NCT00855114撤回2 期
A Phase II Trial of Short-Term Everolimus (RAD001) to Predict Response in Women With Operable Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Decrease of total choline in at least 30% of patients
研究概览
简要总结
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well everolimus works in treating women with breast cancer that can be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Determine whether the administration of everolimus results in a decrease of total choline, a surrogate marker of response, in at least 30% of women with resectable breast cancer.
Secondary
- Determine whether tumors with activated mTOR signaling, as measured by phosphorylation of 4E-BP1 and activity of cap dependent translational complex, will identify those women responsive to everolimus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Diagnosis of invasive breast cancer
- •Resectable disease
- •Measurable disease, defined as a primary breast mass > 2.0 cm by breast imaging or clinical exam
- •Planning to undergo surgical resection after neoadjuvant therapy
- •Menopausal status not specified
- •Eastern Clinical Oncology Group (ECOG) performance status 0-1
- •Absolute neutrophil count (ANC) ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin > 9.0 g/dL
- •Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≤ 2.5 times upper limit of normal (ULN)
- •Creatinine ≤ 1.5 times ULN
- •Total bilirubin ≤ 1.5 times ULN
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
排除标准
- •Intracranial disease
- •Hormone receptor status not specified
- •Obese (> 250 pounds)
- •Immunosuppression from any cause (e.g., known HIV infection)
- •History of severe asthma and/or allergies
- •History of severe claustrophobia
- •Ferromagnetic implants, history of shotgun wound and/or shrapnel, cardiac pacemakers, or other similar situations that would be contrary to strong magnetic force
- •Bleeding diathesis
- •Unstable systemic disease, including but not limited to, any of the following:
- •Uncontrolled diabetes
- •Severe infection
- •Severe malnutrition
- •Uncontrolled hypertension
- •Unstable angina
- •Ventricular arrhythmias
- •Active ischemic heart disease
- •Congestive heart failure
- •Myocardial infarction within the past 6 months
- •Chronic liver disease
- •Renal disease
- •Active upper gastrointestinal tract ulceration
- •Less than 4 weeks since prior investigational drug
- •Prior therapy with sirolimus or its analogues
- •Concurrent immunosuppressive therapy (e.g., steroids, cytotoxic agents, or concurrent radiotherapy)
- •Concurrent anticoagulation (i.e., coumadin)
研究组 & 干预措施
Patients Treated with Everolimus
Experimental
Breast cancer patients treated with Everolimus by mouth, 5 mgs/day x 7 days, followed by surgery.
干预措施: everolimus (Drug)
Patients Treated with Everolimus
Experimental
Breast cancer patients treated with Everolimus by mouth, 5 mgs/day x 7 days, followed by surgery.
干预措施: therapeutic conventional surgery (Procedure)
结局指标
主要结局
Decrease of total choline in at least 30% of patients
时间窗: Pre-Treatment Compared to Post-Treatment (Day 7)
Choline is measured by magnetic resonance imaging (MRI/MRS) scan.
次要结局
- Identification of response to everolimus by activated mTOR signaling(Pre-Treatment Compared to Post-Surgery (Day 7))
研究者
研究点 (1)
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