NCT00005886已完成1 期
A Phase IB Randomized Study of an Antiestrogen in Women With Newly Diagnosed Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 9
研究概览
简要总结
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen or LY353381 may fight breast cancer by blocking the use of estrogen.
PURPOSE: This randomized phase I trial is studying how well tamoxifen works on the biomarkers of the tumor tissue, compared with LY353381, in treating women with newly diagnosed breast cancer.
详细描述
OBJECTIVES:
- Determine whether LY353381 hydrochloride or tamoxifen administered in the interval between biopsy and re-excision alters the expression of tissue biomarkers relative to placebo controls in postmenopausal women with newly diagnosed breast cancer.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study.
- Phase I: Patients are randomized to receive either oral LY353381 hydrochloride or oral placebo daily.
Upon completion of phase I, all treatment centers begin phase II of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed noninvasive or small invasive breast cancer
- •Low or intermediate grade (ductal carcinoma in situ, T1, or T2) OR
- •Estrogen and/or progesterone receptor positive
- •Largest mass no greater than 5 cm
- •Clustered microcalcifications as only abnormality allowed with no upper size limit
- •If no distinction between mass and microcalcifications, size as 1 lesion
- •Lumpectomy or mastectomy must be planned for 2-6 weeks from start of study
- •No evidence of metastases from any malignancy
- •Hormone receptor status:
- •Estrogen and progesterone receptor positive (unless low or intermediate grade tumor)
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal status:
- •Postmenopausal by one of the following:
- •Prior oophorectomy
- •Over age 50 with prior hysterectomy, ovaries remaining
- •Uterus and ovaries intact and no menstrual period for more than 3 months
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Platelet count greater than 100,000/mm^3
- •Hemoglobin greater than 10 g/dL
- •Absolute granulocyte count greater than 1,000/mm^3
- •Albumin greater than 3 g/dL
- •Bilirubin less than 1.5 mg/dL
- •AST less than 100 U/L
- •Alkaline phosphatase less than 200 U/L
- •Creatinine less than 1.5 mg/dL
- •Cardiovascular:
- •No history of deep vein thrombosis
- •No prior pulmonary embolus
- •Not pregnant or nursing
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •At least 1 year since prior chemotherapy
- •Endocrine therapy:
- •At least 1 year since prior aromatase inhibitors, antiestrogens, or LH agonists/antagonists
- •No concurrent hormone replacement therapy or oral contraceptives (from time of randomization)
- •Radiotherapy:
- •Not specified
- •See Disease Characteristics
- •No concurrent treatment for other malignancy
排除标准
- 未提供
研究者
研究点 (9)
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