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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Astra Zeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients receiving different regimens in each Line of treatment (LoT)	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	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)	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarker and Genetic Testing Pattern	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	Metrics include descriptive statistics for age and counts for categorical variables	At baseline
Percentage of Participants with AEs, TRAEs, and SAEs	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	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)	Percentage of participants with different ECOG PS	At baseline
ER/PR status	Percentage of participants with different ER (estrogen receptor) and PR (progesterone receptor) status	At baseline
HER2 status	Percentage of participants with different HER2 (human epidermal growth factor receptor 2) status	At baseline
TNM stage at diagnosis	Percentage of participants with different Tumor (T), Node (N), Metastasis (M) stage at diagnosis	At baseline
Endocrine resistance	Percentage of participants with different endocrine resistance status	At baseline

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Estimated): August 5, 2026
• Primary Completion (Estimated): August 4, 2031
• Study Completion (Estimated): August 4, 2031

Study Registration Dates

• First Submitted: July 10, 2026
• First Submitted That Met QC Criteria: July 29, 2026
• First Posted (Actual): August 4, 2026

Study Record Updates

• Last Update Posted (Actual): August 4, 2026
• Last Update Submitted That Met QC Criteria: July 29, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: China; Observational Study; Metastatic Breast Cancer; HER2-Negative; HR-Positive; Real-world data; Treatment Patterns
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: D3615R00009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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 Sharing Time Frame: 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 Sharing Access Criteria: 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 Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No