NCT00131924终止2 期
Phase II Study of High-Dose Estrogen in Postmenopausal Women With Hormone Receptor-Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapies
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Clinical response rate
研究概览
简要总结
RATIONALE: High doses of esterified estrogens may stop the growth of breast cancer cells that no longer respond to hormone therapy.
PURPOSE: This phase II trial is studying how well high-dose esterified estrogens work in treating postmenopausal women with metastatic breast cancer that has failed previous hormone therapy.
详细描述
OBJECTIVES:
Primary
- Determine the clinical response rate in postmenopausal women with estrogen and/or progesterone receptor-positive metastatic breast cancer that has failed prior sequential endocrine therapy treated with high-dose esterified estrogens (Menest^®).
Secondary
- Determine time to disease progression in patients treated with this drug.
- Determine the toxic effects of this drug in these patients.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed breast cancer
- •Metastatic disease
- •Documented disease progression
- •Must have received and subsequently failed (due to disease progression) ≥ 2 prior sequential endocrine therapies for treatment of metastatic breast cancer
- •Disease progression during adjuvant tamoxifen is considered 1 prior therapy
- •The 2 most recent treatments must have been endocrine agents
- •At least 1 objective measurable disease parameter
- •Brain metastases allowed provided both of the following criteria are met:
- •Brain metastases were previously treated AND are currently stable
- •Brain metastases are not the only site of metastatic disease
- •Hormone receptor status
- •Estrogen and/or progesterone receptor-positive tumor
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal status
- •Postmenopausal, as defined by any of the following:
- •At least 50 years of age with an intact uterus AND amenorrheic for the past 12 months
- •At least 50 years of age without a uterus AND follicle-stimulating hormone (FSH) level within postmenopausal range
- •Under 50 years of age and FSH level within postmenopausal range
- •Prior bilateral oophorectomy
- •Performance status
- •Life expectancy
- •At least 6 months
- •Hematopoietic
- •Adequate hematologic function
- •Adequate hepatic function
- •Bilirubin ≤ 1.5 times upper limit of normal
- •No history of hepatic adenoma
- •Adequate renal function
- •No history of hypercalcemia or severe hypocalcemia
- •Cardiovascular
- •No history of thrombophlebitis or thromboembolic disorders associated with prior estrogen use
- •No active thrombophlebitis or thromboembolic disorders
- •No history of uncontrolled hypertension
- •Not pregnant
- •No undiagnosed abnormal vaginal bleeding
- •No other serious medical illness
- •No psychiatric illness that would preclude giving informed consent
- •No other invasive malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Prior chemotherapy for metastatic disease allowed
- •Prior adjuvant chemotherapy allowed
- •Endocrine therapy
- •See Disease Characteristics
- •Radiotherapy
- •Prior radiotherapy allowed provided the only site of measurable disease was not irradiated
- 另有 1 项未显示
排除标准
- 未提供
结局指标
主要结局
Clinical response rate
次要结局
- Time to disease progression
- Toxicity
研究者
研究点 (1)
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