NCT00066339已完成2 期
An IDBBC Single Arm Phase II Trial Evaluating The Activity Of Iressa (ZD1839) In Metastatic Breast Cancer Patients Pretreated With An Antiestrogen And A Non-Steroidal Aromatase Inhibitor (Anastrozole Or Letrozole)
European Organisation for Research and Treatment of Cancer - EORTC1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2003年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have metastatic breast cancer that has not responded to antiestrogen and nonsteroidal aromatase inhibitor therapy.
详细描述
OBJECTIVES:
- Determine the clinical benefit rate, defined as complete response, partial response, or stable disease after at least 24 weeks, in patients receiving gefitinib for metastatic breast cancer who progressed after prior antiestrogen and nonsteroidal aromatase inhibitor therapy.
- Determine the best overall response rate of patients treated with this drug.
- Determine the progression-free survival of patients treated with this drug.
- Determine the duration of response in patients treated with this drug.
- Determine the safety of this drug in these patients.
OUTLINE: This is a nonrandomized, open-label, multicenter study.
Patients receive oral gefitinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients who go off study in the absence of disease progression are followed every 8 weeks until disease progression.
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
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed breast cancer
- •Radiological and/or clinical evidence of metastatic disease
- •Progressive disease after prior therapy with an antiestrogen (e.g., tamoxifen or faslodex) and a nonsteroidal aromatase inhibitor (e.g., anastrozole or letrozole) in the adjuvant and/or metastatic setting* NOTE: *Endocrine therapy must be the last treatment before study entry
- •Unidimensionally measurable disease
- •No rapidly progressive visceral metastases
- •No uncontrolled CNS metastases
- •Hormone receptor status:
- •Estrogen receptor and/or progesterone receptor positive
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Not specified
- •Menopausal status
- •Postmenopausal, defined as any of the following:
- •Natural menopause with at least 1 year since last menses
- •Radiation-induced oophorectomy with last menses more than 1 year ago
- •Chemotherapy-induced menopause with 1 year since last menses and serum follicle-stimulating hormone, luteinizing hormone, and plasma estradiol levels in the postmenopausal range
- •Surgical castration
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •Transaminases no greater than 2.5 times ULN
- •No severe or uncontrolled hepatic disease
- •No severe or uncontrolled renal disease
- •Cardiovascular
- •No severe or uncontrolled cardiac disease
- •No severe or uncontrolled respiratory disease
- •No evidence of clinically active interstitial lung disease
- •Asymptomatic chronic stable radiographic changes allowed
- •No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix, contralateral breast cancer, or nonmelanoma skin cancer
- •No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
- •No other severe or uncontrolled systemic disease
- •No known hypersensitivity to any excipients of gefitinib
- •No unresolved chronic toxicity greater than grade 2
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent biologic agents
- •Chemotherapy
- •No more than 1 prior chemotherapy regimen for metastatic breast cancer
- •No concurrent chemotherapy
- •Endocrine therapy
- •See Disease Characteristics
- •No concurrent hormonal therapy
- •Radiotherapy
- •Prior radiotherapy allowed
- •No concurrent radiotherapy to any metastatic site
- •No surgery within 4 days after study drug administration
- 另有 11 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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