NCT00049062已完成2 期
A Phase II And Biologic Correlative Study Investigating ARIMIDEX In Combination With IRESSA (ZD1839) In Post-Menopausal Patients With Estrogen Receptor-Positive Metastatic Breast Carcinoma Who Have Previously Failed Hormonal Therapy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Anastrozole may fight breast cancer by blocking the production of estrogen by the tumor cells. Biological therapies such as ZD 1839 may interfere with the growth of the tumor cells and slow the growth of advanced solid tumors. Combining anastrozole with ZD 1839 may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining anastrozole with ZD 1839 in treating postmenopausal women who have metastatic breast cancer that has not responded to hormone therapy.
详细描述
OBJECTIVES:
- Determine the antitumor activity of anastrozole and ZD 1839, as measured by objective response (partial or complete) or stable disease at 6 months, in post-menopausal women with estrogen receptor-positive, hormone refractory, metastatic breast cancer.
- Determine the progression-free and overall survival of patients treated with this regimen.
- Determine the safety of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Correlate molecular markers with clinical benefit in patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
Patients are stratified according to prior objective response to endocrine therapy (yes vs no).
Patients receive oral anastrozole once daily alone for 2 weeks. Patients then receive oral anastrozole and oral ZD 1839 once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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 or locally advanced unresectable disease
- •At least 1 measurable target lesion that has not been irradiated
- •New lesions in a previously irradiated field allowed as sites of measurable disease
- •Progressive disease after more than 2 months of aromatase inhibitor therapy
- •No known CNS disease or unevaluated CNS symptoms suggestive of brain metastases
- •Hormone receptor status:
- •Estrogen receptor or progesterone receptor positive
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal status
- •Post-menopausal by 1 of the following criteria:
- •Age 50 and over and has not menstruated during the past year or has castrate follicle-stimulating hormone (FSH) levels (greater than 40 IU/L)
- •Under age 50 and has castrate FSH levels
- •Received prior bilateral oophorectomy and has castrate FSH levels
- •Performance status
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •ALT or AST no greater than 2.5 times ULN (5 times ULN if liver metastases present)
- •Creatinine no greater than 1.5 times ULN
- •Cardiovascular
- •No history of congestive heart failure requiring therapy
- •No ventricular arrhythmia requiring therapy
- •No unstable angina pectoris
- •No myocardial infarction within the past 6 months
- •Able to swallow oral medication
- •No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No known malabsorption condition or other condition that would impair absorption of study drug
- •No active infection
- •No other concurrent medical condition that would preclude study
- •No known severe hypersensitivity to ZD 1839 or any excipients
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior chemotherapy except in adjuvant setting
- •No concurrent chemotherapy for breast cancer
- •Endocrine therapy
- •See Disease Characteristics
- •More than 30 days since other prior hormonal therapy (including hormone replacement therapy and megestrol)
- •Concurrent steroids for other reasons besides skin toxicity allowed
- •No other concurrent hormonal therapy (including megestrol) for breast cancer
- •Radiotherapy
- •See Disease Characteristics
- •Recovered from prior oncologic or other major surgery
- 另有 7 项未显示
排除标准
- 未提供
研究者
研究点 (2)
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