Conservative Surgery With or Without Axillary Lymphnode Removal in Treating Women With T1N0 Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 565
- 试验地点
- 2
- 主要终点
- Difference in breast cancer mortality and overall survival between the two arms
研究概览
简要总结
Rationale
Axillary surgery is still fundamental part of breast cancer (BC) management for adjuvant treatment planning.
Purpose
Randomized phase III trial to compare the effectiveness of surgical therapy with or without axillary dissection following conservative treatment in women with stage I breast cancer.
To determine the possibility to avoid axillary surgery in patients with early breast cancer, finding an alternative method to define the need of adjuvant treatment without compromising long-term disease control.
详细描述
OBJECTIVES:
To compare the efficacy of conservative surgery, with or without axillary lymphnode removal (quadrantectomy with axillary dissection (QUAD) vs. quadrantectomy alone (QU)) followed by adjuvant treatment.
To plan no adjuvant therapy vs. adjuvant therapy (eA+CMF+TAM regimen) based on a biological panel of the primary tumor in the QU group (defined as good panel (GP) ( ER+, and up to one unfavourable features (G3, Her2+++, Laminin Receptor+) or bad panel (BP)(ER-, or ER+ and more than one unfavourable features), whereas in QUAD group based on good factor ( N-, ER+ and GI-II disease (GF)) or bad factor ( N+ or GIII or ER- disease (BF)).
To determine the relationship between the biological variables (hormone receptor status, grading, Laminin receptor, and c-erbB2) and the clinical outcome of the disease in these patients.
OUTLINE This is a randomized unicenter study. Patients are randomized to 1 o 2 treatment arms.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with T1N0M0 invasive breast cancer
- •18-65 years
排除标准
- •bilateral breast cancer
- •no other prior or concurrent malignancy except basal cell carcinoma
结局指标
主要结局
Difference in breast cancer mortality and overall survival between the two arms
时间窗: median follow-up time: 10 years
次要结局
未报告次要终点
研究者
Roberto Agresti, MD
Principal investigator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano