NCT00002720已完成3 期
QUADRANTECTOMY PLUS AXILLARY DISSECTION VERSUS QUADRANTECTOMY ALONE IN MAMMOGRAPHIC STAGE T1N0 BREAST CANCER PATIENTS AGED OVER 65 YEARS
European Institute of Oncology2 个研究点 分布在 1 个国家目标入组 642 人开始时间: 1995年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 642
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Surgery to remove axillary lymph nodes may be an effective treatment for women with breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of therapy with or without axillary lymph node dissection following quadrantectomy in treating older women with stage I breast cancer that is estrogen receptor positive.
详细描述
OBJECTIVES:
- Compare the efficacy of quadrantectomy with or without axillary lymph node dissection, followed by tamoxifen in terms of local and distant relapse rates and overall survival of patients with stage I, invasive breast cancer.
- Determine the relationship between biological variables, such as hormone receptor status, cell proliferation, and DNA ploidy, and the clinical outcome of the disease in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo quadrantectomy with dissection of level I and II axillary lymph nodes.
- Arm II: Patients undergo quadrantectomy without axillary lymph node dissection. Patients on both arms receive tamoxifen daily for 5 years.
Patients are followed every 4 months for 2 years, every 6 months for 2 years, and then annually thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven stage I, invasive breast cancer
- •Hormone receptor status:
- •Estrogen receptor positive
- •Progesterone receptor positive or negative
- •PATIENT CHARACTERISTICS:
- •Menopausal status:
- •Postmenopausal
- •Performance status:
- •Not specified
- •Life Expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •No serious disease that would preclude surgery
- •No other prior or concurrent malignancy except basal cell carcinoma or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Not specified
排除标准
- 未提供
研究者
研究点 (2)
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