NCT00101062终止2 期
Phase II Study of Letrozole (Femara) and Celecoxib (Celebrex) in Postmenopausal Women With Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving letrozole with celecoxib may kill more tumor cells.
PURPOSE: This phase II trial is studying how well letrozole and celecoxib work in treating postmenopausal women with locally advanced or metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the response rate in postmenopausal women with hormone receptor-positive locally advanced or metastatic adenocarcinoma of the breast treated with letrozole and celecoxib as first-line therapy.
Secondary
- Determine the time to disease progression and overall survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Compare cyclooxygenase activity in blood and tumor cells from these patients before and after treatment with this regimen.
- Determine the effect of this regimen on aromatase activity, tumor proliferation, and angiogenesis in tumor samples from 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 or cytologically confirmed adenocarcinoma of the breast
- •Locally advanced or metastatic disease
- •Measurable disease
- •No bone disease only
- •No history of brain metastases unless controlled with radiotherapy or surgical resection for ≥ 6 months before study entry
- •Hormone receptor status:
- •Estrogen receptor- OR progesterone receptor-positive
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal status
- •Postmenopausal, as defined by 1 of the following:
- •Prior bilateral oophorectomy
- •Prior bilateral ovarian irradiation
- •No spontaneous menstrual bleeding within the past 12 months
- •Age 55 and over AND prior hysterectomy without oophorectomy
- •Age 54 and under AND prior hysterectomy without oophorectomy (or status of ovaries is unknown) AND documented follicle-stimulating hormone level in postmenopausal range
- •Performance status
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •Granulocyte count ≥ 1,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST and ALT ≤ 2.5 times ULN
- •Creatinine ≤ 1.5 times ULN
- •No prior allergic reaction attributed to compounds of similar chemical or biologic composition to study drugs
- •No prior allergic reaction to sulfonamides
- •No active peptic ulcer disease
- •No active infection
- •No other medical condition that would preclude study participation
- •Able to swallow oral medication
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior chemotherapy for metastatic or recurrent disease
- •Endocrine therapy
- •No prior endocrine therapy for metastatic disease
- •Prior adjuvant tamoxifen allowed
- •No prior aromatase inhibitors
- •No prior hormonal therapy for recurrent disease
- •No other concurrent hormonal therapy
- •Radiotherapy
- •See Disease Characteristics
- •See Menopausal status
- •No concurrent radiotherapy
- •See Disease Characteristics
- •See Menopausal status
- •No concurrent fluconazole or lithium
- 另有 3 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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