ImportanceObservational studies of survivors of breast cancer and prospective trials of aspirin for cardiovascular disease suggest improved breast cancer survival among aspirin users, but prospective studies of aspirin to prevent breast cancer recurrence are lacking.ObjectiveTo determine whether aspirin decreases the risk of invasive cancer events among survivors of breast cancer.Design, Setting, and ParticipantsA011502, a phase 3, randomized, placebo-controlled, double-blind trial conducted in the United States and Canada with 3020 participants who had high-risk nonmetastatic breast cancer, enrolled participants from 534 sites from January 6, 2017, through December 4, 2020, with follow-up to March 4, 2023.InterventionsParticipants were randomized (stratified for hormone receptor status [positive vs negative], body mass index [≤30 vs >30], stage II vs III, and time since diagnosis [<18 vs ≥18 months]) to receive 300 mg of aspirin (n = 1510) or placebo once daily (n = 1510) for 5 years.Main Outcomes and MeasuresThe primary outcome was invasive disease–free survival. Overall survival was a key secondary outcome.ResultsA total of 3020 participants were randomized when the data and safety monitoring committee recommended suspending the study at the first interim analysis because the hazard ratio had crossed the prespecified futility bound. By median follow-up of 33.8 months (range, 0.1-72.6 months), 253 invasive disease–free survival events were observed (141 in the aspirin group and 112 in the placebo group), yielding a hazard ratio of 1.27 (95% CI, 0.99-1.63; P = .06). All invasive disease–free survival events, including death, invasive progression (both distant and locoregional), and new primary events, were numerically higher in the aspirin group, although the differences were not statistically significant. There was no difference in overall survival (hazard ratio, 1.19; 95% CI, 0.82-1.72). Rates of grades 3 and 4 adverse events were similar in both groups.Conclusion and RelevanceAmong participants with high-risk nonmetastatic breast cancer, daily aspirin therapy did not improve risk of breast cancer recurrence or survival in early follow-up. Despite its promise and wide availability, aspirin should not be recommended as an adjuvant breast cancer treatment.Trial RegistrationClinicalTrials.gov Identifier: NCT02927249

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阿司匹林与安慰剂作为乳腺癌辅助治疗的比较

重要性乳腺癌幸存者的观察性研究和阿司匹林治疗心血管疾病的前瞻性试验表明，阿司匹林使用者可以改善乳腺癌的生存率，但缺乏阿司匹林预防乳腺癌复发的前瞻性研究。 目的确定阿司匹林是否降低幸存者中侵袭性癌症事件的风险设计、设置和参与者 A011502 是一项 3 期、随机、安慰剂对照、双盲试验，在美国和加拿大进行，共有 3020 名患有高风险非转移性乳腺癌的参与者，招募了来自 534 个地点的参与者2017年1月6日至2020年12月4日，随访至2023年3月4日。干预措施参与者被随机化（根据激素受体状态[阳性与阴性]、体重指数[≤30与>30]进行分层， II 期与 III 期，以及自诊断以来的时间 [<18 与 ≥18 个月]）接受 300 毫克阿司匹林 (n = 1510) 或安慰剂 (n = 1510) 每天一次，持续 5 年。 主要结果和措施结果是无侵袭性疾病生存。总体生存率是关键的次要结果。 结果 当数据和安全监测委员会建议在第一次中期分析时暂停研究时，总共 3020 名参与者被随机分配，因为风险比已超过预先设定的无效界限。中位随访时间为 33.8 个月（范围为 0.1-72.6 个月），观察到 253 例无侵袭性疾病生存事件（阿司匹林组 141 例，安慰剂组 112 例），风险比为 1.27（95% CI） ，0.99-1.63；磷= .06)。阿司匹林组的所有侵袭性无病生存事件，包括死亡、侵袭性进展（远处和局部）和新的原发事件，在数量上均较高，但差异不具有统计学意义。总生存率没有差异（风险比，1.19；95% CI，0.82-1.72）。两组中 3 级和 4 级不良事件的发生率相似。结论和相关性在患有高危非转移性乳腺癌的参与者中，每日阿司匹林治疗并没有改善早期随访中乳腺癌复发或生存的风险。尽管阿司匹林前景广阔且用途广泛，但不应推荐它作为乳腺癌的辅助治疗方法。 试验注册ClinicalTrials.gov 标识符：NCT02927249