elacestrant联合或不联合依维莫司用于内分泌治疗联合CDK4/6抑制剂进展后ESR1突变ER+/HER2-晚期乳腺癌的III期ADELA试验研究设计。
完整摘要 · 中文译文
www.clinicaltrials.gov标识符为NCT06382948；EU临床试验标识符为EUCT 2024-512926-27-00。这是一项什么类型的研究？ADELA是一项全球性、多中心、双盲、安慰剂对照、随机III期试验。该研究旨在比较elacestrant联合everolimus与elacestrant联合安慰剂的疗效。谁符合本研究的入选条件？符合试验入选条件的患者为患有雌激素受体阳性（ER+）、人表皮生长因子受体2阴性（HER2-）晚期乳腺癌的女性（绝经前、围绝经期或绝经后）和男性。此外，患者的肿瘤必须具有雌激素受体1（ESR1）突变，并且在接受内分泌治疗联合CDK4/6抑制剂既往治疗后出现疾病进展。本研究关注什么？ER+/HER2−晚期乳腺癌通常最初对内分泌治疗反应良好，但随着时间的推移，癌细胞可能产生耐药性，使疾病更难以控制。对于在内分泌治疗和CDK4/6抑制剂治疗后疾病进展的患者，需要更有效的基于内分泌治疗的方案。ADELA研究特别关注这些患者，评估将两种作用机制不同的药物联合使用是否有助于比当前治疗方法更长时间地控制疾病。主要目的是确定与elacestrant联合安慰剂相比，elacestrant联合everolimus能否延长无进展生存期，即患者存活且疾病未 开始研究治疗后可出现癌症生长、扩散或恶化。更多信息可在ClinicalTrials.gov检索NCT06382948，或在euclinicaltrials.eu检索EUCT 2024-512926-27-00获取。
完整摘要 · 英文原文
www.clinicaltrials.gov identifier is NCT06382948; EU Clinical Trials identifier is EUCT 2024-512926-27-00. What type of study is this? ADELA is a global, multicenter, double-blind, placebo-controlled, randomized phase III trial. The study is designed to compare the efficacy of elacestrant combined with everolimus versus elacestrant with placebo.Who is eligible for this study? Patients who are eligible for the trial are women (premenopausal, perimenopausal, or postmenopausal) and men with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. Additionally, patients must have tumors with estrogen receptor 1 (ESR1) mutations and have experienced disease progression on prior treatment with endocrine therapy plus a CDK4/6 inhibitor.What is the study looking at? ER+/HER2− advanced breast cancer often initially responds well to endocrine therapy, but over time cancer cells may develop resistance, making the disease more difficult to control. More effective endocrine therapy-based options are needed for patients whose disease has progressed after endocrine therapy and CDK4/6 inhibitor. The ADELA study specifically focuses on those patients, evaluating whether combining two medicines that work in different ways may help control the disease for longer than current treatment approaches. The primary objective is to determine whether the combination of elacestrant and everolimus, compared with elacestrant plus placebo, can prolong progression-free survival, which is the length of time that patients remain alive without their cancer growing, spreading, or getting worse after starting study treatment. More information can be found at ClinicalTrials.gov by searching for NCT06382948 or at euclinicaltrials.eu by searching for EUCT 2024-512926-27-00.