Randomized Clinical Trial Comparing Axillary Dissection "by Principle" and Axillary Dissection Based on the Histological Result of the Sentinel Node, in Patients With Breast Carcinoma of Small Size
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 532
- 试验地点
- 2
- 主要终点
- disease free survival, overall survival
研究概览
简要总结
The purpose of this study is to evaluate the disease free and overall survival of patients with breast carcinomas of small size, i.e., not greater than 2.0 cm and with clinically non palpable axillary lymph nodes, undergoing either conservative surgery and axillary dissection, or a similar treatment for the primary tumor and rapid analysis of the sentinel lymph node, the result of which determines axillary node dissection or its avoidance is based.
详细描述
The axillary lymph nodes represent the most frequent site of metastasis from breast carcinoma. In previous studies, it has been shown that the process of metastasis to the axillary nodes proceeds in an orderly and progressive fashion from the I to the II and to the III level and that a "saltatory" event of metastasis represents a rare event described in only 2% to 6% of cases.
The risk of metastasis is directly correlated with the size of the primary tumor. When smaller than 1 cm in diameter, the risk of metastasis is about 10%; when larger than 5 cm in diameter, the risk increases to more than 70%.
The involvement of axillary lymph nodes by metastases constitutes today the most important prognostic factor in breast cancer. Massive invasion is most certainly associated with a poor outcome and therefore, the information that the lymph node status can provide, is indispensible for administration of appropriate therapies in the postoperative period. Nevertheless, in those cases where the lymph nodes are found to be free of metastases, axillary dissection is a useless treatment that can prove harmful if one considers all the possible short and long term complications.
Presently, there are no diagnostic modalities that are able to provide an accurate lymph node staging preoperatively. This information can only be gained by histologic examination of all lymph nodes after complete axillary dissection.
Standard treatment for operable breast cancer today always involves the dissection of the axillary lymph nodes, regardless of the surgical procedure used for resection of the primary tumor, i.e. conservative or demolitive. This not only results in a large expenditure of resources (longer surgical procedures under general anesthesia), but most notably, in an increased risk of complications (lymphedema and functional limitations of the involved extremity) for the patient, secondary to a more aggressive intervention on the axilla.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 40 and 75 years.
- •Clinical, mammographic or ultrasonographic diagnosis of a unicentric carcinoma with an ultrasonographic diameter of equal or less than 2.0 cm.
- •Although not a factor of exclusion, a breast scintigraphy using MDP-99m is recommended for accurate determination of possible multifocality or multicentricity of the tumor, as well as for the determination of possible bone metastasis.
- •Axillary lymph nodes that cannot be palpated or that are not clinically suspicious for metastasis.
- •No previously executed therapy (including biopsy) at any outside institution.
- •Those patients with nonpalpable lesions will be subjected to preoperative radioactive occult lesion localization (ROLL) or stereotactic biopsy.
- •Adequate patient information and signature of the informed consent.
排除标准
- •Lesions diagnosed as non-infiltrating (in-situ) ductal or lobular carcinoma.
- •Paget's disease.
- •Documented multicentricity and/or abundant multifocality of the neoplasm.
- •Clinically metastatic lymph nodes.
- •Patients previously biopsied at other institutions.
- •Carcinomas detected during pregnancy or lactation.
- •Histotypes diverse from breast carcinoma lesions.
- •History of previous malignancy (excluding basocellular carcinoma, in-situ cervical carcinoma and/or contralateral breast carcinoma without recurrence for at least 15 years of follow-up).
结局指标
主要结局
disease free survival, overall survival
时间窗: every 6 months for the first 5 years and every 8 months afterwards
次要结局
- number of axillary metastases(every 6 months for the first 5 years and every 8 months afterwards)