ISRCTN55808957已完成不适用
A open-label stratified phase II study in patients with hormone receptor positive breast cancer with bortezomib (Velcade®) in the reversal of endocrine resistance
St. Augustinus Hospital, Oncology Centre (Belgium)0 个研究点目标入组 28 人开始时间: 2011年3月18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
- 28
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. Female patients aged more than18 years with metastatic breast cancer
- •2. Postmenopausal status defined as either
- •2.1. Age more than 55 years
- •2.2. Bilateral ovariectomy
- •2.3. Age less than 55 years with menopausal follicle stimulating hormone (FSH) levels
- •2.4. Patients on luteinizing hormone-releasing hormone (LH-RH) agonists in combination with either SERM or AI must continue the LHRH agonist
- •3. ER and/or PgR + disease (at least 10% of nuclei in the initial are either ER or PgR positive) as defined in the participating institution
- •4. Measurable disease by Response Evaluation Criteria in Solid Tumours (RECIST)
- •5. All patients should have been treated either in the adjuvant or metastatic setting with tamoxifen and an AI
- •6. Radiologically documented disease progression of disease as defined by RECIST criteria after second line (if prior adjuvant endocrine treatment and relapse within 12 months of stopping this treatment, this can be considered a resistance to this agent) endocrine treatment for metastatic disease being either tamoxifen or any aromatase inhibitor (AI), with patients still considered to be suitable candidates for a third line endocrine treatment
- •7. Superficial measurable lesions will be included as measurable, provided it is photographed
- •8. Patients need to be on this endocrine treatment for at least three months in order to clearly document endocrine resistance and exclude as much as possible late responses
- •9. Disease progression has to documented on consecutive radiological examinations or photographs [excluding ultrasound and positron emission tomography (PET)]
- •10. Adequate bone marrow reserve white cell count (WCC) > 3.0x109/L, absolute neutrophil count (ANC) > 1.5x109/L, platelets (PLTs) > 100x109/L, haemoglobin (Hb) >10gr/dL
- •11. Normal liver function defined by a bilirubin < 1.25 x upper limit of normal (ULN) and transaminases < 3 x ULN,
- •12. Life expectancy > 6 months
- •13. One line of chemotherapy for metastatic disease is allowed provided this was not the last treatment received prior to study entry
- •14. No peripheral neuropathy > grade 1
- •15. No other life-threatening disease
排除标准
- •1. Non-measurable disease as sole disease sites as defined by RECIST
- •2. More than one line of chemotherapy for metastatic disease
- •3. Radiotherapy within two weeks prior to study entry
- •4. Surgery within two weeks prior to study entry
- •5. Other invasive cancer diagnosis within 5 years prior to study entry
- •6. Severe cardiovascular disease including myocardial infarction within 6 months of
- •enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease or cardiac amyloidosis
- •7. Uncontrolled diabetes mellitus, (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug)
- •8. Pregnant or breast feeding
- •9. Neuropathy > or = grade II
- •10. Has known or suspected hypersensitivity or intolerance to boron, mannitol or heparin, if an indwelling catheter is used
- •11. Serious medical or psychiatric conditions that precludes participation in this study
研究者
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