NCT00532454终止2 期
A Clinical Study for the Evaluation of the Association Between CYP2D6 Genetic Polymorphisms and the Treatment Effect of Tamoxifen in Patients With Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- efficacy of tamoxifen
研究概览
简要总结
Primary objectives of this study is to evaluate the effects of CYP2D6 genotypes on time to progression after tamoxifen treatment in pre- or postmenopausal women with metastatic breast cancer. Furthermore, we will evaluate the effects of CYP2D6 genotypes on clinical benefit and response duration to tamoxifen administration in pre- or postmenopausal women with metastatic breast cancer and also evaluate the effects of CYP2D6 genotypes on the steady state plasma concentration of tamoxifen and its metabolites
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Histologically or cytologically diagnosed stage IV or recurrent breast cancer patients according to American Joint Committee on Cancer (AJCC)
- •Positive estrogen receptor or Positive progesterone receptor.
- •Females at least 18 years of age.
- •Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease
- •Prior hormone therapy less than
- •No history of Megace medication for recent 28 days
- •Performance status of 0, 1 and 2 on the ECOG criteria
- •Clinically measurable disease, defined as bidimensionally measurable lesions with clearly defined margins on x-ray, CT scan, MRI or physical examination. Lesions serving as measurable disease must be at east 1 cm by 1 cm, as defined by x-ray, CT scan, MRI, or physical examination
- •Bone only or pleural fluid only disease is included as long as evaluation for clinical benefit is possible
- •Estimated life expectancy of at least 12 weeks
- •Compliant patient who can be followed-up adequately.
- •Adequate hematologic (WBC count 3,000/mm3, platelet count 100,000/mm3), hepatic (bilirubin level 1.8 mg/dL, AST, ALT 1.5xULN, albumin 2.5 g/dL), and renal (creatinine concentration 1.5 mg/dL) function.
- •Informed consent from patient or patient's relative
- •Childbearing women should use non-hormonal contraceptive method
排除标准
- •Active or uncontrolled infection.
- •Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence).
研究组 & 干预措施
tamoxifen
Other
observation for clinical efficacy on tamoxifen according to CYP2D6 genotype
干预措施: Tamoxifen (Drug)
结局指标
主要结局
efficacy of tamoxifen
时间窗: one year
次要结局
未报告次要终点
研究者
研究点 (2)
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