VERITAS Longitudinal Real-world Registry of HR+/HER2- mBC to Understand Treatment Pattern and Clinical Outcomes in HR+/HER2- mBC
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Percentage of patients receiving different regimens in each Line of treatment (LoT)
研究概览
简要总结
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.
详细描述
The study consists of both retrospective and prospective components, defined relative to the index date.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* 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.
排除标准
- •* Patients who plan to participate in any blinded interventional clinical trial in 2L setting.
结局指标
主要结局
Percentage of patients receiving different regimens in each Line of treatment (LoT)
时间窗: From baseline up to 5 years
Percentage of participants receiving each systemic regimen within a given LoT.
Percentage of participants receiving different treatment sequence across LoTs
时间窗: From baseline up to 5 years
Percentage of participants receiving different treatment sequence among those who entered the subsequent LoT.
The attrition rate after each Line of Treatment (LoT)
时间窗: 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.
次要结局
- Eastern Cooperative Oncology Group Performance Status (ECOG PS)(At baseline)
- Biomarker and Genetic Testing Pattern(From baseline up to 5 years)
- Demographic characteristics(At baseline)
- Percentage of Participants with AEs, TRAEs, and SAEs(From baseline up to 5 years)
- Clinical management of adverse events of special interest(From baseline up to 5 years)
- ER/PR status(At baseline)
- HER2 status(At baseline)
- TNM stage at diagnosis(At baseline)
- Endocrine resistance(At baseline)