A two-arm, non-randomised, prospective, multicentre study using magnetic resonance imaging (MRI) findings and pathology features to select patients with early breast cancer for omission of post-operative radiotherapy (BCT 2401 PROSPECTIVE).

THIS DATASET IS NOT YET AVAILABLE FOR SHARING. Dataset of up to 1400 participants, female >= 50 years with hstilogically confirmed ER-positive and/or HER2-positive invasive breast cancer. Participants will be selected for omission of radiation therapy (RT) (Arm A) after surgery based on having nil/minimal or mild BPE, BCS with unifocal invasive primary tumour =< 20 mm, radial resection margins must be >= 2mm clear of any invasive cancer and DCIS, pN0, absence of LVI and EIC on final pathology, and no additional BIRADs 3+ lesions. Participants who are ineligible for omission of RT, or whose clinical team determines that RT be recommended, or who choose to have RT will be allocated to standard treatment (Arm B). Arm A is further identified as: Arm A1 - Grade 1 or 2, ER positive/HER2 negative; Arm A2 - Grade 3 and/or HER2-positive. Participant recruitment will proceed until 600 participants are recruited to Arm A1. The primary endpoint is ipsilateral invasive recurrence rate (IIRR) in the breast in Arm A1 at a median of 5 years follow up (when 300th patient in Arm A1 reaches 5 years of follow up). Data set includes Cancer Australia demographic data i.e. Year of birth; postcode of home address; ATSI status, CALD status (country of birth; main language spoken as a child; main language other than English). Patient reported outcome data will be available from 192 English-speaking participants in each arm (total: 384) from PROMs measuring Fear of Cancer Recurrence (FCRI-SF); Health related QoL (BCTOS and EORTC IL353); QALYs (EQ-5D-5L), anxiety and depression (GAD-2, PHQ-2), Decision Regret Scale, Risk perception and appraisal, Neuroticism (IPIP-Neur), Experience and impact of treatment, Endocrine therapy adherence (FACT-ES + 3 additional questions).

本数据集暂未开放共享。本数据集涵盖最多1400名受试者，均为年龄≥50岁的女性，经组织学确诊为雌激素受体（ER）阳性和/或人表皮生长因子受体2（HER2）阳性浸润性乳腺癌。

受试者将基于以下标准被纳入免放射治疗（RT）组（A组）：乳腺实质增强（BPE）为极少量/微量或轻度；保乳手术（BCS）后切缘距任何浸润性癌及导管原位癌（DCIS）≥2mm；单灶性浸润性原发肿瘤直径≤20mm；病理分期pN0；最终病理未检出淋巴管血管侵犯（LVI）及广泛导管内成分（EIC）；无额外的乳腺影像报告和数据系统（BI-RADS）3级及以上病变。

不符合免放射治疗指征、临床团队建议接受放射治疗，或自愿选择放射治疗的受试者将被分配至标准治疗组（B组）。A组进一步细分为：A1组——组织学分级1或2级、ER阳性/HER2阴性；A2组——组织学分级3级和/或HER2阳性。

受试者招募将持续至A1组累计招募满600名受试者。本研究的主要终点为A1组受试者中位随访5年（当A1组第300名受试者达到5年随访周期时）的乳腺同侧浸润性复发率（IIRR）。

本数据集包含澳大利亚癌症委员会（Cancer Australia）提供的人口统计学数据，具体包括：出生年份、家庭住址邮政编码、原住民与托雷斯海峡岛民（ATSI）身份、文化与语言多样性（CALD）身份（涵盖出生国家、儿童时期主要使用语言、非英语主要使用语言）。

各分组中各有192名英语使用者可提供患者报告结局数据（总计384名），相关评估采用患者报告结局量表（PROMs），具体包括：癌症复发恐惧量表简版（Fear of Cancer Recurrence Scale-Short Form, FCRI-SF）、健康相关生活质量量表（BCTOS与EORTC IL353）、质量调整生命年（QALYs）量表（EQ-5D-5L）、广泛性焦虑障碍2项量表（GAD-2）与患者健康问卷2项版（PHQ-2）、决策后悔量表、风险感知与评估量表、IPIP神经质量表（IPIP-Neur）、治疗体验与影响量表、内分泌治疗依从性量表（FACT-ES附加3个额外问题）。