients With Advanced Breast Cancer
Skåne University Hospital, Department of Oncology0 个研究点目标入组 126 人开始时间: 2016年5月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 126
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.Patients diagnosed with ER positive/HER2 negative metastatic breast cancer, including locally advanced stage IV disease, requiring systemic
- •endocrine based treatment. If IHC analysis is not available from the metastatic tissue, the ER and HER2 status is determined from archived
- •primary tumor.
- •2.Age > 18 years.
- •3.Performance status of Eastern Cooperative Oncology Group (ECOG) = 2.
- •4.Metastatic disease must be radiologically or clinically assessable, by means of at least one of the following techniques: clinical examination,
- •computerized tomography (CT), magnetic resonance imaging (MRI), bone scintigraphy or positron emission tomography (PET). Bone
- •metastases alone are allowed.
- •5.Pre-menopausal patients must consent to undergo either surgical or chemical castration during the duration of the treatment and utilize an
- •effective contraception barrier method.
- •6.Patient not willing to undergo study specific biopsy from the metastatic site should preferably have enough metastatic tumor sample
- •material archived to perform DNA extraction from formalin fixed paraffin embedded (FFPE) material.
- •7.Patient must be capable and willing to grant signed informed consent prior to any procedure related with this study as well as to allow
- •access to FFPE biopsies for DNA extraction and for serial CTCs ctDNA analysis. Biopsy of the metastatic site upon progression is not
- •mandatory but desirable.
- •8.Signed informed consent according to ICH/GCP, and national/local regulations.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 26
排除标准
- •1.Previous treatment for metastatic breast cancer (previous systemic treatment for early breast cancer allowed).
- •2.Brain as the only site of metastatic breast cancer.
- •3.Ongoing treatment with statins (e.g. simvastatin, atorvastatin, fluvastatin, lovastatin, pravastatin, or rosuvastatin), anion-exchangers (e.g.
- •colestyramin or colesevelam), fibrates (e.g. gemfibrozil), nicotin-acids (or acipimox) or inhibitors of intestinal cholesterol uptake (e.g.
- •ezitimibe) for the first part of the trial.
- •4.Evidence of hepatic dysfunction (alanine aminotransferase level more than three times the upper limit of the normal range) or renal
- •dysfunction (creatine kinase level) more than three times the upper limit of the normal range.
- •5.The patient is unable to pause treatment with anticoagulants/antiagregants prior to biopsy during the recommended times.
- •6.History of haemorrhagic stroke.
- •7.Pregnancy or breast-feeding.
- •8.Untreated psychiatric disorders that will impair the patient’s ability to comply with study treatment or protocol.
- •9.History of allergic reactions attributed to compounds of similar chemical or biological composition to either of the study drugs.
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