Multi-center breast DCE-MRI data and segmentations from patients in the I-SPY 1/ACRIN 6657 trials

ACRIN 6657 was designed as a prospective study to test MRI for ability to predict response to treatment and risk-of-recurrence in patients with stage 2 or 3 breast cancer receiving neoadjuvant chemotherapy (NACT). ACRIN 6657 was conducted as a companion study to CALGB 150007, a correlative science study evaluating tissue-based biomarkers in the setting of neoadjuvant treatment of breast cancer. Collectively, CALGB 150007 and ACRIN 6657 formed the basis of the multicenter Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and moLecular Analysis (I-SPY TRIAL) breast cancer trial, a study of imaging and tissue-based biomarkers for predicting pathologic complete response (pCR) and recurrence-free survival (RFS). Participant Eligibility and Enrollment: Criteria for inclusion were patients enrolling on CALGB 150007 with T3 tumors measuring at least 3 cm in diameter by clinical exam or imaging and receiving neoadjuvant chemotherapy with an anthracycline-cyclophosphamide regimen alone or followed by a taxane. Pregnant patients and those with ferromagnetic prostheses were excluded from the study. The study was open to enrollment from May 2002 to March 2006. 237 patients were enrolled, of which 230 met eligibility criteria.

ACRIN 6657是一项前瞻性临床研究，旨在评估磁共振成像（MRI）对接受新辅助化疗（NACT）的Ⅱ期或Ⅲ期乳腺癌患者的治疗应答及复发风险的预测能力。本研究作为CALGB 150007的配套研究开展，后者是一项针对乳腺癌新辅助治疗场景、评估基于组织的生物标志物的关联科学研究。CALGB 150007与ACRIN 6657共同构成了多中心联合成像与分子分析的系列治疗应答预测研究（I-SPY TRIAL）乳腺癌试验的基础，该试验通过成像与基于组织的生物标志物，预测病理完全缓解（pCR）与无复发生存期（RFS）。

受试者入组与招募：本研究的纳入标准为，在CALGB 150007中入组的患者需满足经临床检查或影像学确认存在直径≥3cm的T3期肿瘤，且接受蒽环类-环磷酰胺方案单独新辅助化疗，或后续联合紫杉烷类药物的新辅助化疗方案。妊娠患者及携带铁磁性假体的受试者被排除出本研究。本研究的招募周期为2002年5月至2006年3月，共计招募237例患者，其中230例符合入组标准。