NCT00245024已完成1 期
Phase IB Sulindac Study for Women at High Risk for Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Sulindac and sulindac metabolite levels in nipple aspirate fluid (NAF) after 6 weeks of treatment
研究概览
简要总结
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of sulindac may prevent breast cancer.
PURPOSE: This randomized phase I trial is studying the effects of sulindac, to prevent breast cancer, in women at high risk for breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the partitioning of sulindac and its metabolites in women at high risk for breast cancer by measuring drug and metabolite levels in nipple aspirate fluid (NAF) after 6 weeks of therapy.
Secondary
- Determine prostaglandin levels in the NAF of patients treated with this drug.
- Determine if NAG-1 levels are induced in the NAF of patients treated with this drug.
- Determine if C-reactive protein levels are reduced in the NAF of patients treated with this drug.
- Determine if NAG-1 levels and/or karyometric features in ductal epithelial cells are modulated in patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Meets 1 of the following criteria:
- •Gail assessment score > 1.7% risk for 5 years
- •History of lobular carcinoma in situ (pathology report required)
- •History of ductal carcinoma in situ (DCIS) (pathology report required)
- •History of breast cancer in ≥ 1 first-degree relative or history of BRCA1 or BRCA2 positivity not treated with oophorectomy or mastectomy (test report required)
- •History of breast cancer in ≥ 2 second-degree relatives
- •Any family history of breast cancer diagnosed prior to age 50
- •Personal history of breast cancer (invasive or DCIS) with 1 breast intact
- •Nipple aspirate fluid production ≥ 5 microliters
- •Negative mammogram for breast cancer within the past 10 months
- •Any suspicious breast masses must be examined by a clinical professional
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal status
- •Pre- or postmenopausal
- •Performance status
- •Karnofsky 80-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC ≥ 3,000/mm^3
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •No history of bleeding or clotting disorder
- •Bilirubin ≤ 2.0 mg/dL
- •AST and ALT ≤ 2.0 times upper limit of normal
- •No indication of abnormal liver function
- •Creatinine normal
- •Cardiovascular
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •Gastrointestinal
- •No frequent, chronic, or moderate/severe gastric complaint
- •No upper gastrointestinal problems (e.g., symptoms of heartburn, dyspepsia, or abdominal pain) requiring prescription or nonprescription medical remedies more than once per week (on average)
- •No history of peptic ulcer or occult or gross intestinal bleeding
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No history of allergic reaction (e.g., urticaria, asthma, rhinitis) or gastric intolerance attributed to compounds of similar chemical or biological composition to sulindac
- •No history of allergy attributed to lidocaine, EMLA® cream, or xylocaine
- •No concurrent uncontrolled illness
- •No ongoing or active infection
- •No psychiatric illness or social situation that would preclude study compliance
- •No more than 2-3 servings of alcohol per week during study participation
- •PRIOR CONCURRENT THERAPY:
- •Chemotherapy
- •More than 6 months since prior chemotherapy for breast cancer (invasive or DCIS)
- 另有 16 项未显示
排除标准
- 未提供
结局指标
主要结局
Sulindac and sulindac metabolite levels in nipple aspirate fluid (NAF) after 6 weeks of treatment
次要结局
- Prostaglandin (PGE2) levels in NAF before and after 6 weeks of treatment
- NAG-1 induction and C-reactive protein (CRP) reduction before and after 6 weeks of treatment
- Magnitude of change and dose response of PGE2, NAG-1, and CRP in NAF before and after 6 weeks of treatment
研究者
研究点 (1)
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