Tamoxifen Resistance in Women With Stage I, Stage II, Stage IIIA, or Stage IIIB Breast Cancer
Tamoxifen Resistance in Breast Cancer
RATIONALE: Studying samples of blood from patients with breast cancer in the laboratory may help doctors identify and learn more about biomarkers related to tamoxifen resistance.
PURPOSE: This laboratory study is looking at tamoxifen resistance in women with stage I, stage II, stage IIIA, or stage IIIB breast cancer.
研究概览
详细说明
OBJECTIVES:
- Identify women who are resistant to tamoxifen citrate and other drugs for the treatment of breast cancer by testing their plasma for the presence of proteins (e.g., macrophage migration inhibition factor) encoded by resistance-inducing genes (RIGs).
- Provide retrospective data on the predictive value of RIGs to serve as the basis for a prospective clinical trial of these genes as predictors of drug resistance.
OUTLINE: This is a multicenter study. Patients are stratified according to response during tamoxifen citrate (TAM) therapy (resistant group [i.e., those who develop recurrent breast cancer while being treated with TAM] vs conditionally sensitive group [i.e., those who have disease-free survival for over 3 years after initial diagnosis while being treated with TAM]).
Patients undergo blood collection at baseline, within 3 weeks of initiation of TAM therapy, and then every 6 months for 3 years or until relapse, whichever comes first. Samples are analyzed by enzyme-linked immunosorbent assay for expression of protein biomarkers (i.e., kallikrein gene 10, macrophage migration inhibition factor, prolyl carboxypeptidase, queuine tRNA-ribosyltransferase, and kinesin) encoded by resistance-inducing genes. An additional blood sample is obtained from patients at the time of relapse, if available.
Patients also undergo assessment of medical history, personal habits, and characteristics of breast cancer (e.g., tumor histology, stage, and grade) at baseline.
研究类型
注册 (实际的)
联系人和位置
学习地点
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North Carolina
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Winston-Salem、North Carolina、美国、27157-1096
- Wake Forest University Comprehensive Cancer Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
Histologically confirmed invasive breast cancer
- Initial pathologic stage I-IIIB disease
- No stage IV disease
Meets the following criteria for breast cancer therapy:
- Received prior primary local therapy for breast cancer
- Scheduled to begin tamoxifen citrate as adjuvant therapy for breast cancer within 3 weeks
Hormone receptor status:
- Estrogen-receptor positive tumor
- Female
- Pre- or post-menopausal
- Must be able to donate 20 mL of blood
Exclusion Criteria:
- Severe anemia, defined as hemoglobin < 11 g/dL
- Psychiatric history that would preclude obtaining informed consent
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
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Evaluation of the mechanisms of tamoxifen citrate (TAM) resistance in breast cancer
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Change in expression levels of protein biomarkers of TAM resistance as measured periodically for 3 years or until relapse, whichever comes first
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Retrospective data on the predictive value of resistance-inducing genes
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合作者和调查者
调查人员
- 学习椅:Steven A. Akman, MD、Wake Forest University Health Sciences
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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