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

RESPONDER 试验 - 乳腺癌新辅助化疗后真空辅助活检诊断病理完全缓解

• 批准号: 286676905
• 负责人: Professor Dr. Jörg Heil
• 金额: --
• 依托单位: Brustzentrum Heidelberg
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 财政年份: 2016
• 资助国家: 德国
• 起止时间: 2015-12-31 至 2018-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/286676905?language=en
• 关键词: RESPONDER; Trial; Diagnosis; pathological; complete

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.

手术前化疗（=新辅助化疗，NAGT）越来越多地用于乳腺癌治疗。此外，随着频率的增加，在乳腺中实现病理学完全反应（pCR-B =无肿瘤细胞存活NAGT）。这种情况引发了广泛争论的问题，局部治疗（手术和/或放疗）是否真的有益于经历pCR-B的患者。任何类型的乳腺癌手术以及放射治疗都与身体和心理疾病的风险有关。如果这些方法被证明不起任何治疗作用，患者应该避免其负面影响。然而，在研究局部治疗的治疗益处之前，必须证明无需手术就可以可靠地诊断pCR-B。目前，pCR-B只能通过手术标本的组织病理学评价来确认;超声、乳腺X线摄影或MRI等成像方法不能提供有效的预测。这项拟议的多中心、确认性临床试验旨在确认pCR-B可以通过使用真空辅助微创活检技术（VAB）进行有效诊断。在本研究中，VAB将在NAGT后和标准手术治疗前进行，标准手术治疗将在每例患者中进行。我们将纳入600例超声和/或乳腺X线摄影和/或MRI至少部分缓解的患者。该研究的目的是证实NAGT后有残留肿瘤的患者中，只有不到10%被VAB错误地归类为无残留肿瘤。

项目成果

Artificial intelligence to accurately identify and select breast cancer patients with a pathologic complete response for omission of surgery after neoadjuvant systemic therapy: an international multicenter analysis

人工智能准确识别和选择新辅助全身治疗后无需手术且病理完全缓解的乳腺癌患者：一项国际多中心分析

• DOI: 10.1200/jco.2020.38.15_suppl.565
• 发表时间: 2020
• 期刊: Geburtshilfe und Frauenheilkunde
• 影响因子: 2.7
• 作者: Pfob A;Sidey-Gibbons C;Tasoulis MK (…) Heil J
• 通讯作者: Tasoulis MK (…) Heil J

Is Breast Surgery Necessary for Breast Carcinoma in Complete Remission Following Neoadjuvant Chemotherapy?

新辅助化疗后，乳腺癌完全缓解是否需要乳房手术？

• DOI: 10.1055/s-0043-124082
• 发表时间: 2018-01
• 期刊: Geburtshilfe und Frauenheilkunde
• 影响因子: 2.7
• 作者: Richter H;Hennigs A;Schaefgen B;Hahn M;Blohmer JU;Kümmel S;Kühn T;Thill M;Friedrichs K;Sohn C;Golatta M;Heil J
• 通讯作者: Heil J

Vacuum-Assisted Biopsy to Diagnose a Pathological Complete Response in Breast Cancer Patients After Neoadjuvant Systemic Therapy.

真空辅助活检诊断新辅助全身治疗后乳腺癌患者的病理完全缓解

• DOI: 10.1097/sla.0000000000002572
• 发表时间: 2018
• 期刊: Annals of surgery
• 影响因子: 9
• 作者: Heil J;Richter H;Golatta M;Sinn HP
• 通讯作者: Sinn HP