奥拉帕利治疗乳腺癌患者的 II 期研究：“机会之窗”试验的生物学评估。
A Phase II study of olaparib in breast cancer patients: biological evaluation from a 'window of opportunity' trial.
机构信息
Section of Pharmacology & University Center DIFF-Drug Innovation Forward Future, Department of Molecular & Translational Medicine, University of Brescia, Viale Europa 11, 25124 Brescia, Italy.
US Terapia Molecolare e Farmacogenomica, ASST Cremona, Cremona, Italy.
出版信息
Future Oncol. 2016 Oct;12(19):2189-93. doi: 10.2217/fon-2016-0116. Epub 2016 Jun 21.
The OLTRE trial (ClinicalTrials.gov number: NCT02681562) is an open-label, 'window of opportunity' Phase II controlled trial to evaluate the biological activity of olaparib in locally advanced triple-negative breast cancer compared with other subtypes of locally advanced breast cancer patients carrying germinal BRCA mutation receiving olaparib with the same treatment approach. The primary end point is to investigate the correlation between baseline gene and protein expression profile in order to identify possible predictive markers of response to olaparib. The OLTRE trial is expected to identify the surrogate markers of the biological activity of olaparib in the treatment of patients with triple-negative breast cancer.
OLTRE 试验（ClinicalTrials.gov 编号：NCT02681562）是一项开放标签、“机会之窗”的 II 期对照试验，旨在评估奥拉帕利在局部晚期三阴性乳腺癌中的生物学活性，并与携带生殖系 BRCA 突变的其他局部晚期乳腺癌患者进行比较，这些患者接受奥拉帕利治疗，采用相同的治疗方法。主要终点是研究基线基因和蛋白表达谱之间的相关性，以确定对奥拉帕利反应的可能预测标志物。OLTRE 试验有望确定奥拉帕利治疗三阴性乳腺癌患者的生物学活性的替代标志物。
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