I-SPY 2 Breast Dynamic Contrast Enhanced MRI (I-SPY2 TRIAL)

I-SPY 2 (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis 2) is an ongoing, multi-center trial designed to quickly evaluate the efficacy of new agents for breast cancer in neoadjuvant chemotherapy (NAC) setting. Women aged ≥18 years diagnosed with locally advanced breast cancer (tumor size ≥2.5 cm) without distant metastasis are eligible to enroll in the trial. Patients with breast cancer at high-risk for recurrence are adaptively-randomized to either control arm (standard NAC) or one of several concurrent experimental drug arms. I-SPY 2 utilizes change in tumor volume by DCE-MRI at serial time-points during NAC to adjust the randomization schema as the trial proceeds, preferentially assigning patients to receive agents showing an increasing likelihood of efficacy against their breast cancer subtype.

I-SPY 2（Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis 2）是一项正在进行的多中心临床试验，旨在快速评估新抗肿瘤药物在新辅助化疗（neoadjuvant chemotherapy, NAC）场景下针对乳腺癌的疗效。本试验招募年龄≥18岁、经确诊为局部晚期乳腺癌（肿瘤尺寸≥2.5cm）且无远处转移的女性患者。高复发风险乳腺癌患者将被自适应随机分配至对照组（标准新辅助化疗）或多个同步试验药物组之一。I-SPY 2会在新辅助化疗期间的多个连续时间点，通过动态增强磁共振成像（DCE-MRI）监测肿瘤体积变化，在试验推进过程中动态调整随机化方案，优先将患者分配至针对其所属乳腺癌亚型展现出逐步升高的疗效可能性的试验药物组。

搜集汇总

背景与挑战

背景概述

I-SPY2乳腺癌动态对比增强MRI数据集是一个多中心临床试验数据，用于评估新辅助化疗方案对局部晚期乳腺癌患者的疗效。该研究采用DCE-MRI技术追踪肿瘤体积变化，并根据实时数据自适应调整治疗方案，重点关注高复发风险患者群体。