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NCT Number: NCT07743944

A Real-world Study Observing Treatment Patterns and Clinical Results for Patients in China With Hormone Receptor-positive, HER2-negative Metastatic Breast Cancer.

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)

Nanjing, Jiangsu, 210029, China

Location status: Recruiting

About this study

The study consists of both retrospective and prospective components, defined relative to the index date.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Percentage of patients receiving different regimens in each Line of treatment (LoT)

    Time frame: From baseline up to 5 years

    Percentage of participants receiving each systemic regimen within a given LoT.

  2. Percentage of participants receiving different treatment sequence across LoTs

    Time frame: From baseline up to 5 years

    Percentage of participants receiving different treatment sequence among those who entered the subsequent LoT.

  3. The attrition rate after each Line of Treatment (LoT)

    Time frame: 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.

Secondary outcomes

  1. Biomarker and Genetic Testing Pattern

    Time frame: 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.

  2. Demographic characteristics

    Time frame: At baseline

    Metrics include descriptive statistics for age and counts for categorical variables

  3. Percentage of Participants with AEs, TRAEs, and SAEs

    Time frame: 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.

  4. Clinical management of adverse events of special interest

    Time frame: 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.

  5. Eastern Cooperative Oncology Group Performance Status (ECOG PS)

    Time frame: At baseline

    Percentage of participants with different ECOG PS

  6. ER/PR status

    Time frame: At baseline

    Percentage of participants with different ER (estrogen receptor) and PR (progesterone receptor) status

  7. HER2 status

    Time frame: At baseline

    Percentage of participants with different HER2 (human epidermal growth factor receptor 2) status

  8. TNM stage at diagnosis

    Time frame: At baseline

    Percentage of participants with different Tumor (T), Node (N), Metastasis (M) stage at diagnosis

  9. Endocrine resistance

    Time frame: At baseline

    Percentage of participants with different endocrine resistance status

Study contacts

Contact information is provided by the study sponsor or research team.

Astra Zeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

VERITAS Longitudinal Real-world Registry of HR+/HER2- mBC to Understand Treatment Pattern and Clinical Outcomes in HR+/HER2- mBC

Acronym: VERITAS

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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