RESPONDER Trial - Diagnosis of pathological complete RESPonse by vacuum-assisted biOpsy after NeoaDjuvant chemotherapy in brEast canceR

手术前化疗（新辅助化疗，NAGT）在乳腺癌治疗中的应用越来越广泛。此外，乳腺病理完全缓解（pCR-B =没有肿瘤细胞存活于NAGT）的频率越来越高。这种情况引发了广泛争论的问题，局部治疗（手术和/或放疗）是否真的对患有pCR-B的患者有益。任何类型的乳腺癌手术和放疗都与生理和心理疾病的风险相关。如果这些程序被证明没有任何治疗目的，患者应该避免其负面影响。然而，在研究局部治疗的治疗效益之前，有必要证明不需要手术就可以可靠地诊断出pCR-B。目前，pCR-B只能通过手术标本的组织病理学评估来证实；超声、乳房x光检查或核磁共振成像等成像方法不能提供有效的预测。这项多中心、确证性的临床试验旨在证实利用真空辅助、微创活检技术（VAB）可以有效诊断pCR-B。在本研究中，VAB将在NAGT之后和标准手术治疗之前进行，标准手术治疗将对每位患者进行。我们将纳入600例在超声和/或乳房x光检查和/或MRI检查中至少部分反应的患者。本研究的目的是确认在NAGT后有残留肿瘤的患者中，只有不到10%的患者被VAB错误地分类为无残留肿瘤。

Chemotherapy before surgery (=neoadjuvant chemotherapy, NAGT) is increasingly used in breast cancer treatment. Moreover, a pathological complete response in the breast (pCR-B = no tumor cells survived NAGT) is achieved with growing frequency. This scenario provokes the widely debated issue whether local treatment (surgery and / or radiotherapy) is actually beneficial in patients experiencing a pCR-B. Any type of breast cancer surgery as weil as radiotherapy is associated with the risk of physical and psychological morbidity. Should these procedures prove not to serve any therapeutic purpose, patients deserve to be spared its' negative effects.However, before this question regarding the therapeutic benefit of local treatment can be investigated, it is essential to prove that a reliable diagnosis of pCR-B is possible without surgery. Nowadays, a pCR-B can only be confirmed by the histopathologic evaluation of the surgical specimen; imaging methods as ultrasound, mammography or MRI do not provide a valid prediction.This proposed multicenter, confirmative, clinical trial aims to confirm that a pCR-B can be validly diagnosed by using vacuum-assisted, minimal invasive biopsy techniques (VAB). Within this study the VAB will be performed after NAGT and before standard surgical treatment which will be carried out in every patient. We will include 600 patients with at least partial response in ultrasound and/or mammography and/or MRI. The aim of the study is to confirm that less than 10% of the patients with a residual tumor after NAGT are falsely classified as having no residual tumor by the VAB.