RESPONDER AI - Reliable exclusion of residual cancer after neoadjuvant systemic treatment for women with breast cancer by an intelligent vacuum-assisted biopsy

RESPONDER AI - 通过智能真空辅助活检可靠排除乳腺癌女性新辅助全身治疗后的残留癌症

• 批准号: 469936508
• 负责人: Professor Dr. Jörg Heil
• 金额: --
• 依托单位: Universitäts-Frauenklinik
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 资助国家: 德国
• 项目状态: 未结题
• 来源: https://gepris.dfg.de/gepris/projekt/469936508?language=en
• 关键词: RESPONDER; AI; Reliable; exclusion; residual

In recent years, neoadjuvant systemic treatments have gained clinical relevance and are nowadays recommended for women with triple-negative, HER2 positive, or (high proliferative) Luminal B breast cancers. Increasing use of neoadjuvant systemic treatment (NAST) and improved efficacy of treatment regimens have led to increasing numbers of patients without any detectable residual cancer upon surgery (pathologic complete response, pCR, ypT0 and ypN0). For these exceptional responders to NAST, surgery may be overtreatment: all local tumor has already been eradicated by NAST. Breast conserving surgery (BCS) with Sentinel Lymph Node Biopsy (SLNB) is the current standard of care. The use of NAST instead of adjuvant treatment has facilitated more BCS instead of mastectomy with equal survival. Although BCS is a low morbidity procedure compared to other oncologic surgeries, it causes morbidity relevant to patients: (1) About 30% of patients undergoing BCS and SLNB report moderate, persistent pain two years after surgery (2) the reduction in patient-reported quality of life up to 8 years after surgery is comparable between patients undergoing BCS or mastectomy. Thus, although women diagnosed with breast cancer are more likely than ever to survive their diagnosis, many must contend with the long-term effects of their treatment on quality of life. In the light of increasing ypT0 rates, current research evaluates alternative diagnostic procedures than BCS to identify these exceptional responders to NAST who achieve ypT0. For this purpose, our research group has developed a so-called intelligent vacuum-assisted biopsy (VAB). The use of a diagnostic intelligent VAB may potentially spare these women diagnostic axillary and breast surgery in the future. Quantifying the relevance of this topic, we estimate that about 10% of all breast cancer patients might be spared surgery in the future. In this multicenter, prospective, confirmatory trial we aim to prove that an intelligent VAB is as accurate as surgery to reliably exclude residual cancer after NAST. If this evidence could be obtained, a subsequent randomized controlled trial may evaluate the long-term oncologic safety of omitting breast and axillary surgery for these exceptional responders to NAST. The trial could therefore lead to a fundamental change of clinical practice for about 10% of all women with breast cancer.

近年来，新辅助全身性治疗已获得临床意义，并且现在推荐用于患有三阴性、HER2阳性或（高增殖性）腔B乳腺癌的女性。新辅助全身治疗（NAST）的使用增加和治疗方案疗效的改善导致手术后无任何可检测残留癌症（病理完全缓解，pCR，ypT0和ypN0）的患者数量增加。对于这些NAST的特殊反应者，手术可能是过度治疗：所有局部肿瘤已经被NAST根除。保留乳房手术（BCS）和前哨淋巴结活检（SLNB）是目前的标准治疗。使用NAST而不是辅助治疗有助于更多的BCS而不是乳房切除术，具有相同的生存率。尽管与其他肿瘤手术相比，BCS是一种低发病率手术，但其引起的发病率与患者相关：（1）约30%接受BCS和SLNB的患者在术后2年报告中度持续性疼痛（2）接受BCS或乳房切除术的患者术后8年的患者报告生活质量下降相当。因此，尽管被诊断患有乳腺癌的妇女比以往任何时候都更有可能在诊断中存活下来，但许多人必须应对治疗对生活质量的长期影响。鉴于ypT0率的增加，目前的研究评估了BCS以外的替代诊断程序，以确定这些对NAST达到ypT0的特殊应答者。为此，我们的研究小组开发了一种所谓的智能真空辅助活检（VAB）。诊断智能VAB的使用可能会在未来为这些女性省去诊断性腋窝和乳房手术。量化这个主题的相关性，我们估计，大约10%的乳腺癌患者可能会在未来免于手术。在这项多中心、前瞻性、验证性试验中，我们的目标是证明智能VAB与手术一样准确，可以可靠地排除NAST后的残留癌症。如果能够获得这一证据，随后的随机对照试验可能会评估这些对NAST有特殊反应者省略乳房和腋窝手术的长期肿瘤安全性。因此，该试验可能导致约10%的乳腺癌女性的临床实践发生根本性变化。