Metadata record for the article: Phase 1b clinical trial of ado-trastuzumab emtansine and ribociclib for HER2-positive metastatic breast cancer

Summary This metadata record provides details of the data supporting the claims of the related article: “Phase 1b clinical trial of ado-trastuzumab emtansine and ribociclib for HER2-positive metastatic breast cancer”. The related study reports the results of an open-label, phase Ib clinical trial designed to assess the safety, tolerability, and activity of ribociclib in combination with T-DM1 among women with metastatic or locally advanced HER2+ breast cancer. Type of data: clinical data; pharmacokinetic (PK) data Subject of data: Homo sapiens Sample size: 12 Population characteristics: one cohort of ribociclib in combination with T-DM1 (cohort A—2 other cohorts from the same trial are reported elsewhere); Pre- and post-menopausal women aged 18 years or older with histologically confirmed unresectable, locally advanced, or metastatic HER2+ breast cancer and measurable or non-measurable disease according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 Trial registration number: NCT02657343 Data access All data are stored in the following files: Excel files ‘Figure 1’, ‘Figure 2’, ‘Figure 3’, ‘Table 1’, ‘Table 2’; Word file: ‘Supplement TDM1 Ribo Manuscript_revision.docx’. The Excel files are housed on institutional file storage and are not publicly available in order to protect patient privacy as informed consent to share participant-level data was not obtained prior to or during data collection. However, the data can be made available upon request to the corresponding author. The Word file is shared publicly via this data record, and is also available in PDF format as part of the supplementary materials of the related article. Corresponding author(s) for this study Aditya Bardia MD, MPH, Attending Physician, Massachusetts General Hospital Cancer Center, Harvard Medical School, Bartlett Hall, 15 Parkman St., Boston, MA 02114. Office: [phone]; Fax: [phone]. Email: [e-mail] Study approval The study received institutional review board (IRB) approval from the Dana-Farber/Harvard Cancer Center Human Research Committee.摘要 本元数据记录详细说明了支撑相关论文《Ado-曲妥珠单抗恩坦辛与瑞博西尼（ribociclib）联合用于HER2阳性转移性乳腺癌的1b期临床试验》结论的配套数据。相关研究报告了一项开放标签1b期临床试验的结果，该试验旨在评估瑞博西尼联合恩美曲妥珠单抗（ado-trastuzumab emtansine，T-DM1）治疗转移性或局部晚期HER2阳性乳腺癌女性患者的安全性、耐受性及抗肿瘤活性。 数据类型：临床数据；药代动力学（pharmacokinetic, PK）数据 数据对象：智人（Homo sapiens） 样本量：12例 人群特征：纳入接受瑞博西尼联合T-DM1治疗的单队列（队列A——该试验其余2个队列已于其他文献报道）；受试者为18岁及以上、经组织学确认不可切除的局部晚期或转移性HER2阳性乳腺癌患者，且根据实体瘤疗效评价标准1.1版（Response Evaluation Criteria in Solid Tumors 1.1, RECIST 1.1）判定存在可测量或不可测量病灶，涵盖绝经前及绝经后女性。 试验注册号：NCT02657343 数据获取：所有数据存储于以下文件：Excel文件《Figure 1》《Figure 2》《Figure 3》《Table 1》《Table 2》；Word文件《Supplement TDM1 Ribo Manuscript_revision.docx》。由于数据采集前后均未获得共享受试者层面数据的知情同意，为保护患者隐私，上述Excel文件存储于机构文件存储系统，暂不对外开放。但可通过向通讯作者提出申请获取相关数据。上述Word文件已通过本数据记录公开共享，同时也可作为相关论文的补充材料以PDF格式获取。 本研究通讯作者：Aditya Bardia MD, MPH，哈佛医学院马萨诸塞州总医院癌症中心主治医师，通讯地址：美国马萨诸塞州波士顿市帕克曼街15号巴特利特大厅，邮编02114；办公电话：[phone]；传真：[phone]；电子邮箱：[e-mail] 研究伦理审批：本研究已获得达纳-法伯/哈佛癌症中心人类研究委员会的机构审查委员会（institutional review board, IRB）批准。