A Real-world Study Observing Treatment Patterns and Clinical Results for Patients in China With Hormone Receptor-positive, HER2-negative Metastatic Breast Cancer.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
VERITAS Longitudinal Real-world Registry of HR+/HER2- mBC to Understand Treatment Pattern and Clinical Outcomes in HR+/HER2- mBC
Overview
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.
Detailed description
The study consists of both retrospective and prospective components, defined relative to the index date.
Primary outcome measures
- Percentage of patients receiving different regimens in each Line of treatment (LoT) [Time frame: From baseline up to 5 years]
- Percentage of participants receiving different treatment sequence across LoTs [Time frame: From baseline up to 5 years]
- The attrition rate after each Line of Treatment (LoT) [Time frame: From baseline up to 5 years]
Secondary outcome measures (9)
- Biomarker and Genetic Testing Pattern [Time frame: From baseline up to 5 years]
- Demographic characteristics [Time frame: At baseline]
- Percentage of Participants with AEs, TRAEs, and SAEs [Time frame: From baseline up to 5 years]
- Clinical management of adverse events of special interest [Time frame: From baseline up to 5 years]
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) [Time frame: At baseline]
- ER/PR status [Time frame: At baseline]
- HER2 status [Time frame: At baseline]
- TNM stage at diagnosis [Time frame: At baseline]
- Endocrine resistance [Time frame: At baseline]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
China · 1 center
- The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital) — Nanjing
Identifiers
NCT: NCT07743944 · D3615R00009