A Real-world Study Observing Treatment Patterns and Clinical Results for Patients in China With Hormone Receptor-positive, HER2-negative Metastatic Breast Cancer. (VERITAS)
2026年7月29日 更新者：AstraZeneca
VERITAS Longitudinal Real-world Registry of HR+/HER2- mBC to Understand Treatment Pattern and Clinical Outcomes in HR+/HER2- mBC
The study aims to describe demographics, clinical characteristics, genetic test diagnosis, treatment patterns, and clinical outcomes in HR+/HER2- (including HER2-low, HER2-ultralow, and HER2-null) unresectable or metastatic breast cancer patients in China; and exploratory describe clinical outcomes by treatment regimens, also report the QoL and other patient-report outcomes (PRO) and to assess healthcare resource utilization (HCRU) and costs overall and by LoT.
研究概览
地位
招聘中
条件
详细说明
The study consists of both retrospective and prospective components, defined relative to the index date.
研究类型
观察性的
注册 (估计的)
2000
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Astra Zeneca Clinical Study Information Center
- 电话号码：1-877-240-9479
- 邮箱：information.center@astrazeneca.com
学习地点
-
-
Jiangsu
-
Nanjing、Jiangsu、中国、210029
- 招聘中
- The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
The study population includes Chinese adult patients with HR+/HER2- (including HER2-low, HER2-ultralow, and HER2-null) unresectable or metastatic breast cancer who are about to initiate 2L systemic therapy or initiated 2L systemic therapy within 2 months at participating sites.
描述
Inclusion Criteria * Must be competent and able to comprehend, sign, and date an Institutional Review Board or Institutional Ethics Committee approved Informed consent form (ICF) before participating in the study.
OR Eligible for exemption from informed consent (for patients who die or became lost to follow-up within 2 months of initiating 2L therapy).
* Chinese men or women ≥ 18 years old at time of consent.
* Pathologically documented breast cancer that: a) is unresectable or metastatic.
b) is HR+/HER2- (IHC 2+/ISH- or IHC 1+ or IHC 0, with/without membrane staining) based on the most recent test result * Planning to initiate 2L treatment or initiated 2L systemic therapy within 2 months prior enrollment as per the prescription or medical records.
Exclusion Criteria * Patients who plan to participate in any blinded interventional clinical trial in 2L setting.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
Patients with HR+/HER2- unresectable or metastatic breast cancer
The study will include adult patients with HR+/HER2- (including HER2-low, HER2-ultralow, and HER2-null) unresectable or metastatic breast cancer who plan to initiate second-line (2L) systemic therapy or initiated 2L systemic therapy within 2 months.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of patients receiving different regimens in each Line of treatment (LoT)
大体时间：From baseline up to 5 years
|
Percentage of participants receiving each systemic regimen within a given LoT.
|
From baseline up to 5 years
|
|
Percentage of participants receiving different treatment sequence across LoTs
大体时间：From baseline up to 5 years
|
Percentage of participants receiving different treatment sequence among those who entered the subsequent LoT.
|
From baseline up to 5 years
|
|
The attrition rate after each Line of Treatment (LoT)
大体时间：From baseline up to 5 years
|
Among participants with a documented therapy end for a given LoT, the percentage who did not initiate the next LoT.
|
From baseline up to 5 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Biomarker and Genetic Testing Pattern
大体时间：From baseline up to 5 years
|
Metrics include percentage of participants who undergo testing per biomarker/mutation within each LoT, testing timing, specimen type, assay method, and result distribution.
|
From baseline up to 5 years
|
|
Demographic characteristics
大体时间：At baseline
|
Metrics include descriptive statistics for age and counts for categorical variables
|
At baseline
|
|
Percentage of Participants with AEs, TRAEs, and SAEs
大体时间：From baseline up to 5 years
|
Proportion of participants with AEs, TRAEs, and SAEs, by MedDRA SOC/PT and CTCAE v6.0 grade; proportions with AEs leading to dose modification, discontinuation, or death.
Includes suspected drug, AE dates, seriousness, causality, and outcomes.
|
From baseline up to 5 years
|
|
Clinical management of adverse events of special interest
大体时间：From baseline up to 5 years
|
Metrics include percentage of participants who underwent diagnostic tests, prophylactic medications, therapeutic medications, dose modifications of treatment regimens, and follow-up assessments.
|
From baseline up to 5 years
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG PS)
大体时间：At baseline
|
Percentage of participants with different ECOG PS
|
At baseline
|
|
ER/PR status
大体时间：At baseline
|
Percentage of participants with different ER (estrogen receptor) and PR (progesterone receptor) status
|
At baseline
|
|
HER2 status
大体时间：At baseline
|
Percentage of participants with different HER2 (human epidermal growth factor receptor 2) status
|
At baseline
|
|
TNM stage at diagnosis
大体时间：At baseline
|
Percentage of participants with different Tumor (T), Node (N), Metastasis (M) stage at diagnosis
|
At baseline
|
|
Endocrine resistance
大体时间：At baseline
|
Percentage of participants with different endocrine resistance status
|
At baseline
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月5日
初级完成 (估计的)
2031年8月4日
研究完成 (估计的)
2031年8月4日
研究注册日期
首次提交
2026年7月10日
首先提交符合 QC 标准的
2026年7月29日
首次发布 (实际的)
2026年8月4日
研究记录更新
最后更新发布 (实际的)
2026年8月4日
上次提交的符合 QC 标准的更新
2026年7月29日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他研究编号
- D3615R00009
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org.
All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD 共享时间框架
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles.
For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD 共享访问标准
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.
Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
IPD 共享支持信息类型
- 研究方案
- 树液
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.