Abstract：
For a second ipsilateral breast tumor event, salvage mastectomy is the standard of care while second conservative treatment is a possible option. However, level 1 proofs are missing, leading to perform salvage mastectomy for patients who could receive second conservative treatment and consequently avoid psychological/quality of life salvage mastectomy deleterious impacts. A phase 3 randomized trial comparing salvage mastectomy to second conservative treatment is needed. Here we discuss what would be to us the optimal design of such trial to confirm the non-inferiority between the two salvage options, with a focus on methodological aspects in terms of patient characteristics and statistical issues.
摘要：
对于第二个同侧乳腺肿瘤事件，挽救性乳房切除术是标准的护理，而第二保守治疗是一种可能的选择。然而,缺少1级证明，导致可以接受第二次保守治疗的患者进行挽救性乳房切除术，从而避免心理/生活质量挽救性乳房切除术的有害影响。需要进行一项3期随机试验，将挽救性乳房切除术与第二次保守治疗进行比较。在这里，我们讨论对我们来说，这种试验的最佳设计是什么，以确认两种救助方案之间的非劣效性，重点关注患者特征和统计问题的方法学方面。
