Local Excision Alone for Selected Patients With DCIS of the Breast
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 711
- 试验地点
- 30
- 主要终点
- Actuarial local recurrence rate
研究概览
简要总结
RATIONALE: The evaluation of breast cancer recurrence rates may improve the ability to plan cancer treatment for patients with breast cancer.
PURPOSE: Study to evaluate the rate of recurrence of breast cancer in women who have had surgery for ductal carcinoma in situ.
详细描述
OBJECTIVES:
- Evaluate actuarial local in situ and invasive recurrence rates at 5 and 10 years after local excision in women with a favorable ductal carcinoma in situ (DCIS) prognosis.
- Evaluate concordance between institutional pathologists and central review pathologists with respect to diagnosis and grading of DCIS.
- Identify parameters that indicate increased or decreased risk of recurrence in the absence of irradiation.
- Evaluate patterns of salvage of recurrence and rates of breast conservation.
- Evaluate actuarial relapse-free, overall, and cause-specific survival at 5 and 10 years post DCIS excision.
OUTLINE: This is a registration study stratified by histologic grade (high vs low or intermediate) and adjuvant tamoxifen therapy (yes vs no).
Patients receive standard clinical and mammographic follow-up for greater than 10 years. If recurrence occurs, treatment will be at the discretion of the investigators. Patients may receive adjuvant oral tamoxifen daily for 5 years after local excision.
A follow up magnification view mammogram must be taken after the last local excision, and microcalcification must be negative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven low or intermediate grade ductal carcinoma in situ (DCIS) of the breast
- •No greater than 2.5 cm in the greatest dimension
- •Histologically proven high-grade DCIS of the breast
- •No greater than 1 cm in greatest dimension
- •Region of DCIS must be at least 2.5 mm in greatest dimension (mammographic estimate of size allowed where pathologic measurement is impossible)
- •DCIS must be non-palpable; detected by a mammogram or found incidentally by a breast biopsy
- •Pathologically confirmed negative margins of at least 3 mm
- •Breast must be suitable for breast conserving therapy
- •Proper tumor size versus breast size
- •No carcinoma or suspicious mammogram findings in other breast sites
- •No prior in situ or invasive breast cancer
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal status:
- •Not specified
- •Performance status:
- •Not specified
- •Life expectancy:
- •Greater than 5 years
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •Cardiovascular:
- •Not specified
- •No other invasive malignancies within the past 10 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix
- •No known HIV infection
- •No Paget's nipple disease
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •Adjuvant tamoxifen allowed
- •Radiotherapy:
- •No prior radiotherapy to breast
- •No adjuvant radiotherapy
- •Not specified
排除标准
- 未提供
研究组 & 干预措施
Pathology Review, Observation and Follow-up
Pathology review, observation and follow-up
干预措施: long-term screening (Procedure)
结局指标
主要结局
Actuarial local recurrence rate
时间窗: Assessed at 5 years
Rate of in situ or invasive local breast cancer recurrence
次要结局
未报告次要终点