Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (KEYNOTE-355): a randomised, placebo-controlled, double-blind, phase 3 clinical trial
Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (KEYNOTE-355): a randomised, placebo-controlled, double-blind, phase 3 clinical trial
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DOI：
10.1016/s0140-6736(20)32531-9
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发表时间：
2020-12-05
期刊：
影响因子：
168.9
通讯作者：
Schmid, Peter
中科院分区：
文献类型：
--
作者：
Cortes, Javier;Cescon, David W.;Schmid, Peter
背景：在转移性三阴性乳腺癌患者中，培溴利珠单抗治疗显示出持久的抗肿瘤活性和可控的安全性。我们的目的是检验加入培溴利珠单抗是否会增强转移性三阴性乳腺癌患者的化疗抗肿瘤活性。方法在29个国家和地区的209个地点进行的这项随机、安慰剂对照、双盲、3期试验中，我们随机分配了2：1的未经治疗的局部复发、无法手术或转移性三阴性乳腺癌患者，采用区组方法(区组大小为6)和交互式语音应答系统，每3周对培溴利珠单抗(200 Mg)进行集成的网络反应，加用化疗(NAB-紫杉醇；紫杉醇；或吉西他滨加卡铂)或安慰剂加化疗。根据研究中化疗的类型(紫杉烷或吉西他滨-卡铂)、基线时PD-L1的表达(合并阳性评分=1或
Background Pembrolizumab monotherapy showed durable antitumour activity and manageable safety in patients with metastatic triple-negative breast cancer. We aimed to examine whether the addition of pembrolizumab would enhance the antitumour activity of chemotherapy in patients with metastatic triple-negative breast cancer.Methods In this randomised, placebo-controlled, double-blind, phase 3 trial, done in 209 sites in 29 countries, we randomly assigned patients 2:1 with untreated locally recurrent inoperable or metastatic triple-negative breast cancer using a block method (block size of six) and an interactive voice-response system with integrated web-response to pembrolizumab (200 mg) every 3 weeks plus chemotherapy (nab-paclitaxel; paclitaxel; or gemcitabine plus carboplatin) or placebo plus chemotherapy. Randomisation was stratified by type of on-study chemotherapy (taxane or gemcitabine-carboplatin), PD-L1 expression at baseline (combined positive score [CPS] >= 1 or