Metadata record for the manuscript: Circulating tumor DNA dynamics using a standardized multi-gene panel in advanced breast cancer treated with CDK4/6 inhibition and endocrine therapy

<b>Summary</b> This metadata record provides details of the data supporting the claims of the related manuscript: “Circulating tumor DNA dynamics using a standardized multi-gene panel in advanced breast cancer treated with CDK4/6 inhibition and endocrine therapy”. The related study aimed to answer critical questions regarding circulating tumor DNA (ctDNA) levels as predictors of response to anticancer drugs such as which assay or statistical method to use. Specifically, it investigated the hypothesis that a standardised plasma-based sequencing assay that analyses multiple genes simultaneously at baseline and after 4 weeks (cycle 2 day 1 [C2D1]) of CDK4/6i plus ET can identify patients with HR+/HER2-negative advanced disease with different treatment outcomes. Type of data: circulating tumour DNA (ctDNA) Subject of data: <i>Homo sapiens</i> Sample size: 45 Population characteristics: Eligible patients were ≥18 years of age with histologically confirmed HR+/HER2- negative inoperable or metastatic breast cancer treated with a CDK4/6 inhibitor and ET. Recruitment: This is a prospective, single-center study in 45 consecutive patients that fulfilled the inclusion criteria. Date of data collection: May/2016 to June/2019 <b>Data access</b> The ctDNA and clinical data are available in two separate tabs in the Excel spreadsheet “ctDNA and clinical dataset.xlsx”. This spreadsheet is openly available and shared as part of this metadata record. The CDK serie - ctDNA and clinicopathological dataset is not publicly available in order to protect patient privacy. Requests for access to this dataset can be made to the corresponding author. <b>Corresponding author(s) for this study</b> Aleix Prat, MD, PhD, Hospital Clinic of Barcelona,Translational Genomics and Targeted Therapies in Solid Tumors, IDIBAPS, Villarroel 170, 08035, Barcelona, Spain. Email: [e-mail], Telephone number: ([phone]. <br> <b>Study approval </b> The study was performed in accordance with Good Clinical Practice guidelines and the World Medical Association Declaration of Helsinki. The study was approved by the local institutional research ethics committee, and all patients provided written informed consent.

<b>摘要</b> 本元数据记录详细记载了支撑相关学术论文《接受CDK4/6抑制剂（cyclin-dependent kinase 4/6 inhibitor, CDK4/6i）联合内分泌治疗（endocrine therapy, ET）的晚期乳腺癌患者采用标准化多基因检测panel的循环肿瘤DNA动态变化》的实验数据细节。本相关研究旨在解答关于循环肿瘤DNA（circulating tumor DNA, ctDNA）水平作为抗肿瘤药物响应预测指标的关键问题，例如应选用何种检测方法或统计分析手段。具体而言，本研究验证了如下假说：采用标准化血浆测序检测panel，可在基线及CDK4/6抑制剂联合内分泌治疗4周后（第2周期第1天[C2D1]）同时对多基因进行测序分析，以此识别HR+/HER2阴性晚期乳腺癌患者中具有不同治疗结局的人群。
数据类型：循环肿瘤DNA（ctDNA）
数据对象：<i>智人（Homo sapiens）</i>
样本量：45例
人群特征：入组患者均为年龄≥18岁，经组织学确诊为HR+/HER2阴性不可手术或转移性乳腺癌，且接受CDK4/6抑制剂联合内分泌治疗。
招募情况：本研究为一项前瞻性单中心研究，共纳入45例符合纳入标准的连续性患者。
数据收集时间：2016年5月至2019年6月
<b>数据获取</b> 循环肿瘤DNA及临床数据分别存储于Excel表格"ctDNA and clinical dataset.xlsx"的两个独立工作表中。该表格随本元数据记录公开共享。CDK系列-ctDNA及临床病理数据集因需保护患者隐私，暂不对外公开。如需获取该数据集的访问权限，可联系本文通讯作者。
<b>本研究通讯作者</b> Aleix Prat，医学博士、哲学博士，巴塞罗那临床医院（Hospital Clinic of Barcelona）实体肿瘤转化基因组学与靶向治疗研究组，IDIBAPS，Villarroel 170，08035 巴塞罗那，西班牙。电子邮箱：[e-mail]，联系电话：[phone]。
<b>研究伦理审批</b> 本研究遵循《药物临床试验质量管理规范》（Good Clinical Practice, GCP）及世界医学协会《赫尔辛基宣言》开展。本研究已通过当地机构伦理审查委员会审批，所有患者均签署书面知情同意书。