NCT00082667终止2 期
EGFR Pathway Modulation In Patients With Ductal Carcinoma In Situ Of The Breast
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 4
- 主要终点
- Compare epidermal growth factor receptor (EGFR) pathway biomarker modulation in tissue samples of women with ductal carcinoma in situ (DCIS) of the breast treated with gefitinib vs placebo followed by surgery.
研究概览
简要总结
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether surgery is more effective with or without gefitinib in treating ductal carcinoma in situ.
PURPOSE: This randomized phase II trial is studying how well gefitinib together with surgery works compared to surgery alone for the treatment of women with ductal carcinoma in situ of the breast.
详细描述
OBJECTIVES:
Primary
- Compare epidermal growth factor receptor (EGFR) pathway biomarker modulation in tissue samples of women with ductal carcinoma in situ (DCIS) of the breast treated with gefitinib vs placebo followed by local surgery.
- Compare the effect of these regimens on cell turnover in vivo in EGFR-positive vs EGFR-negative patients.
Secondary
- Compare the efficacy of these regimens in estrogen-receptor (ER)-positive vs ER-negative and in HER2-positive vs HER2-negative patients with DCIS.
- Correlate levels of HER2 extracellular domain with biomarker modulation in patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed ductal carcinoma in situ (DCIS) of the breast OR mammogram highly suspicious for DCIS
- •No invasive disease
- •Not completely excised
- •Epidermal growth factor receptor (EGFR) positive (> 10% of cells stained)
- •Planned lumpectomy or mastectomy within the next 2-4 weeks
- •Hormone receptor status:
- •Estrogen receptor status known
- •PATIENT CHARACTERISTICS:
- •35 and over
- •Menopausal status
- •Not specified
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Granulocyte count > 1,500/mm^3
- •Platelet count > 100,000/mm^3
- •Bilirubin < 1.5 mg/dL
- •SGOT ≤ 2 times upper limit of normal (ULN)
- •SGPT < 1.5 times ULN
- •PT and PTT ≤ 1.5 times ULN
- •INR ≤ 1.5 times ULN
- •Creatinine < 1.5 mg/dL
- •Cardiovascular
- •No New York Heart Association class I-IV heart disease
- •No acute asthma
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Random blood sugar < 2.5 times ULN
- •No known hypersensitivity to study drug or its excipients
- •No nonhealing wound or fracture
- •No active infection
- •No other malignancy within the past 5 years except basal cell carcinoma, breast carcinoma, or carcinoma in situ of the cervix
- •No psychosis or severe depression
- •No other concurrent uncontrolled illness
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior trastuzumab (Herceptin®)
- •Chemotherapy
- •At least 1 year since prior chemotherapy
- •No concurrent chemotherapy
- •Endocrine therapy
- •At least 1 year since prior aromatase inhibitors
- •At least 1 year since prior antiestrogens or luteinizing hormone-releasing hormone agonists or antagonists
- •No concurrent glucocorticoids
- •Concurrent oral contraceptives allowed
- •Concurrent hormone replacement therapy allowed
- •Radiotherapy
- 另有 33 项未显示
排除标准
- 未提供
结局指标
主要结局
Compare epidermal growth factor receptor (EGFR) pathway biomarker modulation in tissue samples of women with ductal carcinoma in situ (DCIS) of the breast treated with gefitinib vs placebo followed by surgery.
时间窗: at time of surgery, after 7-14 days of gefitinib
次要结局
- Compare the effect of gefitinib vs. placebo, followed by surgery on cell turnover in vivo in EGFR-positive vs. EGFR-negative patients(at time of surgery, after 7-14 days of gefitinib)
- Compare the effects of gefitinib in ER-positive vs. ER-negative DCIS and in HER2-positive vs. HER2-negative DCIS(at time of surgery, after 7-14 days of gefitinib)
研究者
Ingrid Mayer, MD
Assistant Professor of Medicine; Clinical Director, Breast Cancer Program; Medical Oncologist
Vanderbilt-Ingram Cancer Center
研究点 (4)
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